Kirsten Messmer, PhD, RAC, is a Principal Regulatory Affairs Specialist in the Regulatory Intelligence Solutions team at PPD which provides regulatory intelligence to clients and departments within PPD to support drug development and clinical research. Prior to joining PPD she completed a PhD in Neuroscience in Sheffield, held post-doctoral fellowships in London and Baltimore. She worked at Theradigm to develop stem cell therapies for neurodegenerative diseases before joining ERA Consulting.

Dr. Judy Chou has more than 20 years of experience in drug development and biomanufacturing. Before joining AltruBio, she headed the global biotech organization at Bayer Pharmaceuticals overseeing the manufacturing and distribution of Bayer’s $3+ billion per year biotechnology product portfolio & 2000+ employees and leading the drug development activities for Biologics pipeline including cell and gene therapies. Prior to Bayer she has held leadership and drug development roles at Pfizer, Genentech, Wyeth and Abbott. Dr. Chou received her Ph.D. from Yale University, and was named one of the most influential women in business in 2018.

Eliana Clark, PhD is the Senior Vice President of Technical Operations at Intellia Therapeutics, where she is responsible for Process and Analytical Development, Internal and External Manufacturing, Supply Chain, and CMC Strategy and Operations for novel gene editing-based products, both ex-vivo cell-based therapies and in vivo therapies. Prior to Intellia, Dr. Clark was with Biogen for nearly eight years where she held leadership roles in Product Development and Portfolio Management, International Manufacturing Operations and Global Manufacturing Sciences. Prior to Biogen, Dr. Clark was at Sanofi Genzyme for eleven years where she held leadership roles in CMC Regulatory, Manufacturing Sciences and Technology Development.

Scott Furness, Ph.D., Deputy Director, ONDP, OPQ, joined CDER’s OPS/OGD in 2000, serving as a Chemistry reviewer and team leader. In 2007, he was named Director of the Division of Nonprescription Regulation Development in the Office of New Drugs’ (OND). During his time in OND, Dr. Furness led several initiatives to modernize the over-the-counter (OTC) monograph system in areas pertaining to biopharmaceutics and product quality. In 2013, he returned to OPS as the ONDQA Deputy Director for Operations, and he has been the Deputy Director of ONDP since the stand-up of OPQ in 2015. In addition to his Deputy Director duties, Dr. Furness is also the supervisor of the Environmental Assessment Team and the Botanical Review Team within ONDP.

I am an Associate Principal Scientist in Biologics Regulatory-CMC at Merck & Co., Inc.

Sofia Håkansson Buch is the Vice President of Cell Therapy CMC at Novo Nordisk and based in Copenhagen, Denmark. She has a Master of Science in Chemistry and a PhD in Molecular Biotechnology from Linköping University, Sweden and has been working in Novo Nordisk since 2006. In Novo Nordisk she´s been holding different positions both within project- and line leadership. She has headed up Recombinant Technologies, being responsible for the yeast and the mammalian platform, in the Novo Nordisk Research Unit before entering into the cell therapy area four years ago. She has been part of driving the establishment of the Novo Nordisk in California and is now responsible for Cell Therapy CMC in Denmark.

Cynthia Schnedar, Principal, Regulatory Compliance at Greenleaf Health, provides strategic advice to clients in the life sciences industry. She was formerly Director of the Office of Compliance for FDA CDER, where she spearheaded efforts to protect the American public from unsafe and ineffective drug products by ensuring that companies comply with federal standards for quality and safety. Cynthia previously served at the Department of Justice (DOJ) as Acting Inspector General and in other leadership positions focused on compliance and enforcement issues. Cynthia also served as a prosecutor and a civil trial attorney for DOJ.

Barbara Allen, Ph.D. is an International Quality Expert with thirty years experience in Pharmaceutical Quality Systems and Standards. Barbara held roles in Manufacturing Technical Services, and in Quality Assurance with Lilly internationally, including new product introductions, developing global quality systems for research, manufacturing, sales and marketing, and leading external monitoring and engagement. Dr. Allen represented industry on ICH Q10 EWG and the recent Quality Discussion Group. She worked on IFPMA Regulatory Science Committee and GMP Task Force, PhRMA Global Quality Manufacturing WorkGroup, and EU Structured Dialogue on Pharmaceutical Supply. Barbara is a Board Director of the Parenteral Drug Association (PDA).

Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016. He is a Fellow of the American College of Physicians and in 2022 he was elected to the National Academy of Medicine.

Steven is Acting Director of Division of Cell Therapy 1 and 2 in the Office of Cellular Therapy and Human Tissue (OCTHT). He oversees the product quality review program focused on cell therapy and tissue-engineered products. Steven is also the head of the bioinformatics regulatory group in OCTHT. He is involved in developing policies for cell and gene therapy products including individualized medicine, emerging advanced technologies, standards development and recognition, and global regulatory convergence. He was trained as a cell biologist and biochemist at the University of Michigan, Johns Hopkins University School of Medicine, and Massachusetts Institute of Technology. Steven served on the faculty of Tufts University School of Medicine.

Dr. Beumer Sassi is a Senior Director, CMC at Voisin Consulting Life Sciences with over 20 years of experience in biopharmaceutical industry and consulting. She is responsible for the strategy and technical content of projects involving the development of Biologics, Cell and Gene therapy products for EMA and FDA submissions. She is the head of the US CMC regulatory team built to assist clients on bringing safe and quality innovative products to patients. Previously, she held different positions of growing responsibilities at GSK focusing on recombinant proteins. Dr. Beumer Sassi received her PhD in Pharmaceutical Sciences from University of Pittsburgh, Pharmacy degree from University of Sao Paulo, Brazil and post-doctoral studies at MWRI.

Sunitha has more than 20 years of hands-on experience in drug development and biomanufacturing of vaccines, biologics, biosimilars, and cell/gene therapy products. Currently she leads Global Process Engineering group at Bristol Myers Squibb and oversees cell therapy facility buildouts for network expansions, product life-cycle management, new technology implementation, comparability, and Global MS&T labs. Prior to joining BMS, Sunitha has held leadership positions at Kashiv BioSciences, a biosimilars company, Progenics Pharmaceuticals, her own consulting firm, Laureate Pharma and BioReliance. Sunitha holds a master’s degree in Chemical Engineering from Penn State University and an MBA from Northwestern University.

Sara has spent over 11 years working with biotech companies and academic labs focusing on applications of human primary cell cultures and autologous and allogeneic cell therapy products for therapeutic applications. She joined DHC in 2016 bringing her expertise in aseptic and cGMP manufacturing process development, risk analysis, CMC and regulatory filings, facility design and project management to advise growing cell and gene therapy companies. Sara’s range also encompasses experience in managing cross-regional technology transfer, Design of Experiments, raw material risk assessment and root cause analysis for C&GTs. Sara has been fortunate enough to work with over 40 clients on over 45 different products and originate from 8 countries.

Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. Roger has contributed to the evolution of Quality by Design & has advocated for global regulatory harmonization through several ICH, PhRMA, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees. He is currently the Rapporteur for ICH QDG and recently the PhRMA Topic Leader for ICH M9.

Joel Welch is the Associate Director for Science& Biosimilar Strategy in the Office of Biotechnology Products in the Office of Pharmaceutical Quality at the US Food and Drug Administration. He is responsible for assessing emerging, complex, or precedent-setting issues impacting science policies of the office with particular emphasis on the biosimilar program. He also serves as the Rapporteur for the ICH revision to Q5A(R1) and the Vice Chair for the Emerging Technology Program. In his time at FDA, he has also served as a Review Chief, Team Leader, Primary Assessor and Regulatory Project Manager. Prior to joining FDA, he spent 6 years in industry supporting late state analytical development of small molecules.

Katherine Whitley is a Senior Principal Scientist leading a team of Pfizer scientists developing purification processes for AAV gene therapies. She has over 15 years of experience in mAb/vaccine tech transfer and process development project and program management and has previously worked at GSK and Seqirus (formerly Novartis Vaccines).

