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.

Wasfi Alazzam, PhD, is a biopharmaceutical development and operations executive with over 20 years of experience across global pharmaceutical organizations, including GlaxoSmithKline, Takeda, and Regeneron. His expertise spans end-to-end CMC strategy, analytical and biophysical characterization, and drug-product manufacturing across biologics and advanced modalities. At GlaxoSmithKline, he was recognized as a fellow for his leadership in product characterization and higher-order structure (HOS) analytics. At Takeda, he led global CMC regulatory filings and cross-functional operations, supporting IND and BLA submissions and international regulatory interactions. Dr. Alazzam has extensive experience across antibody-drug conjugates (ADCs), radiopharmaceuticals, and emerging therapeutic platforms, with a focus on aligning scientific, regulatory, and operational strategies to accelerate development. He currently serves as Principal CMC and Technical Development Advisor at OmniBioPro, where he supports biotech and pharmaceutical companies in advancing programs from early development through clinical execution and regulatory milestones.

Scott H. Altern is a senior scientist at AbbVie in Worcester, MA, working in purification development. He graduated from Rensselaer Polytechnic Institute in 2023 with a PhD in chemical engineering from Prof. Steven Cramer's group, specializing in mechanistic modeling of multimodal chromatography. Since then, Scott has driven the development and implementation of mechanistic modeling at AbbVie for both early- and late-stage pipelines.

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.

Peter Amaya is an associate director in Bioprocess Development Sciences at AstraZeneca. He holds a bachelor's in Chemical Engineering from the University of Dayton and a PhD in Biomedical Engineering from The Ohio State University, where he developed methods for isolating and characterizing rare circulating human cells and processes for therapeutic extracellular vesicle production. He joined MedImmune in 2017, focusing on upstream process development for cell and protein therapies using fed batch and perfusion technologies. He currently supports CMC activities and the development of AstraZeneca’s integrated dynamic bioprocess platform.

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.

Matt Anderson-Baron is the co-founder and Chief Executive Officer (CEO) of Future Fields, a Canadian biotech company that’s reinventing biomanufacturing with a first-of-its kind protein expression platform that utilizes whole insects. Their patented technology, the EntoEngine utilizes the common fruit fly as the world’s first multicellular expression system with the ability to leverage the cellular diversity of a whole organism. This genetic prowess, coupled to the immense reproductive efficiency of insects, allows Future Fields to manufacture the most complex and intractable proteins at low costs and large scale. A scientist-turned-entrepreneur, Matt obtained his PhD in Cellular and Molecular Biology at the University of Alberta and held a postdoctoral position in one of Canada’s top tissue engineering labs before co-founding Future Fields in 2019.

Dr. Can Araman is a senior manager heading the stability enhancing formulation laboratory in Millipore Sigma´s process solutions department in Darmstadt, Germany. His team is working on delivering solutions to challenges in large molecule formulations and drug delivery technologies. Can holds a Ph.D. from the Institute of Biological Chemistry in Vienna and has had a long-lasting experience in protein biochemistry, including antibody and ADC development for preclinical studies and clinical trials.

Andrea Arsiccio is a Principal Scientist 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.

Michael Barnes has built his career at the intersection of bioprocess R&D, digital transformation, and scientific workflow innovation—spanning roles at the Broad Institute, Pfizer, IDBS (Danaher), and now Revvity Signals. As a Product Manager for Signals LabGistics, he is redefining how scientific work is executed—transforming fragmented processes into scalable operations ready for AI- and robotics-led execution

Matt is a Sr. Scientist in the Applications Research and Development group at Cytiva, where he helps develop new bioprocessing techniques and products and explores innovative new uses for existing products. Prior to joining Cytiva, Matt received undergraduate degrees in chemical engineering and economics from Penn State and a doctoral degree in chemical and biomolecular engineering under Abraham Lenhoff at the University of Delaware.

Dr. Jason Beckwith is Founder & Architect of Talent Science™ Modelling, Senior Vice President Talent Science & Predictive Analytics at BioTalent, and Leader in Residence at the University of Leeds, UK. Creator of the Talent Efficiency (TE) and Biopharma Talent Index (BTI) frameworks, his work applies quantitative modelling, complexity science, and AI to workforce strategy, helping biopharma organisations improve operational performance, scalability, transformation success, and enterprise value. Drawing on research across global biopharma organisations and academic collaborations with UCL and the University of Dundee, he applies advanced methods including Monte Carlo simulation, Bayesian modelling, network optimisation, and Workforce Value-at-Risk (WVaR) to measure organisational capability and execution risk. With more than 30 years’ international experience across biotech, pharma, CDMO, and advanced therapies, Dr. Beckwith has founded and exited multiple bioscience companies and advises executive teams on AI adoption, organisational design, workforce transformation, and emerging technologies.

Justin Beller is a Director of Cell and Gene Therapy Analytical Operations at Novartis, based in East Hanover, NJ. In this role, he leads analytical strategy and operations to support the development and commercialization of advanced therapies, with a focus on ensuring robust, scalable, and inspection-ready analytical capabilities. Justin works at the intersection of science, operations, and digital innovation, partnering across Technical Research and Development, Technical Operations, Quality, and Regulatory organizations to enable compliant and efficient CMC development. His leadership spans analytical lifecycle management, method validation, and readiness for global regulatory submissions. He is also actively driving digital transformation within Analytical Operations, advancing the adoption of AI-enabled solutions and modern data workflows to enhance data integrity, streamline documentation, and improve operational efficiency in regulated environments.

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.

Erik Bierwagen is the Biosciences Portfolio Lead at BIOVIA, Dassault Systèmes. He plays a key role in shaping solutions that advance lab digitalization across life sciences. Erik brings over 25 years of experience in leadership and hands-on experience driving lab digitalization in R&D Informatics. Throughout his career, Erik has partnered closely with scientists across a wide range of disciplines, including in vivo and pathology, complex in vitro models, large-molecule drug development, and electronic laboratory notebooks, to deliver transformative solutions. Before joining BIOVIA, Erik was the Director of Lab Sciences Informatics at Genentech. Erik holds a Ph.D. in Chemistry from the California Institute of Technology (Caltech).

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.

Christian Bleiholder, D.Sc., is Professor of Chemistry and Biochemistry at Florida State University. His research advances ion mobility–mass spectrometry as a next-generation analytical platform for resolving the structural complexity of proteins and biologics. By developing tandem ion mobility spectrometry approaches, his work enables the separation and characterization of coexisting conformational states of intact proteins, subcomplexes, and antibody systems. Dr. Bleiholder’s research bridges fundamental structural insight with analytical challenges in biologics development, including higher-order structure analysis, conformational heterogeneity, glycosylation effects, and antibody–antigen interactions. He is a recipient of the CAREER Award from the National Science Foundation, the Ron Hites Award from the American Society for Mass Spectrometry, and was elected a senior member of the National Academy of Inventors in 2026.

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.

Sharon Bola is a Global Product Manager with the Process Chromatography Business at Bio-Rad Laboratories. She holds a MS degree in Pharmacology and prior to transitioning into her current role, she started her career working in downstream processing groups at major Biopharmaceutical companies. She has had hands-on experience in the purification of proteins including monoclonal antibodies. She is a content marketer at Bio-Rad and enjoys teaching and understanding customer’s needs.

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.

Jill Bradley-Graham is a scientist in the Genomic Medicine Unit at Sanofi 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.

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

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

Dr. Bao Zhong Cai is a senior biopharmaceutical executive with nearly 30 years of experience leading CMC strategy, process development, and GMP manufacturing for oligonucleotides and advanced modalities. He currently serves as Vice President of Oligonucleotide CMC at Gondola Bio, overseeing end-to-end CMC activities from lead nomination through GMP production and regulatory readiness.

Dr. Juan J. Carmona is a biotechnology executive and clinical scientist recognized for leading cross-sector initiatives that drive innovation across industry, academia, and healthcare. He has pioneered programs in oncology, genomics, and infectious disease at Brigham and Women’s Hospital, Dana-Farber Cancer Institute, and Philips Research North America. He later served as the founding Director of Scientific Affairs and Professional Alliances at OraSure Technologies and is now Senior Director of Clinical and Scientific Affairs at the Advanced Regenerative Manufacturing Institute (ARMI). His award-winning work focuses on leading teams that integrate science, technology, and commercial strategy to deliver best-in-class products and transformative clinical advances in patient care.

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

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.

• Biopharmaceutical leader with 30+ years of experience in biologics development and manufacturing across the U.S. and China

• Expertise in monoclonal antibodies, recombinant proteins, and complex biologics

• End-to-end experience across biologics lifecycle: cell line development, upstream/downstream process development, analytical & quality studies, clinical manufacturing, and IND/BLA submissions

• Leads Great Bay Bio’s AI-driven biologics platform to accelerate sequence-to-Pre-Clinical Candidate (PCC) development

• Proven track record in building scalable CMC and manufacturing systems for complex biologics

• 20+ patents and 14 scientific publications; recipient of multiple NIH research awards

• Education: Ph.D. in Biochemistry, University of Georgia; M.S. in Chemistry, Texas A&M University; B.S. in Pharmacology, China Pharmaceutical University

Dr. Cheng is a protein scientist with extensive expertise in therapeutic protein discovery and development, with a particular focus on the purification, characterization, and engineering of complex biologics across diverse modalities. He received his PhD in Biochemistry from the University of Delaware, where he trained in protein biochemistry and mass spectrometry. He began his industry career at NGM Biopharmaceuticals, where he worked on multiple innovative bispecific antibody, hexameric IgG, and ADC programs as part of the biologics team. He is currently a Principal Scientist at ImmunEdge, leading efforts in the design, production, characterization, and development of next-generation therapeutics.

