Speaker Biographies

Dr. Frank Agbogbo has over 18 years of experience in process development, biotechnology, gene, and cell therapy industries. He is currently the Vice President of Process Development at Forge Biologics, responsible for rAAV process development and plasmid DNA production. Previously, Dr. Agbogbo was the Senior Director of Process Development at Cytovance Biologics for over 7 years where he took increasing responsibilities as Director of Process Development with oversight responsibilities over the Upstream and Downstream teams. Frank’s experience includes process development, Design of Experiments (DoE), process optimization, process characterization, and scale-up from R&D to manufacturing (cGMP and non-cGMP). He has co-authored over 15 peer-reviewed publications and contributed to 5 patents. He holds a Bachelor of Science in Chemical Engineering, PhD in Chemical Engineering from Texas A&M University, College Station, TX, and an MBA with a certificate in Entrepreneurship from the Price College of Business, Oklahoma University, OK.

Currently Dr. Udayanath Aich is an Associate Director at Bristol Myers Squibb with extensive experience and management skills in analytical chemistry, and CMC analytical strategies for early, late and commercial biologics products. Dr. Aich completed his Ph.D. from Indian Institute of Technology Madras in the area of Chemical Biology. After completion Ph.D., he has joined in Biomedical Engineering Dept of Johns Hopkins for his postdoctoral study in the field of cell engineering, glycoengineering and structure-activity relationship. Subsequently, he has decided to move to Massachusetts Institute of Technology to gain extensive skills in the area of Biopharmaceutical characterization and drug development. Dr. Aich joined at Thermo Fisher Scientific in the chromatographic and mass spectrometric division to broaden his extensive analytical skills. Then Dr. Aich worked as Investigator at GlaxoSmithKline in the area of protein and glycans characterization, process analytics, CMC analytical strategies as ATL and structure-function study. Finally, before joining at Bristol Myers Squibb, Uday was working at Sanofi related to high throughput technologies, process analytical technologies (PAT), Analytical method harmonization, multi-attribute method Dev, analytical method dev, robustness, qualification and transfer for early and late stage product including 2nd generation commercial product as part of life-cycle analytics.

Christian Airiau is the Global Head of Data Science in Sanofi R&D, Biologics Development, based in the Boston area. He has over 18 years of experience in the pharmaceutical industry, working on Data Science, Process Modeling, and Process Analytical Technologies (PAT). His remit is to drive alignment across the global Sanofi network to develop data science, process modeling and control in Biologics development. Christian is also the Advanced Analytics lead in the iCMC-Digital Transformation program in Sanofi. In this role, he is developing and implementing the program strategy to maximize the use of data across the CMC perimeter, as Sanofi implements its digital transformation. Trained as a chemist, he holds a Masters and a Ph.D. in Data Science/Chemometrics from the University of Bristol in the UK.

Craig is an Associate Scientist II at the Alexion Rare Disease Unit in New Haven, CT. He uses mathematical modelling to predict upstream development, optimizing bioprocesses for better yield and quality of drug substance. He studied a Bachelors of Chemical Engineering at the University of Connecticut (UCONN) a recently achieved a Masters in Engineering with a concentration in Chemical Engineering from UCONN as well. Before Alexion, he worked as a research associate at Yale School of Medicine, using mathematical modelling to predict and treat cancer cell signaling. He also previously worked as an Associate Engineer for Henkel, synthesizing bulk chemicals using large unit operations.

Geneva started at Amgen at their Thousand Oaks campus in 2021 as a Postdoctoral Fellow in the Cell Line Development group in Process Development, where she is currently working in her new role as Senior Scientist. Geneva’s efforts are focused on Amgen’s pipeline needs as well as genome engineering initiatives.

Jacob Andrews leads Strategy and Innovation at CARR Biosystems, where he drives initiatives to advance scalable cell processing technologies for cell and gene therapy, as well as biologics manufacturing. He brings over 15 years of experience in bioprocessing, filtration, and product development, having held key technical and commercial roles at Saint-Gobain, ZenPure, and Entegris. Jacob holds a B.S. in Chemical Engineering from Tufts University.

Ajuna Azad is the Senior Data Strategy Officer at DTU Bioengineering, Technical University of Denmark. She develops data strategy and infrastructure design to support biotech research and automated labs, ensuring seamless data management and integration across various platforms. At DALSA (DTU Arena for Life Science Automation), Ajuna implements robust data management practices to ensure data quality, consistency, and compliance with FAIR principles (Findable, Accessible, Interoperable, Reusable). DTU Bioengineering and DALSA focus on automated data capture processes and best practices for working with retrospective data, including cleaning, standardizing, and migrating legacy data. Ajuna holds a PhD in Bioinformatics from the University of Copenhagen (Denmark), a Master’s degree in Bioinformatics from the University of Nottingham (UK), and a Bachelor’s degree in Biotechnology and Biochemical Engineering. She also completed a postdoctoral fellowship in bioinformatics and data management. In her spare time, she loves playing board games, badminton, and traveling to explore different cultures and histories. Ajuna also enjoys gardening, world cinema, and hiking. Dedicated to both education and the empowerment of women, she is also a volunteer teacher for data analytics and artificial intelligence at ReDI School of Integration in Denmark.

I am currently working as an Associate Director within the Drug Product Development Organization at Sanofi wherein I primarily lead and provide oversight to all the DP development activities (including formulation and process development) for non-viral and viral gene therapy programs. I obtained my bachelor’s in chemical engineering from Institute of Chemical Technology (India) and PhD from New York University in Chemical Engineering with focus on developing lipid-based drug delivery nanocarriers for cancer therapy. Prior to joining Sanofi, I worked at Shire (Takeda) in the drug product development and device development teams on leading early and late-stage programs.

Gabriele Bano currently leads the Process Modelling and Machine Learning group within Sanofi's global CMC Data Science. The team is responsible for the development and deployment of advanced modelling solutions to support Sanofi's growing portfolio of biologics (mammalian, microbial and gene therapies). He holds a PhD in Chemical Engineering at the University of Padova (Italy) with a specialization on advanced data analytics and process modelling to support pharmaceutical process development.

Dr. Maria Barreira Gonzalez is a scientist with over 18 years of experience in molecular and cellular biology, including the last decade dedicated to cell and gene therapy. She holds a BSc in Biology from the University of Oviedo (Spain) and a PhD from the University of Salamanca (Spain), where she investigated oncoprotein regulation in cancer. Following her doctoral studies, she joined the University of Cambridge (UK) as a postdoctoral researcher, focusing on gene regulation and epigenetics during mouse embryo development. In 2016, Dr. Barreira Gonzalez became a Senior Scientist at Touchlight Genetics Ltd. (UK), applying synthetic DNA technology to cell and gene therapies, which led to patents, peer-reviewed publications and the development of new DNA products. She joined the Cell and Gene Therapy Catapult (UK) in 2021 as Lead Scientist, where she spearheaded projects on viral vector manufacturing innovation, with a particular focus on recombinant Adeno-Associated Virus (rAAV) bioprocessing and analytics, collaborating extensively with academia, biotech, and pharmaceutical partners. She is currently Programme Head of Gene Modification at the Cell and Gene Therapy Catapult, leading a strategic, high-impact gene therapy portfolio spanning viral and non-viral delivery systems, in vivo applications, and gene editing technologies. In this role, she drives innovation, scale-up, and global collaboration to accelerate the translation and commercialization of gene therapies for patient benefit worldwide.

Alessandra Basso received her PhD in Pharmaceutical Sciences in 2001. Rich international experience at the NRC, IRB, Canada (Montreal),Leipzig Institute (Germany), University of Edinburgh, with more than 25 years experience in biocatalysis, downstream processing and solid phase synthesis. Founder in 2007 of the company SPRIN with Mitsubishi Chemicals for the development and manufacture of resins for the biocatalysis and solid phase synthesis. In 2012 she joined Purolite (now part of Ecolab) as Business Development Manager for the Life Science division. In 2023 she received her Executive MBA. In March 2023 she joined Sunresin as Global Sales and Marketing Director for the Life Science division. Author of 65 publications and 2 patents.

Leading Biopharma Talent Science & Human Capital Dynamics research.

Dr. Georges Belfort: Endowed Institute Chaired Professor. He received his BS degree in CHME at the University of Cape Town and PhD in Engineering from UC Irvine. He has broad research interests include mass transfer and membrane filtration, protein misfolding and kinetics, single molecule force spectroscopy, RNA purification and bioseparations. He has received the two major awards in the US on Separations (ACS (1995) and AIChE (2000)), the ACS Murphree Award in Industrial and Engineering Chemistry (2008), and is one of the 100 Chemical Engineers of the Modern Era as part of the AIChE Centennial Celebration in 2008. He was elected a member of the US National Academy of Engineering, February 2003 and foreign member of the Bologna Academy of Science, Italy in 2012. He was awarded (with Steven Cramer) the $500,000, 2025 NAE Bernard M. Gordon Prize in April, 2025. He has published over 260 peer-reviewed publications, 25 book chapters, and has 18 assigned patents in separations science, biotechnology, health sciences and transport phenomena. He collaborates with his wife, Dr. Marlene Belfort, Distinguish Professor, a RNA Lifetime Achievement award winner and discoverer of introns in prokaryotes.

I worked in Manufacturing, Science and Technology for 10 years and recently in regulatory Chemistry Manufacturing and Controls (CMC) for 2 years at Pfizer.

Dr. Samira Beyramysoltan holds a PhD in chemistry, specializing in modeling approaches. Over the years, she has gained extensive experience applying data-driven and machine learning methods across various fields. Since joining GSK in 2022, she has been focused on leveraging mechanistic and hybrid models in the domains of both large and small molecules.

Ravi is a Scientific Director with a focus on the Cell Technology department at Jansen R&D. Leading a dynamic process development team, he spearheads autologous CAR T cell therapy, lentiviral vector process development, and cGMP manufacturing of autologous cell therapy products. At Jannsen R&D, Ravi played a pivotal role in successfully leading the team for CAR-t cell therapy process development and lentiviral vector, contributing significantly to the commercial approval of Carvykti (autologous cell therapy product for multiple myeloma). Prior to this, he demonstrated innovation and leadership by implementing the industry's first large-scale single-use bioreactor (1000L) and single-use fluidized bed centrifuge technology for biopharmaceutical manufacturing. Ravi's expertise extends to cell culture process development and scale-up, managing up to 10,000L bioreactors. He has also been instrumental in the development and implementation of single-use technologies for clinical material production. He has delivered numerous presentations on single-use technologies for biopharmaceutical manufacturing and authored publications on cell physiology and single-use technologies.

Dr. Anthony Blaszczyk is in the Pipeline Development group within USP’s Global Biologics department. At USP, he works with scientific experts and stakeholders to develop new standards to support biopharmaceutical quality assessment and development. Prior to USP, Anthony worked at Catalent Cell and Gene Therapy, where he managed an analytical development team responsible for the development, qualification and transfer of methods. He obtained his Ph.D. in Biochemistry from Penn State University in 2018.

Veronica Bonazza is an SME in analytical method development and qualification/validation of analytical assays using qPCR, ddPCR, ELISA, HPLC, ddPCR, infectivity etc. in all aspects of gene therapy drug substance and drug products (raw material, release, stability). She has practiced cGMP principles and regulatory (ICH, USP, FDA) guidelines on both early and late-stage products in both Europe and United States. Veronica is experienced in managing quality control activities at CDMO and CTL, as well as in building QC labs and quality processes in early-stage companies. She is experienced in auditing and inspections with focus on getting Quality control processes ready for accelerated BLA submissions.

Angela is a modelling expert with 10+ years of experience across different fields, including robotics, power grids, medical devices, and bioprocesses. At DataHow, she is specialized in upstream processes for mammalian and microbial cell cultures, and works on scale-up and transfer learning projects, for many multinational pharma companies. Angela is passionate about transfer learning and eager to apply the learnings from other fields to the challenges in the pharma industry, to advance the processes and truly push for Pharma 4.0. Angela holds a BSc and MSc in electrical engineering from ETH Zurich and a PhD in biomedical engineering from the University of Bern.

Kelly Bowen, MS, is leading the potency assay strategy at KSQ Therapeutics, where she is driving innovation in the field of TIL therapy. With more than 9 years of extensive experience in both Analytical Development and Process Development, she has dedicated her career to advancing various cell therapies. Kelly’s unwavering passion for delivering these groundbreaking treatments to patients underscores her commitment to transforming lives through cutting-edge science.

Dr. Bowley is currently the Director of Digital Strategy for AbbVie QC Labs. Previously she led the Digital Transformation efforts for PDS&T-Biologics Development from 2021-2025. She joined AbbVie in 2012 in the R&D-Discovery Biologics group focused on antibody and multi-specific protein screening and engineering, leading multiple programs to the cell line development stage. In 2017 she joined Information Research and led a team of IT professionals who supported AbbVie’s Discovery Scientists in Biotherapeutics, Chemistry, Immunology and Neuroscience. She has a PhD in Molecular Biology from The Scripps Research Institute and Bachelor of Science in Chemistry from The University of Northern Iowa.

Dr. Richard D. Braatz is the Edwin R. Gilliland Professor and the Director of the Center for Continuous mRNA Manufacturing at the Massachusetts Institute of Technology (MIT). He leads the modeling, control, and systems activities in many biopharmaceutical manufacturing efforts at MIT, including for vaccines, gene therapy, and monoclonal antibodies. Most activities are in automated process development workflows and modeling, design, and control of fully automated modular manufacturing unit operations and end-to-end systems, which are experimentally validated. He has consulted or collaborated with more than 25 companies including Novartis, Pfizer, Merck, Biogen, Sanofi, and Amgen. Honors include the AIChE PD2M Award for Outstanding Contribution to QbD for Drug Substance, the AIChE Separation Division Innovation Award, the AIChE Excellence in Process Development Research Award, the Research Collaboration Award from the Council for Chemical Research, and the IEEE Control Systems Society Transition to Practice Award. He is a member of the National Academy of Engineering.

Christopher founded Consulting on Advanced Biologicals Ltd. at the end of 2009, in order to focus his activities within the Regenerative Medicine sector. Advbiols Ltd. provides EU regulatory services to the regenerative medicine industry in addition to business and regulatory research and analysis to identify and focus on the real barriers to commercialisation of regenerative medicine. Christopher has a PhD in xenotranplantation immunology and spent 8 years in biotech (Imutran Ltd., a Novartis Pharma AG Co., and Intercytex) before joining the MHRA as a quality (CMC) assessor (biologicals and biotechnology unit). During this time, Christopher was involved with national implementation of the new Advanced Therapies Regulation and also involved through his participation in the CHMP’s cell products working party (CPWP) in implementation at the EMA level including drafting guidelines.

Corey Brizzee oversees the microbial, mammalian, and plant gene editing groups at Demeetra. His responsibilities include further optimizing and developing our gene editing technologies. With his extensive knowledge in protein engineering and expression, Corey also leads the development of the next generation of Demeetra’s gene editing technologies. In addition to lab work, he assists our potential licensees with product applications and technical know-how. Before coming to Demeetra, Corey received his PhD from the Department of Molecular and Cellular Biochemistry at the University of Kentucky. His graduate research featured a multi-directional approach in which biochemical analysis of enzymes and cellular biology techniques were utilized to understand metabolism in algae. He received his BA in Biology from the University of Rochester (NY), where he researched the role of transglutaminase2 (TG2) in hypoxia/ischemic stress conditions as well as the molecular mechanisms of tau degradation in Alzheimer disease.

Scott R. Burger, MD, is the Principal of Advanced Cell and Gene Therapy, a consulting firm specializing in cell and gene therapy product development, manufacturing, and regulatory affairs. Dr. Burger has over 30 years of experience developing cell and gene therapy products and has consulted for over 200 companies in North America, Europe, Asia, and Australia. He has directed or consulted on process development, manufacturing, and CMC regulatory aspects of a wide range of cell therapy and gene therapy products for immunotherapy and regenerative medicine. Prior to founding Advanced Cell & Gene Therapy in 2002, Dr. Burger was Vice-President for R&D at Merix Bioscience, and director of the University of Minnesota Cell Therapy Clinical Laboratory. His regulatory background includes numerous regulatory submissions and productive interactions with FDA-CBER Office of Tissues and Advanced Therapies, now OTP. Dr. Burger is a member of several scientific advisory boards, and has served on the USP Cell, Gene and Tissue Therapies Expert Committee, the ISCT advisory board, and multiple ISCT committees. A graduate of the University of Pennsylvania School of Medicine, Dr. Burger completed training in clinical pathology and transfusion medicine at Washington University in St. Louis and is author of over 200 scientific publications and presentations, and the recipient of numerous honors and awards.

Michael Butler is a Principal Investigator in Cell Technology at the National Institute of Bioprocessing Research & Training (NIBRT), Ireland, Adjunct Full Professor in University College Dublin as well as Distinguished Professor Emeritus of the University of Manitoba, Canada. He holds degrees in Chemistry and Biochemistry from the Universities of Birmingham, London (UK) and Waterloo (Canada). He was the scientific director of MabNet, a Canadian network for Mab production and founder of Biogro Technologies Inc., a spin-off company dedicated to serum-free media development. His research work focuses on the development of bioprocesses using mammalian cells for the production of recombinant proteins, monoclonal antibodies and viral vaccines.

Shane Byrne received his B.S. in Chemistry from Boston College in 2015 and his Ph.D. in Chemical Biology from the Johns Hopkins University in 2019. He doctoral work involved the investigation of how DNA repair and processing machinery respond to reversible DNA modifications. He completed postdoctoral work at MIT under the supervision of Prof. Peter Dedon where he developed and applied omics-based tools to study stress-induced reprogramming of nucleic acid modifications in biological systems. In particular, he developed the omics and analytics-based Epi-MAX platform technology to re-engineer cell lines in response to the stresses associated with biomanufacturing to overcome bottlenecks hindering protein production. He is one of the co-founders of Codomax, where he leverages the Epi-MAX platform to drive the affordable and widespread production of recombinant proteins that contribute to improved global health and nutrition. Shane leverages his expertise in nucleic acid chemistry, mass spectrometry, systems biology, and tRNA biology to develop tools to facilitate the cost-effective, sustainable, and scalable of difficult-to-express proteins for the betterment of global health and nutrition.

John Carroll, Sales Manager NA at Cytena, was among the first to join the company's US operations at its inception in 2021. Since then, he has taken on roles supporting Cytena’s growth across the United States and Canada. He has helped many pharmaceutical companies, CROs and academic institutions improve their processes in CLD and cell and gene therapy spaces. During his tenure at Cytena, he has primarily spent his time equipping customers with our single-cell dispensing instruments, as well as our microbioreactors, plate washers and out automated workcell solution, the C.STATION. He has spent time across multiple verticals at Cytena, from sales to service/support and installation and trainings, gathering a rounded experience in all aspects of what our valued customers need throughout their process of evaluation, implementation and realization of our solutions.

Jeff Cassel leads the Technical Team within the Chromatography Products group at W.L. Gore & Associates, Inc. He has been with Gore for 15 years in both membrane development and product development. Prior to Gore he worked at two large pharmaceutical companies in small molecule product development and manufacturing, across both drug substance and drug product.

Carlos Castaneda is a Principal Scientist at Pfizer in Chesterfield, MO, where he has developed robust sequencing methods to support nucleic acid-based modalities in gene therapy and mRNA vaccines. He holds a PhD in Biochemistry from the University of Missouri – St. Louis, where he conducted research on antiviral compounds against high-risk human papillomaviruses. Carlos has a strong technical background in next-generation sequencing and various nucleic acid-based analytical techniques.

David Cetlin is the Senior Director of MockV Products at Cygnus Technologies, LLC. Mr. Cetlin founded MockV Solution in 2013 and was CEO until its acquisition by Cygnus in 2020. His lab is dedicated towards establishing a series of BSL-1 compatible viral clearance prediction kits. These kits aim to benefit downstream purification scientists as they develop, characterize, and validate their downstream purification processes. Prior to MockV, David spent 7 years at Human Genome Sciences (now GSK) helping to develop and establish several monoclonal antibody purification processes. He has worked with various separation techniques including column chromatography, tangential flow filtration, nano-filtration. He executed several viral clearance validation studies and nanofilter design of experiment (DOE) studies.

Edward is the Sr. Technical Specialist in Cell Culture Bioprocessing Operation at Roche/Genentech in South San Francisco, California. Edward has over 20 years of experience focused on cell culture process development, technology evaluations, and implementation of new technologies to the Roche/Genentech network including high turndown single use bioreactors, single use harvest system/method, single use mixer, cell retention device, and single use pH and dO2 sensors, and foam sensor. Edward holds a patent on the UNICAN bioreactor system that allows dual sourcing of SUB bag.

Dr. David Chang has 30-year industrial experience, and is currently the CEO of TBMC (Taiwan Bio-Manufacturing Co), Taiwan. Prior to current role, he was CEO of Wuxi AppTec Advanced Therapies Business Unit located in Philadelphia, PA.; Corporate VP and Head of Cell Therapy Global Manufacturing, of Celgene Corporation; the Global Head of Engineering and Strategy at Roche based in Basel, Switzerland; the VP/Site Head of Roche Shanghai Technical Operations in China. Earlier in his career, Dr. David Chang worked at Genentech as the Senior Director of Global Manufacturing Science and Technology, and as the Director of Process Development in its Oceanside, CA site. He was also formerly at Biogen Idec as Director of cell culture R&D, at BASF Bioresearch as a cell culture group leader, and at Schering-Plough Research Institute as a process development engineer. Dr. David Chang obtained his Bachelor’s degree in Chemical Engineering from National Taiwan University in Taiwan, and the Master’s and PhD degrees in Biochemical Engineering​ from MIT in Massachusetts, USA.

