Speaker Biographies

Sudeep Adhikari is a computational biophysicist with over four years of pharmaceutical industry experience in biologics and small-molecule development. He specializes in molecular modeling and simulations to predict high-concentration viscosity, protein-protein/excipient interactions, aggregation, and formulation behavior for monoclonal antibodies (mAbs) and multispecific antibodies (msAbs). Currently a postdoctoral researcher at Stevens Institute of Technology (Lailab, Janssen-sponsored project), he develops physics-based MD and coarse-grained CG models integrated with machine learning to forecast mAb/msAb viscosity and support developability. Previously at Merck & Co. (2022–2025), he modeled buffer effects, designed CG frameworks for protein interactions, and contributed to CMC risk assessments. He holds a PhD in Physics from the University of Mississippi (2015–2022), focusing on biopolymer unfolding and coarse-grained simulations. His publications appear in Molecular Pharmaceutics and Physical Review Research, with additional works on viscosity modeling and formulation in preparation.

Christina leads the US Biotherapeutics Cell Line and Process Development group at Takeda, which is responsible for development of production cell lines and robust and efficient upstream and downstream processes for protein biologics to support the clinical and commercial pipeline. She has held previous roles at Biogen and Chiron and holds a BS in Chemical Engineering from Northeastern University and a PhD in Biomolecular Engineering from Johns Hopkins University.

Samiul Amin is currently Associate Professor of Chemical Engineering at Manhattan College. At Manhattan College Chemical Engineering Department, Prof. Amin currently leads the Cosmetic Engineering focus area. Prof. Amin also holds an appointment as an Adjunct Associate Professor at the Long Island University, School of Pharmacy. Prior to joining academia in January 2018, Prof. Amin has worked in industry across multiple industrial sectors for the past 20 years working across Engineering, R&D and Innovation/Open Innovation Management in global multinationals such as ExxonMobil, Unilever, Yet2, L’Oreal and Malvern Instruments in Asia, Europe and the US. Prof. Amin’s expertise is in colloids & complex fluids, rheology, tribology, advanced characterization and formulation design of consumer, personal care, homecare and biopharmaceutical products. Prof. Amin’s research at Manhattan College is focused on formulation design and performance optimization of consumer, cosmetic, biopharmaceutical and homecare products based on establishing structure-property-processing-performance linkages and generating high performance formulations through utilization of novel sustainable materials such as biosurfactants and biopolymers and novel polymer and surfactant chemistries including stimuli responsive or smart materials, all of which are sourced through collaborations with polymer and materials companies. Prof. Amin's research group is involved in multiple industrial research projects with global cosmetic/personal care, biopharmaceutical and advanced characterization/instrumentation companies. Prof. Amin has served on many committees of national and international societies/organizations such as the Royal Society of Chemistry (RSC)/Society of Chemical Industry (SCI) etc. and has chaired numerous international conferences in the cosmetics, biopharmaceuticals and complex fluids/soft matter area in Europe and the US. He is currently the section editor for Current Opinion in Colloid and Interface Science-Formulations and Cosmetics section. Prof. Amin received his PhD in Chemical Engineering from North Carolina State University, his MS in Chemical Engineering from The Johns Hopkins University and his BS in Chemical Engineering from Rutgers University. Prof. Amin also carried out a postdoctoral fellowship in the Soft Condensed Matter Physics Group at the University of Fribourg in Switzerland.

Andrea Arsiccio is a Senior Scientist leading the in silico team at Coriolis Pharma, where he is implementing innovative modelling concepts for biopharmaceutical formulation and drug product development. He received a master's degree in Chemical Engineering in 2016 followed by a PhD degree in 2020. During his PhD he investigated the computational modelling of proteins, with a special focus on the formulation of biopharmaceuticals. He subsequently worked as a Postdoctoral scholar at the University of California in Santa Barbara and at Politecnico di Torino, and during this time his research focused on molecular dynamics simulations and bioinformatics. His main interests and expertise are in the fields of modelling, protein folding and aggregation, and freeze-drying.

I have worked as a member of the Global Downstream Biologics Development team at Bristol Myers Squibb since August 2015. My primary role has been to conduct research and development, leading to efficient, scalable recovery and purification processes for early-phase portfolio. For the past 17 years and counting, I have worked in a pharmaceutical industry environment. Before joining BMS, I worked in downstream process development at Merck where I was responsible for developing and optimizing purification process for therapeutic proteins. Prior to that, I held roles at Gilead Sciences, Inc. (formerly Pharmasset), working in multiple scientific disciplines. I have also earned my Masters in Biochemistry from Kansas State University.

Leading Biopharma Talent Science & Human Capital Dynamics research.

Krishna D. B. Anapindi is a highly skilled bioanalytical mass spectrometrist with over eight years of experience in peptide and protein characterization. He is currently a Senior Scientist at Gilead Sciences, where he is part of the Molecular Assessment (MA) team. His work focuses on evaluating the developability of protein therapeutics, developing innovative LC-MS workflows to streamline and improve the efficiency of both protein and small molecule analysis. At Gilead, Krishna also contributes to cutting-edge research by integrating machine learning models to predict key developability properties of therapeutic protein candidates. This involves designing and implementing workflows that enhance the characterization process, contributing to the optimization of therapeutic proteins. Krishna holds a PhD in Chemistry and a Master’s in Applied Statistics from the University of Illinois at Urbana-Champaign. His career demonstrates a strong blend of technical expertise, innovative thinking, and interdisciplinary research in the biopharmaceutical field.

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.

Jacquelyn obtained her bachelor’s degree in chemistry from The College of William and Mary where she studied plasmon-enhanced fluorescence of dyes coated on silica-coated silver nanoparticles with the aim of improving electron transfer in dye-sensitized solar cells. She then moved to California where she pursued a PhD in Chemistry at the University of California, Berkeley, under the guidance of Professor Jay Keasling. At Cal, she characterized and engineered polyketide synthases and related enzymes. Immediately after obtaining her PhD, she moved across the San Francisco Bay to Sutro Biopharma in early 2020 where she currently works on the strain engineering team within the Protein Biochemistry group. Her current work focuses on understanding and improving non-natural amino acid incorporation into biologics produced in Escherichia coli.

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.

David Boggs is Senior Scientist in Protein Analytics at the AbbVie Bioresearch Center, where he champions novel approaches for characterizing proteins and advancing therapeutic discovery. He holds bachelor’s and master’s degrees in chemistry from Boston University, with a master’s thesis investigating the kinetics of a pterin-dependent mononuclear iron enzyme. His published doctoral work at the University of Michigan sought to understand and engineer proteins involved in chlorophyll metabolism, pollutant degradation, and clinically-focused artificial metalloproteins. At AbbVie, David leverages a foundation in protein chemistry, biophysics, and structural biology to characterize antibody-antigen, lipid nanoparticle, and virus-like particle platforms. He has developed and deployed methods for particle size and count analysis through robust synergistic techniques, and continues to expand the group’s capabilities to pursue challenging targets. David finds energy turning complex data into real progress on therapeutics and is committed to sharing excitement for scientific discovery.

Dr. Bolton is a An Executive Director at Amgen, where he leads late-stage cell culture and purification development. Prior to joining Amgen, he worked with different organizations including Pfizer and Biogen. He also taught the Protein Purification and Cell and Microbe Cultivation courses at Tufts Univeristy. He has served as Division Chair, Conference Chair and Treasurer for the ACS Biochemical Technology Division and is currently the chair of the 8th International Conference on Accelerating Biopharmaceutical Development (AccBio 2023). Dr. Bolton is a Director of Zepteon Corporation and on the Scientific Advisory Board of AcousticaBio. Glen earned his Ph.D. in Biochemical Engineering from the Massachusetts Institute of Technology.

Lukas Bongers studied biotechnology at the Technical University of Munich before starting in his current position as a PhD-student at the Gene Therapy Technical Research & Development Center at Roche Diagnostics. He works on the optimization of downstream processing for adeno-associated viral vectors in laboratory scale and focuses on chromatographic capture with affinity ligands.

Lynn Bottone is Senior Vice President of Quality, Safety & Environmental Operations (QSEO) at Pfizer, leading a global team that ensures quality, safety, and environmental stewardship across more than thirty internal and four hundred external manufacturing sites. With decades of experience in manufacturing, quality assurance, and compliance, Lynn has held leadership roles at Pfizer and Merck, driving operational excellence and innovation. She holds a B.S. in Chemistry from SUNY Purchase and lives in North Carolina.

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.

Jill Bradley-Graham is a Scientist in the Genomic Medicine Unit at Sanofi, Genzyme focusing on the characterization of cell and gene therapy products by mass spectrometry. With a background in organismal biology and protein maturation and quality control in the cell, Jill applies her understanding of cell biology to the characterization of genomic medicines. Utilizing biophysical and analytical instrumentation, Jill performs in-depth bioanalytics for each product in order to aid process development and deliver innovative, long-lasting and safe therapeutics to patients.

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.

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.

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.

Dr. Cheng is a protein scientist with extensive experience in therapeutic protein discovery and development, specializing in purification, characterization, and engineering of complex biologics. He received his Ph.D. in Biochemistry from the University of Delaware, where he trained in protein chemistry and mass spectrometry. He began his industry career at NGM Biopharmaceuticals, where he worked on multiple innovative bispecific antibody and hexameric IgG programs as part of the biologics team. In 2025, he joined Juvena Therapeutics as a principal scientist in protein science, advancing early-stage AI drug discovery platforms. Currently, he serves as a principal scientist at Immunedge, where he leads efforts in the design, production, and characterization of next generation therapeutics. His expertise spans antibody engineering, purification process development, and biophysical characterization, with a strong focus on translational research in biologics.