Accomplished scientific and business leader with extensive experience advancing innovative therapeutic products, including protein biologics and viral vectors, across leading biopharmaceutical organizations such as Johnson & Johnson, Bayer, BioMarin, Grifols, and Sangamo Therapeutics. Brings deep expertise spanning viral vector and biologics process development, MSAT, clinical and commercial manufacturing, technology transfer, facility start-up, process validation, and continued process verification (CPV). Recognized for building and leading high-performing teams and for successfully progressing programs from early development through clinical evaluation and commercialization. Committed to enhancing manufacturing operations by optimizing processes, reducing cost of goods, and streamlining execution to enable scalable, reliable delivery of transformative therapies.

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.

David obtained a BS in Chemistry from Northwestern University. He continued his graduate studies at KAIST and Johns Hopkins University. David is currently a scientist at Biogen, working on the process development of ASOs.

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, PhD, is currently Senior Director of Analytical Development: Mass Spectrometry, Separation Science, and Protein Chemistry at Sarepta. Previously, he was a Director at 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 PhD in chemistry from Northeastern University.

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

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

Roger Connolly is an R&D Lead Scientist at Lonza Biologics with over 7 years of biopharmaceutical process development and quality control experience. His current role focuses on At-line PAT tools for mammalian cell culture processes, where he supports development and implementation of novel technologies. Roger holds a bachelor’s degree in biology from the University of Maine and is currently pursuing a master’s degree in Bioinformatics from Northeastern University. 

Louis Coplan is a bioprocess engineer with seven 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.

Since transitioning from the lab to the field in 2011, Jason has built a career defined by scientific expertise and a deeply consultative sales approach. With a background in molecular biology, he spent several years in research before making the move to sales—a shift driven by his desire to connect innovative products with the scientists who need them most. Leveraging his lab experience, he quickly developed a reputation for understanding the technical needs of researchers and clinicians alike. He partners with customers to identify pain points and recommend tailored solutions that improve workflows, data quality, and research outcomes. Whether discussing advanced reagents, instruments, or diagnostics, he bridges the gap between technical complexity and practical value.

Juan Cueva Tello is a Purification Process Development Scientist at Biogen’s Research Triangle Park (RTP) facility. With extensive experience in the pharmaceutical industry, Juan specializes in the process design, scale-up, and technology transfer of both biologics and synthetic oligonucleotides. He has led high-throughput and lab automation initiatives as well as projects in the process modeling space designed to accelerate development timelines ahead of clinical production. A dedicated advocate for digital transformation, Juan also champions AI and knowledge management strategies to enhance team collaboration. He holds a B.S. in Biotechnology from Ecuador and earned his M.S. in Biomanufacturing from North Carolina State University, where he was recognized as a National Science Foundation Fellow.

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.

Prasid Dasgupta is an accomplished technology and analytics leader with more than 25 years of experience spanning software development, statistical modeling, data engineering, and enterprise solution architecture. With advanced degrees in statistics, computer science, engineering, and technology management, he blends deep analytical expertise with strong business acumen to deliver impactful, data driven solutions. Currently serving as the Process Statistical Analytics Lead for Johnson & Johnson Advanced Therapies, Prasid drives statistical methodologies, digital transformation, and data-automation initiatives supporting CAR T and Lenti manufacturing. His work includes pioneering reporting architectures, introducing advanced statistical process control methods, and implementing operational digital twins. Across prior roles, Prasid has led complex forecasting, financial modeling, clinical operations, and large-scale system-modernization projects for Fortune 500 clients such as GE Aviation, Nintendo, Spirit AeroSystems, Merck, and Covance. Prasid is known for his ability to translate complex problems into practical, scalable solutions while mentoring teams, guiding cross-functional stakeholders, and consistently delivering high-value outcomes.

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).

Marieke De Bock is a PhD candidate in Chemical Engineering at the Massachusetts Institute of Technology, working under Professors Richard Braatz and Allan Myerson. Her research focuses on engineering the in vitro transcription reaction for mRNA manufacturing—reducing impurity formation, increasing yield, and minimizing reagent loss—and designing new reactor types and integrated process systems to bring down the cost of gene therapies. She holds an Integrated Master's in Chemical Engineering from Imperial College London and has industry experience with AstraZeneca and Dimensional Energy through the MIT Practice School.

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.

Nicholas leads Drug Substance CMC at Third Arc Bio, overseeing cell line development, upstream, and downstream process development for complex antibody programs. He has over 10 years of experience engineering CHO cell lines, optimizing purification and cell culture processes using DOE-driven approaches, and leading tech transfer of complex biologics processes. He holds a B.S. in Chemical Engineering from Northeastern University and previously held bioprocess development roles at Asimov and Biogen.

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 the Head of Engineering at BioCurie, a TechBio company at the forefront of AI-driven digital solutions for genomic medicine production. Francesco leads the development of software for autonomous decision-making and optimization during process development and manufacturing of genomic medicines, manufacturing (including cell, gene, and RNA therapies). Prior to joining BioCurie, Francesco was a postdoctoral researcher and instructor at the Massachusetts Institute of Technology in the laboratory of Professor Richard Braatz, working at the intersection of process modeling and machine learning for genomic medicine manufacturing. Francesco obtained his PhD in Chemical Engineering at the University of Padova, Italy, in 2022, complementing his doctoral training at Purdue University and at Siemens Process Systems Engineering. His thesis on process systems engineering for pharmaceutical manufacturing received the 2024 EFCE Excellence Award for an Outstanding PhD Thesis on Computer-Aided Process Engineering.

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.

Ashna Dhingra is a senior scientist at AstraZeneca, where she contributes to the advancement of integrated and continuous bioprocessing platforms for antibody production. Her work focuses on bioreactor and harvest operations, including advanced process controls and process scale-up. Ashna’s areas of expertise include mechanistic modeling, with an emphasis on applying models to the development of upstream digital twins. She holds an MS in Chemical Engineering from the Massachusetts Institute of Technology and a BS in Chemical Engineering from the California Institute of Technology.

I have been in the cell and gene therapy space for over 17 years, focusing on CMC analytics/QC and process development. I have worked on several clinical-stage programs in small biotechs and large pharma companies. The programs I have worked on range from AAV gene-therapy products, CAR T, CAR-Treg, mesenchymal stem cells, human-embryonic stem cells, and iPSCs.

Nicholas holds a degree in chemical engineering from the University of Massachusetts at Amherst. and has over 9 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, LogicBio therapeutics, and Alexion. He is currently serving as an associate director of CMC leadership 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.

Joanna Donatelli is a Senior Associate Scientist in Cell Line Development at Gilead Sciences focusing on Targeted Integration Host Cell Line Development for antibody production. With a background in molecular biology and cell culture, Joanna aims to engineer a stable host cell line to manufacture complex molecules to address Gilead's various programs. She has held previous roles at Sana Biotech and holds a MS in Biomedical Science from San Francisco State University.

Kathryn Dorst, Ph.D., is Principal Scientist I and bioreactor team lead in Cell Line Development at Johnson & Johnson Innovative Medicine. With more than 15 years of experience spanning academic research, contract research, and vaccine process development at Sanofi Pasteur, she brings extensive experience in upstream process development, bioreactor strategy, and early-stage fed-batch production. Her work focuses on advancing robust cell culture processes through data-driven experimentation, scale-up, and cross-functional technical leadership.

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.

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.

Sumit Dutta leads late-stage upstream process development at Forge Biologics, transitioning AAV gene therapy programs from development to commercial manufacturing. With 13+ years of experience at Forge Biologics, Novartis, Seqirus, Pfizer, and STEMCELL Technologies, he has driven end-to-end process development and CMC across IND- and BLA-enabling studies, scale-up, tech transfer, cGMP manufacturing, and lifecycle management of 10+ biologics—including mAbs, fusion proteins, vaccines, and gene therapy—meeting key patient needs and enabling revenue of US$500M+. Sumit holds an M.Sc. in Biomedical Engineering (UMass Lowell) and B.E. in Biotechnology (RV College, India).

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.

Sam Ellis is an entrepreneur, team builder, business leader, investor, biochemist and molecular biologist who has worked in the Biotech industry for over 20+ years. Sam has successfully closed multiple deals in biotechnology-focused partnerships with large, small pharma, academic, and government entities. He has successfully grown multiple businesses including Thomson Instrument Company. He is listed as inventor on more than 48 patents. He has collaborated to publish with Genentech, Pfizer, Takeda, and other companies in groundbreaking scientific areas. Sam is a regular speaker at PEP Talk & PEGS, and speaks publicly at multiple conferences, and regularly gives technical seminars at companies.

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 23 years of experience in biotechnology and 15 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.

Sahar Esmaeili Samani holds a Master’s degree in Biochemistry and Biomedical Sciences/Chemical Engineering from McMaster University, Hamilton, Ontario, Canada. With over ten years of experience developing innovative strategies for vaccine stabilization, she specializes in lyophilized vaccine formulation development, applying Design of Experiments (DoE) and Quality by Design (QbD) approaches to optimize vaccine formulations. Among her diverse areas of expertise, she has extensive experience integrating in-line and on-line Process Analytical Technology (PAT) sensors into vaccine processes, ensuring product quality through continuous monitoring of Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs). Another key focus of her work is leveraging AI-powered tools to accelerate vaccine formulation development and stability prediction while reducing the need for extensive experimentation. Driven by a passion for innovation in biopharmaceuticals, she is committed to advancing vaccine efficacy and reliability through cutting-edge scientific methodologies.