Dr. Wei-Chiang Chen is currently Associate Director in BioProcess Analytics focusing on gene therapy CMC development at Genomic Medicine Unit of Sanofi. Wei-Chiang is leading a group of scientists to develop high throughput analytical assays (mostly LC and CE based methods) supporting process development and manufacturing of gene therapy products, including of both viral and non-viral gene therapy. Also, Wei-Chiang manages many CMC analytical activities for various gene therapy products for Sanofi. Prior to joining Sanofi, Wei-Chiang worked at different companies, such as Flexion Therapeutics, Solid Biosciences, Biogen, and Immunogen. He had extensive experience in assay development and process development for biologics, such as monoclonal antibodies, fusion proteins, AAV, and adenovirus, etc. Wei-Chiang earned his Ph.D. in Chemical and Biomolecular Engineering from the Johns Hopkins University, a M.S in Chemical Engineering from University of Florida and a B.S. in Chemical Engineering from National Cheng Kung University in Taiwan.

I am a scientist in downstream process development at Ultragenyx. My work focuses on CMC activities that support the development of rAAV-based assets. Active areas include early-stage process development and late-stage process characterization. Interests include integrating high-throughput platforms, process analytical tools, and user-friendly software applications and modeling approaches to enable efficient and effective bioprocess development.

Dr. Jie Chen currently serves as the Chief Technical Operations & Quality Officer of GV20 Therapeutics. She has 28 years of biopharmaceutical industry experience in leading biologics drug CMC development from late discovery to IND/BLA filing and commercialization. Prior to GV20, she served as Senior Vice President/Site Head of US Manufacturing and Operations at WuXi Biologics where she was responsible for managing client CMC projects, leading US process development and manufacturing site design, buildup and operation. Previously, Dr. Chen also spent over 18 years in the biotech industry at Boston area including Dyax and Shire where she led Protein Sciences team, Process Sciences team, CMC team and managed CDMO for corresponding company biologics product development. Dr. Chen received her MD from Medical School of Xian Jiao Tong University and practiced as an oncologist in China. She had her post-doctor fellow training at University of Pennsylvania and holds a Master of Science in Physiology and Neurobiology from Rutgers University.

Yunfan Chen is a Research Associate in Analytical Development at Sanofi’s mRNA Center of Excellence. With over six years of experience in chemistry and analytical sciences, she focuses on impurity analysis and method development to support mRNA drug substance process purification and drug product stability studies. Her work leverages reversed-phase ion-pairing chromatography to monitor process-related impurities, including residual plasmid DNA, abortive transcripts, mRNA adduct, and to enhance control strategies for mRNA-based therapeutics.

Gong Cheng is the Head of Analytical Sciences at Asimov, a company specializing in the programming of living cells to develop advanced therapeutics. He holds a PhD from the University of Chinese Academy of Sciences and has over 12 years of combined academic and industry experience in biopharmaceutical development. At Asimov, Gong leads a team specializing in analytical development, CMC, and regulatory support, driving high-throughput workflows to enhance assay sensitivity and precision. His team provides comprehensive analytical support for cell line development (CLD), process development (PD), and drug product characterization, ensuring rigorous quality standards and deep analytical insights.

Dr. Danny K. Chou is a biopharmaceutical industry veteran with expertise in biopharmaceutical characterization, formulation development, and emerging technologies for protein aggregate/subvisible particle analysis. Currently, Dr. Chou is the Founder and President of Compassion BioSolution, a biopharmaceutical consultancy and Contract Development Service provider that serves clients throughout the world. Dr. Chou has over 20 years of experience in the pharmaceutical industry, both as a pharmacist and pharmaceutical scientist. Over the past 15 years he has led the development of formulations for numerous therapeutic modalities ranging from peptides, growth factors, mAbs, ADCs, and bispecific antibodies. Prior to starting Compassion BioSolution, Dr. Chou was a Senior Scientist and Group Leader at Gilead Sciences, where he successfully built up state-of-the-art analytical capabilities for the company and converted IV formulations of monoclonal antibodies to high concentration formulations that are more stable and can be easily administered by subcutaneous injection. Prior to this, Danny was employed by Genzyme and Amgen, where he played critical roles in drug product process development, manufacturing technical support, and pharmaceutical development. Since founding Compassion BioSolution, Danny has developed stable pharmaceutical dosage form for clients ranging from small start-up biopharmaceutical companies to Fortune 500 pharmaceutical companies. Danny received his PhD from the University of Colorado Center for Pharmaceutical Biotechnology under a NIH Fellowship and his PharmD from the University of Florida.

Scott Clark is a seasoned leader in life sciences manufacturing automation and data strategy, with extensive experience driving digital transformation, modular automation, and data-centric operations in regulated environments. With a deep understanding of ISA-88/95, Pharma 4.0, and Industry 4.0 principles, He specializes in seamless integration of process equipment, lab instrumentation, data orchestration, and standardization frameworks to enhance flexibility, scalability, and compliance in bio-pharmaceutical production. Scott currently serves as the Head of Automation Manufacturing Systems at Sanofi's MA Bio Campus.

Ben Clarke supports USP’s portfolio of documentary and physical reference standards for the Global Biologics group. He specializes in cell and gene therapy, vaccines, and monoclonal antibodies. Before joining USP, Ben developed analytical bioassays at GSK Vaccines for RSV and self-amplifying mRNA vaccines. Before GSK Vaccines, he pioneered the development of mouse models of sphingolipid biology using CRISPR/Cas9 genome editing technology at the National Institute for Health. Before NIH, he optimized upstream PER.C6 cell culture for the production of adenovirus at Janssen. He received his PhD from Cornell University for his work on mammalian membrane biology and lipid remodeling enzymes. He received his BS from Pennsylvania State University for Biochemistry, Molecular, and Cell Biology.

Diana M. Colleluori, PhD, MBA is an Accomplished Executive Leader with 20 years of domestic and global experience in analytical methods, quality control, CMC regulatory affairs, and strategic planning in both start-up and growth organizations focused on biotechnology products, including cell and gene therapy products. Key technical experience includes potency assays, release and characterization assays, stability, specifications, and raw materials. Previous head of Quality Control for several innovator companies including Iovance Biotherapeutics, bluebird bio, and Merck. PhD in Biochemistry from Temple University School of Medicine and MBA in Pharmaceutical and Healthcare Business from the University of the Sciences in Philadelphia.

Myra Coufal, Ph.D., is a Process Development Director who leads the Upstream Process Engineering team. Responsibilities include technical oversight of new process introductions, process performance qualification, and ongoing monitoring to support commercial production in two multiproduct facilities. In addition, she also is the Global Vice Chair for Amgen LGBTQ+ PRIDE and the Diversity Inclusion & Belong lead for Amgen Rhode Island. She joined Amgen in 2006 and has led teams focused on digital transformation initiatives such as Process Analytical Technology, data science, and digital upskilling. She also led the Mammalian Cell Culture Process Development lab in Amgen Puerto Rico and was the Aranesp Drug Substance Team Lead. Myra earned a B.A. degree in Biochemistry from Harvard University, and a Ph.D. degree in Biology from the Massachusetts Institute of Technology (MIT).

Brandon Coyle is currently a Director of pivotal downstream development for Gilead Sciences. He completed a dual PhD in Chemical Engineering and Nanotechnology from the University of Washington and has been working in the conjugation space for over 10 years and holds several patents for novel downstream purification strategies.

Hussain Dahodwala earned his PhD from RPI in 2007 and has an extensive research background. He has worked at SUNY Polytech, NIH VRC labs, and the University of Delaware. His focus lies in understanding how culture conditions and cell physiology impact living systems used in industrial processes. Specifically, he explores mammalian cell systems for therapeutic protein production. His numerous publications delve into the use of modern cell and molecular biology, as well as “omics” approaches, to optimize production systems from both engineering and biological perspectives.

Professor Paul Dalby is Co-Director of the EPSRC-funded Future Targeted Healthcare Manufacturing Hub, and Deputy Head of the Department of Biochemical Engineering at UCL. He recently Chaired the Royal Society of Chemistry Biotechnology Interest Group. His research focuses on routes to improve therapeutic proteins and viral vectors for ease of manufacture, formulation and delivery to patients. His work combines protein engineering and formulation, with biophysical characterisation, molecular modeling and simulation, to understand the factors that influence protein stability, and to guide protein engineering for improved properties.

Alejandro D’Aquino is a Principal Investigator at GSK with over 8 years of experience in development of pharmaceuticals. Specializing in formulation development, Alejandro combines biophysical characterization of biopharmaceuticals and automation to advance programs into late and commercial phase. Alejandro has applied the principles of thermodynamics that he learned during his doctoral studies in Molecular Biophysics at The Johns Hopkins University to develop novel approaches to monitor formulation stability. Following that, Alejandro acquired knowledge of structural biology during his postdoctoral work at Brandeis University. At GSK, he is responsible for the high concentration development of biopharmaceuticals, where he has has introduced screening techniques and statistical analysis to late phase development. Alejandro is passionate about bringing better medicines to patients and it is this passion that gets him up in the morning.

Susan D’Costa, PhD, is the CTO at Genezen. She is a molecular virologist with extensive expertise in viral vector analytics, process development, and manufacturing. She has built a considerable amount of this experience in the contract manufacturing industry (Thermo Fisher/Brammer Bio) working with different viral vectors, liaising with diverse biotech clients, and building teams with scientific and operational excellence. Prior to Genezen, Susan was the CTO at Alcyone Therapeutics, where she oversaw both internal and external CMC (chemistry, manufacturing, and controls), device development operations, and building out new technologies for both gene therapy and precision delivery. In her current role, Susan is working on building out the AAV business unit at Genezen, a reputed CDMO for lentivirus and retrovirus development and manufacturing. Dr. D’Costa holds a PhD in Biology (specializing in molecular virology) from Texas Tech University, an MS in Biochemistry from Mumbai University (Grant Medical College), and a BS in Microbiology/Biochemistry also from Mumbai University (St. Xavier’s College).

Guy de Roo is Principal Scientist at Byondis based in Nijmegen in the Netherlands. He studied bioprocess technology at Wageningen University and obtained a PhD at the ETH Zurich with a focus on protein chemistry. His work experience includes industrial affinity chromatography at CatchMabs and biopharmaceutical process development at Wacker B.V. Since 2008, he works within the Down Stream Processing department at Byondis and is involved in process development for production of antibodies and antibody drug conjugates including scale-up, tech transfer to a GMP manufacturing facility and process validation.

Francesco Destro is a Postdoctoral Associate at the Department of Chemical Engineering and at the Center for Biomedical Innovation at MIT, where he conducts research into process systems engineering and advanced biopharmaceutical manufacturing. He obtained a PhD in Chemical Engineering from University of Padova in 2022, with a dissertation on the use of mechanistic modeling and machine learning for optimizing pharmaceutical systems. He is the first author of 11 peer-reviewed publications, and complemented his research training in systems engineering and (bio)pharmaceutical manufacturing as a Visiting Scholar at Siemens Process Systems Engineering (London, UK) in 2019 and at Purdue University in 2020 and 2022.

Jessay Devassy is a biopharmaceutical leader with over a decade of experience in the downstream process development for purification of monoclonal antibodies and viral vectors. He currently leads the Bioprocessing Applications Lab at Ecolab, where he built the team and lab from the ground up and now partners with top global biopharma companies to accelerate drug development and reduce manufacturing costs. Prior to Ecolab, Jessay led the downstream vector development team at Resilience, where he designed and scaled a novel lentiviral purification platform for CAR-T therapies. His earlier work at Emergent BioSolutions focused on developing and scaling purification processes for antibodies and engineered proteins, contributing to multiple tech transfers, regulatory submissions, and GMP readiness. Jessay’s expertise spans chromatography, TFF, QbD, and tech transfer, and he is known for delivering high-impact, data-driven solutions that meet clinical and commercial demands. He holds a Ph.D. from the University of Manitoba and advanced degrees in biotechnology from India and was recently honored with Ecolab’s GM Leadership Award for his contributions to innovation and team development.

Yanhuai (Richard) Ding is Senior Director, CMC DS/DP, EvolveImmune Therapeutics, Inc. He worked in multiple biotech companies such as ThermoFisher, Shire HGT, Lonza, AnaptysBio, Biogen etc. He earned his PhD in biochemistry and molecular biology in 2000 from Waikato University, New Zealand. He had a few decades of experience in purification process development, technology transfer, manufacturing support, viral clearance, process characterization & validation, CMC and regulatory filing (IND) from bsAbs, mAbs, Fabs, enzymes, vaccine, Collagen 7, biosimilars, plasmids, and AAVs. He published over 35 scientific papers (in USA, New Zealand, and China) including a couple of book chapters, one in Bioprocessing, Bioengineering and Process Chemistry in the Biopharmaceutical Industry (Springer Nature 2024, edited by Dr. K Gadamasetti & SA Kolodziej) and the other (in prep) in Process Scale Purification of Antibodies (3rd edition by Dr. U Gottschalk).

Dr. Alex Dow attended American University, receiving his B.S. in chemistry in 2010. He then studied under Dr. Hilkka Kenttämaa at Purdue University, receiving his Ph.D. in analytical chemistry in 2015. Upon joining Merck in 2016, Alex focused on developing chromatographic methods for impurity isolation to support process development. In 2019 he transitioned from small molecules to biologics, focusing on residual host cell proteins. He has since worked to develop various assays across multiple platforms. He is passionate about the subject of residuals control and refining the use of various assays to inform proper downstream control strategies.

Kelly Flynn is a Senior Research Associate in Analytical Development at Ultragenyx. She works with the molecular automation team, running various PCR assays and developing new automation methods to increase assay throughput. Kelly’s analytical work supports the production of AAV therapeutic materials, aiding in process development and product characterization. Previously, she worked at MGH for a neurology research lab where she led mouse model genotyping. She received her BS from the University of Mary Washington, and MS from Liberty University.

Leading Novasign as CEO, Mark is passionate to improve bioprocesses for the production of biopharmaceuticals, enzymes and substitutes for animal-derived proteins. With his team, he is developing a hybrid modeling software for both up and downstream processes. This software utilizes artificial intelligence applied to process data and first principle models (hybrid models) to not only accelerate bioprocess optimization but also to reuse these models for model predictive control strategies. The company Novasign was founded in 2019 offering this unique software solution which is already in use by several TOP25 pharma companies to also accelerate their process development.

Shannon received his PhD from the University of Tennessee, Knoxville in Biochemistry, Cellular and Molecular Biology. His expertise is around T cell, HSC, and ES/iPSC cell biology, and has been with Cytiva (formerly GE Healthcare) Cell and Gene Therapy for over 10 years. He is a member of the International Society for Cell Therapy (ISCT) Process and Product Development (PPD) committee, and has authored numerous papers within the field of cell biology and manufacturing. He is currently the Technical Leader within Cytiva's Cell and Gene Therapy Enterprise Solutions group. Shannon lives with his wife and 2 kids in Knoxville, TN.

Lori Ellis is the head of insights for BioSpace. She analyzes and comments on industry trends for BioSpace and clients. Previously she was a managing editor at Pharma Intelligence where she produced a variety of written, audio and visual media for in vivo subscribers and for Custom Content clients. In addition to being an editor and writer, she is an experienced host, moderator, and producer of webinars, podcasts, live discussions, and private events. She has received a Creative Muse award and several Vega and Adobe awards for collaborative narration projects. Areas she has covered span the drug development process, from pre-clinical to commercial stages. Her areas of expertise include the following as they relate to the life sciences industry: GenAI, DE&I, cybersecurity, and investments.

Dr. Metewo Selase Enuameh has over 22 years of experience in biotechnology and 14 years’ expertise in cell line development for drug discovery and development. Currently at REGENXBIO Inc., he leads the Vector Core Cell Line Development Group, in the creation of stable cell lines, disease model cell lines and novel engineered cell lines for drug screening and enhanced production of rAAV vectors. Prior to REGENXBIO, Dr. Enuameh served as the Research and Development lead at ATCC for 5 years in the development of 6 commercially viable isogenic cell lines for cancer drug screening and translational research. Additionally, he was the technical lead in the development of 3 epithelial-to-mesenchymal transition/mesenchymal-to-epithelial transition (EMT/MET) reporter cell lines whiles at ATCC. Metewo’ s expertise includes process development, project management, new product development, and mammalian cell engineering using various platforms including, the CRISPR/Cas9 technology, Zinc finger nucleases (ZFNs) and Transcription Activator-like effector nucleases (TALENs). He has co-authored 8 peer-reviewed publications, 1 patent and 2 patent applications. He holds a Bachelor of Science in Chemistry and PhD in Chemistry from the University of Massachusetts in Amherst, Massachusetts.

Iman is currently working as Director of High Throughput Protein Expression group in Biologics Discovery organization at Johnson and Johnson. Prior to this role, he worked in Protein Engineering group at Merck. He has a PhD in Chemical Engineering with focus in Synthetic Biology at Penn State University.

Allen is the Founder and Chief Scientific Officer of HebeCell Corp. Prior to HebeCell, Allen was the Director of Cell Biology of Semma Therapeutics (Acquired by Vertex), R&D Head of Stem Cell Bioprocessing Group at EMD Millipore (Merck, KGaA), Director and Senior Scientist at Advanced Cell Technology (Acquired by Astellas), and Senior Scientist at Stemgent, Inc (Now ReproCell). Allen is an inventor of several key patents of hematopoietic lineage-specific differentiation from human pluripotent stem cells (hPSCs), such as the generation of HLA-negative platelets, and a scalable 3D manufacture platform of NK from hPSCs.

Dana Filoti is Associate Director, Development Sciences Data and Digital Strategy, focusing on the Biologics CMC Data Architecture. She received her PhD in Materials Science from the University of New Hampshire and Bachelor's degree in Physics from the University of Bucharest. She joined Abbvie after working as a Post-Doctoral fellow with Genentech and the Biomolecular Interaction Technologies Center (BITC) on the development of instrumentation to measure protein charge and macromolecular interactions of proteins at high concentration. Her current research focuses on transformative data automation and nominal analysis strategies to interpolate multimodal CMC data and knowledge platforms.

Dr. Namila is a downstream process development scientist with broad experience in gene therapy, monoclonal antibody and vaccine manufacturing. She holds a Ph.D. in Biomedical Engineering from the University of Arkansas and an M.Sc. in Molecular Biotechnology from the University of Kansas Medical Center. She currently works at Genentech (formerly Spark Therapeutics, now integrated into Genentech) and previously held a role at WuXi Biologics, focusing on downstream purification, viral clearance studies, and tech transfer. She is a subject matter expert (SME) in virus filtration and virus clearance. In addition, she has led early-phase program downstream process development and contributed to process characterization (PC) and process validation (PV) efforts for late-phase programs.

Katherine Forrester earned her Bachelor of Science (2019) in chemical engineering and biomedical engineering at Carnegie Mellon University. Following graduation, Katherine began working full-time at Merck & Co. Inc. in Vaccines & Advanced Biotechnologies Process R&D. Over the past six years, Katherine has worked on a variety of vaccine candidates, specializing in cell culture/fermentation optimization and scale up.

Erika Friedl is currently working as quality assessor (pharmaceutical quality/CMC) at the Paul-Ehrlich-Institute (PEI) in Langen, Germany. As a senior quality expert in the European authorization process, she is responsible for the evaluation of blood products covering plasma-derived and recombinant proteins. In addition, she is involved as an expert in national and international GMP inspections. Erika is a member of the Host Cell Protein Working Party at the EDQM (European Directorate for the Quality of Medicines & HealthCare, Strasbourg, France). Erika received her PhD in biochemistry from the Albert-Ludwig University of Freiburg, Germany. During her career she worked in the fields of virology and transcription factors. As research associate, Erika joined the Department of Biochemistry at the Howard Hughes Medical Institute (UMDNJ, USA).

Chris Furcht is a Director in the Biologics Development department at Bristol Myers Squibb. His group supports the development of downstream processes for both early-phase and late-phase biologics across a variety of modalities including monoclonal/bispecific antibodies, Fc-Fusion proteins, and antibody-drug conjugates. Additionally, he has contributed to initiatives focused on enhancing process sustainability through the application of process optimization and facility fit modeling. Chris received a PhD in Chemical and Biomolecular Engineering from the University of Pennsylvania in 2014 and a BS in Chemical Engineering from Villanova University in 2008.

I am an Associate Scientist III at Alexion Pharmaceuticals, bringing four years of experience in advancing therapeutic molecule production. For the past two years, I've led the Bioreactor Automation team, leveraging my expertise in upstream process development, particularly with the Fed-batch platform. I specialize in designing and executing studies focused on optimizing and characterizing upstream and manufacturing processes.

I have been involved in immunology since 1993, initially focusing on rheumatology and transplantation before specializing in antibody research. I joined Genmab BV in 2001 and currently serve as Director, Cell Engineering & Sciences Lead. In this role, I manage and lead several groups including Vector Design, Cell Line Development and Upstream Processing, Cell Bank Manufacturing, and Material Logistics & Inventory, overseeing all cell culture activities in development.

Zahra Ghassemi is a Senior Scientist in the Dosage Form Design & Development within the Biopharmaceutical Development department at AstraZeneca. She holds a PhD in Chemical and Biochemical Engineering from the University of Maryland, Baltimore County, where her research focused on protein stability, aggregation, and enzymatic activity. In her current role, Zahra addresses challenges related to maintaining product stability and recovery, particularly for novel modalities administered at low doses.

For the past 4 years, I have served as a Director in Pivotal Drug Substance Biologics, based out of the Cambridge, MA site. In this role, I lead of team of ~30 staff members developing both cell culture and purification biologics processes for a variety of recombinant protein modalities. We support molecules from Phase 1 through BLA filing. My team has led development and commercialization activities for several acquired biologics assets. Aside from portfolio support I am the Process Characterization and Control Strategy business process owner. Additionally, my team leads multiple technology and business process initiatives.

Laura J. Greenfield, M.S. is a Senior Scientist in Upstream Process Development at Pfizer, where she leads innovation in biologics manufacturing with a focus on Fc-Fusion proteins, ADCs, and next-generation host cell engineering. With over 13 years of experience spanning Pfizer, Sanofi Genzyme, ImmunoGen, and Biogen, Laura has contributed to multiple clinical and commercial programs, technology transfers, and platform development efforts. She is an inventor on a patent for cysteine prototrophy in CHO cells and has presented her work at premier industry conferences including ACSBIOT, ECI Cell Culture Engineering, and Synthetic Biology. Laura holds master’s degrees in Chemical Engineering from Tufts University and Biomedical Forensic Science from Boston University. Her research has been published in Metabolic Engineering, and she is recognized for her leadership in mentoring, cross-functional collaboration, and systems-level cell line design.