Received BS in chemical engineering from Lafayette College while playing softball on an athletic scholarship for 4 years. Received both masters and PhD part-time from Rutgers University while working at Merck. About 20 years of experience in biologics downstream process development with expertise in continuous and fed batch chromatography and biochemical reaction engineering. In my free time, enjoying spending time with my family hiking or playing sports and my kids are currently learning how to play Pokemon.

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.

Chris Chumsae, Ph.D. is currently Associate Director of Process Development Analytics at Bristol-Myers Squibb Company at the Devens, MA campus. Prior to BMS, Chris lead mass spectrometry and analytical characterization efforts at AbbVie Bioresearch Center in Worcester, MA for nineteen years. Chris has authored and co-authored 30 peer reviewed publications and has been granted 10 United States patents. Chris earned his Ph.D. in chemistry from Northeastern University.

Dr. Clarke is an executive level technical leader and has over 15 years of experience developing enabling solutions to support cell and gene therapies. He is currently Vice President of technical operations, IntegriCell, Cryoport Systems. Previously he was a partner and Chief Strategy Officer for Orange County Bio a dedicated cell & gene therapy marketing operations and consulting company where he led the development and execution of the business strategy. Dominic also served as Chief Technical Officer, Cell & Gene Therapies at Discovery Life Sciences providing leadership, direction and development for their cell & gene therapy products and services. Additional roles and experience include Director of Global Cell Therapy Strategy & Innovation at Charles River Laboratories, Global Head of Cell Therapy at HemaCare, a leading provider of source material for clinical development and commercial manufacturing of cell-based therapies, Global Product Manager for Charter Medical's cell therapy and bioprocessing single-use systems portfolio and Director of Research & Development for BioLife Solutions. Dominic currently serves as the Co-chair for the International Society for Cell and Gene Therapies' Process and Product Development Committee with efforts directed towards educating and developing best practices for translating research and process development from bench to clinic.

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.

Louis Coplan is a bioprocess engineer with five years of experience in gene therapy manufacturing. He received his Bachelor of Science degrees in Biochemistry and Biological Sciences, and a Master of Engineering in Chemical and Biomolecular Engineering from the University of Maryland, College Park. As a bioprocess engineer at Regeneron, Louis focuses on upstream preclinical process development for adeno-associated virus vectors.

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.

Dr. Rozaleen Dash is a Senior Research Scientist at the DBT Center of Excellence for Biopharmaceutical Technology, Indian Institute of Technology Delhi, India. She holds a PhD in Biochemistry from AIIMS, New Delhi, and has over twelve years of experience in functional bioassays, immunogenicity assessment, and characterization of monoclonal antibody therapeutics. Her research focuses on advancing robust functional assessment strategies for biotherapeutics characterization, with the aim of supporting the development of safe, effective, and high-quality biologic medicines.

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).

Dr. Xavier de Mollerat du Jeu is Head of Automation and Innovation at Legend Biotech, where he leads the development and implementation of next-generation technologies to support scalable, robust, and compliant manufacturing for both commercial and pipeline cell therapy products. With over 20 years in the biotechnology industry, including a long tenure at Thermo Fisher Scientific, Xavier has driven major innovations across cell and gene therapy, including work in gene delivery systems, process automation, and viral vector technologies. He is an inventor on numerous patents and has contributed to the advancement of closed and automated manufacturing platforms that support clinical and commercial readiness. He holds a PhD in Human Genetics from Clemson University, with postdoctoral training at UC San Diego in developmental genetics and microRNA research. His scientific foundation in molecular and human genetics continues to inform his strategic approach to innovation in cell therapy manufacturing.

Kurtis Denny has been working as an engineer in Biogen’s Cell Culture Development department since 2017. Kurtis has a primary focus of continuous manufacturing process development for biologics. Additionally, he leads a team focused on process analytical technology applications in the upstream space, and he is passionate about when PAT and CM come together!

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.

Dr. Cedric Devos is a Belgian scientist and Postdoctoral Associate in the Department of Chemical Engineering at the Massachusetts Institute of Technology (MIT), where he has worked since 2023 with Professor Allan S. Myerson on lipid nanoparticle delivery for nucleic acid therapeutics. He received his BSc (2017) and MSc (2019) in Chemical Engineering from KU Leuven, where he subsequently completed his PhD in 2023 as a recipient of the prestigious FWO Fellowship for Fundamental Research. Cedric has built a strong research portfolio, including 17 peer-reviewed publications, two patent applications, and 39 conference contributions. His research focuses on crystallization, lipid nanoparticle formulation, and process intensification for advanced pharmaceutical manufacturing.

Nicholas holds a degree in chemical engineering from the University of Massachusetts at Amherst. and has over 7 years of experience in the biotech industry developing biologics manufacturing processes. He got his start supporting commercial manufacturing at Sanofi and has since held roles of increasing responsibility in the process development groups at Bristol Myers Squibb and LogicBio therapeutics. He is currently serving as a manager of genomic medicines process development at Alexion pharmaceuticals.

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).

Rakesh Dixit is an accomplished executive, inventor, and scientist with over 35 years of success with top biotechnology and pharmaceutical companies, including Merck, Johnson & Johnson, and Medimmune - AstraZeneca. Currently, he is President and CSO of Regio Biosciences and Bionavigen, LLC. He is a Board Member of Regio Biosciences and a key member of multiple scientific advisory boards. Rakesh is also a chief adviser and consultant for more than 20 companies worldwide. His biopharmaceutical peers selected Rakesh as one of the 100 Most Inspiring People in the Pharmaceutical Industry by PharmaVOICE in 2015. Rakesh received the Most Prestigious Award of Long-Standing Contribution to ADCs by World ADC (Hanson-Wade), 2020. From 2006 to 2019, Rakesh was a Global Vice President of the Biologics R&D at Medimmune - AstraZeneca. Rakesh has unique expertise in developing biologics (e.g., monoclonal antibodies, bispecific biologics, antibody-drug conjugates, fusion proteins, peptides, gene and cell therapies, etc.) and small-molecule biopharmaceuticals. His areas of expertise include discovery, early and late preclinical development, safety assessment, DMPK, and translational sciences. Dr. Dixit conducted extensive graduate and post-graduate training in Pharmacology/Toxicology–Biochemistry with both Indian and USA institutions (e.g., Case Western Reserve University, Medical College of Ohio, University of Nebraska) and is a Diplomate and Board Certified in Toxicology from the American Board of Toxicology, Inc. since 1992.

Robert Dream is an industry leader with 30+ years of experience, including 20 years of executive leadership in the pharmaceutical and biotechnology industries. He has led projects, improved processes, helped move drug substance and drug products from R&D, clinical, regulatory licensing approvals through operational excellence strategies and leading edge technologies. He is business minded person and has an innovative knowledge and knowhow of manufacturing, logistics, supply chain, risk mitigation and management. He is experienced in therapeutic biotechnology and biological drug substance and drug products manufacturing, with extensive hands-on, senior leadership and executive experience at world-leading organizations. He wrote numerous articles for many journals and publications and lead and presented at many institutions, organizations, and conferences. He is a registered professional engineer and an active member of the ISPE and PDA. He is a member of the editorial advisory Board; Pharmaceutical Processing, Pharmaceutical Manufacturing, Pharmaceutical Technology, Pharmaceutical Engineering, and the INTERPHEX Advisory Council. He is a member and Process Chair of the PDA “Aging Facilities Modernization” Team. He is the Chair of the ISPE GUIDE: “Biopharmaceutical Process Development and Manufacturing”; published 2013, ISPE “Sustainability Handbook”; Published 2015 and numerous other relevant publication to list few.

Lauren M. Drouin is Director of the Genomic Medicine Analytical Development group at Alexion, AstraZeneca Rare Disease. Her team supports analytical testing for AAV gene therapy and gene editing products, including initial method development, assay qualification, and product characterization, in addition to assisting CMC operations with plasmid DNA, cell bank, and DS/DP batch release and stability programs. Lauren managed CMC analytical operations for the Methylmalonic Acidemia clinical program, the first in vivo gene editing therapy delivered systematically to pediatric patients, and was significantly involved in both the manufacturing campaign and subsequent regulatory submission. Her current research interests include novel AAV capsid characterization and developing a robust understanding of the factors that influence potency of gene therapy products. Previously, she worked at Voyager Therapeutics where she was responsible for analytical method development and overseeing CMC analytical operations for the Parkinson’s Disease clinical gene therapy program. Lauren received her PhD in Biochemistry and Molecular Biology from the University of Florida where she utilized molecular, biophysical, and structural techniques to characterize the AAV capsid for improved gene delivery applications. She currently serves as Chair of the AAV Gene Therapy Products Expert Panel for the United States Pharmacopeia and is a member of the Global Outreach Committee for the American Society of Gene & Cell Therapy, working to expand access to cell and gene therapies on a global scale.