Lusheng Fan received his PhD in developmental biology from Chinese Academy of Sciences in 2014. After graduation, he continued his postdoctoral research at University of California, Riverside, where he focused his research on RNA biology. Currently, Lusheng Fan is a senior scientist at mRNA Center of Excellence, Sanofi. He worked on the assay development for mRNA vaccine characterization and quality control.

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

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.

Dr. Snehal Ganjave is a Specialist at the Wells Lab, UCSF, with expertise in recombinant protein expression, proteomics, and antibody engineering. She earned her Ph.D. in Chemical Engineering from IIT Bombay, India, where she integrated metabolomics and high-cell-density E. coli cultivation to optimize soluble production of disulfide-rich proteins. Her research combines mass spectrometry-based protein characterization with host engineering and bioprocess strategies, advancing both fundamental understanding and practical approaches for therapeutic protein and antibody design.

Ana Garcia is a process development engineer II in the Viral Production Core team of the Preclinical Manufacturing and Process Development group at Regeneron Pharmaceuticals. In this role, Ana contributes to the development of purification processes for rAAV therapies at the 2L, 50L, and 500L scales. She received her B.S. from UCLA and her M.S. from Thomas Jefferson University.

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.

Jin Guo is a principal scientist/group lead at Gilead Sciences specializing in upstream cell-culture process development for biologics. Jin has led platform development and process intensification activities across multiple companies, including Pfizer and Bristol Myers Squibb, supporting programs from preclinical through late-stage development. Jin holds a PhD in Chemical Engineering from Tufts University.

A burgeoning bioprocess engineer interested in downstream process development, optimization, modelling, controlling, and scheduling. My work focuses on developing and implementing AI/ML and mechanistic models to build intelligent systems for monitoring and controlling continuous downstream processes.

Chad Hall is a life science leader with expertise in drug development, cell line engineering, and biologics manufacturing. He is a Principal Scientist at Catalent Biologics, advancing protein expression technologies including GPEx® Lightning. Previously, he held R&D roles at Amebagone, Centrose, and Eli Lilly. Chad holds a PhD in Genetics (Baylor College of Medicine), an MBA (Rice), and a BS in Genetics (UW–Madison).

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.

Thomas Hart is molecular biologist at Demeetra whose work involves gene editing in microbes, plants, and mammalian cells. As a member of Demeetra’s research team, he develops creative molecular and cellular assays for improving our gene-editing technology. Thomas is also involved in Demeetra’s production side, performing routine quality control on products and creating custom DNA constructs for clients and collaborators. Before working at Demeetra, Thomas earned his Master of Science degree in biology at the University of Kentucky. While leading a transcriptomics project studying avian neurobiology, he developed a passion for molecular biotechnology.

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 former member of the International Society of Cell Therapy Legal and Regulatory Affair Committee, and United State Pharmacopeia Bio5 Expert Committee. He is the founder of the new Gordon Research Conference on Synthetic Biology in 2000. He also holds 25 issued patents and 54 pending patents, and his work has appeared in more than 50 peer-reviewed scientific publications.

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

Jana is Head of Science at Genedata, where she works with customers and partners to design and implement data strategies that enable AI and automation driven biopharma R&D. She brings over 20 years of experience across academia and industry, focused on combining high quality experimental data, advanced analytics, and scalable data platforms to accelerate scientific decision making. Jana holds a PhD in Biology from MIT and completed her postdoctoral fellowship at the Whitehead Institute in Cambridge, MA, where she developed a strong foundation in data intensive molecular biology and next generation sequencing.

Chervee Ho is the Co-Founder of BioChromatographix International, a Singapore-based biotechnology company developing next-generation monolithic chromatography media to advance downstream bioprocessing. The company’s technology, AXISFLOW™ aims to address critical bottlenecks in virus purification and biotherapeutic manufacturing, enabling faster and more cost-effective production for global biopharma companies. An entrepreneur and life sciences strategist, Chervee brings extensive experience across the pharmaceutical and bioprocessing industries, with a strong focus on commercialization, business development and go-to-market strategy across the Asia-Pacific region. She is passionate about bridging scientific innovation and industry needs, helping translate breakthrough technologies into scalable solutions that advance healthcare globally. Chervee holds an Honors degree in Biotechnology from Universiti Putra Malaysia and a Global Management Certificate from INSEAD.

Maximilian Hoerner is a leading expert in molecular optogenetics and has been at the forefront of the field since its emergence. He joined Prolific Machines as Head of Optogenetics in 2022, driven by a passion to translate this powerful technology into impactful industrial applications.

Max earned his Bachelor’s and Master’s degrees in Molecular Biotechnology from Heidelberg University. Following a research stay at Harvard University, he pioneered the application of photoswitches to control apoptosis with light during his Master’s thesis. Building on this foundation, Max pursued a Ph.D. at the University of Freiburg, where he developed innovative strategies to control mammalian cell signaling through optogenetics. After a brief postdoctoral period, he established his own research group at the University of Freiburg and spearheaded the concept of extracellular optogenetics.Beyond optogenetics, Max brings broad expertise in synthetic biology, mammalian cell line engineering, and protein production and purification.

Jennifer is a Consultant at Cambridge Biostrategy Associates with almost a decade of experience in pharma, medical devices, and life science tools consulting, specializing in market modeling, market research, and business strategy. She holds undergraduate and doctoral degrees in Biomedical Engineering from Johns Hopkins University and Columbia University, respectively. Prior to consulting, she gained hands-on experience in optical imaging, biosignal processing, image processing, and image diagnostics through academic research, incubator, and startup work. Her work bridges advanced engineering principles with practical applications across the life sciences industry.

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.

Zhuangrong Huang is Director and Head of Data Science and Digital Application within the Global Development and Technical Operation, WuXi Biologics. He is responsible for the strategic development and application of digital and modeling technologies for late-stage CMC development and manufacturing operations. Previously, he worked in Biopharmaceutical Process Development at Takeda and Global Upstream and Cell Line Development at Bristol Myers Squibb. Dr. Huang holds a BS and MS from Zhejiang University, and a PhD in Chemical Engineering from the University of Massachusetts Lowell.

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.

Andrei Hutanu is a drug product development scientist at ten23 health, a Basel-based CDMO for formulation, analytics and sterile fill and finish. He works on formulation and development strategy for parenteral products across proteins, peptides, oligonucleotides and viral vectors. He holds a PhD from F. Hoffmann-La Roche Ltd., where he developed capillary electrophoresis methods for biopharmaceuticals, including mAb co-formulations and bispecific antibodies, and later for cell and gene therapy products, with a focus on recombinant adeno-associated viruses. He studied Biochemistry at the Technical University of Munich.

Susan Hynes is Chief Quality Officer at GSK, where she leads quality across the enterprise, an organization of over 6,000 employees. She joined GSK in late 2020, to lead the medicines quality organization and now drives the company’s transformation of quality as a competitive advantage. With more than 25 years’ experience at Merck, BMS, Shire/Takeda, Susan has led major enterprise business transformations, overseen a large-scale biologics greenfield construction, and supported accelerated development and launch of a significant number of innovative medicines and vaccines across all platforms. She is recognized for shaping high-performing organizations and advancing enterprise-wide quality excellence. She currently leads one of three priority AI programs for GSK.

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.

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

Rodney Jarvis, Ph.D. is the Senior Director of Product Management for ChemoMetec in the United States, where he leads initiatives supporting the adoption and successful implementation of the company's XcytoMatic platform of cell counting instruments. In this role, he works closely with customers and internal teams to provide technical guidance, user training, and strategic product support, while also overseeing the development and effectiveness of ChemoMetec's field application teams. Dr. Jarvis earned his Ph.D. in Genetics from the University of Georgia, where his research focused on the genetic mechanisms governing thymus development. Following his doctoral studies, he joined ChemoMetec as a Field Application Scientist, spending six years training researchers and biomanufacturing professionals on the company's advanced cell counting technologies. During this time, he helped customers optimize cell counting workflows, troubleshoot technical challenges, and improve cell culture processes across a broad range of applications. His technical expertise and leadership capabilities led to roles as Manager and subsequently Director of Field Application Scientists, where he spent two years leading and developing scientific support teams. Throughout his career, Dr. Jarvis has combined a strong scientific foundation with a passion for customer success, helping bridge the gap between innovative technologies and practical laboratory and bioprocessing applications.

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.

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

Peiyuan Kang is a cell therapy scientist with strong experience developing and improving manufacturing processes for CAR-T, CAR-NKT, and TIL therapies. He specializes in drug product process development, including cryopreservation, fill finish and drug product clinical compatibility. Currently at AstraZeneca, he leads late-stage process validation for CAR-T programs and works across teams to help bring cell therapies into commercial phase. He earned his Ph.D. in Mechanical Engineering from The University of Texas at Dallas and completed postdoctoral training at Harvard Medical School, where he worked on immune cell processing and assay development.

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.

Dr. Anupama Kante is a Scientist in the Downstream Process Development lab at Avid BioServices. In her role she develops robust and scalable bio-manufacturing processes to purify mAbs, recombinant proteins, fusion proteins, and various other modalities.  Anupama received her PhD in Biochemistry and Biophysics from the University of Kansas and did a post-doc at UCLA. Her research focused on understanding the thermodynamics of multi-protein complex assembly.