Ashutosh Gupta is a CMC consultant. He has over 15 years of experience in process development and optimization across various modalities. He previously worked at uniQure, Fujifilm, Takeda, Sanofi and Pfizer.

Brian Haldeman is Product Manager for Lunatic and Stunner at Unchained Labs. Prior to this role, he spent 10 years as a Field Application Scientist supporting biophysical characterization of proteins and viral vectors. Brian received his Ph.D. in Biochemistry from the University of Nevada, Reno where he studied the mechanics of muscle contraction. His research utilized single-molecule microscopy, pre-steady-state kinetics, protein affinity and binding characterization, and protein isolation techniques.

Austin Hallgren manages Revvity's Bioproduction licensing in North America, supporting biopharma companies with the CHOSOURCE expression platform (formerly from Horizon Discovery). With a strong technical background in molecular biology and protein expression, Austin brings a unique blend of scientific expertise and strategic licensing acumen to the bioproduction landscape.

BPEC Laboratory Supervisor and Associate Industrial Liaison Officer

Ken Hamilton is a chemical engineer with over 30 years' experience. He has a Master's and Ph.D. from University of Wales and undergraduate at University of Manchester Science & Technology, in the UK. His background includes process and facility design and engineering and leading projects to enable drug substance manufacturing sites to receive new products and platforms. He also undertakes process economic analyses for new processes. He is a Distinguished Engineer at Roche/Genentech, in their global technology organization, and has been at Roche/Genentech for the past 18 years. Responsibilities include leading evaluations of new process platforms and new equipment technologies for manufacturability and cost, working closely with R&D, Finance, business strategy groups and the drug substance manufacturing sites. Previously, he led the process-engineering group at one of the drug substance sites, supporting ongoing manufacturing operations and the engineering aspects of product transfers to the site. He was chapter president of the ISPE San Diego chapter, and is a co-lead for the NIIMBL Sustainability team. Several years ago, he was an affiliate professor at Colorado State University. Ken has made roughly 20 presentations and publications to the biopharm industry.

Dr. Jongyoon Han is currently a professor in the Department of Electrical Engineering and Computer Science and the Department of Biological Engineering, Massachusetts Institute of Technology. He received B.S. (1992) and M.S. (1994) degree in physics from Seoul National University, Seoul, Korea, and Ph.D. degree in applied physics from Cornell University in 2001. He was a research scientist in Sandia National Laboratories (Livermore, CA), until he joined the MIT faculty in 2002. He received NSF CAREER award (2003) and Analytical Chemistry Young Innovator Award (ACS, 2009). His research is mainly focused on applying micro/nanofabrication techniques to a very diverse set of fields and industries, including biosensing, desalination/water purification, and biomanufacturing. He is currently the lead PI for MIT’s participation for NIIMBL (The National Institute for Innovation in Manufacturing Biopharmaceuticals).

Renee Hart serves as the President and Chief Business Officer of LumaCyte, bringing over 25 years of executive experience in life sciences operations and business leadership. Her broad and deep experience and diverse expertise across clinical development, commercialization strategies, bioanalytical instrumentation, and regulatory considerations for advanced biomanufacturing has touched many aspects of the biopharmaceutical and life sciences industry, providing her a unique perspective into the needs and challenges of the market. Renee's passion for innovation drives her to challenge the status quo, ensuring the industry is ready to meet the commercial scale and yields required to address the increasing demands for advanced therapies and vaccines. She recognizes the need to break through traditional approaches to stay ahead in the evolving biomanufacturing landscape. Her collaborative mindset and focus on solution management, coupled with her commitment to innovation and high trust partnerships, have been instrumental in accelerating the adoption of LumaCyte’s advanced bioanalytics PAT platform, leveraging Laser Force Cytology to reliably and consistently achieve high product quality through its real-time cellular response metrics.

Dr. Mo Heidaran is currently Chief Scientist at Cellx Inc. and Founder of CHCF a non profit organization with interest in discovery and development of gene based biomarkers for diagnosis of serious brain disorders. He is a recognized expert in the development of cell and gene therapies with more than 9 years of experience at the FDA’s working in both product and compliance offices (CBER/OTP/OCBQ), 3+ years in a large CRO, Parexel as VP of Technical, and 15+ years as Director R&D in biotech industry working in companies like Celgene, BD, and GC Therapeutics. He is currently a member of the International Society of Cell Therapy Legal and Regulatory Affair Committee, and United State Pharmacopeia Bio5 Expert Committee. He is the founder of the new Gordon Research Conference on Synthetic Biology in 2000. He also holds 25 issued patents and 54 pending patents, and his work has appeared in more than 50 peer-reviewed scientific publications.

Dr. Caryn L. Heldt is the Director of the Health Research Institute, the James and Lorna Mack Chair in Continuous Processing, and a Professor in the Department of Chemical Engineering at Michigan Technological University. She received her PhD in Chemical Engineering from North Carolina State University in 2008 and completed a two-year postdoc at Rensselaer Polytechnic Institute. In 2015, Dr. Heldt was awarded an NSF CAREER award to study virus surface chemistry. She was awarded the Bhakta Rath Research award at Michigan Tech in 2021 and the Faculty Distinguished Service award in 2022. Her lab is focused on the purification, inactivation, and stability of viral vectors.

Therese Herling completed her undergraduate degree in Biochemistry at University College London in 2011. She moved to the University of Cambridge for a PhD in Biophysical Chemistry. Following her PhD, she held an Oppenheimer Early Career Research Fellowship in the School of Physical Sciences at the University of Cambridge and a Junior Research Fellowship at Murray Edwards College. Her research is focused on the development and application of quantitative microfluidic methods for the study of protein interactions. She realises the translational potential of her research through collaboration with partners in industry, including the work with Novo Nordisk she presents here. Therese currently holds an AstraZeneca-funded Research Fellowship on peptide self-assembly.

Christoph Herwig, bioprocess engineer from RWTH Aachen and obtained a PhD in bioprocess identification at EPFL, Switzerland. From 2008 to 2023, he was full professor for biochemical engineering at the Vienna University of Technology. The research area focused on the development of data science methods for integrated and efficient bioprocess development along PAT and QbD principles for biopharmaceuticals. During his employments in various industries, such as with Lonza, he was deeply involved in the design and commissioning of large chemical and biopharmaceutical facilities. In 2013 he founded the company Exputec, which is now part of Körber Pharma, pioneering data science software solutions for the biopharma life cycle. Here, Christoph currently also acts as senior scientific advisor for Körber. In 2021 he cofounded Fermify and acts as CPO, focusing on providing a fully digitalized production platform for vegan cheese.

Angela has dedicated her career to the design, configuration, installation, support, and management of control systems and data historians. She confesses to being obsessed with Operational Technology and Data Management. In her role at Regeneron, Angela supports the Preclinical Manufacturing & Process Development group, specializing in lab equipment ETL and IT/OT convergence. She holds a Bachelor of Engineering in Chemical Engineering from the University of Salford, UK.

Kevin Hill-Byrne is the Co-Founder and CTO of PAK BioSolutions. As CTO, he is responsible for overseeing new product development and driving innovation in PAK BioSolutions’ current product offerings. With a background in automation and software development, Kevin designed all the control and software for PAK BioSolutions’ automated continuous manufacturing systems. Prior to PAK BioSolutions, Kevin worked at AstraZeneca in a new technology evaluation role where he led the development and implementation of the control strategy used for a continuous purification process of monoclonal antibodies. Kevin has a B.S. degree in Chemical Engineering from the University of Maryland, College Park, and has published on works related to continuous viral inactivation, single pass TFF, and continuous processing of biologics.

Moo Sun Hong is an assistant professor at the Seoul National University (SNU). Moo Sun received a B.S. from SNU and an M.S. and Ph.D. from Massachusetts Institute of Technology (MIT). His research focuses on developing advanced biomanufacturing systems through a novel systems engineering approach. Specific research topics and applications include mechanistic modeling, process data analytics, artificial intelligence, hybrid modeling, optimal design and control, and automated process construction.

Over 20 years' experience in upstream process development with a focus on both early- and late-stage development. Recently joined a tech-development group within process development with a focus on PAT development and implementation in development labs, pilot labs, and GMP. In the past I have also supported manufacturing sciences for deviation impact, CAPAs, and change controls on commercial processes.

Mengyang (Claudia) Hu is a Ph.D. graduate in Chemical Engineering from Rensselaer Polytechnic Institute, where her research focuses on the development of peptide affinity ligands for nucleic acid purification. She has designed and validated ligands targeting distinct mRNA features—including the 5' cap and double-stranded RNA—through rational design, phage display, and high-throughput screening. Her work bridges molecular design with bioprocess applications, supporting scalable purification strategies for RNA therapeutics and AAV gene therapy vectors.

Dr. Zheng Huang is the CTO of Ark. He previously served as the Director of Manufacturing Science and Technology (MSAT) at Sanofi. As the Director of MSAT, Zheng led multiple teams working on machine learning, cell culture simulation, CFD, and process Raman. Zheng holds a PhD in chemical engineering.

Dr. Ruud Hulspas works at the Dana Farber Cancer Institute as Technical Director of Process Development in the Cell Manipulation Core Facility. He is the Founder of Cellular Technologies Bioconsulting, a company dedicated to increase reproducibility and quality of (pre-)clinical research, with a focus on incorporating reliable analytics into cell therapy manufacturing processes. Previously, Dr. Hulspas was Vice President of Scientific Affairs at Cytonome, a company originally created to develop technologies for cell sorting in manufacturing of cell-based products for cell therapies. Prior to joining Cytonome, Dr. Hulspas led the R&D and lean operations of cytometry assays and cell-sorting methods in the stem cell expansion and cord blood storage divisions of ViaCell, Inc. He received his B.S. and M.S. from Leiden University, his Ph.D. in Cell Biology from University of Amsterdam, and his technical training at the TNO Radiobiological Institute in Rijswijk, the Netherlands. As a postdoc at the newly founded Cancer Center at the University of Massachusetts, Dr. Hulspas headed the Cytometry core facility, while his research projects focused on the identification and purification of a wide range of hematopoietic and neural progenitor cell types.

Chris brings over 30 years of experience in the biopharmaceutical industry, specializing in CMC development, technology transfer, and manufacturing. He is the CTO and EVP of Process Development at Transcenta/HJB, where he leads CMC development and drives advanced biomanufacturing innovations to reduce costs, enhance agility, and improve patient access to biologics. Before joining Transcenta/HJB in 2016, Chris spent 25 years at Genzyme and Sanofi as Senior Director of Late-Stage Process Development. He led the Integrated Continuous Biomanufacturing (ICB) program and played a key technical role in multiple clinical and commercial-stage products. Chris holds a PhD in Biochemical Engineering from MIT.

Pavan is a graduate research assistant under the supervision of Professor Richard D. Braatz in the Department of Chemical Engineering at the Massachusetts Institute of Technology. His current research focuses on the development of multiscale mechanistic models for the formation and production of lipid nanoparticles for the delivery of nucleic acid therapeutics.

Michael is a founding Partner at Cambridge Biostrategy Associates, LLC (CBA). With over 20 years’ industry and consulting experience, Michael has a strong business, scientific and technical background as well as pharmaceutical product development experience. He has led multiple engagements in the areas of pharmaceutical development and commercialization, contract services, diagnostics, medical devices, and life science tools. Product areas include oncology, immunology, bleeding disorders, cardiovascular, psychiatry, surgical devices, molecular diagnostics, and pathology. In addition, he has extensive experience in corporate and product strategy; new product development; and partnering, market entry, geographic, and market access strategies.

William E. Janssen, Ph.D. has worked for more than 30 years at translating lab bench models into cell and gene therapy products for administration to patients. In the course of these efforts he has developed and refined methodologies for all aspects of cell based therapy from cell collection, through manufacturing and administration. Dr. Janssen has also been responsible for facility design, drug master file creation, development of staff training programs, process engineering, technology transfer, SOP development, process validation, comparison studies and integration of processes, equipment and raw materials. He is particularly interested in and has been both a proponent and implementer of informatics solutions for management of cell and gene therapy development and manufacturing data.

Scott Jeffers, PhD, serves as Chief Technology Officer at GenSight Biologics, where he leads global teams in developing innovative gene therapy solutions. His journey in gene therapy began in 1997 at Purdue University, where his groundbreaking doctoral research focused on viral vectors and led to three US patents for gene therapy applications. After completing his PhD, Dr. Jeffers made significant contributions to virology research, including pivotal work on SARS-CoV receptor identification at the University of Colorado. His international experience deepened during his tenure at the prestigious Institute Pasteur in Paris, where he led multinational research teams and published in leading journals including Science. Transitioning to industry in 2014, Dr. Jeffers has established himself as a leader in chemistry, manufacturing, and controls (CMC) for gene therapy products. His expertise was instrumental in the successful commercial launch of Hemgenix, the first FDA-approved gene therapy for hemophilia B. Throughout his career, he has demonstrated excellence in regulatory submissions, including INDs, BLAs, and MAAs, while managing complex process performance qualification efforts across global operations. As an entrepreneur and strategic leader, Dr. Jeffers has built and led high-performing teams across multiple organizations, consistently driving innovation in gene therapy development and manufacturing. His combination of scientific expertise, operational leadership, and business acumen has been crucial in advancing life-changing gene therapies from concept to commercial reality. Today, Dr. Jeffers continues to push the boundaries of gene therapy technology, focusing on developing efficient, scalable processes that accelerate the delivery of transformative treatments to patients.

Dr. John Jenco has 45+ years of experience in chromatography and downstream processing. This includes analytical and preparative techniques at bench, pilot, and manufacturing scales for a wide variety of biomolecules. John joined GE Healthcare Life Sciences (now Cytiva) in 2014, starting as a Downstream Technical Sales Specialist in the Mid-Atlantic area, helping many of Cytiva’s largest biopharm customers design and troubleshoot purification processes. For the last 7 years, John has managed the Bioprocess Applications Lab and leads the Large-Scale Applications Group at Cytiva’s headquarters in Marlborough, MA. His team provides chromatography support for Cytiva’s clinical and full-scale biopharmaceutical manufacturing customers. Prior to joining Cytiva, John received his B.S. in Biology from Loyola University of Chicago, after which he worked as a research technician in Chicago at both Northwestern Memorial Hospital and the University of Illinois Medical Center. He then earned his Ph.D. in Molecular and Cellular Pharmacology from the State University of New York at Stony Brook, studying lipid and protein cofactors involved in the control of phospholipases. From there John went on to industrial purification of biopharmaceuticals at Collaborative BioAlliance, Dow Biopharmaceutical, International BioImmune Systems, and Pall Life Sciences. His extensive experience covers all the different chromatography modalities including ion exchange, affinity, size exclusion, hydrophobic interaction, and multimodal.

Lisbet is the Vice President and General Manager for AstraZeneca’s Biologics manufacturing center in Frederick, Maryland where she leads a workforce of 750 people who make life-changing medicines for patients around the world. Living and working in five countries before moving to Frederick, coupled with her background in chemical engineering, prepared Lisbet for various roles of increasing responsibilities within manufacturing, quality assurance, supply chain and validation. She has a strong focus on inclusion, and a passion for ensuring robust career development opportunities for her teams and advancing sustainability results.

Ioscani leads the Animal Cell Technology Group (ACTG) at the School of Chemical & Bioprocess Engineering, University College Dublin. ACTG is a multidisciplinary team that combines bioprocess modelling with advanced experimental strategies to optimise pharmaceutical bioprocesses. Ioscani studied Chemical Engineering at the National Autonomous University of Mexico (UNAM) and then obtained his PhD from the Department of Chemical Engineering, Imperial College London. His PhD thesis was awarded the Dudley Newitt Prize for theoretical and computational excellence. After postdoctoral work at Imperial, Ioscani joined UCD in 2014.

Zuwei has more than 25 years experiences in Life Sciences Industry. Prior to Lisure, Zuwei was an industry consultant for Zenith/Cognizant for 3 years specializing in MES. Prior to that Zuwei was a Life Sciences industry consultant for Emerson Automation Solution for 6 years, specializing in MES, Process Analytics, and Advanced Process Control (APC). He had also 16 years with GE Healthcare Life Sciences (Cytiva) having taken different roles from operation to engineering to product marketing. Zuwei has been involved in many engineering projects in global Life Sciences Industry and is well versed with the best practice in the industry. He has a Ph.D. in Chemical Engineering from Ohio State University.

I currently work at Editas Medicine Inc. as Associate Director of Downstream Process Development on In-vivo Gene Editing program. I am a Process Development leader with >15 years of experience in downstream process development, scale up, technology transfer and manufacturing of multiple molecule modalities such as monoclonal antibodies, complex enzymes, Fc-fusion proteins, antibody-drug conjugates, AAV Viral Vectors (Gene Therapy) and antisense oligonucleotides (ASO).

Professor Alois Jungbauer received his PhD in Food Technology and Biotechnology from the University of Natural Resources and Life Sciences Vienna, Austria 1986. He serves since then as a professor at the Department of Biotechnology. He teaches Protein Technology and Downstream Processing and Bioprocess Engineering. He also acts as area head and Deputy Director of Research in the Austrian Centre of Industrial Biotechnology. He is currently working in the field of bioengineering of proteins, plasmids and viruses with special focus on expression, downstream processing and characterization of large biomolecules. For more than 10 years he is working on continuous manufacturing of biopharmaceuticals. As a proliferate researcher he has more than 340 publications on recombinant protein production and bioseparation, 17 patents and 12 book contributions and recently a monograph entitled “Protein Chromatography , Process Development and Scale Up”. He is executive editor and co-founder of Biotechnology Journal, and member of editorial boards from numerous journals in the area of biochemical engineering. He acts also a the vice president of research of the European Society of Biochemical Engineering Science.

I am a biophysicist and postdoctoral fellow in the Leslie Lab at the University of British Columbia’s Michael Smith Laboratories. I hold Bachelor's and Master's degrees in Physics from the University of Massachusetts Boston and earned my PhD in Physics from McGill University in 2021. My research centers on lipid nanoparticle (LNP) drug delivery, single-particle fluorescence microscopy, and quantitative imaging of RNA-loaded nanocarriers. This work involves developing advanced microscopy and analytical methods to investigate the structure–function relationships of therapeutic nanoparticles. I am also involved in translational research through ScopeSys Inc., a startup emerging from the Leslie Lab, where we are advancing next-generation single-particle analytics for nanomedicine applications.

Sarita Kattel serves as a Principal Scientist in USP’s Global Biologics Department. At USP, she utilizes her extensive vaccine experience to advance the development of standards supporting vaccine manufacturing. Her role also includes creating new standards for analytical testing of oligonucleotide products and exploring additional opportunities for standards in various other areas. Ms. Kattel’s career spans over biotech companies, academic institutions, contract research organizations (CROs), and pharmaceutical giants like GlaxoSmithKline (GSK) and Janssen Pharmaceuticals. She has held lab-based roles in method development and validation, Chemistry, Manufacturing, and Controls (CMC) leads, as well as quality control, working on monoclonal antibodies, proteins, and mRNA-based vaccines.

Esko leads both the sequencing lab and bioinformatics team at Forge, driving the development and implementation of innovative long-read sequencing strategies for gene therapy products. With a background in Computer Science and Engineering and a PhD in Biomedical Science from The Ohio State University, Esko’s early career included bioinformatics roles in cancer research—with his first gene therapy experience at the Institute for Genomic Medicine at Nationwide Children's Hospital. At Forge, he focuses on the comprehensive characterization of rAAV products, overseeing projects from early development through quality control analytics that underpin the regulatory testing of cGMP materials. His work bridges analytical development and quality control, ensuring safe and effective gene therapies.

Tadayoshi Kawasaki is a bioprocess technology consultant. He received his PhD in Science from Hokkaido University in 1984. He studied biopolymer chemistry. In 1984, he joined Pharmacia Biotech Japan (Civita), a subsidiary of a Swedish biotechnology company. He was involved in the development of biopolymer separation technology and the process development to meet the diverse needs of the pharmaceutical industry. In 1997, he became General Manager of Genzyme Transgenics Japan Co., Ltd., where he introduced biopharmaceutical manufacturing technology using genetically engineered animals. However, following the outbreak of mad cow disease in the UK, restrictions were imposed on the use of mammalian-derived raw materials in biopharmaceutical manufacturing, and Genzyme Transgenics was forced to withdraw from its business in Japan. In 1999, he moved to Nihon Millipore Co., Ltd. as a director and was in charge of the bioprocessing business and the management of the Yonezawa Filter Plant. During his tenure at the company, he acquired knowledge of filtration technology and had the opportunity to be exposed to cutting-edge technology in biopharmaceutical manufacturing. During that time, he was invited to the Startup Support Center of the AIST, where he was involved in the launch of GlycoGene Co., Ltd. In July 2006, he was invited to work at GE Healthcare Co., Ltd. (Citiva) as a technical advisor in the bioprocessing division, where he worked until 2016. Since 2016, he worked at the MAB (Manufacturing Technology Association of Biologics) as a director of research and technology development. He organized several projects, and also developed several innovative technologies such as "Column-less Continuous Purification System", "Two-Column Switching Continuous Purification System" and "Single-Pass UF/DF System", so on. He currently serves as a technical advisor to MAB. He also serves as a technology development advisor for Noritake Company Limited, supporting the development of a "Column-less continuous purification system." As mentioned above, he has over 40 years of experience and a career in the biopharmaceutical manufacturing process, and has extensive knowledge and connections, including within Japanese pharmaceutical companies.

Dr. John Kellie is currently a Director in the Integrated Bioanalysis department at AstraZeneca. John received his B.S. in Biochemistry from Indiana University and his Ph.D. in Chemistry from Northwestern studying under Dr. Neil Kelleher. He was previously a Post-Doctoral Scientist at Eli Lilly and Company, and an Associate Director at GSK. At AstraZeneca, John leads a team that utilizes mass spectrometry for Antibody Drug Conjugate analysis, complex biotherapeutic characterization in vivo, and biomarker protein quantitation from preclinical and clinical samples.