Kristy Wood is currently VP of Nucleic Acid Therapeutics Development & Manufacturing at Intellia Therapeutics, which focuses on process development and manufacturing of our sgRNA, mRNA, and LNP platforms. Kristy started in 2017 at Intellia Therapeutics and was initially responsible for developing Intellia’s LNP platform and over-seeing delivery technologies for therapeutic applications of CRISPR/Cas9. She has more than 15 years of industrial experience in developing novel drug delivery systems for the delivery of nucleic acids. She received her Ph.D. in Biomedical Engineering from the University of Texas at Austin working with Professor Nicholas Peppas and her B.S. in Biomedical Engineering from the University of Wisconsin-Madison.

Dana Alexander is the SVP Technical Operations at AlloVir where he is responsible for Manufacturing, Process and Analytical Development, Supply Chain, CMC Program Management and OPEX, and Quality Operations. He has more than 20 years of experience in biologics manufacturing and CMC operations. Prior to joining AlloVir, Mr. Alexander was VP Operations at Brammer Bio (ThermoFisher) where he led the start up of their first last stage and commercial Viral Vector manufacturing site. Prior to Brammer, he was Chief Operations Office at Anika Therapeutics and held multiple manufacturing and operational leadership roles at Sanofi Genzyme. Mr. Alexander has a BS Chemical Engineering from Northeastern University and a MBA from Boston University.

Richard has over 20 years of experience in the research, development, and manufacturing of cell therapy, immunotherapeutic and vaccine products. He is currently Senior Director of Manufacturing Science and Technology for Fate Therapeutics, Inc., leading the development of scaled-up manufacturing processes for Fate’s iPSC-derived NK and T cell therapy products. Prior to Fate, Richard led the research and development of cell therapy products for NantKwest, Inc., and worked for Pfizer, Inc. in the USA and UK where he developed vaccines and immunotherapeutic products against cancer and infectious diseases. Richard obtained his Ph.D. in Biochemistry from Imperial College London and completed postdoctoral studies in the University of Oxford.

Khandan Baradaran, Ph.D., is Vice President Regulatory CMC at Ultragenyx. Prior to this role Dr. Baradaran was Head of Quality and Principal Scientist of CMC Product Quality. Dr. Baradaran has extensive expertise in the areas of viral safety, gene therapy vector development, vaccine development and assay technologies, and has held positions of increasing responsibility in regulatory affairs, quality control and quality at Dimension Therapeutics, Shire, Biogen, Dyax and Novartis Vaccines and Diagnostics. Dr. Baradaran received her B.A. degree in molecular biology from Wellesley College and her Ph.D. in virology from Harvard University.

Dr. Norman Baylor is the President and CEO of Biologics Consulting Group, Inc. responsible for managing a team of consultants who provides national and international regulatory, clinical and product development advice on the commercial production of biological, pharmaceutical and device products. Prior to joining Biologics Consulting, Dr. Baylor was the Director of the Office of Vaccines Research and Review in the U.S. Food and Drug Administration. He served as FDA’s liaison to CDC’s Advisory Committee on Immunization Practices, the US Department of Health and Human Services National Vaccine Advisory Committee, the Advisory Commission on Childhood Vaccines, and was a member of the National Institutes of Health NIAID Advisory Council.

Linda Engle received her Ph.D. from the University of Pennsylvania, Philadelphia, PA, USA in Molecular and Cellular Biology and completed her Post-doctoral training at Harvard Medical School Cambridge, MA, USA studying molecular mechanisms of neurodegeneration. Dr. Engle has focused her career on developing small molecule, biologic and gene therapy therapeutics for oncology, immunology, immune-oncology, metabolic and neuroscience applications. During her 20-year career, Linda has held senior level positions at Cetek Corporation, Bristol-Myers-Squibb and Amgen. At Biogen, she is currently a Principal Scientist/Assistant Director where she is the CMC Lead for the Gene Therapy Portfolio.

Dr Hidalgo-Simon is currently head of Advanced Therapies in the European Medicines Agency (EMA). Previous positions include the head of the Specialised Scientific Disciplines Department, head of Signal Detection, and head of Risk Management, also at EMA. She has a degree in Medicine and Surgery from the University of the Basque Country, Spain, and a PhD from the University of London, UK. Additional qualifications include Health Economics (University of York) and Computing (University of Westminster).