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.

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

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.

Kris is part of analytical development at Kite In Vivo, formerly Interius, supporting vector characterization. Kris has held positions in oncology, immunology, and immuno-oncology, focused on discovery of small molecules, ADCs, and nanoparticle delivery systems, with a strong background in flow cytometry. Her current focus is on the advancement of how nano flow cytometry complements and supports other orthogonal measurements of particles and characterization of surface proteins on viral particles.

Victoria Kennedy is a Senior Scientist in the Purification Process Development group at Sanofi, where she specializes in Process Analytical Technology (PAT). She earned her Master's Degree from Northeastern University and has developed significant expertise in bioprocess analytics. Her work encompasses various analytical technologies, ranging most notably from liquid chromatography to spectroscopy. At Sanofi, Ms. Kennedy focuses on advancing both upstream and downstream processes through innovative analytical approaches, contributing to the development of more efficient and robust bioprocesses.

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.

Ben Knappett is the Sr. Product Manager for the Sunny Suite, Unchained Labs’ automated microfluidic nanoparticle synthesis instruments, used primarily for LNP encapsulation in drug delivery, vaccines, and gene therapy applications. Ben received his MChem degree from Durham University, and completed a PhD in nanoparticle synthesis and characterization at the University of Cambridge. Ben previously worked for Particle Works as Head of Science and Applications, playing a key role in the development and commercialization of the instruments that now make up the Sunny Suite.

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

Lead Application Engineer supporting adoption of fluids simulation across healthcare, consumer products and process industries. Proven track record of interfacing well with technical experts as well as business leadership.

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.

Stephan O. Krause, PhD, is a biopharmaceutical quality and analytical science leader with over two decades of experience advancing global standards across biologics, cell therapies, and analytical control strategies. As Executive Director for Analytical Strategy at Bristol Myers Squibb, he leads analytical strategy development and lifecycle execution for cell therapy products across global sites. Stephan has received more than a dozen awards for his publications and industry leadership. He is a member of multiple advisory boards and chairs industry task forces, such as Phase-Appropriate QMS for ATMPs and ANS-07 Analytical Standard Development.

Satya Kuchimanchi is Senior Vice President, Tech Ops and CMC, at CAMP4 Therapeutics. He has more than 20 years' experience in research and development of oligonucleotide therapeutics, primarily focusing on ASO and siRNA modalities. While at Alnylam, he was actively involved in development of several approved siRNA drugs including Onpattro, Amvuttra, Givlaari, Leqvio, and Oxlumo.

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.

Dr. Jed Lampe is a multi-R01-funded principal investigator, educator, and scientific leader in the ADME/DMPK field. After receiving his Ph.D. in Medicinal Chemistry from the University of Washington studying under Professor William Atkins, he completed post-doctoral training at UCSF under the tutelage of Professor Paul Ortiz de Montellano. Currently, he serves as an Associate Professor in the Department of Pharmaceutical Sciences at the University of Colorado, Skaggs School of Pharmacy, where his research interests involve the application of bioanalytical, biophysical, and computational techniques to understand and predict drug metabolism and disposition in special populations, including neonates, pregnant persons, cystic fibrosis patients, and African Americans. Dr. Lampe has made seminal contributions to our understanding of drug metabolism and drug toxicity in both the developing fetus and the neonate. Additionally, he is chair of the NIH DBDT study section and also serves on the FDA Scientific Advisory Board and on several journal editorial boards, including: Nature Scientific Reports, PLOS One, and Drug Metabolism and Disposition.

Sebastien Latapie is a Partner at Avant Bio where he invests in life science industrials companies at the early growth stage. He has evaluated 1,400+ companies and backed platforms spanning AI-driven drug development, enabling technologies, and cell and gene therapy, sourcing and leading investments in companies like PathPresenter, Intrepid Labs. Sebastien holds an MBA from Columbia Business School and graduate degrees in biochemistry and immunology from McGill University.

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.

William Lee is a chemical engineer who focuses on developing analytical methods to support process development. In the past, he has worked in several research areas including photovoltaics, medical devices, and small molecule manufacturing. He has worked on analytical development teams at Takeda Pharmaceuticals, Voyager Therapeutics, and LogicBio Therapeutics. Currently, he works at Alexion-Astrazeneca Rare Disease focusing on characterization of AAV vectors.

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.

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 Founder and Principal of Eight Crest Strategies, a CMC, technical and regulatory advisory for biologics, cell therapy, gene therapy and gene-editing programs. He has more than 20 years in biologics research and development, specializing in CMC, analytical sciences, quality control and regulatory strategy for advanced therapy platforms. He has held leadership positions at Metagenomi, Aura Biosciences, Editas Medicine and Thermo Fisher Scientific, helping advance more than 15 advanced therapy programs across gene therapy, cell therapy and gene editing. That work has spanned AAV, retroviral and adenoviral vectors, mRNA and guide RNA, lipid nanoparticles, Cas enzymes and oligonucleotides, for rare disease and oncology indications including hemophilia, retinal and optic-nerve disorders, and lysosomal storage disease. He has built analytical and quality organizations of 15 to 20 scientists, established GMP manufacturing and analytical infrastructure from the ground up, managed multimillion-dollar portfolios, and contributed to the CMC content behind regulatory submissions and health-authority interactions in the U.S. and Europe. An active contributor to the biotechnology and regulatory communities, he serves as a member of the U.S. Pharmacopeia Biologics - Cell and Gene Therapy Expert Committee, as a U.S. Technical Advisory Group member and working-group expert for ISO/TC 276, and as Chair of the Regulatory Affairs Professionals Society San Francisco Bay Area Chapter, developing the standards and expectations that advanced therapies are measured against. He earned his PhD in Biochemistry from the National University of Singapore and a BSc in Pharmacy from the University of Strathclyde, and conducted postdoctoral research at MIT and UC San Diego.

Dr. Yannan Lin is a Senior Scientist in Biologics Analytical Research and Development at Merck & Co., Inc. He earned his PhD in Chemistry from the University of Pennsylvania (2017–2023) and has authored multiple peer-reviewed publications in analytical chemistry for both small molecules and biologics. At Merck, Dr. Lin supports analytical method development and method validation for biologics including monoclonal antibodies, antibody-drug conjugates, and fusion proteins.

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.

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.

J. Christopher Love is the Raymond A. (1921) and Helen E. St. Laurent Professor of Chemical Engineering and member of the Koch Institute for Integrative Cancer Research at MIT. His research focuses on advancing next-generation approaches for accessible and affordable biomanufacturing and on single-cell analyses in chronic diseases like cancer and food allergy. He served as a Distinguished Engineer in Residence at Biogen in 2015 and is the founding director of the Alternative Host Research Consortium at MIT. He has also co-founded four companies for biopharmaceutical services and technologies, including Honeycomb Bio, OneCyte Bio, and Sunflower Therapeutics.

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.

Ryan Lybarger is the Marketing Manager for the Cedex and QC product portfolios at Roche CustomBiotech, where he oversees strategic growth and market positioning for industry-leading analytical solutions in the US. Since joining the organization in 2018 as an Application Consultant, Ryan has leveraged his technical expertise to bridge the gap between complex bioprocessing challenges and high-performance quality control workflows. He holds a PhD in Physics from Purdue University, a background that provides a rigorous scientific foundation for his work in driving innovation and precision within the biotechnology sector.

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.

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 20 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. Olivier joins Gilead Science via the acquisition of Tubulis GmbH (Munich, DE) where he was SVP CMC. He joined Tubulis in April 2022 after holding positions at Vaxcyte (San Carlos, CA) including Senior Director,. There 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.

Dr. Michalis Mastri is Manager of High Throughput Capabilities within the BioProduction Group at Thermo Fisher Scientific. His work focuses on applying high-throughput screening, automation, and advanced data analytics to accelerate CHO cell line development, media development, and process optimization. By integrating computational biology with experimental workflows, he helps transform complex biological data into actionable insights that enable data-driven bioprocess development. Dr. Mastri's multidisciplinary expertise spans cell biology, bioinformatics, statistics, and computational biology, with a particular interest in leveraging high-throughput technologies, multi-omics, and machine learning to better understand cellular behavior and improve bioproduction workflows. His team combines automation, high-throughput experimentation, and advanced analytics to rapidly evaluate cell clones, media formulations, and novel raw materials, enabling faster, data-driven decision-making across bioprocess development. He earned his Ph.D. in Biochemistry from the University at Buffalo and completed postdoctoral training in cancer biology and computational biology.

Veronika Matosa holds a master’s degree in Chemistry and is currently employed at Novartis R&D as a method expert in the analytical department. Her professional work focuses on the development, optimization, and application of analytical techniques to support pharmaceutical research and development.

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.

Jenn McNary is a trusted voice in the rare disease community, as a mother, public speaker and fierce advocate. Her work in the rare disease space as a thought leader earned her the Ryan’s Quest Ryan’s Hero award in 2013, and the prestigious 2017 Meyer- Whalley instrument of change award. Formerly as the director of outreach and advocacy at a Massachusetts based non-profit foundation, she was responsible for the organization of the largest FDA advisory committee hearing in history, with over 1000 duchenne advocates, families, clinicians and researchers in attendance. Jenn has unique experience in the drug development field, as a parent of children enrolled in clinical trials, an advocate engaging with the regulators and as a patient engagement professional in the life sciences. Currently, Jenn is the CEO of both Canary Advisors and Canary Concierge, boutique firms with a focus on patient experience, regulatory and access engagement as well as specialized patient travel. Her other activities include serving as the Founder of One Rare, a non-profit formed to meet the needs of young adults with rare and chronic conditions and raising her children in Massachusetts.