Umang Khamar serves as Senior Scientist in Sanofi's Genomic Medicine Unit, where he works on drug product development for advanced biologics and gene therapies. With specialized expertise in formulation and process development, he has successfully guided multiple programs from early-stage formulation through clinical manufacturing. His technical mastery spans microfluidics, tangential flow filtration, and sophisticated analytical techniques. At Sanofi, Umang implements innovative DOE approaches to optimize mRNA and DNA formulations, while encouraging in-silico modes of working with Sanofi's digital efforts. His extensive industry experience encompasses diverse therapeutic modalities including vaccines and complex biologics.

Over the last two decades, Shahzad Khan has been developing and delivering process control solutions for the process industry. He holds an MBA and a degree in Computer Science and has been with Yokogawa for the past 20 years. Currently, his responsibilities are laser-focused on providing automation solutions to the bioprocessing industry. Having a deep understanding of current bioprocessing challenges, Shahzad aims to provide solutions to overcome these obstacles.

I received my Masters degree in Organic chemistry in India. In addition, I obtained PhD degree in chemistry from University of Kentucky in 2010. Then I joined University of Minnesota for Postdoctoral training in the Department of Chemistry until 2012. I joined BioVision Inc where I built a team focused on designing, manufacturing and analytics for metabolic enzymes for commercial use. Then I pivoted to Gene Therapy when I joined Brammer Bio (now a part of Thermofisher Viral Vector Services) as principal scientist and led the team for developing analytical assays for viral vectors. Furthermore, in 2018, I joined Sangamo Therapeutics as a Senior Scientist for helping build analytical team on developing assays for viral vectors. I left Sangamo to join Asklepios Biopharmaceuticals (North Carolina) as the Director of Analytical Development but after a short duration, I rejoined Sangamo Therapeutics as an Associate Director where I am overseeing analytical development for early and late phase viral vectors.

Pharmaceutical professional with a PhD in Chemical Biology and over four years of experience in protein characterization, critical reagent development, and biotherapeutics production. Expertise in advancing critical reagent workflows, supporting biotherapeutic pipelines (mAbs, bispecifics, ADCs, ATLs), and ensuring alignment with CMC and regulatory requirements. Proficient in biophysical and biochemical characterization techniques, including SEC, SPR, BLI, CE-SDS, HIC, IEX, and UPLC/HPLC, to support bioanalytical assay development across preclinical and clinical stages. Skilled in recombinant protein production, purification, and extended characterization to ensure high-quality reagents for ADA, PK, and NAb assays. Extensive experience in critical reagent lifecycle management, including reagent selection, optimization, stability assessment, and conjugation strategies (biotinylation, fluorescent labeling, and enzymatic conjugation) to enhance assay performance. Led extended ligand characterization using SEC-MALS, CE-Western, and SPR to assess purity, stability, binding kinetics, and structural integrity, ensuring reagent suitability for robust bioanalytical assays.

Hyungseok “Hyu” is a Postdoctoral Associate at MIT's Department of Chemical Engineering. Hyu received his PhD from MIT in mechanical engineering and statistics. He's now working at the Institute's Center for Continuous mRNA Manufacturing, directed by Professors Richard Braatz and Allan Myerson.

Jennifer Knister is a Commercial Product Manager for Process Solutions, at Tosoh Bioscience. Jennifer came to Tosoh in 2023, with over 5 years of experience in downstream process development for mAbs and next-gen proteins. She quickly put her understanding of current purification approaches and challenges to use for the Octave Multi-column Chromatography product line. Her responsibilities have recently expanded to include the entire process product portfolio: TOYOPEARL and TSKgel process resins, SkillPak prepacked columns, and Octave Multi-column Chromatography. Jennifer completed her Bachelors and Masters of Science in Biomedical Engineering at the University of Michigan.

Rishi Ramesh Kothari is a Process Development Engineer at Regeneron Pharmaceuticals, specializing in analytical characterization of gene therapy with a focus on Adeno-Associated Viruses (AAV). He is adept at analytical technologies, ensuring the quality and safety of AAV products. His skill set includes planning and executing assay development, data analytics, and analytical technology transfers. Rishi has experience in high-throughput technologies and automation to enhance efficiency. He holds an M.S. in Biotechnology from Drexel University.

Kat is passionate about making therapies personalized and accessible to more patients faster. She has founded Cell Therapy Manufacturability Program, a precompetitive consortium focused on reducing development and manufacturing timeline and costs and on accelerating standardization in cell therapies. While unlocking the power of AI and large, comprehensive data sets, Kat leverages innovations in Decentralized AI to bring data privacy, confidentiality, security, and control to biomanufacturing to protect biotech and pharma IP and know-how. In addition to the enterprise-level privacy, Kat is an advocate for patient and donor rights to privacy and control of their data. Kat obtained her Bachelor's degree from MIT, did her graduate work at Stanford, commercialized technology innovation across modalities at Thermo Fisher Scientific, Sartorius, and others for over 10 years, and helps companies bring their innovative technologies to market.

Dr. Stephan Krause is currently the Executive Director and Head of Analytical Science and Technology, Cell Therapy Quality, Bristol Myers Squibb. Before, he was Global Quality CMC Strategy Director and External Advocate for AstraZeneca Biologics. He is an accomplished leader of industry quality-focused task forces to improve and standardize best practices. His breadth of exposure to various biological/biopharmaceutical products includes mAbs, ADCs, coagulation factors, vaccines, ATMPs, and biosimilars. He has 20 years of management experience in the development, manufacture, and testing of commercial and clinical biologics. A recipient of various industry awards, Stephan was invited to represent an industry perspective to multiple leading regulatory agencies to support accelerated product development and approval.

Dr. Amit Kumar has many years of experience spanning industry, academia, and global biopharmaceuticals. Currently serving as global process engineering and technology lead for small and large molecules at Moderna Therapeutics, Dr. Kumar leads strategic initiatives across mRNA, DNA, and protein platforms. Prior to Moderna, he held roles at Amgen in process development and commercial technologies. He holds a Ph.D. in Bioscience Engineering specializing in biochemical process from Ghent University, with collaborative research conducted across UMass Amherst, TU Delft, and TU Munich. He completed postdoctoral training in Chemical Engineering at MIT along with Harvard University, specializing in process science and technology. A recipient of more than 25 national and international awards, including the prestigious Marie Curie Fellowship, He is an active contributor to the field through roles on editorial boards, industry ISPE working groups including the community of Biotechnology Practice, and scientific committees.

Christopher Ladd Effio, PhD, MBA, is a Director of Gene Editing CMC at Ionis Pharmaceuticals, where he oversees CMC development strategies for gene editing therapeutics. His work focuses on establishing CMC strategies, managing CDMO partnerships, and ensuring analytical and process readiness for mRNA, gRNA, and LNP platforms. Prior to Ionis, he spent over five years at Moderna in various leadership roles, including Director of Process Development, where he led late-stage CMC activities for rare disease therapeutics and Moderna's personalized cancer therapy platform. He played a key role in the manufacturing strategy for SPIKEVAX and has contributed to multiple regulatory submissions and process innovations. He holds a PhD in Chemical Engineering from the Karlsruhe Institute of Technology and an Executive MBA from Hult International Business School.

Dr. Pin-Kuang Lai is an Assistant Professor in the Department of Chemical Engineering and Materials Science at Stevens Institute of Technology. He received his B.S. and M.S. degrees in Chemical Engineering from National Taiwan University in 2011 and 2013, respectively, and completed his Ph.D. in Chemical Engineering at the University of Minnesota in 2018. His doctoral research focused on developing computational and experimental approaches to study antimicrobial peptides. From 2018 to 2021, Dr. Lai conducted postdoctoral research at MIT, where he investigated antibody stability at high concentrations. Dr. Lai has collaborated with leading pharmaceutical companies, including AstraZeneca, Merck, Sanofi, and Takeda, as well as national laboratories such as NIST and Brookhaven. His work focuses on advancing computational tools, including machine learning and molecular simulations, alongside biophysical characterization methods such as NMR and SAXS, to predict and analyze antibody aggregation and viscosity at high concentrations. He also explores the underlying mechanisms driving these phenomena. In addition to his academic and research endeavors, Dr. Lai serves as an Assistant Editor for the mAbs journal.

Dr. Khai Wooi Lee is a Senior Lecturer at the School of Biosciences, Taylor’s University, Malaysia, specializing in molecular virology and nanobiotechnology. His research focuses on virus-like particles (VLPs), drug delivery systems, and vaccine development. He has contributed to impactful publications, including works on His-tagged VLP purification and influenza vaccine technologies. For more, visit Taylor's University profile https://expert.taylors.edu.my/cv/khaiwooi.lee

Dr. Gihoon Lee is an accomplished researcher with a PhD in Chemical Biology from The University of Chicago and postdoctoral training at Princeton University, specializing in chemical proteomics. With over 16 years of experience, including 4 years in the industry, Dr. Gihoon Lee has developed innovative chemical proteomic technologies that explore cellular signaling networks for novel therapeutic targets. Currently a Senior Scientist at Johnson & Johnson Innovative Medicine, Dr. Gihoon Lee has published nine scientific articles in prestigious journals such as Nature and has filed two patents. Passionate about advancing biotherapeutics production, Dr. Gihoon Lee seeks to leverage expertise in advanced proteomics technology and chemical biology to contribute to groundbreaking research in CHO cell engineering, ultimately enhancing treatment options for patients.

Abigail Lee is an Applications Scientist at Beckman Coulter Life Sciences, where she specializes in the Cydem VT automated clone screening system. With expertise spanning cell viability analysis and clone screening technologies, she brings both technical depth and customer-focused problem-solving to her role. Abigail holds a Master's degree in Biomedical Science and a Bachelor's degree in Biomedical Science with a minor in Chemistry from the University of Northern Colorado. Her experience includes previous work as a Development Scientist at Beckman Coulter, where she contributed to advancing automated cell analysis technologies. She is passionate about collaborating with customers to understand their unique workflows and the underlying science, helping them optimize processes and achieve their research goals.

Seth Levy, PhD, joined Modalis Therapeutics in 2021 as Director of Bioprocess Development to build and oversee internal process development and analytics efforts, as well as manage external manufacturing. Prior to Modalis, Seth lead teams in Manufacturing Science and Technology and Small-Scale Development for AAV and LV manufacturing at Viral Vectors Services. Seth worked in gene therapy R&D before his time at a CDMO and drove numerous AAV projects including basic biology research, capsid engineering, and translational gene therapy approaches at Sanofi Genzyme and academia.

Dr. Lewis is a Professor of Pediatrics and Bioengineering at the University of California, San Diego. He received his BS in biochemistry at Brigham Young University, and his PhD at UC San Diego, where he focused on proteomics and developing novel approaches for analyzing biological big data using genome-scale systems biology modeling techniques. Dr. Lewis completed his postdoctoral training at the Wyss Institute at Harvard Medical School, where he worked on genome editing and the use of systems biology for the interpretation of genetic screens. Dr. Lewis' lab integrates all of his previous work by focusing heavily on the use of systems biology and genome editing techniques to map out and engineer the cell pathways controlling mammalian cell growth, protein synthesis, and protein glycosylation.

Paul Lewus is the head of site operations for Amgen’s new advanced drug substance manufacturing site in Holly Springs, North Carolina. He has over 20 years of biotechnology industry experience leading Process Development, Manufacturing, and Quality functions. He is passionate about hiring and developing the best talent, deploying innovative manufacturing technologies, and commercializing new medicines for the benefit of patients. He has a B.S. in Chemical Engineering from Colorado State University and a Ph.D. in Chemical Engineering from the University of Virginia.

Dr. Huijuan Li is currently the Vice President of Analytical R&D in Vaccine Technology R&D of GSK. She leads the Global Analytical R&D function in support of the entire vaccine portfolio (viral, bacterial, adjuvant as well as mRNA technology) from candidate selection through to commercialization and life cycle management. She leads a team of experts across multiple Vaccines R&D sites in US, Italy and Belgium. Dr. Huijuan Li was the Vice President in Technology Development at Moderna. Over her eight and half year tenure, she focused on building the Analytical Development, strengthen the Analytical Science and Technology for both the internal and external method robustness and lifecycle management in support of the development and commercial operations. Huijuan and her team have successfully supported the development, regulatory filing and commercialization of mRNA-1273 COVID19, mRNA-1345 (RSV) and mRNA-1283 (COVID-19 mNEXSPIKE) vaccines. Huijuan and her team established the analytical control strategy for the Moderna vaccines, therapeutics including the Individualized Neoantigen Therapies, which she and her team defended to regulators and inspectors across the globe. Most recently, Huijuan spent her time on the CMC early development portfolio management, overseeing the planning, execution, and delivery of early-stage development projects from research to Ph1/2. Huijuan has also successfully established, implemented and optimized a Technical Team Lead model and a mentorship program within the Technology Development organization. Prior to join Moderna, Dr. Huijuan Li was the director at Merck Research Laboratory. Huijuan and her team successfully supported the development, regulatory filing and commercialization of two monoclonal antibodies, KEYTRUDA® and ZINPLAVATM. Huijuan also worked at Biotechnology Development at BMS in supporting the manufacturing of ORENCIA®. Huijuan received her BSc and MSc from Lanzhou University in 1990 and 1993; PhD from University of Melbourne, Australia in 1998. From there she pursued her postdoctoral studies in McGill University, Montreal, Canada. VOLUNTEER EXPERIENCE • USP Expert Committee Member (2015-2020, and 2020-2025) • Sino-American Pharmaceutical Professionals Association–New England/Boston (SAPA-NE) Executive Committee Member (2018- 2024) and 26th president (2024-2025) • Member of Amgen Bioprocessing Center Advisory Board (ABCAB) at Keck Graduate Institute (KGI) (2022-2026). • Expert Committee Member of European Pharmacopoeia (Ph. Eur.) Commission mRNAVAC Working Party (2022-2025)

Young Li is a Field Application Scientist for Process Chromatography at Bio-Rad Laboratories serving clients on the east coast of the US and Canada. He has over 25 years of experiences working in various business sectors including the NIH, IAVI, Elanco, Eli Lilly, and Uvax Bio on recombinant proteins, enzymes and mAbs for product development. He received B.S. and M.S. degrees from Fudan University, and Ph.D. from Kyoto University, and had post-doctoral training at the NIH.

Dr. Timothy Licknack has several years of expertise developing LC-MS-based proteomic assays with a strong focus on data quality, instrument upkeep, and practical application of mass spectrometry. At Cygnus Technologies, Timothy is working to advance analytical method development for biopharmaceutical impurity testing. Timothy holds a Ph.D. in Cellular and Molecular Biology from Arizona State University.

Dr. Martin Linhult is currently working at Diamyd Medical AB, Stockholm as a CMC Lead. He is working in scaling up and tech transfer of recombinant processes. Dr. Linhult has over 20 years of industry experience and has been involved in several different BLA and MAA submissions.

Dr. Whitney Liu is the Principal Scientist in the Discovery Biotherapeutics Department at Bristol Myers Squibb, where she leads the development of a high-throughput automated protein production platform for biotherapeutics discovery. She earned her Ph.D. in Microbiology from Nankai University in China, followed by five years of postdoctoral training at the University of California, San Diego, and The Scripps Research Institute in La Jolla, gaining extensive academic expertise in protein sciences. Following her postdoctoral work, Dr. Liu transitioned into the biopharmaceutical industry, where she has spent the past eight years advancing biotherapeutics. With nearly a decade of research experience, she has become a key figure in driving innovation in therapeutic protein discovery. Her combined academic and industry background has made her an essential contributor to the development of life-saving therapies. At Bristol Myers Squibb, Dr. Liu’s focus is on using cutting-edge technologies to enhance the efficiency of biotherapeutic protein production, a critical step in early-stage drug discovery. Her work plays a pivotal role in accelerating the discovery of novel therapies that improve patient outcomes globally. Dr. Liu’s contributions have firmly established her as a leader in the field, helping to shape the future of biotherapeutics discovery.

Dingjiang (Dean) Liu, PhD, is currently Senior Director in Formulation Development Group at Regeneron Pharmaceuticals, Inc. (Tarrytown, NY). Dean’s current work is focused on formulation and drug product development of protein therapeutics and genetic medicines, as monoclonal antibody, bispecific antibody, antibody drug conjugates (ADC), AAV, LNP, and siRNA from research to commercialization. He has successfully led the product development, commercialization, and life cycle management for 6 FDA approved products. In the past 20 years, Dean has accumulated extensive experience in developability assessment, drug product development and manufacturing strategy, shelf-life stability and compatibility, and in-use stability of biological drug products and application of QbD in development of biologics. He has authored/co-authored more than 60 scientific papers and patents. Dean graduated from Fudan University (Shanghai, China) with a BS degree in Chemistry; then from University of Wisconsin-Milwaukee with a PhD in Chemistry and Biochemistry. Dean worked at Schering Plough (now Merck Co.) and Amgen prior to join Regeneron.

Dr. Hao Liu is a Senior Advisor in the BioProduct Research Development at Eli Lilly and Company. Over the past three years, Dr. Liu has been instrumental in designing and developing innovative LC-MS methodologies. These methodologies are crucial for the characterization of therapeutic monoclonal antibodies, antibody-drug conjugates, and antibody-oligonucleotide conjugates. Dr. Liu will particularly share insights on the intact multi-attribute method for the characterization and quality control of therapeutic antibody-oligonucleotide conjugates

Dr. Liu Yingjie, a graduate of National Yang Ming Chiao Tung University, Taiwan, is a preeminent expert in cell and gene therapy (CGT) quality control, with deep expertise in optimizing the stability and efficacy of testing methodologies. With years of specialized experience, she excels in advancing quality control testing for CGT, leveraging cutting-edge technologies to ensure products meet stringent international standards—critical for safeguarding clinical safety and efficacy. Proficient in ChP, USP, and EP, she specializes in optimizing activity detection systems for CAR-T cells, viral vectors, and other CGT modalities, while her background in tumor microenvironment regulation, recombinant metabolism, and cellular molecular mechanisms enables her to establish internationally standardized quality control processes. As Senior Product Manager in ACROBiosystems’ Pharmaceutical Production Quality Control Division, she leads development of QC products for emerging therapies like antibody drugs and mRNA, addressing their unique needs. Through cross-functional collaboration with scientists, engineers, and industry experts, she delivers regulatory-compliant, state-of-the-art solutions to global pharmaceutical enterprises, driving the translation and commercialization of innovative therapies and solidifying her role as a key contributor to the global biotech landscape.

Andreja is the Head of the Process Analytics Development department at Sartorius BIA Separations. She leads a team focused on advanced chromatographic solutions, involving the development of innovative chromatographic analytical methods for analyzing biological molecules, including viruses, pDNA, mRNA, and LNPs. Throughout her career with biotech companies, she has gained extensive experience in protein chemistry, including characterisation of biosimilars and biologics. She holds a Master of Science in Biochemistry from the University of Ljubljana, Slovenia.

Gisel Lopez is an Associate Scientist in the Process Development group at Gilead Sciences in Oceanside, CA. She received her B.S. in Bioengineering from the University of California, San Diego and her M.Eng. in Biopharmaceutical Processing from Keck Graduate Institute. In her current role, Gisel develops upstream processes with a primary focus on late-stage programs and supports manufacturing activities for commercial products.

Kristina Lopez has over 18 years of experience in biopharmaceutical development and data science technologies. She earned her Bachelor of Science in Biology from Boston College and her Master of Science in Microbiology and Molecular Genetics from Rutgers University. Kristina is currently pursuing an MBA in Artificial Intelligence and Machine Learning at Villanova University. In her current role as Senior Director of Analytical Operations at Johnson & Johnson Innovative Medicine, she spearheads transformational digital strategies, including hands-free intelligent automation, to drive innovation, enhance operational efficiency and accelerate biopharmaceutical development.

Dr. Xiaohui Lu is the Executive Director of Analytical Development in Ultragenyx Gene Therapy, overseeing analytical activities for the development of Ultragenyx’s gene therapy products. Before join Ultragenyx, Dr. Lu was a Director of Analytical Development in CRISPR Therapeutics. Dr. Lu spent 8 and a half years in Analytical Development at Biogen from 2009 to 2018, leading bioassay development and process-related impurity assay development for biologics and gene therapy programs. Prior to joining Biogen Idec, he was Senior Research Scientist at Ariad Pharmaceuticals in Cambridge, MA from 2007 to 2009. Dr. Lu received his Ph.D. in Biochemistry from Dartmouth Medical School, and had post-doctoral training at the Whitehead Institute.

Dr. Lutzko has over 30 years of experience in the field of cell and gene therapy. She has held faculty positions at University of Southern California (2005-2010) and University of Cincinnati (2010-2025), most recently as Professor of Pediatrics. Her research focused on the preclinical development of a wide range of cel-l and gene-based therapeutics for hematologic and genetic diseases and cancer. While in Cincinnati she held multiple leadership roles at Hoxworth Blood Center Cellular Therapies and Cincinnati Children’s Hospital Applied Gene and Cell Therapy Center (formerly the Translational Core Laboratories). She is currently the Scientific Director of the Connell and O’Reilly Families Cell Manipulation Core Facility at Dana Farber Cancer Center where she is focused on the translation of new cell and gene based therapies into FDA approved Phase I/II clinical trials.

Rohit Mahajan, PhD, is Vice President of Analytical Development and Quality Control at Arcturus Therapeutics. Dr. Mahajan is responsible for overseeing the analytical strategy for characterization, release testing, and stability testing of mRNA drug substances, novel lipids, and LNP drug products. Prior to Arcturus, he worked at Emergent BioSolutions, Inc. (formally PaxVax, Inc.), where he managed development and tech transfer of analytical methods for a variety of vaccine platforms including nanoparticles, viral vectors and in vitro produced virus-like particle products. Prior to that, Dr. Mahajan spent 20 years at Vical, Inc. developing new assays for potency, safety, and cleaning validation to support GMP manufacturing of DNA vaccines. Dr. Mahajan has been involved in multiple IND and drug product approval regulatory filings in the US, Europe, and Japan. Dr. Mahajan earned a PhD from Weill Cornell Graduate School of Medical Sciences in New York City and completed his post-doctoral studies at The Scripps Research Institute in La Jolla, California.