Daryl has 30 years of experience in the research and development of liposomal and lipidic nanoparticle (LNP) based therapeutics and vaccines. Daryl is currently the Founder, Chief Scientific Officer, and Senior Vice President of Akagera Medicines. At Akagera, he is advancing the use of sophisticated lipid-based nanotechnologies to deliver novel and highly potent anti-bacterial agents directly to innate immune cell reservoirs for mycobacterium or gram-positive bacterium and mRNA vaccines, targeting some of the world’s most challenging and neglected infectious diseases. Daryl also joined Tidal Therapeutics in 2019 as an SAB member, and later as the Interim Head of Research and Development, prior to be acquired by Sanofi in April 2021. At Sanofi he oversees the engineering and pharmacology of immune cell-targeted mRNA lipid nanoparticles (LNPs). Through June of 2019, Dr. Drummond served as the Head of Research and Senior Vice President of Discovery for Merrimack Pharmaceuticals, a public biotechnology company headquartered in Cambridge, MA, where he oversaw the discovery efforts for Merrimack’s Nanotherapeutics and Biologics-based therapeutics. Dr. Drummond received a Ph.D. degree in Biochemistry from Indiana University in 1997, with an emphasis on membrane biochemistry and biophysics, and later completed a postdoc under the renowned father of lipid-based drug delivery systems, Demetrios Papahadjopoulos at California Pacific Medical Center in 1999. Dr. Drummond was a principle inventor for a wide range of nanotechnology-based drugs and platform technologies, most notably Onivyde, a highly stabilized liposomal formulation of irinotecan. He joined Merrimack in 2009 following the merger of Merrimack with Hermes Biosciences. Overall, Dr. Drummond has more than 30 years of experience in the research and development of advanced drug delivery systems, including five unique drugs or imaging agents that have been tested in various clinical trials, an NDA and EMA approval for Onivyde, >40 issued patents or patent applications, and more than 75 peer reviewed publications. The focus of his research at Merrimack had been in developing targeted nanotherapeutics for treating a wide range of solid tumors. He successfully developed novel platform technologies for targeting lipidic nanocarriers such as liposomes or lipid nanoparticles (LNPs) using a range of novel ligands, but most notably Fab’ or scFv antibody fragments. He has also developed platform technologies for dramatically improving the in vivo drug retention of difficult to stabilize small molecule drugs, and for systemic delivery of nucleic acids. Three of these nanotherapeutics were studied in clinical trials, including an ErbB2-targeted liposomal doxorubicin which was evaluated in a Phase II study in ErbB2-overexpressing breast cancers and a nanoliposomal formulation of irinotecan which was approved by both the EMA and FDA following promising results in a Phase III trial in gemcitabine-refractory pancreatic cancer. Onivyde is currently being studied in front line pancreatic cancer in combination with oxaliplatin and 5FU and in second line small cell lung cancer by Ipsen Pharmaceuticals. A fourth antibody targeted lipososomal drug (MM-310) was recently evaluated in a Phase I study in multiple EphA2 overexpressing solid tumors. In addition, Dr. Drummond previously oversaw the discovery and development of more traditional biologics, such as a stabilized TRAIL-Fc fusion and a monoclonal antibody against the immuno-oncology target, TNFR2.

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.

Matt Edwards is a strategic CMC and Process Development executive with more than 12 years of leadership experience building biologics manufacturing platforms, driving AAV process innovation, managing CDMOs, and advancing programs from discovery through IND and late-stage readiness. He currently serves as Vice President of Technical Operations at Affinia Therapeutics, where he has led the development of scalable AAV manufacturing platforms, established CMC strategies, authored IND Module 3 submissions, and delivered significant yield improvements through innovative plasmid design and process intensification. Matt previously held scientific and operational leadership roles at LogicBio Therapeutics, Translate Bio, AstraZeneca, Constellation Pharmaceuticals, Harvard University, and Emory University, contributing across AAV and mRNA development, oncology and epigenetics research, and early biologics discovery. He is recognized for his ability to integrate scientific rigor with operational clarity, build high-performing teams, and align CMC strategy with R&D, regulatory, clinical, and quality functions. His work includes multiple conference presentations, peer-reviewed publications, and patent filings in AAV vector manufacturing. Matt holds an MBA from the University of Massachusetts Isenberg School of Management and a B.S. in Biology from the University of Georgia.

Dr. Magdi Elsallab is the Director of Process Development at the Cellular Immunotherapy Program, Mass General Cancer Center, and an instructor in medicine specializing in the clinical manufacturing and regulatory science of gene and cell therapies. His work focuses on advancing CAR T cell process development, with a particular emphasis on point-of-care to improve access, reduce vein-to-vein time, and enhance scalability. He completed a fellowship at the Harvard-MIT Center for Regulatory Science, where he concentrated on regulatory frameworks and innovation in immune-effector cell therapies. He currently directs efforts in process optimization, regulatory strategy, and translational development to accelerate the safe and equitable delivery of advanced cellular immunotherapies.

Sean completed his PhD in Chemical Engineering at the University of Texas at Austin in 2024, under the advisement of Dr. Lydia Contreras. During his time at the University of Texas, Sean developed and deployed bioinformatics, multiomics technologies, and quantitative imaging for a variety of biological and environmental applications. In his role in Enabling Technologies at Merck, Sean has applied his data-rich skillsets and cross-functional experience to implement innovative bioinformatics and multiomics technologies to improve vaccine and biologics process research and development efforts across Merck’s portfolio.

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.

I joined Genentech as a Postdoctoral Fellow in April 2022, in the Cell Culture and Bioprocess Operations (CCBO) department. I work with the Cell Line Development team to improve the expression and titer of Chinese Hamster Ovary (CHO) cells which are the most commonly used platform to produce protein-based therapeutic molecules in the industry. I graduated with my PhD in Biomedical Sciences from University of Central Florida (UCF) in 2021, where I focused on the regulatory role of specific noncoding RNAs in prostate cancer. I earned my Master’s degree in Cell and Molecular Biotechnology from University of Houston in 2015, and also worked for a year at a small startup testing ELISA-based assays with diagnostic applications in reproductive biology. All of these research experiences have strengthened my Molecular Biology and Cell Culture skills. Finally, I would like to describe myself as a person who doesn't give up very easily and "Never Says Never."

Jishna Ganguly is an associate scientist in Antigen Expression Technology within Drug Substance at GSK vaccines. She is responsible for cell line development of some of the critical CHO-based vaccine candidates in the pipeline leveraging rapid high-throughput clone selection and screening strategies . Jishna holds a Master of Cell and Microbial Biology from Catholic University of America and a Bachelor of Biotechnology from West Bengal University of Technology, India. Prior to her graduate studies, she worked in Pfizer (formerly known as Hospira) in Chennai, India as a research executive in upstream process development for biotherapeutic proteins.

Ronit Ghosh, a Purification Process Development Scientist at Sanofi’s Genomic Medicine Unit, holds a Ph.D. in Chemical and Biological Engineering from Rensselaer Polytechnic Institute. Specializing in downstream bioprocessing, Ronit has led innovative research in developing biomanufacturing processes for non-viral and viral gene therapy vectors like AAV and lentiviral vectors. With expertise in gene therapy process development, he has been involved in developing purification strategies for diverse modalities, contributing to the advancement of gene and cell therapy applications.

I am an advisor supporting biologics research and development through advanced analytical strategies. In my current role, I provide scientific leadership in the characterization of biologics, with a focus on biophysical and higher-order structure analyses that enable informed decision-making across development stages.

Dr. Hanley is the Chief and Director of the Cellular Therapy Program and an associate professor of pediatrics at Children’s National Hospital and the George Washington University, respectively. He oversees processing for standard of care stem cell transplantation as well as the development, manufacture, quality, and testing of novel cellular therapies and is responsible for seeking partnerships and commercialization of promising cell and gene therapies. Trained as an Immunologist, Dr. Hanley has an extensive background and interest in cellular therapy and is passionate about improving regulations for cellular therapy, training the next generation of cell therapists, and facilitating the translation of new therapeutics. Over the past 16 years he has helped to translate more than 300 products on over 25 cell therapy protocols – ranging from mesenchymal stromal cells to cord blood virus-specific T cells and tumor-associated antigen specific T cells – into the clinic. Dr. Hanley was elected Vice President, North America of the International Society for Cell and Gene Therapy (ISCT) where he also serves on the board of directors, on the Immuno-Gene Therapy Committee (and former co-chair),and co-founded and served as the inaugural co-chair of the Early Stage Professionals committee which focuses on workforce development and training. He also serves on the board of directors of the Foundation for the Accreditation of Cellular Therapy (FACT) and is an active cellular therapy and cord blood inspector. Dr. Hanley has actively participated in the Cell Therapy Liaison Meeting with the Food and Drug Administration since 2018 and he is the commissioning editor of the journal Cytotherapy. In 2017, along with Drs Catherine Bollard and Russell Cruz, he founded Mana Therapeutics, a biotech company aimed at educating immune cells and eliminating cancer. In his free time he enjoys tweeting with fellow scientists and Bills fans, playing soccer, cycling, cooking, and traveling.

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.

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.

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.

Zdravko Ivanov is a Ph.D. candidate in the School of Chemical and Bioprocess Engineering at University College Dublin, Ireland. He is conducting his doctoral research at the National Institute for Bioprocessing Research and Training (NIBRT), also in Dublin, under the direction of Drs. Elizabeth Topp and Steven Ferguson. His research is focused on characterising the degradation pathways of RNA oligonucleotides and mRNA in solution. Zdravko holds a bachelor’s degree in Biochemistry from King’s College London.

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.