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.

Kedric L. Milholland is a senior scientist within the Biologics CMC Developability team at AbbVie. With a PhD in Biochemistry from Purdue University, Kedric brings deep expertise in protein biochemistry, biophysical characterization, and protein stability, with postdoctoral training in protein mass spectrometry. In the Biologics CMC Developability team, he performs biophysical, chemical, and structural screening of biologics at the discovery-development interface to help advance the best candidate into pre-clinical development. His experience spans several modalities, including monoclonal and bispecific antibodies and antibody-drug conjugates. He is currently interested in generating large developability datasets with high-throughput methods and leveraging this data to advance next-generation AI/ML models aimed at informing protein therapeutic development.

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

Dr. Rahul Misra is a Scientist in the Biophysics and Process Analytical Technology platform at Sanofi Pasteur, Canada. He develops analytical methods for size and structural characterization, antigen content, purity analysis and thermal stability of vaccine candidates. He is also working on providing inline/online PAT solutions to monitor CQA’s in vaccine manufacturing process. Prior to joining Sanofi, he has worked as a Scientist in Eurofins Canada, Keenan Research Centre of St. Michael’s Hospital, and Intas Pharmaceuticals. He was a Fulbright Postdoctoral Research Fellow at Purdue University, USA and received a PhD in Biochemistry at the Indian Institute of Technology, Delhi. He is co-author of 20 research papers and co-inventor of patents in the field of nanomedicine and drug delivery.

In her role as Chief Scientific Officer, Platform Research, Dr. Melissa Moore was responsible for leading mRNA biology, delivery and computation science research at Moderna. She joined Moderna in 2016 from the University of Massachusetts Medical School (UMMS), where she served as Professor of Biochemistry & Molecular Pharmacology, Eleanor Eustis Farrington Chair in Cancer Research and a long-time Investigator at the Howard Hughes Medical Institute (HHMI). Dr. Moore was also a founding Co-Director of the RNA Therapeutics Institute (RTI) at UMMS, and was instrumental in creating the Massachusetts Therapeutic and Entrepreneurship Realization initiative (MassTERi), a faculty-led program intended to facilitate the translation of UMMS discoveries into drugs, products, technologies and companies. Dr. Moore is a elected member of the National Academy of Sciences (2017) and a Fellow of the American Academy of Arts and Sciences (2019). Dr. Moore holds a B.S. in Chemistry and Biology from the College of William and Mary, and a Ph.D. in Biological Chemistry from MIT, where she specialized in enzymology under Prof. Christopher T. Walsh. She began working on RNA metabolism during her postdoctoral training with Phillip A. Sharp at MIT. During her 23 years as faculty member, first at Brandeis and then at UMMS, her research encompassed a broad array of topics related to the roles of RNA and RNA-protein (RNP) complexes in gene expression, and touched on many human diseases including cancer, neurodegeneration and preeclampsia.

Charles Morgan is currently the Head of Regulatory CMC at Denali Therapeutics leading the development and execution of CMC regulatory strategies across Denali’s portfolio for the treatment of neurodegenerative diseases. Previous roles included technical regulatory team leader and protein formulation scientist at Genentech including contributions to the development and approval of POLIVY® (polatuzumab vedotin). At Genzyme, he focused on the analytical characterization, biophysical and biochemical analysis of glycoprotein therapeutics. Charles has two decades of experience in the development of proteins as therapeutics following postdoctoral research at Yale University on protein amyloids and a doctorate from the University of Oxford in protein folding.

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).

Dana Motabar is a senior scientist at AbbVie where she works on the cell culture process development of early and late stage biologics. She holds a PhD in bioengineering from the University of Maryland College Park.

Aaron received his Bachelor of Science in Biology and Ph.D. in Biochemistry, both from Brandeis University, where his doctorate focused on X-ray crystallographic studies. Aaron was then a Post Doctoral Associate at Genzyme Corporation for three years, worked briefly as an Applications Scientist at Microlytic, and then moved on to a Technical Sales/Project Management role at Emerald Bio/Beryllium Discover Corp. After this, Aaron spent nearly six years at GE Healthcare/Cytiva, first as a Support Scientist and then as a Product Specialist for Bioprocess Chromatography Resins before moving to Sartorius as a Field Applications Specialist for Chromatography instruments/hardware and media. Currently, Aaron is a Global Technical Consultant at Ecolab, Purolite Resins supporting primarily North Eastern America where he supports the use of Purolite Praesto Resins for downstream bioprocess applications.

Dr. Mulukutla received his PhD from the University of Minnesota’s Chemical Engineering program and joined Pfizer in 2012. At Pfizer, he is involved in developing cell culture processes for active portfolio projects and contriving newer technologies to improve cell culture process performance, specifically through optimization of cellular metabolism. Dr. Mulukutla’s PhD research entailed identifying mechanisms that governed metabolic shifts to lactate consumption in the late stages of fed-batch culture by employing systems biology approaches. He developed a mechanistic kinetic model to demonstrate the presence of a multiplicity of steady states in glycolytic activity that could explain metabolic shifts in cell culture. For this work, Dr. Mulukutla received the award for best poster presentation at the Cell Culture Engineering XII conference in April 2010. Dr. Mulukutla and his research group at Pfizer has been developing novel technologies for enhancing the fed-batch processes of CHO cell lines used for therapeutic production. Dr. Mulukutla’s research team was the first to identify inhibitory metabolic byproducts produced in CHO fed-batch cultures, and devised strategies to alleviate the inhibition. His group has metabolically engineered CHO cells to reduce or eliminate production of these metabolic byproducts. The tyrosine prototrophs of CHO cells that his team engineered can synthesize tyrosine and proliferate in tyrosine-free environments. His recent work applied systems biology approaches to determine the underlying cause for the glycosylation dynamics observed in CHO fed-batch cultures. Dr. Mulukutla has co-authored 19 scientific articles, 4 patents and 6 patent applications, and is an active member of the cell bioprocessing community.

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.

Sri Narayanan is an award-winning Regulatory Affairs Professional at Asahi Intecc USA, specializing in AI-enabled medical devices, Software as a Medical Device (SaMD), FDA regulatory strategy, and quality-system compliance. She has delivered presentations, webinars, and guest lectures at more than 40 national and international conferences and professional forums on AI risk assessment, regulatory-ready innovation, medical-device compliance, and emerging healthcare technologies. Sri serves as an SDG Commissioner with the International Peace Commission (IPC), contributing to responsible innovation, sustainable development, and global healthcare advancement through UN-focused initiatives. She holds a Master of Science in Regulatory Affairs from Northeastern University and combines clinical insight with regulatory expertise to help advance safe, effective, and trustworthy health technologies.

Bella Neufeld, Vice President of Operations at Teknova, oversees manufacturing across the company’s full portfolio of research- and GMP‑grade reagents. Previously serving as Director of Research and Development and Scientific Director, she led the creation of Teknova’s first internal R&D team, launched the company's first proprietary product line — AAV‑Tek™ Solutions — to support emerging gene therapy development, and drove rapid development efforts during Covid-19 which included the introduction of a novel transport media. With a PhD in Chemistry from Colorado State University, Bella has built and managed multiple research laboratories, expanded scientific capabilities across the organization, and continues to present and publish her work across numerous industry events and publications.

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 Principal Data Scientist at Sanofi focusing on advanced control and optimization of upstream and 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 only.

Ricky Okafor graduated with a bachelor's in biochemistry from Villanova University and now is an associate scientist at Alexion Pharmaceuticals working in upstream process development. He primarily conducts work with CHO cells, works with the bioreactor operations team, and is mostly focused on the scale up of upstream operations, filter sizing, and harvest development.

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, study design, and data pipeline.

Malvina Papanastasiou, PhD, is a Senior 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.

William Parker is a PhD student in Chemical and Biomolecular Engineering at NC State University in the Crook Lab. His research focuses on engineering probiotic yeast for localized therapeutic delivery in the gastrointestinal tract. He is particularly interested in understanding and engineering protein secretion in Saccharomyces boulardii to expand its potential as a platform for living therapeutics.

Dr. Debasis Patra is a veteran chemist with 25 years of experience in pharma/biotech industry leading small-molecule and oligonucleotide projects from discovery through clinical development and commercialization. Currently he is heading a CMC team engaged in the clinical development of several novel modalities.

My undergraduate degree is in Chemistry from Hope College. I obtained my Ph.D. degree in Biochemistry from the University of Wisconsin-Madison. I spent time as a Post Doc at Fox Chase Cancer Center outside Philadelphia and a shorter time in the Dermatology department at the University of Pennsylvania. I worked at Novartis/Syngenta designing high through-put screens. I have spent the last 21 years running the Protein Expression Facility at the NIEHS.

I'm passionate about researching, developing, and deploying production-grade machine learning solutions that enable domain experts to leverage advanced analytics at scale. Our team works together with the largest Pharma companies in the world, to transform their production facilities to incorporate AI into critical development and manufacturing processes—from process optimization and predictive quality control to real-time monitoring and decision support.