Juergen is the co-founder of enGenes Biotech, leveraging his deep expertise in genetic and bioprocess engineering, as well as continuous bioproduction and plasmid DNA production. He previously worked as a Research Associate at the University of Natural Resources and Life Sciences (BOKU), Vienna, Austria. Before founding enGenes Biotech, Juergen held a Postdoctoral position at the Austrian Centre of Industrial Biotechnology (ACIB GmbH), where he contributed to the 'Microbial Cell Design' research initiative, focusing on sequencing and engineering various host strains for the production of recombinant proteins. In addition to his work on continuous bioproduction processes and plasmid DNA production, Juergen has authored numerous peer-reviewed scientific publications and book chapters. He has also received advanced training in Systems Biology and genome-scale stoichiometric modeling from the University of Iceland and in Microbial Genomics and Transcriptomics from the University of Bielefeld. He holds a PhD in Biotechnology from the University of Natural Resources and Life Sciences, Vienna, Austria.

Sean Marnane is a biopharmaceutical technical leader with deep expertise in manufacturing operations, technical support, and CMC lifecycle management across both autologous and allogeneic cell therapies. In his current role, he works to support the development, transfer and clinical manufacturing of a novel B Cell Therapies. Sean brings a strategic and hands-on approach to enabling the development and delivery of next-generation cell and gene therapies.

Cydney Martell completed her Bachelor's degree in Chemistry at Kalamazoo College and is currently a PhD candidate in Gabriel Rocklin’s lab in the Pharmacology Department at Northwestern University. Her research focuses on investigating the biophysical determinants of protein aggregation to better understand and predict aggregation resistance.

35+ years researching the enzymology of T7 RNA polymerase. Postdoc, Yale Univ; Ph.D., California Institute of Technology

Dr. Erik Martinsson, CEO and Co-founder of ArgusEye AB, has over 15 years of experience in researching and developing optical sensors utilizing nanoplasmonic detection. He holds a Master’s degree in Chemical Biology and earned his PhD in Molecular Physics from Linköping University in 2014.

In 2017, Dr. Martinsson and his research team founded ArgusEye AB, a spin-off from Linköping University where pioneering research on optical biosensors began in the 1980s. Dr. Martinsson remains committed to transforming bioprocessing by developing cutting-edge sensor systems for the biopharmaceutical industry.

Dr. Marcia Mata is an experienced Biological Engineer with a PhD in Biotechnology from Instituto Superior Técnico (Lisbon, Portugal). As Programme Head of Automation at the Cell and Gene Therapy Catapult, she brings extensive expertise in bioprocess automation and engineering to lead the strategic implementation of innovative automation solutions across key therapeutic platforms—including allogeneic, gene delivery, and immunotherapy programmes. Her work focuses on streamlining bioprocessing through scalable, data-driven technologies, with a strong emphasis on digital integration, process control, and smart manufacturing. This includes the adoption of advanced Process Analytical Technologies (PAT) and associated analytics to enhance process understanding, monitoring, and control in the cell and gene therapy field.

I graduated from Worcester State University with a double major in both Chemistry and Biology. I started my career working at Abbvie in Worcester, moving to Acceleron and now at Novartis. Over the past ten years, I have worked on multiple LC- and CE-based techniques for multiple therapeutic modalities including biologics, conjugates, and cell and gene therapies.

Dr. Mukesh Mayani is a Senior Director in Global CMC Development for Gene Therapy at Ultragenyx Pharmaceuticals, Inc., based in Woburn, MA, USA. In his current role, Dr. Mayani leads the Downstream team and overseeing the Downstream and Formulation support of late-phase and commercial-ready Gene Therapy programs. Prior to joining Ultragenyx, Dr. Mayani led Upstream, Downstream, and Pilot teams for Gene Therapy Process Development (PD) at Resilience. He also played a key role in AAV and LVV Downstream PD within the Gene Therapy CMC organization at Sanofi, USA. Dr. Mayani's earlier experience includes working at Cytiva, Bristol-Myers Squibb (BMS), and Therapure Biopharma (now Resilience), where he contributed to the development of viral vectors, monoclonal antibodies (mAbs), RNA-based vaccines, and other biopharmaceutical modalities. Dr. Mayani holds a PhD in Chemical Engineering and is a licensed Professional Engineer, with nearly 18 years of industry experience.

Mam Mboge obtained a Bachelor of Science degree in Biology with a specialization in Research from St. Thomas University in Miami Gardens, Florida. Before enrolling into a graduate program, Mam worked for 3 years as first a Research Associate at the University of Miami and later as a Laboratory Technician at Nova Southern University. In 2018, Mam graduated with a PhD in Biomedical Science from the University of Florida’s (UF) Cancer Biology program. Her dissertation project focused on studying the role of carbonic anhydrases in breast cancer metabolism, growth, and progression. Mam accepted a Postdoctoral position in Lawrence Berkeley National Lab before joining Pfizer in December of 2020. In her current role, Mam works on multiple cell line development projects that span the portfolio, technology and innovation space and is also involved is several leadership roles within the organization.

Prof. Menegatti has earned his Ph.D. in Chemical Engineering at NC State University in 2013, with a project on affinity purification of protein therapeutics using peptide affinity ligands (advisor: Dr. Ruben Carbonell). After 2 years as a postdoctoral fellow working on drug delivery technology in the group directed by Dr. Samir Mitragotri at UCSB (now Harvard University), Dr. Menegatti rejoined the Department Chemical Engineering at NC State University as an assistant professor in 2015. Dr. Menegatti has made key contributions in bioseparations: he has introduced the new paradigm of “affinity flow-through chromatography” for continuous purification of therapeutic antibodies; he has invented and patented single-use adsorbents for plasma fractionation, and purification of CRISPR-Cas nucleases and other therapeutic proteins; he has developed novel, rapid at-line assays to support continuous bioprocessing; and designed novel biomaterials for drug delivery and tissue engineering. This intense research activity has translated into numerous impactful publications, patents, and invited lectures in universities and industries. Prof. Menegatti is highly recognized by the academic and the industrial communities alike, and has established a broad network of collaborations with distinguished scholars across three continents (US, Europe, and Australia). He also leads joint research projects with and consults for global companies including Merck & co., Genentech, Merck KGaa, CSL Behring, Millipore Sigma, KBI Biopharma, Johnson and Johnson, and Eastman Chemical Company. He was the key contributor to the $27M AIM-Bio research instituted funded in 2019 by the Novo Foundation (https://news.ncsu.edu/2019/08/future-of-biomanufacturing/). Dr. Menegatti has also established himself as a successful entrepreneur, pursuing the translation of his technology to broaden the access of patients of advanced biological therapies. His IP portfolio has been licensed to private companies - such as LigaTrap, for which he serves as main scientific advisor - and is now being converted into commercial products. Prof. Menegatti is actively engaged in a number of outreach activities in North Carolina: he co-chairs the Triangle Soft Matter Symposium, and collaborates with the NC Biotech Center, the NC Center of Innovation Network, and the UNC Institute for Convergent Science.

Andre is the Sr. Product Manager for Aunty & Honeybun at Unchained Labs. His expertise covers fluorescence, static light scattering, and dynamic light scattering for biophysical characterization of proteins and viral vectors. His research experience spans from structural biology to plant physiology and across labs in Germany, Sweden, Denmark, and the USA. Andre earned his PhD at the Carlsberg Laboratory and had a post-doc appointment at Stanford University.

Partha S. Mukherjee, Ph.D., Head CMC Analytical Development, Amicus Therapeutics During 29 years, Partha has worked at Pfizer, AstraZeneca, GlaxoSmithKline, Novartis, Bristol Myers Squibb, Merck, and Endo to cover branded, generics, and OTC products. His R&D leadership roles include Cardiovascular, CNS, GI, Pain and Inflammation, Oncology, Respiratory, Antibacterials, Rare Diseases, Oral, Nutrition, and Smoking Cessation. He led or contributed to 22 IND, 15 NDA, 3 BLA, 4 ANDA, 21 commercial global products, and 110 development projects in various dosage forms. Partha rolled out several R&D Centers of Excellence. He has 15 publications and 45 presentations. Partha obtained his Ph.D.from Virginia Commonwealth University. He has chaired numerous scientific R&D symposia and workshops and has obtained R&D Awards in Innovation and Leadership Excellence. He is a member of the USP Expert Committee, BIO, BioPhorum, Scientific Reviewer of WHO, and Working Group Members of International Consortium on Quality (IQ). Partha is also a Corporate Alliance Ambassador of IndoUSrare, a nonprofit global organization.

Dr. Nesredin A. Mussa is a seasoned biopharmaceutical executive with over 24 years of experience in the development and commercialization of traditional biologics and advanced medicines, encompassing protein therapeutics, mRNA, and gene therapy platforms. Currently, Dr. Mussa serves as the president of Dynamica Biologics LLC, a consulting firm specializing in CMC, drug development, and operations. Throughout his career, he has led global development teams and established numerous biological process analytics, analytical development, and QC labs. Dr. Mussa's experience spans multiple global pharmaceutical and leading small biotech companies, where he has led and supported CMC for several IND, BLA, and NDA filings. His current focus includes supporting biologics BLA applications, IND enabling studies for gene therapy, and biologics CMC training for global regulatory agencies and academic institutions. Dr. Mussa holds a PhD in Protein Biochemistry and a Master's in Clinical and Analytical Biochemistry.

Janet is an mRNA Analytical Development Scientist at Sanofi’s mRNA Center of Excellence in Waltham, MA, where she develops and optimizes UPLC-CAD methods for lipid quantitation and identification in mRNA-LNP formulations. She integrates her background in organic synthesis to investigate lipid degradation pathways and design stability-indicating methods that support process development and regulatory readiness for RNA-based therapeutics.

Bella Neufeld is the Vice President of Operations and is responsible for the manufacturing of all catalog and custom reagents across Teknova’s vast portfolio of research- and GMP-grade products.

Most recently, Bella was Teknova’s Director of Research and Development, where she built and managed a gene therapy bioprocessing research program utilizing viral delivery systems for the development of novel products and solutions to help customers accelerate their breakthroughs. Through her leadership, Teknova introduced their first proprietary product line for AAV gene therapy development — AAV-TekTM Solutions — based on the findings from her research program, and successfully launched a suite of innovative products designed to streamline and accelerate development across the entire gene therapy workflow.

Bella had previously assembled Teknova's first internal R&D team during her role as Teknova's Scientific Director, when she led the rapid development of a novel transport media for Covid-19 testing. She also oversaw the building of Teknova’s new, state-of-the-art research laboratory. Originally joining the company's Quality organization in 2018, Bella expanded their scientific capacity by increasing their testing capabilities through instrumentation and new techniques.

After graduating with a Bachelor of Science degree in Chemistry from Sonoma State University, she earned her PhD in Chemistry from Colorado State University (CSU) where she set up and maintained two bacterial and tissue culture laboratories for studying drug delivery systems, including solid substrate and nanoparticle platforms. Bella actively presents her latest findings at industry events and her research is regularly featured in industry journals and publications.

Jay Newman has over three decades of commercial experience that includes gene and cell therapy, traditional pharmaceutical and biotechnology. Most recently, Jay led Spark Therapeutic’s Commercial Development, Pricing & Reimbursement for Spark’s assets in early stage (pre-clinical) through clinical development. As a founding member of Spark Therapeutics commercial team, Jay was responsible for the payer strategy for LUXTURNA®, the first gene therapy approved in the US. His vision, focus, creativity and ability to operationalize creative solutions resulted in the first innovative payment model called the Spark PATHSM. Spark PATH aims to advance patient access to care while balancing the needs of the stakeholders. Within two years of launch, Jay assumed responsibility for the US P&L, leading all aspects of Spark’s US Commercial business that included Diagnostics (genetic testing), Sales, Patient Services, Zone and Commercial Operations, Brand Marketing, and Market Access. Under Jay’s leadership of the US Commercial organization, Spark tested over 50,000 individuals for the potential genetic cause of their Inherited Retinal disease while ensuring patients have access to treatment. Jay is passionate about the reform of payment models that will sustain patient access to complex therapies in the future. He actively participates in numerous industry speaking events and is currently a strategic advisor to clinical stage start ups. Previously, he led Biogen’s payer and channel marketing team which included multiple sclerosis, hemophilia, and a rare disease. Prior to Biogen, Jay spent 24 years at Allergan in roles of increasing responsibility in the commercial organization across multiple disease areas. Before his tenure at Allergan, Jay spent five years in the U.S. Army, achieving the rank of Captain. Jay earned a bachelor’s degree from Lock Haven University of Pennsylvania and is a two-time finisher of the NYC Marathon with a Personal Best of 3:48:15.

Dr. Siemon Ng is an expert in CMC and analytical development with experience in designing analytical strategies for biologics. He previously served as Senior Director of Analytical Development and Quality at Notch Therapeutics and as Head of the Molecular Biology Center at Sanofi, where he led the implementation of advanced methods, including next-generation sequencing (NGS), digital PCR, MSD, BLI, and a range of other molecular, biochemical, and immunological assays. He is an active member of the PDA Advanced Virus Detection Technologies Working Group (AVDTWG) and has contributed to multiple collaborative studies as well as the development of regulatory guidance supporting the application of NGS for viral safety.

After earning his BS degree in Biochemistry from the University of Massachusetts in Boston in 2012, Tai joined the Analytical Development department at Biogen where his work focused on compendial and chromatographic assays for monoclonal antibodies. Over the years he acquired additional experiences working across modalities such as AAV gene therapies, and more recently antisense oligonucleotides where his work focuses on mass spectrometry-based assays for the characterization of these products.

Anastasia Nikolakopoulou was a graduate student at the group of Professor Richard D. Braatz at the Massachusetts Institute of Technology (MIT). She received a Diploma in Chemical Engineering from the National Technical University of Athens, Greece, and an MS in Chemical Engineering Practice and a PhD from MIT. Her research is in the optimization and control of modular manufacturing systems, state estimation and control of nonlinear dynamical systems, and model predictive control of distributed parameter systems. In 2021 Anastasia moved to an industrial position in the pharmaceutical industry. Currently she is Senior Data Scientist at Sanofi focusing on advanced control and optimization of downstream biomanufacturing.

Theresa O’Brien is a Senior Scientist working at Sanofi in Framingham, MA. Theresa received her Bachelor’s of Science degree from The University of Massachusetts, MA. She joined Sanofi (previously Genzyme) in 1997, with focus on development of residual Host Cell Protein Impurity assays to support a number of drug development programs.

Emily O'Driscoll recently completed her PhD in Ophir Shalem's laboratory at the University of Pennsylvania, which focuses on the development and use of functional genomic tools to understand how perturbations in proteostasis contribute to neurodegenerative diseases. Emily's thesis work involved large-scale CRISPR screens for neurodegenerative phenotypes and therapeutic strategies, including a screen for genetic regulators of rAAV production.

Jeff Odum, CPIP, is a globally recognized SME in Biomanufacturing Facilities with over thirty years of experience in the development, design, construction, and delivery of facilities in the biotechnology Industry. A recognized expert in biopharmaceutical manufacturing assets, Mr. Odum has authored over 60 published articles and four Industry reference books on subjects related to biopharmaceutical manufacturing facility assets. He is a recognized speaker at international industry forums and conferences, presenting on topics relating to next generation facility design, bioprocess manufacturing, project development, and GMP compliance. Mr. Odum, a Certified Pharmaceutical Industry Professional (CPIP), served as the North American Education Advisor to the International Society of Pharmaceutical Engineering (ISPE), past Chair of the ISPE Global Biotechnology Community of Practice, and a contributing author to numerous industry baseline and reference guides focused on ATMP and biotechnology manufacturing, process development, project delivery. He is a member of the ISPE Technical Training Faculty and is a Teaching Fellow in North Carolina State University’s BTEC graduate program in biomanufacturing. He has led training efforts in fifteen countries in over 100 sessions, including training for global regulators from the US FDA, Health Canada, Thailand FDA, FDA-COFEPRIS, and the Chinese SFDA.

Michael Orrico is an Executive-in-Residence at the Advanced Regenerative Manufacturing Institute (ARMI) in Manchester, NH focusing on commercialization of ARMI’s cell manufacturing technology and that of its members. He has led R&D and Manufacturing at tissue engineering and regenerative medicine organizations for over 25 years including the Cryobiology Lab at MIT, Axogen, and Aastrom Biosciences (now Vericel). Mr. Orrico is an Executive Committee Board Member of the Standards Coordinating Body (SCB) for Regenerative Medicine. He holds graduate degrees from MIT and Columbia Business School.

Jianfa is a Principal Scientist in the Cell Culture team at the Creavis Innovation Satellite at Evonik, where he drives bioprocess improvements, including media optimization. Jianfa holds a PhD in Biomedical Engineering from the University of Alabama at Birmingham, with extensive experience on biologics drug discovery and cell culture process development. Through six years in the Upstream Process Development groups at Bristol Myers Squibb and Boehringer Ingelheim, he led the development of multiple biologics molecules through both early stage and late stage, using CHO cell and other mammalian cell culture techniques.

Jill received her BS in Biochemistry and MS in Biotechnology at Northeastern University. Since joining Pfizer in 2015, Jill has been a member of the downstream team within the Bioprocess Research and Development department. Jill has had the opportunity to contribute to multiple biologic processes in early and late-stage development across modalities. Jill also has a strong interest in high-throughput purification technologies and automation of workflows.

Roger Pak is a Research Fellow in the BioTherapeutics Pharmaceutical R&D department of Pfizer, Inc. located in Andover, MA. He has more than 25 years industrial experience working at Bristol-Myers Squibb, Infinity, Wyeth and Pfizer. Prior to that, he was an NIH Postdoctoral Fellow at the Univ. of California - Davis and he received his Ph.D. in Chemistry from UCLA. Dr. Pak specializes in drug delivery technologies, and within Pfizer, he’s led many efforts on lipids, polymers and conjugation technologies related to nanoparticles and biotherapeutic drug delivery. He led the team responsible for the novel lipid excipients used in Comirnaty®.

Shyam Panjwani is a Principal Data Scientist in CMC Digital Transformation & Data Science department, Bayer Pharmaceuticals. He has been with Bayer since 2017. He performs process data analysis, modeling and model deployment to support Bio-pharmaceutical manufacturing and process development. Shyam has a PhD in Chemical Engineering from the University of Houston and Bachelor of Engineering in Chemical Engineering from the Indian Institute of Technology, Kanpur. His PhD research was in the application of data-driven modeling techniques for energy industries. Prior to joining Bayer, he worked as a Data Scientist with Halliburton, Houston. Outside work, Shyam likes to write poetry and spend time for social volunteering.

Mr. Swapnil Pansare is Director at AstraZeneca and in his current role, he is the MSAT process lead, responsible for evaluating new technologies for mfg. site and leading tech transfers for clinical cell therapy products. Swapnil has 16+ years of experience in Cell and Gene Therapy and Biologic modalities for clinical and commercial manufacturing. He is a key leader of newly built cell therapy manufacturing site within AstraZeneca and currently leading tech transfers of late-stage clinical assets to the manufacturing site. In his previous role, Mr. Pansare was responsible for development and life cycle management of clinical and commercial cell and gene therapy and biologic products. He has received his MS in Pharmaceutical Sciences from Northeastern University.

Jin is an Associate Director of Analytical Development at Ultragenyx. Her work focuses on assay development, troubleshooting, and providing support for internal and external projects related to the biophysical characteristics of AAV, and other Ultragenyx pipeline product. Her team handles various techniques including AUC, MALS, HPLCs, DLS, CE-SDS, iCIEF, LC-MS, etc. Prior to Ultragenyx, Jin worked for many years at Takeda Global Gene Therapy, Takeda Vaccine, Charles River Laboratories, and Sanofi. She has extensive experience in building biophysical profiles for viral and non-viral gene therapy products, vaccines, biologics, and small molecules.

Krishna Patel is a Purification Development Scientist at Sanofi based in the Boston area. With specialized expertise in Ultrafiltration/Diafiltration (UFDF), Krishna has successfully led Viral Clearance studies, process characterization, and resin lifetime studies that enhance purification efficiency. Krishna also serves as a Product Owner in Sanofi's CMC digital transformation initiative, combining scientific knowledge with strategic insight to drive innovation in biologics manufacturing processes. Krishna holds a B.S. in Chemical Engineering from UC Irvine, an M.S. in Chemical Engineering from UC Berkeley, and an MBA from the University of Louisiana, Lafayette.

Ravi Patel is our resident expert in in our Smart object technology, a graduate of Rutgers University, Ravi has been with COPA-DATA since 2021. Besides being an expert for several manufacturing industries Ravi is also a part of the professional services team an invaluable bonus for our customers.

Purbasa Patnaik has over a decade of industry experience specializing in Biologics formulation, Drug Product development and GMP manufacturing. Currently at Exelixis, Purbasa spearheads the drug product development and manufacturing initiatives for various early-phase biologics across diverse domestic and international Contract Development and Manufacturing Organizations (CDMOs). Prior to Exelixis, Purbasa made significant contributions at NGM Bio, directing the development and manufacturing of oncological and ophthalmic biologics navigating unique challenges with expertise and innovation. At Harpoon Therapeutics (Merck), Purbasa served as an instrumental early team member, leading the formulation development efforts pivotal in securing IND approval for Harpoon’s pioneering T cell engager. Purbasa's journey through the biotech landscape also includes roles at Cook Pharmica (acquired by Catalent), Bayer and Eli Lilly. Throughout her career, she's passionately advanced novel oncology therapeutics, driving innovation in drug product development and manufacturing. Purbasa holds a Master's in Biotechnology from Northwestern University, USA and a Bachelor's in Biotechnology from India.