Kaushal Jerajani is a Scientist II in Genomic Medicine at Alexion, AstraZeneca Rare Disease, leading drug product formulation and process development for early-stage AAV programs and contributing to regulatory submissions and clinical documentation. Previously, as a Senior Scientist in Early-Stage Formulation Sciences at AstraZeneca, he developed formulations for trispecific T-cell engagers and monoclonal antibodies, advanced lyophilized and liquid presentations, and established platform strategies for rapid Phase 1 enablement. Kaushal’s experience spans mAbs, recombinant vaccine antigens, and rAAVs, with a focus on formulation development, analytical characterization, stability, and tech transfer. He earned a PhD in Pharmaceutical Chemistry from the University of Kansas and an M.S. in Biomedical Science from Northeastern University. His collaborative work on HPV vaccine formulation and biotherapeutic analytics is published in the Journal of Pharmaceutical Sciences and Vaccines.

Sanjeev Jeyabalan is an Engineer II at Biogen, Inc working on purification processes of antisense oligonucleotides. He holds a MS in Bioengineering and a BS in Chemical Engineering from Tufts University.

Xin Jin is a Scientist within CMC Drug Product Development Department at Sanofi. She joined Sanofi in 2019 to support protein formulation platform establishment. Later, she joined the gene therapy group and lead one of the AAV drug product development, including formulation study, fill finish process study, enclosure system and administration device selection, and in-use study. Prior to Sanofi, she worked at Armstrong Pharmaceuticals for 7 years and lead Metered Dose Inhaler drug product development. She obtained her PhD in Chemical Engineering from Ohio University.

Thomas is an academic member of staff at UCL Biochemical Engineering, focusing on the characterisation and design of advanced downstream bioprocessing materials.

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.

Dr. Melis Kant is a scientist at the National Institute of Standards and Technology, where she focuses on cell and gene therapy–focused analytical research. She integrates Process Analytical Technology (PAT) with mass spectrometry and cell-based assays to monitor cell growth kinetics, viability, metabolic state, and functional quality. Dr. Kant applies these approaches to support bioassay development, bioprocess characterization, and data-driven decision-making in cell and gene therapy workflows.

Albert Kao is currently a purification process development scientist with Genentech/Roche at the Roche Innovation Center of Philadelphia (formerly Spark Therapeutics). His efforts are focused on Genentech/Roche’s AAV pipeline needs including leading early phase process development, authoring relevant regulatory filing sections, supporting clinical manufacturing, and contributing to late phase process characterization and process validation. Prior to joining Genentech/Roche, Albert worked at Teva Pharmaceuticals, focusing on monoclonal antibody purification process development, viral clearance, and tech transfer. He has also previously worked at Enzo Life Sciences, and Bristol Myers Squibb. Albert obtained both his Bachelor’s and Master’s degrees in Biomedical Engineering from the University of Michigan in Ann Arbor, MI.

Sukru currently leads the IT organization at AbbVie’s multiple sites in Massachusetts with two teams focused on research informatics supporting early R&D and biologics development/CMC. At Abbott/AbbVie for over 10 years, he started in the discovery organization focused on data and bioinformatics supporting biologics research and ultimately transitioned to the information research R&D IT organization in 2016. His prior experiences and roles span across the bench and clinical sciences as well as IT, software engineering, and data science. Sukru has a B.A. in Biochemistry and Molecular Biology and a M.S. in Bioinformatics, both from Boston University.

Dr. Sarwat Khattak has 20+ years of experience in the biopharmaceutical industry and has been with Biogen since 2016. She is the Head of Cell Culture Development and Cell Line Development Biologics. Sarwat received her PhD in Chemical Engineering from University of Massachusetts at Amherst and her B.S. in Chemical Engineering from MIT. She has extensive experience in recombinant protein program development through commercialization, cell culture media design, upstream PAT, modelling cell culture processes, product quality optimization, and continuous manufacturing.

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.

Dr. Spyridon Konstantinidis is a Principal Scientist and bioprocess development leader specializing in empirical and mechanistic modelling, high-throughput experimentation, and automation. With over 15 years of experience across vaccines, biologics, and gene therapies, he has built and led cross-functional teams that integrate modelling, analytics, and microscale platforms to accelerate process development and pipeline decisions. His work includes implementing chromatography modelling in vaccine and biologics programs, establishing automated high-throughput downstream workflows, and driving data-driven optimization using multivariate methods and numerical techniques. Trained as a biochemical engineer with an EngD in Biochemical Engineering and Bioprocess Leadership, Dr. Konstantinidis is committed to turning complex models into practical tools that enable robust, scalable bioprocesses.

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.

Surjeet Kumar Arya, Ph.D., is a Research Scientist at the University of Kentucky, where his work focuses on the intersection of insect biotechnology, functional genomics, and advanced bioprocessing. He has extensive experience in insect cell line development and characterization, applying multi-omic approaches—including RNA-seq, single-cell sequencing, and chromatin accessibility profiling—to advance alternative expression systems. His research bridges fundamental insect biology with industrial applications, exploring non-model insect platforms as scalable and efficient alternatives to traditional mammalian hosts. He also integrates bioinformatics and machine learning to support trait discovery, regulatory network analysis, and optimization of biomanufacturing-relevant cell systems.

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.

Christine Le Bec joined Sensorion Pharma, a company dedicated to the development of therapies for genetic forms hearing loss, in early 2020 as Head of CMC Gene Therapy. She is responsible of all CMC activities, including process and analytical development, CMC technology transfer to CMOs, manufacturing and supplying of phase I and II clinical trials. Before joining Sensorion Pharma, she worked for more than 20 years at Genethon in the field of Gene Therapy vectors (AAV, Lentivirus, Baculovirus) for rare diseases. She has a strong expertise in the development, qualification, validation of analytical methods for process and product characterization, release testing of gene therapy products and in stability studies. She has also a solid knowledge of International regulations and reviewing CMC documents for clinical trial applications.

Dr. Dong-Yup Lee is a professor of the School of Chemical Engineering at the Sungkyunkwan University (SKKU), a director of White Bioinnovation Research Center, and leads both the Process Design and Systems Engineering (PDSE) lab and Bioprocess Digital Twin lab at SKKU. He has a stellar track record and expertise in multiomics integration, model-guided metabolic engineering, and mammalian systems biotechnology. He has coauthored more than 170 research articles on these and other topics. His current research focuses on bioprocess digital twins, computational synthetic gene design for biotherapeutics, and microbiome engineering for health, biotechnology, and cosmetic applications. With a strong emphasis on applied research, he has successfully led numerous consultancy and industrial projects for global biopharma, biotech, and cosmetic companies.

I am a bioprocess scientist in the Bioprocess Development group at Denali Therapeutics, advancing transformative biotherapeutics for neurodegenerative and lysosomal diseases. At GigaGen, I architected the company’s scale up strategy and led the transition to stirred tank bioreactor systems to enable robust, scalable manufacturing. At Tenaya Therapeutics, I built a HEK293 AAV production platform from the ground up and supported both HEK293 and Sf9 systems.

Professor Sabrina Leslie studied honours physics and mathematics at the University of British Columbia twenty years ago before moving to UC Berkeley where she obtained her PhD in optical physics in 2008, followed by her Mary Fieser postdoctoral fellowship in biophysics at Harvard University 2009-2011. There she invented a tether-free, high-throughput single-molecule imaging technology called Convex Lens-induced Confinement (CLiC), which established her as a pioneer in single-molecule investigations. In 2012, she became an Assistant Professor at McGill University and founded her research group in the Physics Department. There she developed CLiC into a platform technology and used it for new single-molecule studies of nucleic acids, proteins, polymers, nanomaterials, biologics, and cells. In 2019 she was honored with the Young Investigator Award from the Biophysical Society of Canada, and in 2020 she was elected to the Royal Society of Canada (RSC) College of New Artists Scholars and Scientists. In 2021, she and her team re-located to the Michael Smith Labs at UBC where her Associate Professor appointment is joint with the Department of Physics and Astronomy and affiliated with the School of Biomedical Engineering, Genome Science and Applied Technology and Bioinformatics programs.

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.

Lijuan is Associate Director of Process Modeling within Sanofi’s Global CMC Data Science team, where she supports the development and deployment of advanced modeling solutions across Sanofi's biologics portfolio, including mammalian, microbial, and gene therapies. With 10 years of experience, she specializes in advanced data analytics and mechanistic/hybrid modeling to support process development and manufacturing. She previously held roles at Bristol Myers Squibb and Takeda and received her PhD in Chemical Engineering from Rensselaer Polytechnic Institute.

Yi is a Principal Scientist at Gilead Sciences in the San Francisco Bay Area providing scientific leadership in CMC statistics, data sciences, and data-rich experimental design and modeling. Prior to Gilead, she worked as a co-op scientist at GSK, applying in-line Process Analytical Technology (PAT) tools to strengthen pharmaceutical development and manufacturing control strategies. In her current role, Yi leads a high-impact team within Analytical Development, shaping innovation strategy and scientific direction for analytical sciences. She partners extensively with process chemistry, formulation, and biologics functions, driving cross-functional solutions to complex technical challenges. Her skillset integrates mechanistic modeling, empirical modeling, and AI/ML approaches to accelerate pharmaceutical development across multiple therapeutic modalities.