Francis Poulin is Head of Biologics Analytical Development & Quality Control at Takeda. He leads the development of analytical procedures intended to release and characterize biologics in preparation for process performance qualification and to support commercial launches. Prior to Takeda, he led analytical development and QC teams at Sail, Lyell Immunopharma, Sanofi, and Genzyme, and contributed to several successful regulatory filings. Francis received his PhD in Biochemistry from McGill University, where he worked with Professor Nahum Sonenberg on the regulation of mRNA translation initiation.

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.

Yu Qian is a seasoned cell therapy leader with a PhD in Biomedical Science and over a decade of experience spanning academia and industry, including more than ten years of focused training in immunology and cancer immunology through PhD and postdoctoral research. He began his cell therapy career at Takeda, where he contributed to multiple cell therapy programs across diverse modalities and clinical stages. Yu currently serves as Director and Head of Cell Therapy Analytical Project Leads at Novartis, leading teams responsible for end-to-end analytical strategy development and execution for cell therapy programs.

Shalini Raj is a Senior Scientist with a background in Chemical Engineering and Ph.D. research in cancer cell biology, biomaterials, and quantitative imaging. Her experience spans cell therapy process development, bioprocessing, and pharmaceutical development, providing a multidisciplinary perspective on complex scientific challenges. Drawing on her bench science experience, she applies statistics, mechanistic and hybrid/data-driven modeling, and AI/ML to enable process characterization, digital twins for upstream process development, root cause analysis, platform method development, and computer vision applications for cell line development. She partners across biologics development functions, including analytical development, cell line development, and cell culture process development, to advance scientific workflows. She is an active scientific communicator and versatile researcher who is passionate about translating complex data into actionable insights and fostering cross-functional collaboration.

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

Dr. Divya Ravirala is Director of Analytical Development at Immatics, where she leads analytical strategies supporting cell and immunotherapy programs. She has extensive experience leading cross-functional teams in method development, validation, technology transfer, and execution of GxP-compliant studies. Her background includes leadership of immunology and immunotoxicology functions at LabCorp Drug Development, as well as roles at Bellicum Pharmaceuticals, GlaxoSmithKline, Novartis, and Pfizer focused on assay development and translational support for cell therapies and immunology programs. Dr. Ravirala holds a Ph.D. in Cell and Molecular Biology from the University of Houston and has published articles in the fields of cancer immunotherapy and oncolytic virotherapy.

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 Kite In Vivo, formerly Interius, to support development of lentiviral vectors for direct administration to patients. Trained as a virologist, Jim has over 30 years of experience developing viral products, including multiple gene therapies and viral vaccines for the prevention and treatment of human disease. Previously, Jim led 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 (now Minaris Advanced Therapies) 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.

Jay Rosanelli is the Founder and CEO of Syenex, a biotechnology company leveraging synthetic biology to develop next-generation gene delivery vesicles and universal genetic medicine delivery platforms that accelerate the future of cell and gene therapies.

A biotechnology operator, entrepreneur, and investor, Jay brings deep expertise in cell and gene therapy, synthetic biology, platform business models, and company building. Prior to founding Syenex, he served as Chief Financial Officer and General Partner of Venture Studios at Alloy Therapeutics, where he helped scale the company from fewer than 10 to more than 100 employees and played a key role in launching multiple biotechnology ventures.

Earlier in his career, Jay led a venture capital strategy focused on early-stage life science companies and served as an Investor-in-Residence in the Church Lab at Harvard's Wyss Institute for Biologically Inspired Engineering, supporting the commercialization of breakthrough technologies. He began his career in healthcare investment banking at Goldman Sachs before joining Highbridge Capital Management, a division of JPMorgan, where he invested in data-driven technology companies.

Today, Jay is focused on advancing scalable gene delivery technologies that simplify development, broaden access to genetic medicines, and unlock the next generation of therapeutic innovation.

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

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.

John is a principal scientist within the Mammalian Expression Technologies Centre of Excellence at GSK, where he leads a matrix team responsible for establishing the next-generation CHO-based CLD platform for recombinant vaccine antigen expression. Engagement with academic-private biopharmaceutical consortia (NIIMBL and AMBIC) and expertise in multispecific antibody design, expression, and assessment has enabled John to provide key perspectives to the CLD team at GSK. Prior to GSK, John performed post-doctoral research at the University of Wisconsin-Madison and earned his PhD in Chemical & Biomolecular Engineering at the University of Delaware (NSF GRFP fellow) and BS in Chemical Engineering at The City College of New York CUNY.

Dr. Peter Sagmeister is an Austrian scientist advancing drug manufacturing through digitalization, process analytics, and scalable process development. He earned his PhD from the University of Graz under Prof. Oliver Kappe, focusing on digitalizing continuous flow chemistry for pharmaceutical production. He then worked at the Research Center of Pharmaceutical Engineering GmbH and the University of Graz on AI-enabled approaches for small-molecule process optimization. During his appointment at the Massachusetts Institute of Technology (MIT) as a postdoctoral associate in the Department of Chemical Engineering in Prof. Allan S. Myerson’s group, he developed autonomous experimentation platforms and advanced drug delivery systems.

With over 13 years of experience in Ansys technologies, technical sales, leading engineering teams and business development, I specialize in aligning cutting-edge simulation solutions with customer needs to drive revenue growth and innovation. My background spans CFD, multiphysics applications, and digital transformation, helping global enterprises optimize their engineering workflows. 🔹 Key Achievements: ✔ Secured multi-million-dollar License Agreements with Enterprise clients ✔ Influenced $35M+ in revenue generation ✔ Drove 100% YoY growth for the Rocky initiative, expanding adoption across global regions ✔ Spearheaded competitive positioning strategies, improving close rates by 20% in key deals 🔹 What I Do Best: ✅ Technical Sales & Strategic Execution – Mapping customer goals to Ansys' vision of pervasive simulation ✅ Competitive Positioning & Market Strategy – Articulating high-value solutions against competitors ✅ Account Expansion & Relationship Building – Growing key accounts and developing sales pipelines ✅ Executive-Level Presentations & Persuasion – Delivering high-impact proposals and solutions If you're looking for a results-driven professional with deep expertise in engineering simulation, sales strategy, and digital transformation, let's connect!

Shriya Sahu is a Product Manager at Thermo Fisher Scientific, where she drives the development of innovative analytical solutions for the biopharma industry and supports product lifecycle management. She brings a strong background in both product management and R&D, enabling her to bridge scientific expertise with market-driven strategies. Shriya holds a PhD in Molecular and Cellular Biology from Stony Brook University, New York, and an MBA from Santa Clara University, California.

Rob is Head of Bioprocess at Constructive Bio, where he leads the development and scale-up of novel microbial strains for the production of peptides and proteins containing non-canonical amino acids and their subsequent downstream processing. Rob has extensive experience across the full bioprocess development workflow, gained through roles at multiple biotechnology companies in the UK. Most recently, he led the scale-up and manufacture of Johnson Matthey’s enzyme portfolio, delivering processes from development through to production. He holds a PhD in microbial physiology and protein biochemistry from the University of Sheffield.

Ilaria leads the analytical development portfolio at Resolution Therapeutics, overseeing the assay strategy supporting the company's autologous engineered macrophage clinical programme. Her expertise spans CMC analytics, from the development to the qualification and regulatory lifecycle of critical quality assays for advanced cell therapies. She brings seven years of prior experience from the Cell and Gene Therapy Catapult, where she developed a novel single-cell method for vector copy number quantification — a key analytical challenge in the ATMP field. Ilaria holds a Master's in Molecular Biotechnology from the University of Bologna and completed a Marie Sklodowska-Curie Fellowship PhD at the University of Liverpool, focusing on cellular therapies for kidney regeneration.

Dr. Jorge Santiago-Ortiz is the Vice President of Chemistry, Manufacturing, and Controls (CMC) and Regulatory Affairs at Apertura Gene Therapy. He holds a B.S. in Chemical Engineering from the University of Puerto Rico, Mayagüez, graduating with maximum honors, and a PhD in Chemical and Biomolecular Engineering from the University of California, Berkeley. His doctoral research in Dr. David Schaffer’s laboratory focused on the engineering of lentiviral and adeno-associated virus (AAV) vectors for gene therapy applications. Dr. Santiago-Ortiz began his industry career at BioConsortia Inc., where he directed the fermentation, scale-up, and technology transfer of beneficial plant-associated microbes to enhance crop yields and plant health. He later served as Senior Director of Process R&D at BioCentriq, a cell and gene therapy CDMO, where he led the Process R&D group and oversaw technology transfer and process development for gene and cell therapy clinical products, contributions that directly supported the CDMO’s eventual acquisition. At Apertura, Dr. Santiago-Ortiz oversees internal and outsourced manufacturing operations and drives CMC and regulatory strategy, ensuring alignment with preclinical and operational priorities. Beyond his role at Apertura, Jorge serves as the Co-Chair of the American Society of Gene and Cell Therapy’s Workforce Development Committee and is a member of the Scientific Advisory Board (SAB) for the TBCK Foundation.

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.

Dr. John Schiel joined ARPA-H as a Program Manager in December 2024. Prior to joining ARPA-H, Schiel led a research team focused on developing innovative analytical characterization methods for next-generation biotherapeutics, such as monoclonal antibodies (mAbs), viral vectors, cell therapy products, and vaccines, and mitigating risks associated with new technologies. Schiel also spearheaded the development of the National Institute of Standards and Technology’s mAb Reference Material (NISTmAb). As the Federal Technical Program Manager for the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), he oversaw programs aimed at accelerating the adoption of advanced biomanufacturing technologies and enhancing pandemic preparedness and response. Schiel has extensive experience in federal interagency coordination and has contributed to shaping national biomanufacturing policy and priorities. He is the author of over 50 publications and national strategy reports, an editor of three books, and the recipient of prestigious honors, including the Department of Commerce Gold Medal and the Arthur S. Flemming Award. Schiel earned his doctorate in chemistry from the University of Nebraska and completed postdoctoral work at NIST.