Nejc is a Project Manager in Analytics development department at Sartorius BIA Separations, for 5 years. Nejc has extensive experience in analytics development for different biological molecules such as pDNA, mRNA, LNPs, etc., intended for therapeutically use. He managed several projects for clients, mainly in field of new generation gene therapy products. He holds a PhD in Chemistry from the University of Ljubljana, Slovenia

Laura Pereira Diaz joined Takeda in 2023 as a Digital CMC Scientist, where she leverages her expertise to drive innovation and excellence in the field. Laura holds a PhD in Pharmaceutical Sciences and Biomedicine from the University of Strathclyde, UK, with a specialization in machine learning, artificial intelligence, and digitalization.

Dr. Perilla serves as an Associate Professor in the Department of Chemistry & Biochemistry at the University of Delaware. He earned his Ph.D. in 2011 from Johns Hopkins University, where his research focused on applying transition state theory to significant conformational changes in proteins. Following this, he joined the University of Illinois at Urbana-Champaign to conduct in silico studies of entire viruses under physiological conditions. His work emphasizes developing physical and chemical methodologies to comprehend biological processes associated with life and disease. His research encompasses a range from quantum-mechanical calculations to mesoscale simulations, utilizing the computational capabilities of petascale (and upcoming exascale) supercomputers. Prof. Perilla’s team has also pioneered comprehensive molecular simulations of viral components, contributing to the advancement of a robust statistical analysis framework. He has published over 50 peer-reviewed papers, appeared on 11 journal covers, and contributed to three book chapters. His research is funded by NIH grants R01AI178846, R01AI157843 and U54AI170791. Outside of academia, Dr. Perilla is an enthusiast of sports such as squash and bike touring.

Nick Pittman brings over two decades of expertise in mass spectrometry and liquid chromatography, with a strong focus on applying Waters’ analytical technologies to biopharmaceutical research and development. With 13 years at Waters in a variety of roles spanning business and technical domains, Nick has developed deep insights into both the science and strategy behind analytical solutions. Prior to joining Waters, he spent 10 years at Pfizer UK, where he specialized in LC and LC-MS techniques to support drug development efforts

Jeff has over six years of experience in bioprocessing proteins and viral vectors, specializing in formulation and downstream platform development, process characterization, tech transfer, and GMP manufacturing. He is currently a Senior Scientist at Spark Therapeutics, where he leads formulation and drug development efforts to enhance the long-term stability of AAVs in both liquid and frozen states. His work leverages high-throughput methodologies for design, execution, and characterization. Before joining Spark, Jeff was a protein engineer focused on developing novel protein compartments to encapsulate biological pathways and metallopeptides capable of electron transfer. He earned his PhD in Chemistry from the University of Michigan.

Maria del Carme Pons Royo is a bioprocess engineer with experience in development and optimization of biotechnological products. She completed her bachelor's degree in biotechnology from Universitat Autonoma de Barcelona, followed by a master's degree in Life Science and Technology from TU Delft. Recently, she successfully defended her PhD thesis at BOKU, titled "Millifluidic devices to accelerate process development with a primary focus on protein precipitation and filtration." Currently, she is employed as a postdoctoral researcher at MIT, where she continues her research on the development and optimization of innovative bioprocesses utilizing cutting-edge prototyping tools.

Tilen Praper holds a PhD in Biochemistry and Molecular Medicine from the Faculty of Medicine at the University of Ljubljana. He has over 15 years of experience working in various roles within Analytical Development at Novartis and currently serves as the Associate Director of Analytical Experts. In addition to his work at Novartis, Tilen is a guest lecturer at the Faculty of Pharmacy, where he teaches about CQA assessment and analytical methods for biotherapeutics. Outside of his professional life, he enjoys hiking, rock climbing, and tourist cycling.

Yossi Quint is the CEO and founder of Ark Biotech. Prior to Ark, Yossi worked at McKinsey as an Engagement Manager. Yossi began his career at a quantitive hedge-fund as a modeler. He is a graduate of Princeton University.

David A. Ramirez Cadavid is a Senior System Design Engineer at Thermo Fisher Scientific’s Bioprocessing Collaboration Center (BCC) in St. Louis, MO. Since 2022, he has been dedicated to developing innovative, automated processes aimed at enhancing the production of monoclonal antibodies (mAbs), with a strong focus on process intensification. Prior to this role, he served as a Principal Researcher in bioprocess development at The Ohio State University, where he led projects on biomaterials and bioproducts in collaboration with academic institutions and industry partners. Dr. Ramirez has also worked in research and development positions at various biotech startups, including Kultevat, Green Arrow, and EnergyEne. He holds a Ph.D. in Biological Engineering, specializing in bioprocess development and optimization, biomaterials and bioproducts, as well as techno-economic analysis. Dr. Ramirez applies a multidisciplinary approach to the design and innovation of bioproduction systems.

Phillip Ramsey is the Senior Vice President of Technical Operations at Sangamo Therapeutics where he oversees manufacturing, technical development, supply chain and quality. He has over 35 years of experience in biotech and pharmaceutical operations, development, and quality and has been active in multiple therapeutic areas including autoimmune, cardiovascular, central nervous system, emerging infectious diseases, oncology, rare genetic diseases, and vaccines. Prior to joining Sangamo, Phillip was Senior Director at Emergent BioSolutions where he played a key role in the design and construction of a 85,000 square foot award winning commercial facility, as well as Leidos where he was a part of the development of a 130,000 square foot vaccine pilot plant for the NIH. Additionally, Phillip has contributed to multiple regulatory submissions for product approval and more than 50 investigational new drug submissions. Phillip received his B.S. in Chemistry and Physics from the University of Nebraska, an MBA with a specialty in regulatory sciences from San Diego State University, and his M.S. in Biochemistry from John Hopkins University.

Matt is a Senior Applications Scientist in the Market Development team at Refeyn. He has over 10 years of industry experience in small-molecule drug discovery campaigns and developing gene editing technologies. As a protein scientist, Matt has worked with various classes of proteins including GPCRs, enzymes, multimeric complexes, and ribonucleoprotein complexes. Matt holds a PhD in Biochemistry from the Universtiy of Connecticut, where he studied the application of photoactive proteins in biophotonic devices.

Baley Reeves was appointed interim director in 2023 and currently leads NCTM’s mRNA project initiatives. She has over 15 years of experience in downstream processing and over 11 years of experience in biomanufacturing workforce training, and has expertise in the recovery and purification of recombinant proteins, vaccines, and gene therapy products, as well as experience in cGMP manufacturing and process development. Prior to joining NCTM, Baley was a senior scientist at the Biomanufacturing Training and Education Center (BTEC), where she developed and taught courses for biotech industry leaders, regulatory agencies, and the WHO. She has also worked on numerous vaccine-related projects, including a global survey of the vaccine manufacturing landscape with the Bill and Melinda Gates Foundation. Baley holds a Ph.D. in chemical engineering from Princeton University, where she was a National Science Foundation Graduate Fellow. She has authored articles on protein purification in Trends in Biotechnology, Protein Science, Protein Expression and Purification, and Microbial Cell Factories, as well as articles on biomanufacturing training and education published in Chemical Engineering Education.

Jennifer Reid is a Senior Scientist in Global Bioprocess Development at Sanofi Vaccines in Toronto Canada. At Sanofi, she incorporates new-process analytical technologies and automation solutions to improve drug substance yield and operational efficiency in upstream processes. Jennifer has a PhD in biochemistry, with experience in bioinformatics.

Jian Ren serves as a Principal Scientist in the Manufacturing Science and Technology (MSAT) organization at AbbVie Bioresearch Center, located in Worcester, MA. She leads a team of senior scientists in process technology transfer, validation, and manufacturing support activities for downstream manufacturing processes related to late-phase and commercial biologics programs, including monoclonal antibodies, bispecific antibodies, and fusion proteins. With over 8 years of industrial experience, Jian possesses extensive expertise in biologics purification process development, scale-up, tech transfer, GMP manufacturing, process characterization, validation, regulatory filing, and CMC management. She has worked on the downstream process development for more than 15 biologics programs prior to joining MSAT. Before her tenure at AbbVie, her research focused on developing and optimizing polymeric membranes and modules for diverse separation applications. Jian holds a PhD in Chemical Engineering from the University of Connecticut.

Lyndi Rice, PhD is the Head of Gene Therapy Analytical Technologies (GTAT) at BioMarin, focusing on analytical strategies from early phase development through commercialization for gene therapy products. GTAT works closely with Technical Development teams, CMC, Regulatory, site QC, QA, and several other departments to streamline method development, optimization, transfers and validations, and to platform methods with a focus on method lifecycle strategies. Previously, she served as Head of QC Viral Vector Analytical at BioMarin and has been with the company for almost four years. Her team focused on routine testing and method life cycle management for gene therapy products, including method transfer, validation, and optimization work. Prior to BioMarin, Lyndi was the Director of Analytics at the Gene Therapy Program (GTP), University of Pennsylvania, where she led multiple teams that conducted analytical development and QC release of toxicology and GMP material. Prior to GTP, she spent nearly a decade working at a biotechnology company where she oversaw a team that worked on oncology and cardiovascular disease therapeutics, spanning target identification/validation through pre-clinical development.

Dr. Sarah Richer holds a BS in Chemistry from Wheeling Jesuit University and a PhD in Biochemistry from Indiana University Bloomington. She has worked at Eli Lilly and Company for the past 10 years and is currently a Director in Bioproduct Research and Development. She leads a team in Analytical Development that specializes in PCR and Immunoassay development with focus in the past few years in the AAV gene therapy space.

Anne Skaja Robinson is Trustee Professor of Chemical Engineering at Carnegie Mellon University, where she served as Department Head from 2018-2023. Robinson has earned many honors, including a DuPont Young Professor Award, a National Science Foundation Presidential Early Career Award for Science and Engineering, and, most recently, the 2022 Marvin Johnson Award from ACS BIOT. She is also a fellow of both the American Institute for Medical and Biological Engineering, and the American Institute of Chemical Engineers. She has graduated over 30 PhD students and published over 100 journal articles on protein expression and protein refolding.

Christopher Rold has served as Vice President of Vector Development, Analytical Development, and Quality Control at Adicet Therapeutics since 2022. He leads development for release, characterization and potency program development for both Adicet's clinical programs ADI-001 and ADI-270. Prior to joining Adicet Christopher was a Principal Scientist at TCR2 Therapeutics where he developed the viral vector programs for TC-110, TC-210, and TC-510.

Dr. Irene Rombel is the CEO, President, and Co-Founder of BioCurie, a TechBio startup company that is harnessing AI to transform the process development and manufacturing of cell and gene therapies. She is deeply committed to transforming great science and technology into disruptive products that will help patients and society, while creating shareholder value. Dr. Rombel is an industry veteran and entrepreneur with 25+ years of leadership experience in science and business, spanning biotechnology, big pharma, consulting, investing, and academia. Prior to founding BioCurie, she was Chief of Staff, Research, at Spark Therapeutics, a leading gene therapy company, and Senior Director of Strategy and External Innovation at Janssen, J&J. Irene was previously the Founder and President of Biomedical Intelligence LLC, a life science consulting company, and a biotech hedge fund analyst. Dr. Rombel started her career in academia as an Assistant Professor at UT Southwestern Medical Center in the Center for Biomedical Inventions, where she conducted research on DNA vaccines, synthetic biology, and cell-specific targeting. Prior to her faculty position, she was a postdoctoral fellow at UC Berkeley and UC Davis, where her research on transcriptional regulation made fundamental scientific contributions to the understanding of promoter-enhancer control of gene expression. Dr. Rombel has advised and mentored many start-up companies over the past 20+ years, serving as a JPAL for the J&J JLABS Incubator companies, and as a Scientific Advisory Board member of the North Texas Enterprise Center (a life science incubator). She is on Columbia University’s Translational Therapeutics Accelerator Steering Committee and the Columbia University Irving Cancer Drug Discovery Advisory Board. Dr. Rombel received her PhD in Biochemistry and B.Sc. (First Class Honors) in Biochemistry with a double major in Microbiology from the University of Otago, New Zealand, and her MBA from Southern Methodist University, Dallas, Texas. Irene is also a registered U.S. Patent Agent with the USPTO.

Juancarlos Rosario obtained his bachelor's and master's degree in chemical engineering at the University of Puerto Rico at Mayaguez. He is currently a 4-year PhD candidate as part of the Lilly graduate program at IU where he is focusing his thesis work in gene therapy development. Short after graduating from his master's degree, he started working as a process development engineer in a few major biopharma companies such as Amgen, Janssen and Merck. For the past 10 years he has been working at Eli Lilly in multiple roles within the Manufacturing and bioproduct developing organizations. At his current role as a Sr. Principal Engineer, he is supporting the development of a first to try platform for AAV downstream process and leading the evaluation and subsequent implementation of process analytical technologies for batch and continuous mAbs and AAV downstream processes.

Avraham Rosenberg earned his master’s degree in biotechnology from Johns Hopkins University. He is currently a Principal Scientist at Regeneron Pharmaceuticals, Inc. and has spent the last 15 years pushing biotherapeutic drug candidates through the pipeline, while developing new mass spectrometry-based techniques. Prior to joining Regeneron, he spent 4 years in academic research: 1 year at Johns Hopkins University in Dr. Jenny Van Eyk’s proteomics laboratory and 3 years at the National Institutes of Health in Dr. Irving Wainer and Dr. Ruin Moaddel’s laboratory of clinical investigation.

Qian Ruan, Ph.D., is the Vice President of Technical Operations and Manufacturing of Arcturus Therapeutics. Dr. Ruan is responsible for mRNA drug substance and LNP drug product productions at CMOs. Dr. Ruan has extensive experience in bioprocess development from preclinical to licensure. Prior to Arcturus, Dr. Ruan worked at Emergent BioSolutions/PaxVax Inc. as Sr. Director of Process Development and Clinical Production. She has successfully built and led the team developed/manufactured/tech transferred oral delivery vectors and injectable virus-like particles for vaccines. She was the main contributor for multiple Investigational new drug (IND) and Biological Licensure Application (BLA) submissions. Prior to Emergent BioSolutions/ PaxVax Inc, she worked for the Center of Cell and Gene Therapy at Baylor College of Medicine and developed early phase gene therapy drugs with adenovirus, herpes, and retrovirus platform technology. She published multiple articles and was the co-author of chapter “Purification of Adenovirus” in the book Adenoviral vectors for Gene Therapy. Dr. Ruan holds a Ph.D. and a Bachelor's degree in Biochemical Engineering from South China University of Technology.

I am passionate about developing next-generation biomedical solutions with nanotechnology and aim to strengthen the bridge between traditional material science and medical application. My research focuses on leveraging molecular engineering of drug carriers—starting from drug-conjugate to recombinant nanoparticle and from LNP to drug depot—with an emphasis on cancer therapeutics and vaccines. I have multiple US patents and peer-reviewed publications in my name and received the Duke-Coulter Translational Partnership Award for my innovative work. In addition, I serve as an editorial board member in internationally acclaimed journals such as Pharmaceutics, Cancers, and IJBMR. I have managed multimillion-dollar industry-sponsored projects and worked closely with CROs and tech-transfer teams. Currently, I am spearheading the development of next-generation PEGylated LNPs and biologics at Duke University. This technology has been licensed to a stealth-mode biotech company where I serve as a CSO.

Dr. Rachel Salzman serves as Chief Executive Officer at Armatus Bio, a privately held preclinical stage biotech focusing on curative approaches for neuromuscular disorders where toxic gain of function plays a causative role in disease pathology. Prior to joining Armatus, Rachel was Executive Vice President of Portfolio, External Affairs & Development at Alcyone Therapeutics, a precision medicines company advancing therapies in serious neurological disorders by integrating novel delivery technologies with innovative genetic platforms. Rachel co-founded SwanBio Therapeutics in 2017, and served as Chief Executive Officer (CEO) and Director through 2019. She was the company's President and Chief Portfolio & Development Officer until January 2021. She then founded UltraSquared Bio, a not-for-profit organization dedicated to bringing gene therapies to ultra-rare populations where traditional business cases are not tractable, and in this capacity was awarded a prestigious Termeer Foundation Fellowship. Prior to her time at Swan, she was the Chief Science Officer (CSO) of The Stop ALD Foundation since 2001. The Stop ALD Foundation is a non-profit Medical Research Organization dedicated to employing entrepreneurial approaches and innovative methodology towards effective therapies, cures, and prevention of X-linked adrenoleukodystrophy (ALD), an often-fatal neurodegenerative disease. As CSO she made critical contributions in driving forward the world’s first ex vivo lentiviral gene therapy clinical trial conducted in non-HIV infected patients. Dr. Salzman has been an active member of ASGCT (American Society of Gene and Cell Therapy) for over 20 years and has served in a leadership capacity including elected membership to the Board of Directors, along with multiple committees and task forces designed to build and enhance the state of gene and cell therapy in both the US and EU. She currently represents ASGCT at the National Academy of Sciences Forum on Regenerative Medicine.

Dr. Nick Sanek is a Group Leader in Cell Line Development at Catalent Pharma Solutions, where he works closely with Research and Development, Molecular Biology, and Process Development. He received his PhD in Genetics from the University of Wisconsin, Madison.  He brings his eight years’ experience in cell line to enable clients to go from DNA to GMP scale drug substance at Catalent.

Luis Santos, PhD, is currently the Senior Director of RNA & LNP Product Development at Prime Medicine, where he leads a team of scientists and engineers working on developing mRNA and LNP processes, LNP formulation, and drug product development to bring Prime Editing to patients. He also heads cross-functional and CMC teams. Prior to joining Prime Medicine, he held multiple roles of increasing responsibility in AstraZeneca's Biopharmaceutical Development organization. There, he was a team leader with focus on intracellular delivery, drug delivery technologies for nucleic acid and biologics, and technology strategy. He was responsible for mRNA-LNP development programs and was a CMC team leader for early-stage programs. Before that, Dr Santos led the implementation and development of an artificial antigen-presenting cell platform at NexImmune to enable an adoptive cell therapy pipeline. More broadly, he has contributed to several industrial consortia, has published over 40 articles, and holds several patents in drug delivery, process to manufacture, and enabling the development of nanomedicines and biologics.

Helen has over 10 years of experience in the biotech industry, and has held positions in QC, QA, and R&D, supporting method validation and transfers, as well as safety testing and potency strategy. She is currently Associate Director, Analytical Strategy & Execution, within the Analytical & Quality Control department at BlueRock Therapeutics. Helen lives in Toronto with her husband and two daughters.

Dr. Sareen is the founding executive director and chief biomanufacturing officer of the Cedars-Sinai Biomanufacturing Center (CBC). He has extensive experience with human iPSC-based platform technologies, GMP biomanufacturing, space medicine, mechanistic drug discovery, process development, and translating advanced cell therapies into the clinic. The CBC has led the establishment of a state-of-the art cGMP facility as a leading center of excellence in the manufacturing of iPSCs and cell and gene therapies. He led the development of the world’s largest ALS iPSC and motor neuron biorepository for the Answer ALS program with over 1,200 iPSCs, distributed globally. The center he founded provides specialized cGMP-compliant biomanufacturing services integrating cutting-edge automation technologies. He specializes in developing regenerative therapies for neural, vascular, pancreatic, and cardiac diseases with an emphasis to translate novel immune-evasive cell therapies. He is a prolific inventor with patents on stem cell reprogramming, differentiation and cell biomanufacturing technologies. He has published in high impact journals, investigating mechanisms underlying some of today’s most intractable diseases.

Sumona Sarkar is a Biomedical Engineer at the National Institute of Standards and Technology in Gaithersburg MD. She has been at NIST for 8 years with a focus on cell material interactions for tissue engineering and regenerative medicine, and analytical methods for cell and gene therapy. She serves as a subject matter expert and project leader in ISO TC 276: Biotechnology with particular expertise in cell count, viability, and characterization. Prior to joining NIST Sumona received her Ph.D in biomedical engineering from Drexel University, and her M.S. from Boston University.

Over the course of my career, I have gained extensive experience in numerous areas that have enabled me to support a wide range of projects. After graduating from the Virginia Military Institute, I served as a commissioned officer in the United States Navy where I taught nuclear power principles (Mathematics; Reactor Principles) to over 150 junior enlisted sailors over the course of four years. Upon completing my commission in the United States Navy, I took a position as a Project Manager in the ISE Division of M.C. Dean Incorporated and led numerous IT integration and design/build projects for United States Military bases located in both Stuttgart, Germany and Ramstein, Germany, most with multi-million-dollar valuations. Upon returning to the United States, I earned my Ph.D. from Syracuse University where I specialized in bone tissue engineering and 3D printing. After graduating, I joined the U.S. FDA as a postdoctoral fellow and my research focus shifted to regulatory science applications, specifically improving the characterization of regenerative medicine products designed to facilitate cell and tissue-based therapeutics. Once my postdoctoral training was complete, I was promoted to a Staff Fellow at the U.S. FDA where I not only continued my research into improved biological therapeutics, but also began reviewing regulatory applications such as Investigational New Drug Applications (INDs) and Master Files (MFs). Most recently, I took an Assistant Professor faculty position at the Wake Forest Institute for Regenerative Medicine (WFIRM), where I have begun to continue my regulatory science research, as well as provide regulatory advice and oversight for the members of the WFIRM Translational Core (TC) who both manufacture and support the development of GLP and cGMP cell and tissue-based products needed to support IND applications.

Pedro Seber e Silva is a PhD candidate whose computational research uses the power of artificial intelligence (AI), especially machine learning (ML) and deep learning (DL), to solve problems related to biomedicine and bioproduction. Pedro has made contributions to the research community with powerful new ML and DL models that predict the glycosylation of monoclonal antibodies (mAbs), which are important biotherapeutics in the treatment of autoimmune conditions, infections, and cancer—and have the potential to treat many other diseases. With the support of a MathWorks Fellowship, Pedro will continue to build and refine his AI models, which could offer substantial improvements over existing models, and expand his work to study the Chinese hamster ovary cell lines used to produce mAbs, an area of great importance in long-term perfusion cultures now being developed to reduce costs and improve glycosylation control. Pedro’s work is already speeding the development of urgently needed biotherapeutics, and his work in computational modeling could help researchers in many fields—including non-experts in data science and programming—to leverage cutting-edge AI methods and tools in their work.