Julie Ming Liang, PhD is the co-founder and Chief Scientific Officer at Opera Bioscience. Liang is a synthetic biologist and interdisciplinary scientist combining her chemistry, metabolic engineering, and strain development training to create innovative solutions toward a sustainable future. She received her PhD in biological sciences from the Tullman-Ercek lab in the Chemical and Biological Engineering department at Northwestern University. There, Liang was instrumental in developing Opera Bioscience’s core technology, a gram-negative bacterial protein production platform that reduces the cost and developmental timelines for making reagents, enzymes, and therapeutics. She engineered the type III secretion system (T3SS) to secrete heterologous proteins to eliminate steps in the most expensive part of protein manufacturing: downstream processing and purification. Her research resulted in the creation of constitutively active T3SS strains which do not require inducer in the culture media to activate protein secretion, reducing the total media cost by 28% and the total cost of protein production by up to 10%. Before her role at Opera Bioscience, she was a strain engineer at Amyris, developing yeast strains to ferment sugar into renewable fuels.

Kok-Seong Lim, BPharm, PhD, RAC, is a pharmaceutical leader with over 20 years of experience in biological research and development, specializing in analytical sciences, quality control, and CMC strategy for advanced therapy platforms. He has held management roles at Metagenomi, Aura Biosciences, Editas Medicine, and Thermo Fisher Scientific. In these roles, he supported the development of more than 10 gene therapies and CRISPR-based medicines across rare disease and oncology. His work includes building GMP-compliant facilities and analytical infrastructures to support early- and late-stage development. He has managed multimillion-dollar budgets and contributed to regulatory submissions in both the U.S. and EU. An active industry contributor, Kok-Seong serves as Chair of the RAPS San Francisco Chapter and as a member of the U.S. Pharmacopeia Biologics—Cell and Gene Therapy Expert Committee, where he contributes to the development of industry standards and best practices for cell and gene therapy. He earned his PhD in Biochemistry from the National University of Singapore and a BSc in Pharmacy from the University of Strathclyde.

Nico Lingg is senior scientist at the Austrian Centre of Industrial Biotechnology, specializing in downstream processes for biomacromolecules. He received his PhD degree in Biotechnology in 2014 from the University of Natural Resources and Life Sciences, Vienna. From 2011-2013 he conducted two years of PhD research at the Bioprocessing Technology Institute, Singapore. Here, he developed novel separation methods for monoclonal antibodies, based on controlled pH gradient elution in ion exchange chromatography. His current research focuses on platform processes for protein production, continuous bioprocessing and novel separation techniques for bionanoparticles, as well as fundamental research in chromatography. He is also actively involved in teaching the subjects of bioprocess engineering and downstream processing at his home university (BOKU) and at the Fachhochschule Campus Wien.

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.

Cassie Liu is a senior principal statistician in Biologics Development Department at Bristol Myers Squibb. Over the 10 years with BMS, she has provided statistical supports in various CMC projects, including stability analysis and specification assessment for IND/BLA filings, statistical and ML modeling, risk assessment, bioassay analysis, design of experiment, analytical method performance monitoring, dataflow integration, and automation, etc. She received a master’s degree in statistics from University of Connecticut and bachelor's degree in statistics from Nankai University in China. Prior to joining BMS, she was a statistician in a health-related research lab at Yale University.

Yuxin Liu is a senior scientist at Sanofi’s Framingham site and holds a PhD in chemical engineering from Rutgers University. Her work at Sanofi includes implementing advanced analytical instrument such as LCMS into cell culture process development and supporting early-stage pipeline projects and media development.

Xiaohua Liu works as a Principal Scientist in Mass Spectrometry at Sanofi in Cambridge, MA. Within the Large Molecule Research division, he has been analyzing therapeutic proteins using mass spectrometry for 6 years. He started his scientific career by studying gas phase ion-ion interactions generated by electrospray ionization. Xiaohua is an experienced scientist with strong knowledge of pharmaceutical bioanalysis, protein/peptide characterization and quantitation, and mass spectrometry-based proteomics.

Ronnie is the Director of Analytical Development at BlueRock Therapeutics. In his role, Ronnie leads a dedicated group that provides deep technical expertise to drive the performance management of assays that deliver sound analytical data. Ronnie has 14 years of experience spanning cell and gene therapies, clinical diagnostics, and product development. Ronnie received a PhD in Biochemistry from the University of Toronto, Canada.

Delia Lyons is a senior principal scientist in the Cell Culture Process Development Group at AbbVie, where she leads scientists responsible for developing drug substance manufacturing processes across all pipeline stages, including first-in-human (FIH), late-stage, and life-cycle management programs. Previously, Delia worked at Gibco and SAFC, deepening her expertise in cellular metabolism and its modulation via cell culture media and process optimization, including both fed-batch and perfusion systems. In her current role at AbbVie, she continues to advance robust and high-yielding manufacturing processes by integrating raw material understanding and metabolic insights into rational process design.

Zhen earned his bachelor’s degree in Biological Sciences from Fudan University, and obtained his PhD degree in the lab of Prof. David Giedroc at Texas A&M University. His PhD research focused on protein biochemistry, protein-ligand interactions and allosteric regulation. He then carried out a post-doctoral fellowship at Cornell with Prof. John Helmann in the area of Bacillus subtilis genetics and physiology. He began his professional career at Dupont Nutrition & Biosciences (now part of IFF – International Flavors & Fragrances) working on improving the expression of difficult-to-express proteins and industrial enzymes. Working with various expression hosts, he successfully led the straining engineering effort to commercialize multiple products. Prior to joining Merck, he managed a new Biotransformation group in the global R&D organization of Ingredion to deliver innovative solutions for food ingredients. In his current role, Zhen leads the Novel Expression Systems group, focusing on enabling and enhancing the production of diverse biomolecules to support the discovery and development of therapeutics.

My name is Prashant Mainali, a microbial scientist at Bioprocessing Technological Institute (BTI), A*STAR, Singapore. Currently, I am working on the valorization of spent animal cell culture media to cultivate Lactococcus lactis for the production of FGF-2, an important and expensive component for serum free animal cell culture media. Following my undergraduate studies, I was honored to receive the SINGA scholarship to pursue a PhD at the National University of Singapore while being a research attaché at the Singapore Institute of Food and Biotechnology Innovation (SIFBI), A*STAR. My PhD research work focused on developing a bioprocess model for E. coli engineered to produce a high value terpenoid compound. The model thus developed was used to optimize feeding profile to enhance titre of my compound of interest. Currently, I am working with Lactococcus lactis and E. coli for production of FGF-2 using spent animal cell culture. Working with these diverse microorganisms has provided me with invaluable insights and skills in bioprocess optimization. I am excited about the opportunity to broaden my expertise by exploring different microorganisms, each with its unique advantages. Looking ahead, I am eager to integrate techniques such as machine learning into bioprocess optimization, aiming to enhance predictive capabilities and efficiency. On the other avenue, I am looking forward to exploring the application of cell engineering techniques to fine-tune microbial strains for better bioprocess characteristic, further optimizing their performance and productivity. In essence, my long-term aspiration is to continue pushing the boundaries of microbial biomanufacturing, leveraging innovative approaches to drive sustainable solutions and contribute meaningfully to the field.

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.

Dr. Haripada Maity is currently working as Chief Development Officer & Head of Biosimilars at Cipla. Haripada also worked at Jazz Pharmaceuticals, Bioverativ – a Sanofi Company, Sanofi, ImClone Systems and Eli Lilly with a combined industry experience of about 15 years. Before, joining biotech industry in 2006, he spent about 8 years in academia (post Ph.D.) and performed his major postdoctoral research in the Department of Biochemistry and Biophysics at the University of Pennsylvania School of Medicine, USA. Therefore, Haripada has about 23 years of post-Ph.D. research and development experience in the area of Biologics Development including formulation and drug product development, biophysical and analytical development, Comparability assessment, protein folding/unfolding studies, hydrogen exchange monitored by NMR, structure-function relationships, protein-ligand interactions, and protein-protein interactions, resolving challenges in downstream process development, and multiple regulatory submissions. Haripada obtained his Ph.D. from Tata Institute of Fundamental Research, India. Haripada was awarded Extraordinary Effort Award of Lilly NJ twice. He was also awarded BHU Medal (Gold Medal) from Banaras Hindu University, India. At present, Haripada has already authored/co-authored thirty articles in scientific journals/book. Haripada has presented multiple external presentations on pharmaceutical research as an invited speaker including the role as chairperson and panelist. He is an Editorial Board Member of the journal “Current Pharmaceutical Biotechnology.”

After completing my PhD in Pharmacology, in which I developed new biotherapeutics to reduce complications in diabetic patients, I started a post-doc with Dr. Yves Durocher to generate a new inducible expression system for the large-scale production of difficult-to-express recombinant proteins. I am currently Research Officer at National Research Council of Canada where I am developing platforms for diagnostic and analytical applications.

Dr. Dina Manceva is a PhD-trained Biochemist/Biophysicist with over 20 years of experience in biologics and biosimilars development, spanning vaccines, adjuvants, protein therapeutics, and monoclonal antibodies. She has deep expertise in drug substance and drug product development for cGMP manufacturing, including formulation, high-concentration protein therapeutics, bioanalytical characterization, process analytics, scale-up, and technology transfer to pilot plants and CMOs. Her work has supported programs from target identification through commercialization and has included diverse modalities such as subunit and conjugate vaccines, VLPs, proteins, and mAbs. In recent roles, she has led high-throughput formulation development and data-driven platform design to enable AI/ML approaches in biologics development. She has also directed novel adjuvant formulation efforts for first-in-human vaccine studies. Dr. Manceva has held multiple scientific leadership roles, serving as a project lead, steering committee member, and cross-functional contributor driving complex programs under fast-moving timelines.