Lina Schulte is a Scientist at StemVAC GmbH, the German subsidiary of Calidi Biotherapeutics. She received her master’s degree in Bioengineering in 2022. StemVAC focuses on process and analytical development of oncolytic virus therapy. At StemVAC, Lina Schulte is responsible for upstream development. She performs small scale process optimizations of cell culture and virus production, as well as the scale-up to a bioreactor.

Dr. Serban joined Sunresin in 2023 as the Global Applications Director, bringing with her a vast expertise in providing technical support for a wide range of resin-based life sciences applications. Simona holds a PhD in analytical chemistry from the University of Nantes, France, and has authored over 30 publications on the use of specialty resins in applications including Solid Phase Peptide Synthesis (SPPS), Solid Phase Organic Synthesis (SPOS), chromatographic purification, biocatalysis, and the development of medical devices.

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).

Ragavi Shanmugam is a Scientific Data Strategy Consultant at Zifo, with a decade of experience in bioinformatics. She has previously worked as a bioinformatician decoding drug resistance in infectious diseases at Gilead and SDSU research foundation. Her expertise lies in integrating data, technology, and science to streamline scientific infrastructures and engineer knowledge, to accelerate research.

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.

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

Dr. Ying 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.

Oleg Shinkazh is founder and CEO of Chromatan and the inventor of Continuous Countercurrent Tangential Chromatography. Oleg is a chemical and biotechnology engineer with 20 years of experience in R&D and technical support in the biotechnology industry, specializing in downstream processing / purification biological products.

Angela Shiu is a Process Development Engineer in the Viral Production Core group at Regeneron Pharmaceuticals, specializing in the analytical characterization and method development of Adeno-Associated Virus (AAV)-based products to support AAV process development. Angela plays a key role in performing, designing, and optimizing various analytical assays that evaluate AAV safety, integrity, strength, purity, and quality. From biochemical to cell-based assays, her expertise helps support routine sample testing of drug products and process intermediates, as well as GMP technology transfers.

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

Chadakarn Sirasitthichoke is a Principal Scientist in Data Science at Bristol Myers Squibb in Devens, Massachusetts, where she builds and deploys computational and AI models across the biologics and cell-therapy manufacturing portfolio, spanning multi-physics CFD, hybrid mechanistic–machine-learning modeling, and agentic LLM systems that support scale-up, technology transfer, and real-time process decisions. She established the enterprise CFD modeling capability now supporting more than ten global commercial programs, and she leads the global CFD Community of Practice. She holds a Ph.D. in Chemical Engineering from New Jersey Institute of Technology, has authored more than ten peer-reviewed publications, and serves as an Executive Council Officer of the North American Mixing Forum within AIChE.

Varsha Sitaraman is the Director of Cell Line Development Project Management at ATUM. Varsha's in-depth knowledge of Leap-In transposase, her expertise in vector engineering and her experience with essentially every one of our cell line development projects over the last 10 years has made her an invaluable resource for our clients. Before joining ATUM, Varsha's postdoctoral work and subsequent research was on Adenovirus and AAV viral vector production.

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.

Dr. Nicole Smiddy works in the Vaccine Analytical Research & Development department at Merck & Co., Inc., Rahway, NJ, USA on the High Throughput Analytics team supporting vaccine process and formulation development through assay development and automation. Specifically, her work focuses on the development and automation of imaging and flow cytometry assays for characterizing potency, neutralization, expression and sub-visible particles. Before joining Merck, Dr. Smiddy received a BS in Chemistry from Bradley University and a PhD in Analytical Chemistry from UNC-Chapel Hill.

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.

Stephen Soltys has recently accepted a role as Chief Manufacturing Officer at Primera Genotech where he will be responsible for the complete build out and operations of this recently established CDMO. Formerly, Steve was Vice President of Process Development at Kriya Therapeutics where he developed a platform process for generation for several indications of various AAV serotypes with world class quality attributes. Proir to Kriya Director of MSAT at Novartis Gene Therapies (formerly Avexis) where he was responsible for improving the former manufacturing process. Steve also was a Senior Scientist at Precision Biosciences where he developed AAV manufacturing processes for several programs and has a patent for separation of empty and full particles of several AAV serotypes. Steve was also one of the first employees of UNC/Bamboo therapeutics where he led downstream process development prior to being sold to Pfizer. Steve performed various roles in the vector cores of UNC, University of Pennsylvania, and Thomas Jefferson University where he received his master’s degree in molecular biology and virology. Steve received his undergraduate degree in biology from Marietta College.

Dr. Song Zhiwei earned his Biochemistry PhD from the University of Michigan where he studied protein glycosylation in cancer cells and their interactions with plant lectins. He completed his post-doctoral research in MIT’s Biology Department, investigating the genetic control of apoptosis. Following that, he worked in Professor Daniel I.C. Wang’s lab at MIT’s Biotechnology Process Engineering Center (BPEC). In 2002, Dr. Song moved to Singapore. Currently, he is a Senior Principal Scientist at the Bioprocessing Technology Institute (BTI) of A*STAR, Singapore. His lab has been focused on developing novel expression vectors for antibody production, protein glycosylation, glycoengineering of CHO cells with different genome editing techniques, and production of antibodies with these glycosylation mutants for in vitro and in vivo characterizations.

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.

Richard is a member of the Process Development team at Sutro Biopharma emphasizing the support of technology transfers of Sutro’s Pipeline Antibody Drug Conjugates to CDMOs as well as supporting the CMC function of the Technology Operations group. He has held previous roles in Biologics Process Development and MSAT teams at Baxter, Lonza and Nektar over his 20 year career in the BioTech and BioPharma industries. Richard holds dual BS degrees in Biology and Chemistry from the University of California Irvine and a PhD in Chemistry from the University of Utah.

Prakitr Srisuma is a postdoctoral researcher in the group of Prof. Richard D. Braatz in the Department of Chemical Engineering at MIT. He received a PhD from MIT, an MPhil from the University of Cambridge (UK), and a BEng from Chulalongkorn University (Thailand). Before moving to MIT, he was a process engineer at PTT Exploration and Production in Thailand. His research focuses on the development of computational tools and algorithms for advanced manufacturing, specifically for (bio)pharmaceutical processes such as lyophilization (aka freeze drying), cell thawing, and agitated filter drying. His work spans multiple key areas in process systems engineering (PSE), including process modeling, optimization, control theory, and data analytics. His recognitions include the AIChE CAST Director’s Student Presentation Award (third place), the AIChE PD2M Student Award, and the Thai Graduate Fulbright Scholarship.

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

Jennitte brings an impressive track record in therapeutic discovery, design and development at Amgen. Jennitte will spearhead how insitro continues to build a unique research and preclinical engine that incorporates both experimental and computational technologies to generate a pipeline of differentiated therapeutics. For close to two decades, Jennitte was closely involved in advancing a range of Amgen’s novel technologies and modalities, including biologics, synthetics, cell therapies and oligonucleotides. In total, she supported 100+ therapeutic programs, including 30+ IND submissions and 10 BLAs. She has more than 40+ publications and multiple patents to her name and was recognized for the development and use of cutting-edge technologies to improve efficiency and shorten timelines. Jennitte was previously an Executive Director in Process Development at Amgen, having first joined Amgen in 2005 in the Protein Sciences Department in Discovery Research, with a focus on advancing protein expression technologies, protein engineering and molecule assessment. She was instrumental in advancing Amgen’s CHO expression platforms and implementation of cutting-edge technologies to improve efficiency and shorten timelines, winning 2 gold medals and 1 silver medal Amgen Innovation awards, and author on over 40 publications and an inventor on multiple patents. She also led a Pre-Pivotal Process Development organization, managing teams that have advanced therapeutics modalities such as biologics, synthetics, cell therapies and oligonucleoties to the clinic.

Aaron Stout serves as Sales Manager for Liebherr's Scientific and Healthcare product portfolio in North America. With extensive experience in laboratory, healthcare, and life science markets, he works closely with customers and distribution partners to deliver premium refrigeration and freezing solutions that meet the highest standards for performance, reliability, and regulatory compliance. Aaron is passionate about building strong customer relationships and helping organizations identify the right solutions for their critical cold storage needs.

Shashank Sunkara is a scientific leader with more than 13 years of experience in drug discovery, bioanalytical sciences, and biologics characterization. He currently serves as a Senior Scientist II at Novartis, where he specializes in antibody therapeutics, bioanalytics, biophysical characterization, and analytical strategy development. His expertise spans Surface Plasmon Resonance (SPR), biomolecular interaction analysis, and the characterization of complex biologics to support discovery and early development programs. Shashank holds a graduate degree from Northeastern University and is passionate about leveraging innovative analytical technologies and AI-driven solutions to accelerate drug development. He is committed to advancing scientific excellence while mentoring colleagues and driving cross-functional collaboration to deliver impactful therapies for patients.