Manuel Osorio is the lead for the Advanced Technologies Program in the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). Prior to this role, Dr. Osorio was a researcher/reviewer for 16 years in the Office of Vaccines Research and Review in CBER. He received a BS degree from UCLA in Biochemistry and PhD degree in Cellular Immunology from the University of California at Santa Cruz. He was a postdoctoral fellow at the National Institutes of Health before joining the FDA.

Dr. Salmikangas is a clinical biochemist by training, with a Ph.D. in muscle cell biology. Her main research work career has been in cell and molecular biology of various inherited diseases. Since 2006, she has been an Adjunct Professor of Biochemistry for the University of Helsinki. Dr. Salmikangas joined NDA in 2017 from her position as a Research Professor at the Finnish Medicines Agency (2003-2017). She has served as a member of the EMA Committee for Advanced Therapies (CAT) 2009-2017 and as the Chair of the CAT 2014-2017. She has also been the Chair of EMA CPWP and a member of the BWP. Her main areas of expertise are biological medicinal products, especially ATMPs, CMC and immunogenicity aspects of biopharmaceuticals.

Michael Chang is a Director of Regulatory CMC at PTC Therapeutics where he focuses on regulatory CMC strategy for gene therapy products. He has previously worked at bluebird bio, Shire, and Genzyme.

Dr. Paul Kopesky is Senior Directory of Cell Process Development at Beam Therapeutics and has more than 12 years of drug discovery and development experience in the cell and gene therapy and specialty pharmaceutical fields. Prior to joining Beam, Dr. Kopesky led cell therapy CMC at Magenta Therapeutics responsible for clinical manufacturing of a personalized-medicine cell therapeutic and process optimization to support late stage development. Dr. Kopesky has also been responsible for process development of nanotherapeutics XTuit Pharmaceuticals and discovery of novel regenerative medicines at Merrimack Pharmaceuticals. Dr. Kopesky holds a Ph.D in Bioengineering, and an MS and BS in Chemical Engineering from MIT.

Reena Patel is a Director, Analytical Development in the Cell & Gene Therapy, Vaccines group at Janssen R&D. In her current role, Reena is responsible for shaping and leading the analytical strategies for all the gene therapy programs within the Janssen portfolio. She has experience with Cell Therapies, Oncolytic Virus & Gene Therapies. Reena began her career at Janssen as a Scientist in 2009 and prior to joining Janssen, she was at Schering-Plough Research Institute for 10 years. She holds PhD in Microbiology from the Maharaja Sayajirao University of Baroda, India.

Dr. Carmen Warren is currently a Senior Research Scientist in Product Attribute Sciences within Analytical Development at Kite Pharma, a Gilead company, where she leads development of the analytical control strategy for CAR-T programs. Prior to joining Kite, Dr. Warren worked in Discovery Research at Agensys, an affiliate of Astellas Pharma. Dr. Warren obtained her PhD in Biological Chemistry at UCLA under the guidance of Dr. Ralf Landraf, then completed a post-doctoral fellowship in the laboratory of Dr. Luisa Iruela-Arispe at UCLA, where she examined mechanisms of pathological angiogenesis and VEGF signaling in diabetes and in the tumor microenvironment.

Tessie McNeely PhD is a Principal Scientist in Merck’s Cell Based Sciences Department, Analytical Research and Development, West Point PA. Tessie’s career has focused on her interest in infectious agents and their interaction with the human immune system. Her research has contributed to the understanding of cellular and humoral immune responses to investigational vaccines, through development of animal models, analytical methods, and serological tools. Her current role is to lead development of analytical strategy for investigational viral vaccines and oncolytic viruses, design vaccine potency methods and develop new analytical methods for legacy vaccines.

Omar is Acting Director of the Centre for Oncology, Radiopharmaceuticals and Research of the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) at Health Canada. With over 18 years at Health Canada, Omar has experience as Manager of Cell, Gene Therapies and Radiopharmaceuticals Division and the Monoclonal Antibodies Division in BRDD. Prior to Health Canada, he served as a research scientist working on Alzheimer’s disease. Omar holds a Ph.D. in Pharmacology from the University of Paris VI, a Masters in Regulatory Affairs form the University of Montreal and a Master’s in Business Administration from University of Quebec. He completed a postdoctoral fellowship in the field of neurosciences at the Lady Davis Institute, McGill University.