With 12 years of experience in biopharmaceutical purification, Khushdeep serves as Associate Director of Downstream Process Development, specializing in the transition of innovative research into robust manufacturing processes. Their current focus centers on advancing AAV purification strategies to meet the rigorous demands of gene therapy production. A skilled cross-functional leader, Khushdeep excels at navigating high-stakes technical challenges to deliver on strategic organizational goals.

Olivier is an expert in bioconjugation therapeutics with more than 15 years of leadership expertise in the pharmaceutical industry encompassing CMC operation and strategy, GMP manufacturing as well as R&D, early and late phase development of biologics, particularly ADCs and conjugate vaccines. Previously, he was working in several positions at Vaxcyte including Senior Director, where he led programs and well as process development and manufacturing activities for multivalent bioconjugate vaccines. Olivier is also the founder and Principal of Omnium Bioconsulting, that provides bioconjugates process development and CMC strategy counseling. His prior experiences also comprise positions at Astellas Pharma, Pfizer and Wyeth, where he led team and projects for the development and manufacturing of ADCs and other bioconjugate therapeutics. Olivier obtained his PhD in Chemistry at the Université de Bourgogne, France.

Damian Marshall is the Vice President of Analytical Development at Resolution Therapeutics, a UK biopharmaceutical company developing engineered macrophage therapies for end-stage liver disease. Prior to joining Resolution, Damian spent 2 years as Vice President of Bioprocess Development at Achilles Therapeutics and 8 years as Director of New Technologies at the Cell and Gene Therapy Catapult. In these roles he led multi-national programs working on bioprocess automation, PAT integration, and advanced product characterisation.

Dr. Matveeva is the Director of cGMP Cell Production Operations within the Department of Neurosurgery at the Mass General Hospital/Harvard Medical School. Dr. Matveeva is in charge of all aspects of a cGMP cell manufacturing facility for early-phase clinical trials focused on regenerative cell therapy. Within this role, she created all compliance and quality programs required for safe and efficient cell production within the startup, with a focus on feasibility, safety, and fiscal efficiency. From logistics to environmental monitoring to documentation and personnel management, Dr. Matveeva has been key in developing an all-encompassing infrastructure for cGMP manufacturing within a hospital setting.

Dr. McCarthy is Senior Director, Science and Standards in USP’s Global Biologics Department, where she leads development and maintenance of standards and tools to support quality of medicines and oversees the USP biologics laboratories in the US and India. Her team supports standards and tools across a diverse range of therapies, including vaccines, peptides, cell and gene therapy, monoclonal antibodies, and other protein therapeutics. Prior to joining USP, Diane worked for several small CROs that focused on the use of mass spectrometry for characterization of biologics, host cell proteins, and biomarkers. Dr. McCarthy earned her Ph.D. in Biochemistry from the University of Texas at Austin.

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.

Tomás Mesurado is a final-year PhD student in the Doctoral School Bioprocess Engineering from the BOKU University, Vienna, Austria. Working on downstream processing and analytics of bionanoparticles, his research focuses on developing innovative purification strategies and novel analytical methods for enveloped bionanoparticles, including viruses, virus-like particles, and extracellular vesicles.

Dr. Yixuan Ming is a scientist specializing in the development and strategic alignment of purification processes for AAV-based gene therapies. He currently serves as a senior scientist in Purification Development at Roche/Genentech in Philadelphia, PA. In this role, Dr. Ming spearheads process development for critical operational steps, overseeing the lifecycle from small-scale optimization through to manufacturing implementation. Prior to joining Genentech, Dr. Ming was a downstream process development scientist at Spark Therapeutics, where he focused on developing robust, efficient, and scalable purification processes for gene therapies. Earlier in his career, he served as a postdoctoral researcher at Washington University in St. Louis. Dr. Ming holds a PhD from Lehigh University.

Dr Mire-Sluis is currently Head of Quality for Gilead Sciences. He was Head of Global Quality for AstraZeneca and Vice President, North America, Singapore, Contract and Product Quality at Amgen Inc. He was previously Principal Advisor, Regulatory Science and Review, Office of Biotechnology Products, CDER and Head of Analytical Sciences and Standards, Office of the Director, CBER, FDA, in Bethesda, Maryland. He trained in Genetics and Biometry and has a PhD in Cell biology and Biochemistry. Dr Mire-Sluis was the Head of the Cytokine Group in the Division of Immunobiology at the National Institute for Biological Standards and Control, Potters Bar, UK. Dr Mire-Sluis specialized in the development of assays for the characterization and quantitation of biological products. He then became Director of BioAnalytical Sciences at Genentech and prior to joining FDA, was Executive Director of Analytical Sciences at CancerVax Corporation, San Diego. He is the Chairman of the IABS Biotherapeutics Committee, Vice Chairman of the USP Biologicals Characterization Expert Committee, an expert for the International Committee for Harmonization and on the board of the Journal of Immunological Methods

Julie Morse serves as the Vice President of Technical Operations at Satellite Biosciences. Julie has over a decade of technical experience in developing cell therapies. Her experience ranges from early-stage development to BLA-enabling activities and includes manufacturing, process, and analytical development. Julie led the successful scaling of Satellite Bio’s proprietary hepatocyte cell culture expansion techniques and the establishment of associated analytical methods. Prior to Satellite, Julie was the CMC lead for allogeneic CAR T programs at CRISPR Therapeutics where she formed and led the MSAT group that supported various activities leading to the commercialization of Casgevy. Before CRISPR, Julie also had CMC-related roles at Semma Therapeutics (now Vertex) and Ocata Therapeutics (now Astellas Institute of Regenerative Medicine).

I am a downstream process development scientist with a B.S. in biological engineering and an M.S. in biology. I began my career at Pfizer working in gene therapy purification process development and have since supported multiple therapeutic modalities, including complex proteins, bispecific and trispecific antibodies, and mRNA. My work focuses on developing and optimizing purification processes to support efficient and scalable biotherapeutic manufacturing with a continued focus on enabling robust platforms and advancing next-generation therapies.

Srividya Narayanan is a dedicated regulatory affairs professional with a background in dentistry, now specializing in medical devices, and AI integration in health systems. She currently works with Culture Care Collective, where she contributes to AI-driven platform to enhance community health worker interactions and provide automated guidance for clients. Her expertise includes FDA 510(k) submissions, EU MDR compliance, and quality system management. She is pursuing a Regulatory Affairs degree at Northeastern University and has a strong interest in leveraging AI/ML for healthcare and medical device oversight. In addition to her professional endeavours, she has led community outreach programs, published research, and actively volunteers in health and fitness initiatives.

Kai serves as a staff engineer in Biotherapeutics Process Development (Downstream) at Takeda. With expertise spanning downstream purification, bioconjugation, and process characterization, he has led cross-functional, multi-site collaborations across pipeline programs of multiple modalities as well as technology development initiatives.

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.

Dr. Duk Jae Oh obtained his BA degree in Chemical Engineering in 1986 from Seoul National University, then received an MS and a PhD in Chem. Eng. from KAIST in 1988 and 1992, respectively. His major research field was development of bioreactors for animal cell cultures. He spent one and a half years on his postdoctoral fellowship, until 1993, at the Univ. of Michigan (Ann Arbor). He participated in the research projects for development of ‘Cell Expansion System for Bone Marrow Cells’, collaborating with Aastrom Biosciences Inc. After he came back to Korea, he joined CJ Corp. as a research scientist for bioprocess development, particularly, purification of functional sugars and microbial pharmaceuticals such as fructo-oligo sugars, lovastatin, and cyclosporine A. In 1997, he moved to the US and joined Prof. Bernhard Palsson’s group at UCSD as a project scientist, participating in projects for ‘ablation of cells by laser’ and ‘developing fluorescence labeling techniques for visualizing inter-cellular interaction’ until 2000. He then joined a US gene therapy company, Cell Genesys in Bay Area (Foster City, CA), developing bioprocesses for production of viral vectors such as adenovirus, AAV (adeno-associated virus), and lentivirus. Dr. Oh is currently a professor of Dept. of Integrative Bioscience and Biotechnology at Sejong University, Seoul, Korea, since 2001. He served as a president for the KSBB, the Korea Society for Biotechnology and Bioengineering, which is the biggest academic biotechnology society in Korea. He is participating in the ISO/TC276 “Biotechnology” as a representative expert from Korea, particularly in the “Bioprocessing” committee for global standardization of biotechnology. He is also an active member of an international academic organization, AFOB (Asian Federation of Biotechnology) since 2010, and currently acts as a secretary general until this year (2026). His research areas are based upon the animal cell technology, including bioreactor development, development of cell culture processes for therapeutic protein production (antibodies, cytokines, hormones, etc.), development of chemically defined culture media for CHO and HEK293, development of DMSO-free/serum-free chemically-defined cryopreservation media, and gene delivery technology using viral/non-viral system. Among those, process development for perfusion cultures has been his main interest since the mid-1980s with about 15 peer-reviewed publications on perfusion culture technology.