I am a senior engineer specializing in upstream process development for adeno-associated virus (AAV) products, with over five years of industry experience in gene-therapy manufacturing and bioprocess development. I hold a PhD in Biomedical Engineering and Biotechnology from the University of Massachusetts Lowell. My work focuses on developing and optimizing scalable upstream platforms for viral vector production, supporting the advancement of next-generation gene therapies from early development through process scale-up. I am passionate about translating innovative biotechnology into robust manufacturing processes that enable safe and effective therapies for patients.

Brooke Tam is a USP Modeling Expert at Sanofi, where she is the technical lead of the Global MSAT Cell Culture Simulator Team and the Cell Retention Technology Functional Team. Brooke is particularly interested in using digital twins to improve the development, scale-up, and monitoring of cell culture processes. Her work has enabled cell culture digital twins to become a standard component of tech transfers for biologics processes at Sanofi. Her area of expertise also includes bioreactor design, process control, and data analytics. Prior to joining Sanofi, she received her PhD in chemical engineering from the Massachusetts Institute of Technology.

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.

Robert Tona is a scientist specializing in downstream process development for cell and gene therapy applications. He currently works at Kite In Vivo, following the acquisition of Interius Bio, where he previously served as a senior scientist. In his current role, he leads downstream process development efforts for in vivo lentiviral vectors, supporting vector characterization and scale-up through 200-L for clinical supply. Prior to Interius, Robert spent several years at GlaxoSmithKline in vector process development, where he focused on lentiviral vector purification, process characterization, and technology transfer to GMP manufacturing. He holds an M.S. in Chemical and Biochemical Engineering from Rutgers University and a B.S. in Biomedical Engineering from Boston University.

An Vy Tran is currently working as a gene-therapy process engineering lead at UCB Pharma in Belgium. With her engineering degree in biotechnology, she has been working for 9 years in upstream and drug-substance CHO process development, scale up, and tech transfer to commercial for both UCB Pharma and argenx. She has closely collaborated with CMOs like Rentschler, Lonza, and Samsung. For the past three years, An Vy has been working on the UCB Genesis project as a gene-therapy process engineering lead. She is currently finalizing the validation of their new clinical facility and getting ready for tech transfer and GMP manufacturing. In this context, An Vy will be sharing today some insight about gene therapy rAAV clinical manufacturing readiness and challenges.

Anubhav Tripathi is a Professor of Medical Science and Engineering at Brown University. At Brown, Tripathi’s research group develops new biotechnology platforms by integrating biological and engineering principles. This work has a broad impact on scientists, engineers, physicians, and entrepreneurs. He holds more than 20 patents (issued or filed), has over 160 peer-reviewed publications, delivered more than 130 invited talks, and co-founded four companies. He is a Fellow of the American Institute of Medical and Biological Engineering and has won multiple recognitions from the scientific community. Prior to Brown, Tripathi led the development of microfluidics chips for protein and DNA sizing at Caliper LifeSciences (now Revvity).

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. Hua Tu is a scientist and biotech entrepreneur with more than two decades of experience in drug discovery and product development. After earning his PhD in 1998, he began his career at Tularik, later part of Amgen, in South San Francisco, where he focused on metabolic disorders and built deep expertise in translational research and drug development. In 2009, he founded LakePharma, which grew into a leading US biologics contract research, development, and manufacturing organization with six sites across California, Massachusetts, and Texas, and was acquired by Curia Global in 2021. Following this, Dr. Tu spent several years developing technologies in lab automation, enterprise software, and artificial intelligence, reflecting a broader interest in improving the efficiency of scientific research. He currently serves as President and CEO of the Metabulin, a Texas biotech focused on developing ultra-stable insulin, and as President and CEO of Cerepeut, a Bay Area biotech company developing small molecule therapeutics targeting mitochondrial biology for functional aging and neurodegenerative diseases.

Richa Tyagi is Director of Product Characterization for Cell and Gene Therapy at Johnson & Johnson with over 15 years of experience in virology, analytical sciences, and CMC development. She leads deep characterization and comparability strategies supporting the development and commercialization of advanced therapeutics, with a focus on enabling safe, effective, and scalable cell and gene therapy products.

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.

Jake Ure is a product leader with experience across multiple industries, with deep expertise in product development for life sciences. He has served as a strategic contributor to BioPhorum and has spent the past two years building manufacturing solutions for life sciences organizations. Jake is passionate about leveraging technology to help teams move faster and do more.

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.

Lucas Vann, PhD Head of Innovation, Modersys

Lucas has over 15 years of hands-on experience with PD and Pilot Scale Biomanufacturing Upstream and Downstream processes. He is also an Adjunct Professor in Bioprocessing at North Carolina State University specializing in advanced automation (PAT), AI Implementation, data analytics, predictive maintenance, event management and model predictive control. His expertise is mechanistic hybrid models for process and equipment performance using science guided machine learning (SGML) leveraged by expert unfolding. He has spent the last 10 years leading teams in developing and implementing successful & disruptive solutions.

Education:
PhD North Carolina State University, Bioprocessing MS Eng McGill University.

Biosystems Engineering Areas of Expertise:
Disruptive Software Solution Design & Implementation MDx (Manufacturing Data Engineering / Science / Analytics / Research ....) Automation, PAT & SGML Pharmaceutical Manufacturing Process & Equipment Behavior

Uday Velagapudi is a Senior Scientist at Pace Analytical Life Sciences, supporting analytical characterization programs for biopharmaceutical companies. He specializes in the application of high-resolution mass spectrometry for the characterization of oligonucleotides, biologics, and bioconjugates. Uday holds a PhD in Medicinal and Pharmaceutical Chemistry and has contributed to multiple peer-reviewed scientific publications.

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).

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

Ross Walton is a Sr. Marketing Applications Scientist at Unchained Labs. He has published works on single-particle protein analysis by transmission electron microscopy and the interaction of the innate immune system and viruses in cancer. He did his undergraduate work at UC Berkeley and earned his PhD in Molecular Genetics and Microbiology from Duke University.

Simon Yuan Wang, Ph.D. is a Senior Expert in Analytical Development Molecular Biology at Novartis, based in East Hanover, New Jersey, where he develops and applies advanced molecular analytical methods to support cell and gene therapy products. His expertise includes genomics, next-generation sequencing (NGS), digital PCR, and bioinformatics. Simon is passionate about advancing innovative analytical technologies that enable the characterization and development of transformative cell and gene therapies.

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 enjoys serving on committees and boards, such as chair of the 3SMAGNET Industry Advisory Board. Bill has an h-index of 19 and an i10 index of 39.

Chris earned his MSE in Biomedical Engineering from the University of Michigan. For the following 17 years, Chris held various roles in process development and manufacturing of biologics in the United States and Europe. Today, Chris works as an independent consultant for organizations developing AAV-vectored gene therapies for rare diseases. As the NIIMBL Viral Vector Lead, Chris is guiding the development of an open-access AAV platform to serve the technical foundation for collaborative manufacturing and analytical development.

Andrew Wu is a Senior Application Scientist at Beckman Coulter Life Sciences with experience spanning diagnostic manufacturing, assay development, and bioprocessing technologies. He currently supports cell line development applications involving the Cydem VT automated clone screening platform and the Vi-CELL BLU cell viability analyzer, helping researchers streamline clone selection and cell culture workflows. Before joining Beckman Coulter Life Sciences, Andrew previously worked as a manufacturing engineer producing diagnostic assays for autoimmune and infectious diseases and later moved into R&D, where he focused on infectious disease and molecular assay development. His career has been dedicated to advancing technologies that improve the accuracy, efficiency, and scalability of biological research and diagnostic testing. This combination of diagnostics and bioprocessing experience provides Andrew with a unique perspective on developing robust workflows that support modern biopharmaceutical development.

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).

Yohei is currently Vice President of Business Development at Ajinomoto Bio-Pharma Services. His goal is to create value for biopharma clients and their patients by delivering top-quality CDMO services based on Ajinomoto's innovative platform technologies, Corynex, Ajiphase, and Ajicap. His career at Ajinomoto spans over two decades, having lived and worked in Japan, Belgium, San Diego, and now Cambridge MA. He obtained a Master's degree in Systems Biology from Keio University in Japan, and an MBA from Bond University in Australia.

2001: Earned a Master of Science (M.Sc.) in Cell and Developmental Biology, Kyoto University, Japan. 2004: Obtained a Doctor of Philosophy (Ph.D.) in Cell and Developmental Biology, Kyoto University, Japan. 2007–2009: Served as a Postdoctoral Research Associate at the Department of Craniofacial Development, King’s College London, United Kingdom, focusing on signaling pathway in the morphogenesis. 2009–2018: Conducted postdoctoral research at the Laboratory of Pattern Formation, Osaka University, Japan, contributing to elucidate morphogenic pattern formation by cell groups. 2020–Present: Engaged as a Bio-Application Scientist at Yokogawa Electric Corporation, contributing to advancements in biomanufacturing process development system

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.

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

Dr. Rose Yin is a Senior Scientist in the Digital Technologies department at Merck, specializing in in silico approaches to accelerate analytical method development. She uses AI, ML, and advanced data science workflows to drive data-driven, efficient, and robust decision-making. Dr. Yin holds a B.S. in Chemical Engineering from Cornell University and a PhD in Chemical Engineering from MIT.

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 Senior Principal Scientist II 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 senior 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.

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

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

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.

Dr. Alla Zilberman leads strategic technical marketing and business development at Cygnus Technologies. She has over 25 years of experience in product management, strategic marketing and technical sales in the bioprocessing and life science industries. Alla earned a Ph.D. degree in Biochemistry from the First Moscow Medical Institute and an MBA degree from the University of Cincinnati.