With a background in biology, I began my scientific career at Vanderbilt University, where I focused on proteomics and studied antibody responses to flu vaccines. I later joined the Broad Institute of MIT and Harvard, developing high-throughput assays to support small molecule hit validation. Currently, I’m a Senior Scientist at the Novartis Institutes for BioMedical Research, where I specialize in mass spectrometry-based characterization of therapeutic modalities, including antibodies, lentiviruses, and adeno associated viruses, across multiple pipelines.

As an innovative and transformational leader, Dalip Sethi, currently serves as the commercial lead for Terumo BCT's Cell Therapy Technologies portfolio in North America. He holds a doctorate and conducted post-doctoral studies at Thomas Jefferson University, School of Medicine. Throughout his career in the industry, Dalip has been engaged in developing technologies & methods for use in cell therapy applications. Dalip has authored multiple scientific publications and is a co-inventor on several patents & patent applications. Dalip co-authored publications on modular automated systems for CD3+ T-cell manufacturing and monoculture of cord-blood derived CD34+ using an automated, membrane-based dynamic perfusion system. The articles highlighted the benefits of modular automation in cell therapy manufacturing. Dalip is also an ISCT member and serves as the co-chair of the process automation, analytics, and development (PAAD) committee. In addition, he serves as a board member of the Colorado Bioscience Association (CBSA).

Merlinda-Loriane Sewavi, M.S., is a bioprocess and molecular systems engineer specializing in high-fidelity iPSC differentiation and regenerative platform readiness. At Stanford, she leads work on cell-type mapping and sequencing-grade RNA validation to support GMP-scale biomanufacturing across iPSC lineages. With a masters degree in Chemical Biology, her research spans cancer pathway analysis at Michigan Medicine and 3D stem cell development at the Institute for Quantitative Health Science and Engineering. A National GEM Consortium Fellow, her current focus is building a molecular atlas for reenerative scale-up—enabling whole-organ fidelity from bench to bioreactor.

Danielle Sexton is a seasoned biopharma professional with nearly 20 years of industry experience, including 16 years specializing in upstream process development. Their expertise spans cell line development, feed optimization, vessel characterization studies, and process optimization. Passionate about translating innovation from benchtop to clinic, Danielle is dedicated to leveraging robust process optimization to drive impactful advancements in patient care.

Connor Shank is a Senior Research Associate working in Upstream Process Development at Ultragenyx, Woburn. Connor has been at Ultragenyx for over 5 years and has worked on several programs and strategic initiatives across both PCL and HEK platforms including key media development, cell banking, and late-stage process characterization and development (BLA enabling).

Susan Sharfstein is a Professor of Nanoscale Science and Engineering at the University at Albany in Albany, New York. Professor Sharfstein received her B.S. in chemical engineering with honors from Caltech in 1987 and her Ph.D. in chemical engineering from UC Berkeley in 1993. Her interests include mammalian and microbial cell bioprocessing, control of protein glycosylation, metabolic engineering, biosensing, and development of systems for high-throughput screening of nucleic acids and small molecules. She is the author of over 85 papers and book chapters in the fields of biotechnology and bioprocessing.

Shamik Sharma manages the Process Development team within Technical Operations at Voyager Therapeutics—responsible for development of cell lines, plasmid designs as well as the upstream and downstream process for AAV Drug Substance manufacturing. Previously he worked at Pfizer Inc., in the Biotherapeutics Pharmaceutical Sciences group. While at Pfizer he was part of the Bioprocess R&D Portfolio Group and Culture Process Development group.

Yuefei Shen is an Associate Director within the CMC Drug Product Development Organization at Sanofi wherein she leads early Drug Product Development for gene therapy programs. Prior to Sanofi, she worked at Novartis. She obtained her PhD in Chemistry from Washington University in St. Louis and Postdoc from the University of Massachusetts Medical School with focus on non-viral RNA therapy and gene therapy.

Dr. Ying Shen obtained her Ph.D. in Molecular and Cell Biology from University of Tennesse and worked in the cell line development at Regeneron first and then Takeda.

Dr. Chun Fang Shen is a principal research officer with the Human Health Therapeutics Research Centre, the National Research Council of Canada (NRC) in Montreal. During over 25 years with the NRC, Dr. Shen has made significant contributions to the development, optimization and scale-up of cell culture processes for the production of viral vectors and vaccines. He leads and manages internal research projects and industrial contracts in the field of cell culture process development and manufacturing of viral vaccines. Dr. Chun Fang Shen received his PhD in Biochemical Engineering from Western University in Canada.

Dr. Ying Sheng is a Senior Scientist and an accomplished glycobiologist with a specialization in mass spectrometry-based glycoproteomics and cell glycocalyx engineering. She earned her Ph.D. at the University of California, Davis, under the mentorship of Prof. Carlito B. Lebrilla, where she led a dynamic research group and spearheaded pivotal projects on host-pathogen interactions. Her groundbreaking work included studying the effects of N-glycan subtypes on viral and bacterial infections. Currently, Dr. Sheng is part of Regeneron, where she develops and applies innovative analytical methods, including advanced mass spectrometry technologies, to support the biochemical characterization of antibody-based protein candidates. Her work contributes to the development of life-changing medicines for conditions such as eye diseases, high LDL-cholesterol, atopic dermatitis, rare inflammatory conditions, rheumatoid arthritis, asthma, pain, cancer, and infectious diseases. Dr. Sheng's expertise and impactful research continue to advance the field of glycobiology and therapeutic development.

Dr. Wen Shi received his BS degree in Pharmacy from Huazhong University of Science and Technology and obtained his PhD in Pharmaceutical Sciences from University of Nebraska Medical Center. His PhD and post-doc research are involved in drug delivery and tissue engineering. He started his industry career first as a protein formulation scientist and now he works in Regeneron as an analytical scientist for characterizing both antibody and AAV molecules to support the formulation studies.

Dr. Shuangping Shi is an Associate Vice President at Merck & Co. leading the Biologics Process R&D organization. Her responsibility includes clinical and commercial process development as well as manufacturing of clinical supplies for biologics programs of all modalities in Merck’s portfolio. Prior to the current role, Shuangping was the Head of Biological Technologies at Genentech (2020-2022) and the Head of Manufacturing at Progenics (2018-2020) where she led the launch of Azedra®. Between 2006 and 2018, Shuangping worked at Merck with increasing responsibilities and was a key contributor to the launch of Keytruda®. Shuangping holds a PhD in Immunology and Microbial Pathogenesis from Weill Medical College of Cornell University and she received her postdoctoral training from The Rockefeller University.

Oleg Shinkazh is a founder of ChromaTan and inventor of “Countercurrent Tangential Chromatography.” He is a chemical and biotechnology engineer with 17 years of experience in R&D and technical support in the biotechnology industry, specializing in downstream processing/purification of human biologics. Oleg has extensive experience with all unit operations in the modern marketplace and has worked and collaborated with such industry leaders as Millipore Corp., Pall Corp., Genentech, Biogen and many others.

Andrew has over 30 years’ design and operational experience in the biopharmaceutical industry, with direct responsibility for manufacturing, logistics, maintenance and capital programme management. He has developed Biopharm Services into a leading provider of bioprocess modelling and knowledge management tools that support bioprocess innovation. The focus of his work is in the understanding the impact of innovative technologies on biomanufacturing with focus on single use systems and continuous processing. Prior to Biopharm Services, Andrew was Director of Engineering and Logistics at Lonza Biologics and holds an MSc in Biochemical Engineering from UCL. He was a finalist in “The Manufacturing Processing Thought Leader of the Decade” category at the 2012 BioProcess International Awards and in 2014 was appointed a Fellow of the Royal Academy of Engineering in the UK.

Guru is a molecular biologist turned tech founder. He has launched and scaled several biotech‑software ventures across North America and Europe. Today, he leads Scispot, an AI-powered, API-first Lab Operating System built to make data instantly analysis-ready. His goal is simple: to help every biotech run like a cloud-native AI powerhouse, so life-saving therapies reach patients faster.

As a Senior Process Engineer at Bristol Myers Squibb, I specialize in process modeling, CFD, hybrid modeling, and data analytics to help support technology transfer, process optimization and drive innovation in biopharmaceutical manufacturing. With a PhD in Chemical Engineering and over 8 years of experience solving complex scientific problems—including 4+ years in the pharma/ biopharma industry—I focus on enabling efficient tech transfer, process optimization, and digital transformation. My work has directly contributed to increased throughput, improved yield, and enhanced process robustness across upstream and downstream bioprocessing. I lead BMS's global CFD Community of Practice, mentor early-career engineers, and actively engage in cross-functional and cross-site collaboration. I’m passionate about applying advanced modeling and digital tools to reduce at-scale studies and accelerate development timelines.

Dr. Lee Smith’s experience spans biopharmaceutical CMC, process, analytical, formulation pre-clinical and clinical assay development as well as experience in product characterisation and regulatory submissions and interactions. He is regularly involved in applying QbD and advising on the use of DoE and data analysis for processes, formulation and assays, with a particular expertise in bioassays. This includes the development, optimisation and validation of both biopharmaceutical processes and methods.

Our work focuses on elucidating aspects of dynamic and heterogeneous protein conformations and assemblies, using an integrated structural approach based on "native" mass spectrometry, ion mobility, H/D exchange, chemical crosslinking and covalent labelling techniques (e.g., Fast Photochemical Oxidation of Proteins) in combination with electron microscopy and other biophysical and computational methods. The group develops and applies new mass spectrometry tools for the analysis of the structure and interactions of biomolecules and biomolecular complexes, including lipids, carbohydrates and oligonucleotides. We work at the interface of biology, chemistry and physics and collaborate widely with our Astbury colleagues at Leeds and across the UK as well as internationally, but also with instrument manufacturers and the biopharma industry. Our mission is to uncover molecular detail of dynamic biological structures relevant to physiology of health and disease, with high spatial and temporal resolution in a near-native environment.

Fabian Soltermann is the Lab Head for Phys-Chem Analytics in the “Analytics, Bioanalytics and Formulation” unit at the Biologics Research Center in Novartis, based in Basel, Switzerland. He holds a PhD in Analytical Chemistry from the University of Oxford, where he worked with Professor Kukura on developing Mass Photometry applications and with Professor Dame Carol Robinson on analyzing protein complexes using native MS. Fabian has previously served as an analytical project leader and group leader in Lonza's Biologics Analytical Development unit and Canton Biologics, Characterization unit.

I hold a PhD in pharmaceutical sciences and have experience in drug product development for vaccines and gene therapy. I have been a part of the gene therapy team at Biogen for nearly 4 years, where the focus of my work has been end-to-end drug product development (formulation to fill-finish) for Adeno Associated Viruses (AAVs) both in early and late stages of clinical development.

Nivethitha is an Associate Scientist III in downstream process development at Alexion AstraZeneca. She holds a master’s degree in chemical engineering from the University at Buffalo, SUNY, and has over four years of experience in biologics drug substance process development. At Alexion, she has played a pivotal role in optimizing and characterizing downstream processes. Her technical expertise includes chromatography-based purification, viral filtration, tangential flow filtration, statistical modeling, project management, and high-throughput process development, all complemented by her strong ability to foster collaborative team environments. Before joining Alexion, Nivethitha was a quality assurance intern at Cresilon, focusing on regulatory compliance and quality management.

Raja Srinivas, Ph.D., is co-founder of Asimov, a Boston-based mammalian synthetic biology company. He earned his B.S. in Biomedical Engineering and Applied Mathematics from Johns Hopkins University (2007-2011) and a Ph.D. from MIT where his work focused on computational protein and drug design using all-atom simulations.

In 2017, Raja cofounded Asimov with three co-founders with the aim to radically advance humanity's ability to design living systems.

I have been a bioprocessing scientist at Cell and Gene Therapy Catapult for 1.5 years, where I am a member of the technology and process innovation team. My work focusses on upstream bioprocess development, across a range of platforms such as AAV production, T-cell and iPSC expansion. My focus in these areas is process adaptation from 2D to 3D and intensification. Prior to this I completed a PhD in cell therapies and tissue engineering at the University of Leeds, focussing on the development of a scaffold to assist autologous cell implantation.

Geoffrey Stephens, PhD, the Founder and CEO of AiCella, Inc., is an experienced scientific executive with more than 20 years of experience working in all aspects of the biotech industry. Dr. Stephens spent nine years leading teams in drug discovery and development. His experience spans regulatory T cells, CAR-T, TCR-T, iPSCs, large and small molecule therapeutics for cancer, autoimmunity, and inflammatory diseases. As head of Process Development at Tessa Therapeutics he played an integral role developing CD30-CAR-T cell therapies for the treatment of Hodgkin and non-Hodgkin lymphoma. Dr. Stephens was also the Director of Product Science at Immatics, LLC, where he led the development of TCR-T cell-based therapies for the treatment of a variety of cancers.

Anne Stokes (PhD) obtained her PhD in Viral Immunology in 1989, and she spent sixteen years in virus research in the UK and USA resulting in several publications in peer reviewed journals and presentations at National and International Conferences. Anne joined GSK in 1997 in Biopharmaceutical Development as Head of Molecular Biology and Virology. She is an Industry expert in Cell Banking, Transmissible Spongiform Encephalopathy and virus safety of Biopharmaceuticals. She represented PhRMA on the ICHQ5A Expert Working group. She is currently the Director of TSE and Virus Control within Biopharm R & D at GSK.

Nathan Stover is a graduate student at MIT working under Prof. Richard Braatz. Nathan works on process systems engineering of the IVT reaction for RNA manufacturing.

Yue Su is a Senior Scientist at Regeneron, where she contributes to the characterization of biotherapeutics, including monoclonal antibodies, bispecifics, RNA biotherapeutics, and other modalities to support drug development. Since joining Regeneron in 2023, Yue has applied her experience from her postdoctoral research in Dr. Shenglong Zhang's lab, where she worked on mass spectrometry-based direct RNA sequencing and modification studies. She has a keen interest in the accurate identification and quantification of RNA modifications, and she is dedicated to advancing the understanding and development of therapeutic solutions.

With 8 years of experience in biotech, Keerthana has developed a deep expertise in AAV (Adeno-Associated Virus) downstream process development. Over the course of her career, she has contributed significantly to the optimization of manufacturing processes for AAV-based gene therapies, working across a variety of stages from early development to scale-up.

Jonathan Sun is a Scientist within Analytical Development at Sanofi, bringing over a decade of experience in the BioPharma industry. Prior to joining Sanofi in 2021, Jonathan honed his skills at AbbVie Inc. His focus lies in addressing process-related impurities, developing ELISA-based methods that support both early and late-stage programs, and GMP testing to support clinical programs. He is also involved in supporting CMC analytical activities, serving as analytical lead for early-stage programs and authoring filings.

Yudong obtained his BS degree in molecular biology from the University of Wisconsin-Madison. He then pursued his PhD in biochemistry at Duke University, studying the link between methionine metabolism and epigenetic regulation. He is now a postdoctoral fellow at Merck exploring the applications of mass spectrometry-based metabolomics and proteomics in bioprocesses.

Dr. Rui Sun is a Scientist in the Computational Science Research at Takeda Pharmaceuticals, where she leads efforts to integrate AI and machine learning into upstream bioprocess development and manufacturing. With a Ph.D. in Biomedical Engineering from Carnegie Mellon University, her work spans digital twin modeling, generative AI applications for data access, and statistical frameworks for process optimization. Drawing from her academic and industry experience, Dr. Sun brings a pragmatic perspective to deploying AI/ML solutions in complex bioprocessing environments and navigating the technical challenges that come with it.

I'm currently a Senior Scientist in the Vaccines and Advanced Biotechnologies Process Research and Development organization within Merck Research Laboratories at Merck and Co., Inc. I've supported both early and late-stage pipeline programs with focus on fermentation process development.

Lawrence (Larry) Thompson is an Associate Research Fellow and Group Leader in Analytical R&D within BioTherapeutic Pharmaceutical Sciences at Pfizer. He is an analytical CMC SME for Pfizer’s adenoviral & plasmid DNA based immunotherapeutics, mRNA drug substances and nucleic acid starting material pipeline (used in rAAV and mRNA production). Prior to joining Pfizer, he worked at a couple of small biotech companies developing of serum-based cancer diagnostics. He received his PhD in Biochemistry from Vanderbilt University and did his post-doctoral work at the University of Tennessee. His work has generated several peer reviewed publications and presentations at scientific conferences.

Vishal Toprani is Director of Formulation and Drug Development at UpstreamBio where he leads efforts to advance innovative biologic drug products. Prior to joining UpstreamBio, he worked at Pfizer and Alexion-AstraZeneca Rare Disease Unit in various capacities to develop clinical and commercial biologic drug products spanning multiple dosage forms and modalities. He made significant contributions during his career, including leading efforts that resulted in the licensure of the Penbrayaâ„¢ vaccine. He has remained an active member of the scientific community, sharing insights through presentations, symposia, academic seminars, and publishing in peer-reviewed journals. Vishal holds a PhD in Pharmaceutical Chemistry from the University of Kansas, which he earned in 2018, and has since built a career dedicated to advancing pharmaceutical sciences and driving innovation in biologics development.

Dr. Huiping Tu is currently a Senior Principal Scientist at USP, where she manages the Microbiology and Statistics Expert Committees and leads efforts to develop microbiology and bioassay-related USP standards. Previously, she served as Director of the Biologics Laboratory at USP, overseeing bioanalytical, bioassay, and microbiology teams. Before joining USP in 2012, Dr. Tu worked at Merck as a Senior Research Scientist within the Cardiovascular Diseases Franchise. There, she contributed to the early drug discovery process, focusing on target identification, lead compound optimization, and safety assessments. Dr. Tu holds an M.S. in Organic Chemistry and a Ph.D. in Physiology. She has a broad scientific background, with expertise in cardiovascular and neurological diseases, as well as in microbiology, molecular/cell biology, biochemistry, and analytical chemistry. With more than 20 years of experience in the pharmaceutical industry, academia, and regulatory science, she has extensive knowledge of the USP-NF and the development of reference standards for pharmaceutical products. Dr. Tu is a lead or co-author of numerous prestigious, peer-reviewed publications, including Cell, J. Clinical Investigation, and Neuron, and holds several patents.

Aniket Udepurkar is a Postdoctoral Associate in Chemical Engineering at MIT, working under Prof. Allan S. Myerson. His research focuses on continuous manufacturing of mRNA-loaded lipid nanoparticles at MIT’s Center for Continuous Manufacturing. He earned his PhD in Chemical Engineering from KU Leuven, specializing in particle synthesis, characterization, and process scale-up using microfluidic platforms.

Dr. Undey has over 25 years of experience in Biopharmaceuticals industry. Currently, he is leading the global iCMC Digital Transformation Program at Sanofi. More recently he has headed up the Pharmaceutical Technical Development (PTD) Data & Digital organization in Roche/Genentech. He was responsible for strategizing, architecting and delivering major digital and data programs and solutions for both PTD and Pharma Technical Cell & Gene Therapy Development and Manufacturing to accelerate speed to patient and increase productivity during drug development and advancement. Prior to that role, he led the Operations Digital Strategy and Capabilities Advanced Analytics team at Amgen. His group helped improve end-to-end Operations for Reliability, Efficiency, Agility and Differentiation harnessing the power of digital capabilities including Industry 4.0, machine learning, statistical learning and digital twins. Dr. Undey and his team’s work were externally recognized receiving CIO100 Award in Life Sciences in 2013 for Amgen implementing advanced data analytical solutions. He has co-authored and co-edited two books, published in scientific journals and books in the areas of process systems engineering, PAT, artificial intelligence, process monitoring, control, supervision, biotechnology and bioengineering. He has received his BSc, MSc and PhD degrees all in Chemical Engineering from Istanbul University, Turkey. He also holds an Executive MBA degree from the University of California, Los Angeles, Anderson School of Management. Dr. Undey is based in Framingham, MA, USA.

Gene therapy and biologics Formulation Scientist, experienced in siRNA LC characterization, gene therapy, and biologics stability testing, drug development, small molecule method validation, small molecule stability testing, cosmetic stability testing. Background in chemistry and nanomaterials.

Dr. van der Loo is the Director of the Clinical Vector Core at the Children’s Hospital of Philadelphia (CHOP). He has been instrumental in GMP manufacturing of viral vectors for early phase clinical trials and pharm/tox studies for 23 years. His expertise includes process development and manufacturing of pre-clinical and clinical grade vectors using on several viral vector platforms, including gamma-retrovirus, lentivirus and AAV. Dr. van der Loo is a member of the 4Bio Ventures Management Advisory Board and scientific advisory board of Avantor and serves as consultant in several capacities.

Pharmaceutical Scientist with 17 years of cross-functional expertise in drug discovery, development and supply. Made significant contributions to discovery, characterization, early- and late-phase development of multiple therapeutic and diagnostic modalities (peptides, small-proteins, monoclonal antibodies, multi-specifics, antibody conjugates and chimeric antigen receptors) supporting multiple disease portfolios (hematological malignancies, solid tumors, immune disorders, and infectious diseases). R&D leadership in academia and industry highlighted through 10+ NME, IND and BLA filings, 20+ publications and patents, 40+ scholarships and awards, 50+ invited talks, panel discussions and posters, and 70+ conferences and workshops. Program and people leadership: led internal and external teams with conflicting interests to accomplish critical business deliverables (with tangible financial benefits). Big picture thinker with strong passion for E2E drug development (discovery to launch), addressing unmet medical needs and improving access to health care.