Hanlin came from University of Science and Technology of China with a bachelor’s degree in chemistry and studied at University of Illinois Urbana – Champaign for his PhD under Dr. Robert B. Gennis, focusing on membrane protein (respiratory chain complexes) biochemistry and biophysics. He joined Novozymes North America in 2014 with his expertise in enzymology to develop various high-throughput assays for industrial enzyme products that convert biomass into biofuel (ethanol). Hanlin joined Merck since 2020 and started his journey on high-throughput workflow transformation in biological drug product development cross various modalities with robotic platforms, HT-compatible stressing setups, HT analytical instruments, and JMP study design.

Malvina Papanastasiou, PhD, is a Group Leader and Research Scientist at the Broad Institute of MIT & Harvard, where she spearheads structural proteomics initiatives. With over 15 years of experience, Dr. Papanastasiou focuses on developing advanced Hydrogen Deuterium Exchange Mass Spectrometry (HDX-MS) technologies to elucidate protein function in health and disease. Her group pioneered a novel nanoflow HDX (nHDX) platform that achieves a 100-fold sensitivity improvement, enabling the high-resolution analysis of challenging transcription factors, membrane proteins, and MDa-scale macromolecular assemblies using only fmol sample quantities. Her expertise extends to high-throughput epitope/paratope mapping and characterizing protein-ligand interactions. She currently serves as Vice-Chair of the International Society of HDX-MS. Dr. Papanastasiou previously held research positions at the University of Pennsylvania and FORTH (Greece) after earning her PhD from Manchester Metropolitan University.

Todd M. Przybycien, PhD, Professor of Chemical and Biological Engineering at Rensselaer Polytechnic Institute, received undergraduate degrees in chemical engineering and in chemistry from Washington University in St. Louis and Masters and PhD in chemical engineering with a minor in biology from Caltech. Todd started his professional career with Monsanto Agricultural Company where he worked in downstream bioprocess development for recombinant somatotropins for about two years. He then launched his academic career at Rensselaer Polytechnic Institute, where he worked for eight years, followed by another twenty years at Carnegie Mellon University, where he was a faculty member in the Chemical Engineering department and the Founding Head of the Biomedical Engineering department. In fall 2018, he returned to RPI. In summer 2025, he became the Department Head. Todd’s primary research interests are in the downstream manufacturing (purification) of biotherapeutics.

Emma is a Sr. Associate Scientist specializing in formulation development and developability assessment of biologics. Her research is focused on understanding formulation-dependent stability, including metal-induced oxidation and excipient degradation, to support robust drug product design.

Jim leads analytical development at Interius, cutting across all scientific efforts at the company. Trained as a virologist, Jim has over 25 years of experience developing viral products for the prevention and treatment of disease. Jim comes to Interius from Altimmune, where he was Director of Scientific Affairs. Previously, Jim led the cell and gene therapy standards development efforts at US Pharmacopeia. In previous roles at Advanced BioScience Laboratories and Foundation Fighting Blindness, he led translational science activities for the development of vaccines and biologics to prevent and treat infectious and retinal diseases. Jim has also held positions responsible for performing viral clearance and adventitious agent testing at Viromed Biosafety as well as AAV vector development and characterization at Genovo/Targeted Genetics.

Sage is a postdoctoral fellow in Analytical Research & Development at Pfizer, based in St. Louis, MO. She has a strong technical background in next-generation sequencing approaches and high-dimensional data analysis. Sage holds a PhD in Biology from the University of Missouri – St. Louis, where she studied the influence of immunogenetics and disease on avian gut microbial communities. She next joined Eurofins PSS in 2023 as a molecular biologist to contribute to mRNA process development. Since starting her current role with Pfizer ARD in 2025, she has been developing next-generation sequencing methods to support nucleic acid-based biotherapeutics.

Jonathan has 20+ years’ experience in the Biologics Development, and Manufacturing division. Jon currently works at Merck, providing scientific direction and leadership within the Biologics Process Organization partnering with early/late stage Biologics development, Enabling Technology Teams, and Manufacturing Divisions. In past roles, Jon has led the Biologics and Cell therapy Operations at Bristol Myers Squibb where he was responsible for Process Development, technology transfer and clinical manufacturing which includes the selection and oversight of Drug Substance and Drug Product CMO's. Jonathan has held roles of increasing responsibility in PD, tech Ops and CMC oversight for Biogen. Jonathan graduated from RPI with a BS in Chemical Engineering then received his Doctorate in Chemical Engineering at the University of Delaware under Dr. Andrew Zydney in 2002.

Dr. Roy is an accomplished associate director of Formulation Development in Drug Delivery at Aviceda Therapeutics, a clinical-stage biotechnology company based in Cambridge, Massachusetts, where she has served since 2023. With over 20 years of experience in drug delivery, nanomedicine, and formulation development, she has made significant contributions across biotechnology and advanced materials industries through her innovation, technical leadership, and strategic vision. At Aviceda Therapeutics, she supports the development of targeted therapeutics using glycan-based technologies designed to deliver medicines to specific organs or tissues with improved safety and efficacy. Previously, Dr. Roy joined Lyndra Therapeutics as a principal investigator, formulation lead, and CMC lead, where she played a key role in developing a long-acting oral drug delivery system designed to remain in the stomach for up to 20 days for the treatment of chronic conditions, including schizophrenia. She also served as Scientific Director at Phosphorex LLC (2022–2023), leading lipid and polymer nanoparticle-based drug delivery programs. Earlier in her career, Dr. Roy worked at The Lubrizol Corporation (2012–2018) as an Innovation and New Product Development group leader, where she managed multidisciplinary teams and developed a cost-effective membrane purification technology that successfully advanced to commercial application. Dr. Roy holds a Master of Science in Biotechnology from the University of Calcutta (2003) and a PhD in polymer, organic, nanomaterial, and supramolecular chemistry (2011). She completed her postdoctoral training in Polymer Science at the University of Massachusetts Amherst and earned a diploma with specialization in Leadership and Management from Harvard Business School.

Jenna Rutberg is a PhD candidate in the Biomedical Engineering program at Brown University. Her research focuses on the development of microfluidic electrophoresis-based methods to characterize novel therapeutics and biomarkers. In collaboration with market leading companies, she leads a team to develop new microfluidic assays for its commercial and customer use. Prior to Brown University, Jenna received her Bachelor of Science in Bioengineering with a concentration in Molecular, Cell & Tissue Engineering from Northeastern University. During her time at Northeastern University, she had the opportunity to work full time in both the medical device and pharmaceutical industry.

Azadeh is a dedicated researcher in gene therapy, focusing on the fundamental biology of Adeno-Associated Virus (AAV). Her current work centers on enhancing the safety profiles of recombinant AAV (rAAV) products through the innovative design of Rep/Cap plasmids. Before transitioning to viral vector engineering, Azadeh completed her PhD on the intricate mechanisms of mitochondrial DNA transcription and replication. By bridging her expertise in replication and transcription mechanisms with AAV biology, she aims to develop more robust and reliable delivery systems for next-generation therapeutics.

Jack is the Head of Cell Line Development at Sanofi, where he leads a team of scientists responsible for generation of cell lines expressing Sanofi’s preclinical large molecule candidate therapeutic proteins. These cell lines have the eventual purpose of supporting clinical and commercial manufacturing. With extensive expertise in cell and molecular biology, Jack also drives strategic development of cutting-edge cell line expression platforms. Prior to Sanofi, Jack held roles of increasing responsibility at Pfizer and Abcellera (FKA Tetragenetics). Jack conducted post-doctoral research at New England Biolabs, earned his Ph.D. in Biochemistry at Dartmouth College, and his B.S. in Biochemistry at Syracuse University.

David Schaffer is the Hubbard Howe Professor of Chemical and Biomolecular Engineering, Bioengineering, and Molecular and Cell Biology at the University of California, Berkeley, and he also serves as the Director of QB3, Bakar Labs, and the Bakar Fellows Program. He completed his B.S. at Stanford University in 1993 and his PhD at MIT in 1998, both in chemical engineering, as well as a postdoctoral fellowship at the Salk Institute for Biological Studies before joining Berkeley in 1999. There, he applies engineering principles to optimize gene and stem cell therapies, work that includes developing the concept of applying directed evolution to engineer targeted and efficient viral gene therapy vectors as well as new technologies to investigate and control stem cell function. He has published >250 papers, advised >100 graduate students and postdoctoral fellows, is an inventor on >50 issued patents, and developed technologies used in >10 human clinical trials. In addition, he has co-founded seven companies from his lab, including 4D Molecular Therapeutics (NASDAQ FDMT), Ignite Immunotherapies (acquired by Pfizer), and Rewrite (acquired by Intellia). Finally, has received recognitions including the National Academy of Engineering, National Academy of Inventors, Daniel I.C. Wong Award for Excellence in Biochemical Engineering, Andreas Acrivos Professional Progress Award, the American Institute of Chemical Engineers Pharmaceutical and Bioengineering Award, the American Chemical Society Marvin Johnson Award, the Biomedical Engineering Society Rita Shaffer Young Investigator Award, and others.

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).

Patricia Seymour, M.B.A., CSCP, is a managing director and part of the senior management team with the BioProcess Technology Group at BDO USA, LLP. With over 35 years of experience in the biotechnology industry, her expertise spans the development and commercialization spectrum, quality, regulatory and manufacturing, supply-chain strategy, and management and operations leadership. Ms. Seymour was formerly Principal Consultant at BioProcess Technology Consultants (BPTC) and Senior Director, Global Investigational Supply Operations at Millennium. She previously held positions at Covance, Collaborative BioAlliance, ImmunoGen, Dana Farber Cancer Institute, and Sloan Kettering. Ms. Seymour received her B.S. from Villanova University and her M.B.A. from Boston University and is a Certified Supply Chain Professional (APICS).

