Providing solutions to the manufacturing challenges of gene and cell therapy has never been so important. Successes in gene therapy are taking center stage and we are seeing a new dawn in terms of commercialization. Pricing and reimbursement often take the headlines, but the challenges of manufacturing are equally important. Processes must be robust, scalable, and meet regulatory requirements.
This webinar explores plasmid DNA and other critical materials and components for gene and cell therapy manufacturing including specifications, regulatory considerations, timelines and supply agreements.
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The discussion includes:
- Guidance from our experts on how to best manage supplier partnerships across your supply chain to minimize delays and additional costs throughout development.
- Understanding the potential regulatory impact of changes to raw materials used within your manufacturing processes and how to mitigate risks.
- Real world experiences of sourcing and managing raw materials as your product progresses towards commercial scale manufacture.
Hear from our panel of experts:
- Josh Grieger, Chief Technology Officer, Asklepios Biopharmaceutical, Inc.
- James Brown, Vice President, Corporate Development, Aldevron
- Maritza McIntyre, President, Advanced Therapies Partners LLC
- Curran Simpson, Senior Vice President, Technical Operations, REGENXBIO
- Jung Lee, Business Development Consultant, Asklepios Biopharmaceutical
- Dr Richard Snyder, Chief Scientific Officer, Brammer Bio
James Brown PhD
Vice President, Corporate Development, Aldevron
James Brown, PhD, joined Aldevron in 2015 and serves as Vice President of Corporate Development. His responsibilities include developing and implementing strategies for expanding Aldevron’s DNA, mRNA, antibody, and protein products and services. Prior to joining Aldevron Dr. Brown was Vice President, Technical Operations at REGENXBIO Inc., a gene therapy company. In this role he was responsible for contract manufacturing, vendor management, operations, quality assurance, and biological reagent sales. Prior to REGENXBIO Dr. Brown held positions of increasing responsibility at Medimmune, Meso Scale Discovery, and IGEN International. Dr. Brown holds a PhD. in Chemistry from Stanford University and a B.S. in Chemistry from Butler University.
Maritza C. McIntyre, PhD
President of Advanced Therapies Partners LLC
Dr. McIntyre has 20 years of experience in the development, evaluation and regulation of biological and small molecule products within startup biotech firms, the Food and Drug Administration (FDA), and as a consultant. Dr. McIntyre was a product reviewer and ultimately Branch Chief in the Division of Cellular and Gene Therapies at FDA/CBER, where she was actively involved policy development and liaison activities to stakeholder groups. She has since worked in regulatory affairs and product development at Bavarian Nordic, REGENXBIO, Inc., and NanoCor Therapeutics. She served as Executive Vice President of Regulatory Affairs and Product Development at Bamboo Therapeutics where, as part of the senior management team, she participated in portfolio selection, product development and fundraising that resulted in an initial $50 million finance round and ultimate the sale of the company to Pfizer. As president of Advanced Therapies Partners LLC Dr. McIntyre provides strategic regulatory and product development advice to biotech companies, academics, and venture capital firms. She has proven success in defining development strategies for products with complex regulatory challenges including special designations (orphan, RMAT, pediatric orphan drug designation), endpoint selection, accelerated approval, complete response letters, and dispute resolution. She has also been involved in the preparation of some of the first BLA and MAA submissions for gene therapy products to FDA and EMA.
Senior Vice President, Technical Operations, REGENXBIO
Curran M. Simpson is the Senior Vice President of Technical Operations at REGENXBIO. Prior to joining REGENXBIO, Mr. Simpson was the Head of North American Supply Chain and Interim Chief Operating Officer and Integration Lead at GlaxoSmithKline and the Human Genome Sciences division of GlaxoSmithKline. Mr. Simpson earlier served as Senior Vice President of Operations and Vice President of Manufacturing Operations at Human Genome Sciences. Prior to Human Genome Sciences, Mr. Simpson was Director of Manufacturing Sciences at Biogen and Director of Engineering at Covance Biotechnology Services. Earlier in his career, Mr. Simpson served as Recovery Technology Coordinator, Worldwide and Pilot Plant Manager of the North America Division at Novo-Nordisk Biochem; Senior Research Engineer at Genentech; Senior Scientist, Development at Genencor; and Senior Chemist at Nalco Chemical Co. Mr. Simpson has an M.S. in surface and colloid science from Clarkson University and a B.S. in chemical engineering and chemistry from the Clarkson College of Technology.
Business Development Consultant for AskBio, Inc
Jung Lee, Ph.D. is currently a business development consultant for AskBio, Inc. and a couple of other start-ups. Previously, he spent five years with MedImmune (a global biologics arm of AstraZeneca), lastly as a business development head of Technology, Biopharmaceutical development, and Biosuperior. He was responsible for acquiring and licensing all technologies that would be beneficial for development of biologic drugs.
Prior to MedImmune, he was executive director of business development/innovation at Martek (acquired by DSM). He managed the pharmaceutical application of docosahexaenoic acid (DHA) and developed active pharmaceutical ingredient manufacturing process for DHA. He also managed the fluorescent pigment business unit until it was spun off as Columbia Biosciences. Before joining Martek (DSM), he spent twelve years in developing small molecule therapeutic drugs at both Johnson & Johnson, and Affymax (GSK). He has completed more than thirty (30) business transactions as lead/co-lead. His scientific work has been published extensively. He has thirteen peer-reviewed publications, twenty one patents and patent applications, and one review chapter. He is a founder of BORA, LLC and co-founder of Corchip Technology and Brain Health Education and Research Foundation. He was trained at MIT, University of Michigan and University of Maryland.
Richard Snyder PhD
Chief Scientific Officer, Brammer Bio., USA
Dr. Snyder was the founder of Florida Biologix, which was spun out of the University of Florida in 2015 and merged to create Brammer Bio in 2016. Dr. Snyder has been investigating virus biology, vector development, cGMP manufacturing and analytical technologies, and viral vector-mediated gene transfer for over 30 years, and was a member of teams who developed novel viral vector-based human gene therapies. Dr. Snyder was an Associate Professor of Molecular Genetics and Microbiology, and Director of Biotherapeutic Programs at the University of Florida; an Assistant Professor of Pediatrics at Harvard Medical School; and was previously employed by Cell Genesys, Somatix, Merlin, and Avigen where he was engaged in the development of gene transfer vector and vaccine technology, along with therapeutic applications. Dr. Snyder was a postdoctoral fellow at Johns Hopkins University School of Medicine, received his doctoral degree in Microbiology from The State University of New York at Stony Brook, and obtained his B.A. in Biology from Washington University in St. Louis.