Raghavan Venkat (Venkat in short) obtained his M.S. and Ph.D. degrees in Chemical Engineering at The Ohio State University and a Certificate in Business from the Wharton School at University of Pennsylvania. Venkat joined MedImmune / AstraZeneca in 2006 and has worked in the biopharmaceutical industry for more than 27 years across many roles at GSK, Lilly and AZ. Over his career, Venkat has led teams or directly contributed to the commercialization of more than 12 biologics medicines, including Vaxzevria and Evusheld developed in response to the COVID pandemic. Venkat has strong expertise in pharmaceutical process and product development, especially in biologics process development and manufacturing, with keen interest and strength in novel modalities. At AstraZeneca, he currently leads the Biopharmaceutical Development function responsible for end-to-end CMC development of all biologics within the AZ pipeline.

Christina Vessely, PhD, RAC, has over 18 years of experience in analytical and formulation development within the biotechnology industry. Her experience ranges from early stage research and development for small and start-up firms through late stage development and commercialization for mid-sized and large pharmaceutical companies. She has been involved in priority review and/ fast track programs, she has participated in pre-approval inspections (PAI) and PAI enabling activities such as design and execution of validation studies and evaluation of GMP systems, as well as authoring and editing of analytical sections for multiple filings in both the U.S. and in the EU (IND/IMPD, BLA/MAA).

Francesca is an established biotech executive with 20+ years leading technical operations and CMC in cell and gene therapy. She excels at building high-performing teams and scaling talent through organizational transitions. As VP at Intellia Therapeutics, she drove process development and manufacturing for breakthrough in vivo and ex vivo therapies, significantly expanding technical capabilities while reducing costs. At Lonza, she launched large-scale AAV manufacturing platforms and led cell therapy manufacturing readiness for inspection. Recognized for her strategic vision and cross-functional leadership, Francesca combines rigorous development expertise with operational excellence to deliver innovation at scale. She is providing consulting services as FPV Advisors.

Sudhakar Voruganti is Business Development Director at Pfanstiehl, a world’s leading manufacturer of low endotoxin and high purity GMP parenteral grade carbohydrate based excipients for biopharmaceuticals. At Pfanstiehl he provides commercial and technical support to the Biopharma customers. Sudhakar received his doctorate in Biochemistry and Molecular Biology from Oklahoma State University and has several years of Biopharma research experience in the areas of upstream process development and analytical method development. Prior to joining Pfanstiehl he worked for six years in the Biologics Analytical Method Development department at Bristol-Myers Squibb in New Jersey.

Mark holds a Bachelor's degree in Biology and a Master's in Biochemistry from Bowling Green State University. With 27 years at MilliporeSigma, he gained extensive experience across various roles, including Chromatography Specialist, R&D Liaison, and Sales. Now at DFE Pharma, he aims to drive innovation in excipient development, creating effective solutions tailored for biologic applications.

Peter Walters is a Fellow of Advanced Therapies at CRB with 20 years of experience specializing in pharmaceutical process and facility design. He has a deep technical background designing equipment and processes for multi-process facilities predicated on maximum flexibility, logistics optimization and technologies that reduce costs while allowing for pipeline expandability and higher quality therapeutics. In addition to leading projects, Peter is responsible for CRB’s companywide strategy and growth in the cell and gene therapy market.

XuShan Wang serves as a Director at Eli Lilly & Company within the BioProduct Research & Development department. He holds both an M.S. in Molecular Biology/Biochemistry and a Bachelor of Medicine from Hunan Medical University. XuShan completed his postdoctoral training under Dr. Arun Srivastava, where he concentrated on Adeno-associated virus (AAV) biology and gene therapy, with a particular focus on the impact of D sequence on AAV rescue, replication, and packaging. Since joining Eli Lilly & Company, XuShan has contributed to numerous GPCR and kinase-related projects. His efforts have centered on developing and validating critical new assays, supporting screening and structure-activity relationship (SAR) efforts, and especially focusing on mechanism of action (MOA) studies. These endeavors have resulted in the development of over 10 drug candidate molecules. More recently, XuShan has been dedicated to advancing novel methods for characterizing and accurately quantifying rAAV genome integrity and Baculoviral DNA impurities in rAAV products. His work aims to enhance the quality of rAAV products by optimizing production processes. He has published over 50 scientific papers and holds multiple patents. His contributions include significant advancements in AAV biology and the drug development of GPCRs and kinases, particularly within the field of GPCR positive allosteric modulators (PAM).

Dr. Yongping Wang is the director of the Cell Based Therapy Lab (CBTL) at the Children's Hospital of Philadelphia and an associate professor of Clinical Pathology and Laboratory Medicine at the University of Pennsylvania Perelman School of Medicine. He has been at the CBTL for 13 years. The CBTL is a current Good Manufacturing Practice facility accredited by the Foundation for the Accreditation of Cellular Therapy and the College of American Pathologists. It processes and manufactures cell and gene therapy (CGT) products for bone marrow transplant and other CGT patients at CHOP. These range from standard-of-care, to investigational (IND/IDE), to commercially available CGT products. CBTL is currently involved in more than 50 trials that cover transplant graft manipulation, virus specific T cells, chimeric antigen T (CAR T) cells, and gene therapy for hemoglobinopathies. Sponsors for these trials include internal CHOP investigators, outside academic institutions, and industrial/commercial collaborators. With its partners at Penn, CHOP was the main clinical site that conducted the trials leading to the FDA approval of Kymriah. CHOP has infused more than 500 unique CAR T patients.

Senior Manager of Analytical Science and Technology at Solid Biosciences focused on operationalizing the analytical strategy to enable product growth from early to late stage.

Jie Wei is an accomplished scientist with a strong background in drug development and extensive experience in analytical development for cell therapies. Currently at Tr1X, Inc., Jie leads efforts in developing and optimizing analytical strategies to support Tr1X T cell therapy programs, ensuring product quality and process consistency from early development through manufacturing. With a focus on immunophenotyping, potency assays, and other critical quality attributes, Jie plays a key role in advancing robust analytical platforms to accelerate therapeutic development. Jie’s expertise reflects a deep understanding of immune-based therapies and their translational challenges, making her a valuable contributor to the field of bioprocessing.

Jonathan is a scientist in the Formulation Development group at Regeneron Pharmaceuticals. For the last 5 years, his primary focus has been formulation development of adeno-associated viral vectors. In this role he supports formulation development for research, early, and late phase programs and provides manufacturing support. Prior to working at Regeneron, Jonathan worked at BMS in a group supporting analytics for antibody, peptide, and small molecule discovery and at GSK in a preparative chromatography group. Jonathan received his MS in Biophysics and Structural Biology from the University of Pittsburgh.

Bill is Founder of Oamaru BioSystems with over 20 years experience in biotechnology product and process development. He now publishes oral papers, print articles, and book chapters on such topics as ATMP process intensification, AI/ML tools, and net positive building economy in biomanufacturing. Recently his work has been acknowledged in the 2022 APEX Award for Publication Excellence in the Technical & Technology Writing category and the 2023 ISPE Roger F. Sherwood Article of the Year award. He currently enjoys serving on such committees as the BioProcess International Editorial Advisory Board, and the chair of the 3SMAGNET Intersectoral Advisory Board. Bill has an h-index of 18 and an i10 index of 35.

Bo is a seasoned leader with extensive experience from both academia, the pharmaceutical and biotech sectors, focusing on strategic and operational leadership throughout the drug development value chain. Bo was previously an Entrepreneur in Residence at the BioInnovation Institute and at Novo Nordisk A/S, Bo held several leadership positions over the years, including Head of Strategy & Operations for the Stem Cell unit. Bo is a Doctor of Veterinary Medicine, earned a PhD from the University of Copenhagen and has numerous publications in peer-reviewed journals.

Philip Wills, Chief Commercial Officer at Catalent Cell & Gene Therapy, is a veteran business executive and scientist with over two decades of contract manufacturing experience, primarily focused in viral vectors and other complex biologics. After joining Paragon in 2002, Philip held positions of increasing scope and responsibility, including appointments as the Principal Scientist and VP of Business Development. His career began at the University of Maryland and worked in a variety of scientific roles in both the School of Medicine and Cancer Center. Philip obtained a Bachelor of Arts in Chemistry from Johns Hopkins University and a PhD in Pharmacology from the University of Marylan

Claus Wirnsperger is a Senior Machine Learning Engineer at DataHow AG in Zürich, where he leads research and development of novel algorithms for biopharmaceutical data analytics and architects scalable data transformation microservices using Python, Rust, and Golang orchestrated by Kubernetes. With experience supporting the digital transformation of production facilities for many of the world’s largest pharmaceutical companies, he has a strong background in time-series forecasting, optimization, and control, as well as the development of ML tools and SDKs. Before joining industry, Claus conducted research at ETH Zürich, applying variational autoencoders to detect exoplanets in large infrared image datasets. He holds both a Master’s and Bachelor’s degree in Physics from ETH Zürich, specializing in machine learning and astrophysics.

David Wood is currently a professor of Chemical and Biomolecular Engineering at The Ohio State University, where he continues to work on self-cleaving tag technologies for research and biopharmaceutical applications. He holds an undergraduate degree from Caltech with a double major in biology and chemical engineering, as well as a PhD from Rensselaer Polytechnic Institute in Chemical Engineering, and has experience in downstream processing and proess development at Amgen and Bristol Myers Squibb. He has published over 50 papers, book chapters and reviews in protein engineering, and holds several patents on technologies developed in his lab. Most recently, he is a co-founder of Protein Capture Science; a company formed to commercialize his split-intein technology for protein purification.

Jiewei Wu is a Principal Scientist at Regeneron, where she has been leading the formulation development for monoclonal antibodies (mAb) and small interfering RNA (siRNA) drug products. Before joining Regeneron, she worked at Vaccine Research and Development of Pfizer, where she led and supported analytical development for mRNA-Lipid Nanoparticle (LNP) vaccines, including the COVID-19 vaccine (COMIRNATY®). Jiewei holds a Ph.D. in Energy, Chemical, and Environmental Engineering from Washington University in St. Louis.

Dr. Wei Xie's research interests focus on process analytical technologies (PATs), machine learning (ML), interpretable Artificial Intelligence (AI), digital twin, data analytics, risk/sensitivity/predictive analyses, optimal design of experiments, data-driven stochastic optimization, systems and synthetic biology, and bioinformatics for biomanufacturing process risk management, optimal learning, and robust control.

Meng holds a Bachelor of Science in Biology from Nankai University and a PhD in Chemical Biology from the Stevens Institute of Technology. She began her professional career at WuXi AppTec, where she specialized in designing and executing High-Throughput Screens (HTS) for small molecule libraries in drug discovery. In 2022, Meng joined the Merck Biologics Analytical R&D automation team, focusing on developing and implementing automation solutions to enhance analytical testing processes.

Engaged as a Bio-Application Scientist at Yokogawa Electric Corporation, contributing to advancements in biomanufacturing process development system

Ph.D. in Cell and Developmental Biology, Kyoto University, Japan.

Khaled Yamout is a thought leader in Analytical Sciences, Quality and Manufacturing. Previously held a position as a Senior Director, Analytical Services and Quality Control at TriLink Biotechnologies where he oversaw the Analytical Sciences Center of Excellence and all analytical aspects of method development and validation to product release and stability to support regulatory filings for both small and large molecules. Prior to TriLink, Khaled held various positions in Quality Control, Research and Development, and Manufacturing where he supported several Drug substances and Drug products (both small molecules and biologics) from clinical phase to commercial. These include diverse experience and expertise ranging from discovery to manufacturing with Fortune 500 firms, as well as small entrepreneurial businesses in the areas of synthetic, analytical, colloidal, surface modification, protein, and antibody modification and purification covering both manufacturing and analytical testing and characterization.

Dr. Yan heads Beam Therapeutics' Attribute Sciences team, developing cutting-edge characterization and bioanalytical assays for various molecules. His work supports research, development, and GMP release of ex vivo and in vivo base editing drug substances and drug products. He has 50+ peer-reviewed papers, a Peking University B.S., and a UMass Amherst Ph.D.

Dr. Lihua Yang has been at AbbVie for over 20 years and is currently a Senior Principal Research Scientist and Group Leader within the Purification Development Department in Product Development Science and Technology organization. Dr. Yang led 25+ early and late phase programs and numerous innovation initiatives on biologics in areas of mAb, bispecific, antibody-drug conjugates and gene therapy. She has extensive experience in bioprocess development, characterization, validation, tech transfer to global GMP manufacture, process internalization, product launch, IND and BLA filing. Besides leading strong functional and cross-functional teams to deliver innovative and improved purification process, Dr. Yang is also a subject matter expert in bioanalytical assay development and protein characterization. Dr. Yang holds a Ph.D degree in Chemistry and Chemical Biology from Northeastern University, and a BS degree in Physical Chemistry from Peking University in China.

Dr. Wenjie Yao joined Bayer’s Analytical Development and Clinical Quality Control (ADQC) team in 2020. As a Staff Scientist, she leads the establishment of Bayer’s Next-Generation Sequencing (NGS) Core Facility, where she implements bulk RNA-seq, single-cell RNA-seq, and whole-genome sequencing methodologies to advance quality control strategies for cell and gene therapies. Her work enables genomic characterization of therapeutic candidates, ensuring compliance with regulatory standards (FDA/EMA) and supporting late-stage clinical programs. Prior to Bayer, Wenjie completed her PhD at the University of Cologne, investigating molecular mechanisms of heart development and regeneration using CRISPR/Cas9 genome editing, zebrafish/mice models, and stem cell differentiation in vitro models. Combining her expertise in multi-omics data analysis with strategic leadership skills from her MBA (WHU-Otto Beisheim School of Management), she drives innovation in therapeutic analytics and cross-functional collaboration at Bayer.

James has extensive experience in leading the development of molecular and cell-based assays to support CGT and biologics products. He is passionate about advancing innovative therapeutic products and collaborating with cross-functional teams and external partners. His core competencies include PCR-based release and characterization assays, cell-based functional assays, as well as lentiviral and AAV titer assays.

Tuna Yucel is a Pr. Scientist in CMC Drug Product at Sanofi Genomic Medicines Unit, where he leads DP Development teams for Viral & Non-viral Gene Therapy programs. Prior to Sanofi, he served as Process & Analytical Development Lead in 2 biotech innovators (Parallel Bio & Ekteino). He completed his post-doc training in Biomedical Eng at Tufts & his PhD in Materials Science at University of Delaware.

Kevin is a passionate, committed CMC subject matter expert, developing biologics to help patients and serving biotech community by teaching CMC-related training courses. Kevin has served leadership positions developing therapeutic biological products at AbbVie, AnaptysBio, Catalent Biopharma Solutions (CDMO), IGM Biosciences and Opthea. Kevin not only has in-depth expertise in Analytical Development but also has broad experience in Biologics CMC operation. In the past decades, he has successfully managed many biological drug candidates from early development to commercial. In addition to developing therapeutic biological products in-house, Kevin also had extensive experience working with external CDMO and CRO, including production cell line development, bioprocess development, DS/DP cGMP manufacturing, process characterization, process performance qualification (PPQ), formulation development by DoE, analytical procedure development and validation, reference standard qualification, extended characterization, and CMC analytical comparability.

Dr Zhang Wei is a Principal Scientist and heading Downstream Processing Group (DSP) in Bioprocessing Technology Institute (BTI), Agency for Science, Technology and Research (A*STAR) in Singapore. Her team focuses on purification process development and product characterization for the production of a variety of biotherapeutics, including monoclonal antibodies, bispecific antibodies, vaccines, viral vectors, mRNA, etc. Her team is also committed to work towards intensified and continuous downstream processing. Her team in BTI actively collaborate with dozens of biopharmaceutical companies and bioprocessing solution providers worldwide, including both leading industrial players and local SMEs.

Jiabao Zhang was born in China where he obtained his Bachelor of Science degree in Nankai University. He then moved to University of Illinois at Urbana-Champaign under the supervision of Prof. Martin Burke for his PHD, focusing on improving the therapeutics of antifungal natural product. He joined Biogen in 2022 as a process chemist, focusing on ASO synthesis and development. He will give a presentation on hybrid ASO synthesis for his talk today.

Shengyuan Zhao received his PhD in Pharmacology and Toxicology from the University of Texas at Austin. He is currently a Senior Scientist in the department of Process Cell Sciences at Merck, where he leads several platform optimization efforts to facilitate pipeline development and streamline workflow between early discovery and preclinical development. His areas of expertise include DNA repair, gene editing, and cell biology, with extensive experiences in CHO engineering and fed-batch process optimization.

Ms. Zheng is a biotechnology industry veteran who brings more than 25 years of experience in biotechnology operations across multiple geographies to Landmark Bio. Ms. Zheng most recently served as Chief Technical Officer at Orchard Therapeutics, a commercial-stage global gene therapy company specializing in HSC based gene therapies. In this role, Ms. Zheng established the technical operations function and manufacturing network, and advanced the company’s product pipeline, including the approval of Libmeldy™ – the first gene therapy product for metachromatic leukodystrophy. Ms. Zheng has also held leadership positions at several major biotechnology companies including Genzyme (now Sanofi) and Amgen. At Amgen, Ms. Zheng played a key role in building differentiating capabilities in manufacturing for clinical supply and commercial product launch to enable speed to clinic and speed to market strategies for Amgen’s innovative products.

Dr. Xiaoyang Zheng is currently a Scientific Fellow at Takeda, responsible for the technical oversight of method life cycle management, release/stability testing, OOS/OOT investigation, commercial manufacturing, and tech transfer for biological products. Prior to joining Takeda, she worked over 11 years at Sanofi Genzyme where she led her team in method development/qualification, analytical comparability, developability, control strategy establishment and corresponding CMC regulatory filings. She leads various method transfers including from development to QC, from one internal site to another internal site, to/from external testing labs, and corresponding timeline planning. She received a Doctor of Philosophy degree from Northeastern University.

Professor Zhou’s laboratory applies protein chemistry, analysis and engineering to biology and medicine. One program is “Hybrid Modality Engineering of Proteins”—a platform to introduce non-canonical chemical moieties and/or scaffolds into peptides and proteins to confer novel functions otherwise unavailable, such as photomedicine. The second is to devise chemo-enzymatic methodologies to characterize protein modifications, such as crosslinking, isoaspartic acid formation (asparagine deamidation) and methylations. In collaboration with biologists and clinicians alike, we also investigate their biological effects, and moreover, as critical attributes in protein pharmaceuticals. Over the past decade, Professor Zhou has been actively collaborating and consulting with biotech and pharm companies on biotherapeutics, enzymes and protein chemistry. These collaborations have led to the elucidation of product and process-related modifications (many of which were previously unknown). He also developed and now teaches a new advanced course entitled “Chemistry and Design of Protein Pharmaceuticals,” as well as workshops on antibody-drug conjugates (ADC), and training courses for scientists from industry, academia, and regulatory agencies in the US, China, and APEC economies.

Chen Zhou is a Principal Research Scientist at Abbvie Bioresearch Center. Chen has a PhD degree in Pharmaceutical Sciences from University of Colorado and has over 10 years of experience in Drug Product Development for biologics including peptide, mAb, fusion protein, ADC, bispecific Abs, and rAAV gene therapy.

Xiaolei Zhuang is a senior scientist II in Global Biologics at USP, who focuses on reference standard development. Before joining USP, she had been working on analytical and preclinical/clinical studies to support biological drug development in biopharmaceutical companies.

Colin J. Zick is a partner with the law firm Foley Hoag LLP, where he serves as Chair of its Health Care Fraud and Compliance Practice Group and Co-Chair of its Data Privacy & Security Practice Group. His practice is focused on health care and compliance issues, and often involves the intersection of those two subjects in investigations, administrative proceedings, or litigation. His work has had a particular emphasis on compliance issues related to life sciences, pharmaceutical and medical device companies, laboratories, hospitals, providers, and provider organizations. This compliance work includes helping clients establish and maintain effective compliance programs. Colin also defends clients in disputes alleging kickbacks, overpayments, and billing and coding problems, and represents clients before state health care licensing and regulatory entities. He counsels clients ranging from the Fortune 1000 to start-ups on issues involving information privacy and security, including compliance with state, federal, and international data privacy and security laws and government enforcement actions. He also frequently counsels health care, life sciences, technology, and consumer-facing clients on issues involving information privacy and security (including the GDPR, HIPAA, SEC, FTC, CCPA, CPRA, and other US federal and state data privacy and security laws, privacy policies, cloud security, cyber insurance, the Internet of Things, artificial intelligence/AI, and data breach response). Colin co-founded the firm's Privacy and Data Security Practice Group and regularly contributes to its "Security, Privacy and the Law" blog, www.securityprivacyandthelaw.com. He speaks regularly on a variety of subjects relating to privacy and security, including to the Association for Corporate Counsel on breach response, on cyber risk and insurance at the New York Stock Exchange, to the Advanced Cybersecurity Center, the Massachusetts Technology Leadership Council, the French-American Chamber of Commerce, and to the members of the Massachusetts Hospital Association, the Massachusetts Medical Society and the Boston Bar Association, and with representatives of the Office of the Attorney General of the Commonwealth of Massachusetts and the Office of Civil Rights of the Department of Health and Human Services. Colin has served as the editor of the Massachusetts Health Information Management Association’s Medicolegal Guide to Health Record Information and he served as a member of Law360’s Privacy & Consumer Protection editorial advisory board. Colin is ranked as one of the Best Lawyers in America for Healthcare and for Privacy and Data Security Law, ranked since 2010 by CHAMBERS USA as one of Massachusetts' leading health care lawyers, and he has been selected by his peers as a Massachusetts “Super Lawyer” since 2004.

Dr. Andrew L. Zydney is the Bayard D. Kunkle Chair and Professor of Chemical Engineering at The Pennsylvania State University. Dr. Zydney also serves as Director of the Penn State Center of Excellence in Industrial Biotechnology, as well as the Penn State site in the Membrane Science, Engineering, and Technology (MAST) Center. Professor Zydney's research is focused on the application of membranes in bioprocessing, including the purification of monoclonal antibodies, vaccines, and gene therapy agents. He is the most recent recipient of the Alan S. Michaels Award for Innovation in Membrane Society and Technology (from the North American Membrane Society) and the ACS Separations Science and Technology Award (from the American Chemical Society), and he is a past recipient of the AIChE Gerhold Award for Excellence in Separation Science and the Excellence in Biological Engineering Publications.