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.

Megan Sharma, PhD, is a senior scientist at Johnson & Johnson. She has a bachelor's degree in chemical engineering from Widener University and earned a doctoral in chemical engineering from Drexel University. At Johnson & Johnson Innovative Medicine, Megan works to analyze biotherapeutic proteins.

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.

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.

Sivashankar (Siva) Sivakollundu is an accomplished biopharmaceutical leader with more than 19 years of experience spanning biologics development, commercial manufacturing, and data-driven process robustness. A six sigma black belt, he has built and led high-performing technical teams while driving yield improvement, tech-transfer excellence, and advanced data analytics across the biologics network. His expertise includes protein biochemistry, GxP assay development, statistical modeling, and regulatory documentation. Siva is recognized for innovative problem solving, cross-functional leadership, and his recent contributions to machine learning–enabled yield optimization and robustness initiatives at Bristol Myers Squibb.

Justin is the Vice President of Technical Operations at Caribou Biosciences which is a leading clinical-stage CRISPR genome-editing biopharmaceutical company advancing a pipeline of off-the-shelf CAR-T and CAR-NK cell therapies for the treatment of patients with hematologic malignancies and solid tumors. He is responsible for developing, manufacturing, and distributing the company’s critical raw materials and clinical trial materials. Prior to Caribou, Justin was Chief Development Officer at Actym Therapeutics, and served in various positions of increasing responsibility in immuno-oncology and vaccine development at Cerus Corporation, Anza Therapeutics, and Aduro Biotech. Justin has authored over 12 publications in peer-reviewed journals and is an inventor on U.S. and foreign patents and patent applications. Justin earned his undergraduate degree in Biology from Vassar College, his Ph.D. in Molecular and Cell Biology from the University of California, Berkeley, and did his post-doctoral fellowship at the University of California, San Francisco.

Julia Solonenka is a current PhD candidate in plant biotechnology at the Queensland University of Technology. Her doctoral research is focused on the development of economical methods for purifying recombinant proteins in N. benthamiana. Previously, she completed an MSc in analytical chemistry at the University of British Columbia, characterising non-protein amino acids in plants and cyanobacteria, and a BSc Hon in medicinal chemistry from the University of Waterloo.

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.

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.

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.

Dr. Shahid Uddin is currently Director of Drug Product, Formulation & Stability within the CMC department at Immunocore. His team is responsible for bringing research candidates into clinic and commercialization. Technology is focused around developing ImmTAC as therapeutic agents for different disease models. Prior to this he held the position of Head of Formulation at MedImmune (AstraZeneca) where he supported the biologics portfolio covering Monoclonal antibodies, Peptides, bispecifics, and other proteins. He has extensive experience in pre-formulation/formulation, forced degradation, delivery of biologics both for early and late-stage programs.

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. 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.

Daniëlle studied Bioprocess technology at the Wageningen University in The Netherlands. During her PhD she studied enzyme expression in Aspergilli. After her PhD she worked at several small biotech companies and 18 years ago she joined Byondis BV (previously known as: Synthon Biopharmaceuticals) were she is working in the Downstream Processing department. Byondis has since then, developed itself from a company producing biosimilars, to a specialty company. Currently, Byondis main focus is on the production of Antibody Drug Conjugates (ADCs). Daniëlle is mainly involved in the process development of antibodies and variants thereof (like masked antibodies) up and until Clinical Phase I.

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.

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).

Dhanuka Wasalathanthri, PhD, is an Associate Director at Bristol Myers Squibb (BMS) where his main role is to serve as the strategy lead for Process Analytical Technology (PAT), High-Throughput Automation, and Digital Capabilities at Biologics Development organization. He is a versatile leader with more than 12 years of biotech industry experience in strategic implementation of technologies, CMC analytical development, project management, and building high-performing teams in meeting corporate goals. Dhanuka represents BMS at several academic and industry consortia, and he holds a PhD in Analytical Chemistry from University of Connecticut, USA.

Shuang Wei is a Senior Scientist at MRL San Francisco (2022–present), driving early biologics development by assessing manufacturability, critical quality attributes, and enabling smooth handoff to process development. She supports discovery milestones with innovative, fit-for-purpose methodologies across molecule design, screening, and developability. She got her PhD candidate in Biochemistry and Molecular Biology (UC Riverside, advisor Ian Wheeldon, 2017–2022), specializing in synthetic biology, inducible transcription factors, and metabolic regulation in yeast. Her selected publications span metabolic engineering and programmable biosensors, including work in Metabolic Engineering (2024), Nature Biotechnology (2022, joint first authorship), and Nature Chemical Biology (2023), alongside earlier enzyme discovery and characterization studies.

Bill is the 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. Bill has an h-index of 18 and an i10 index of 38.

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.

Lingling Xia is a principal scientist at AbbVie, specializing in antibody purification process development, validation, and continuous process improvement. Lingling holds a PhD in Chemical Engineering and is passionate about advancing innovative approaches for biologic manufacturing.

Dr. Michael Hongwei Xie is VP of Analytics & Head of Bioassay and Analytical Development, Shanghai Henlius Biotech., Inc. He is an established scientist and leader for development, characterization, quality study and control (QC) of biotherapeutics. In recent two years he has lead finishing analytical similarity, process comparability and E&L studies of 3 biosimilar mAbs for China NDA filing, with one approved in February 2019 and another made EMA MAA filing in May 2019, and supporting more than 8 IND filings across candidates from mAbs, combo therapy to ADCs. The efforts set a precedent for analytical similarity assessment of biosimilar products in China, and quickly extending to quality study for bispecific antibodies. Before joining Henlius in 2017, Michael was Executive Director of Suzhou Suncadia Biopharmaceutical Inc., Hengrui Medicine and Senior Director of Wuxi Biopharmaceutical Inc., Wuxi AppTec. Before that, he worked in USA as Director of KBI Biopharma, Inc., Senior Research Scientist of Waters Corporation, Department of Biopharmaceutical Sciences. Michael received his Ph.D. from Trinity College Dublin and has published 46 scientific papers in peer-reviewed journals such as mAbs, Analytical Chemistry and Trends in Biotechnology, including 2 articles on biosimilarity evaluation of mAbs (mAbs, 2010 and 2019).

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. 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.

Jason Yu is a research scientist at MIT’s Koch Institute. His research integrates tissue engineering, biophysics, and machine learning to advance cell-based therapies and study tumor-T cell immunology. Holding a PhD in Biomedical Engineering from UW-Madison, Jason has over a decade of cross-disciplinary publications spanning materials science, physics, and cell biology. He specializes in the precise ex vivo manipulation of physical and chemical microenvironments to uncover the mechanistic drivers of cell-cell interactions.

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.

Bo Zhai holds the position of principal scientist at Johnson & Johnson, where he is part of the Cell Engineering and Analytical Science group within the Department of Protein Therapeutics API Development—Biologics. With a PhD in Biochemistry and Cell Biology, Bo Zhai possesses extensive experience in biologics characterization, with a specialized focus on mass spectrometry data analysis and the streamlining of data analysis processes. Furthermore, he leads the data analytics endeavors within the group.

Dr. Yaozhong Zhang is a Principal Scientist in Purification Process Development at Sanofi's Genomic Medicine Unit CMC, where she leads downstream process development for AAV. Previously at Codiak Biosciences, she developed purification processes for exosome-based therapeutics. Her earlier experience includes ADC purification at Abzena and small molecule process development at Adesis. Dr. Zhang's career progression—from small molecules through ADCs and exosomes to gene therapies—provides comprehensive insight into bioprocessing challenges across the biopharmaceutical spectrum.

Dr. Yunlong Zhao is a Principal Scientist in the Analytical Chemistry Department, at Regeneron Pharmaceuticals. In his current role, Yunlong leads analytical characterization of biotherapeutics, providing analytical guidance and solving real-time development issues in the process development and formulation development. He also leads a team to support early discovery by performing LC-MS-based proteomics and glycoproteomics. Yunlong holds a PhD in Chemistry from University of Massachusetts, Amherst.

Dr. Weichang Zhou, Chief Technology Officer (CTO), MediLink Therapeutics, is a globally recognized leader in cell culture engineering and biomanufacturing. He previously held key leadership roles at Merck, Genzyme (Sanofi), PDL BioPharma, and WuXi Biologics. His pioneering research, industrial innovation, and leadership have driven a number of publications, patents, and groundbreaking bioprocessing technologies. He earned his Ph.D. from the University of Hannover and conducted postdoctoral research at DECHEMA, ETH Zurich, and the University of Minnesota. He is a recipient of Asia-Pacific Biopharma Excellence Awards CTO of the Year 2023 award (2024), ECI Cell Culture Engineering Award (2025), and ECI Integrated Continuous Biomanufacturing (ICB) Award (2025).

Laura has been a Principal Scientist in Pfizer’s Bioprocessing R&D Cell Line Development group since 2021. Since her time at Pfizer, Laura has focused on optimizing Pfizer’s SSI stable CHO cell expression system as well as portfolio work in the recombinant protein space. A native of upstate New York, Laura received her BS in Biomolecular Science from Clarkson University in 2013 and completed her PhD in Chemistry at Binghamton University in 2021. Laura enjoys playing volleyball and tennis, as well as painting and drawing in her free time.