Streamlining and optimizing viral vector bioprocess and analytical development

Abstract

Joseph Tarnowski Ph.DSenior VP, Cell & Gene Therapy Platform, GlaxoSmithKlineExperience in the research, development, registration and commercialization of products made using recombinant DNA technology. Earned a B.S. degree in Chemistry from Southeast Missouri State University, a Ph.D. degree in Biochemistry from the University of Tennessee Center for the Health Sciences and was a post-doctoral fellow at the Roche Institute of Molecular Biology. Held critical development roles for Roferon® A, Alpheron N®, Fiblast® Spray, CEPRATE® SC Stem Cell Concentration System, Natrecor®, Erbitux® Orencia®, Yervoy®, Nulojix®, Eperzan®/Tanzeum®, Nucala®, and Strimvelis™.Nina KotsopoulouVice President of Cell And Gene Therapy Technologies, Orchard TherapeuticsLeading a team focussed on in-house and external process and analytical development as well as outsourced manufacture. Nina has a BSc in Chemistry from the University of Athens and a DPhil in lentiviral vectors for gene therapy from Oxford University. Following her PhD, she briefly worked in her supervisors’ company, Oxford BioMedica, and went on to do 2 post-docs on haematopoietic stem cell biology, at Harvard Medical School and the University of Cambridge. She then joined GSK, where she initially led cell line development and associated process research for monoclonal antibodies and derivatives thereof. She then led Process Development for GSK’s Cell and Gene Therapy portfolio, including working with the inspirational team at TIGET, and completing the MAA submission for the first product, Strimvelis, for the treatment of ADA-SCID. Following on from GSK, and prior to joining Orchard, she was Vice President of Process Development at Autolus.Kinnari PatelCOO & Executive VP of Development, Rocket PharmaceuticalsShe has fifteen years of rare disease Research & Development experience including in Regulatory Science, Pharmacovigilance, Policy and Quality Compliance gained at leading pharmaceutical companies including AstraZeneca, Bristol-Myers Squibb, Novartis, Hoffmann La-Roche and Pfizer. She has led both small molecule and biologic development programs from Phase I through Phase IV across multiple therapeutic areas including immuno-oncology, oncology, respiratory, virology, transplantation and metabolism. Kinnari received the dual degrees of B.S. in Biology and Doctorate of Pharmacy from the USciences in Philadelphia, PA. She also completed a two-year Post-Doctoral Regulatory Affairs Fellowship through Rutgers University. Additionally, she received her Executive MBA from NYU Stern School of Business with specialization in Corporate Finance, Leadership and Strategy. Most recently, she graduated from the C-Suite Harvard Business School Advanced Management Program.Ramin BaghirzadeGlobal BD Head for Cell & Gene Therapy at AGC BiologicsDr Ramin Baghirzade is the Global Head of Business Development for Cell & Gene Therapy (C&GT) at AGC Biologics. With 15+ years of experience in life science and healthcare, Dr Baghirzade previously held roles of increasing responsibility at Roche and Lonza in global business development, strategic marketing and market intelligence functions. He holds a PhD Degree in Medical Sciences, as well as an MBA. Mark WomackChief Business Officer, AGC BiologicsAfter a decorated career in the U.S. Navy, Mr. Womack joined the management consulting industry, ultimately serving as the Chief Operating Officer for two global consultancies. He led both organizations to record highs in revenue and profit, while serving Fortune 200 clients across a wide range of industries. In 2018, he joined the AGC Biologics executive team and led the integration of three companies – across the U.S., Europe and Asia – that merged to create AGC Biologics. Following the highly successful integration, the board appointed Mr. Womack to the role of Chief Business Officer on January 1, 2019. In each of the past two years, he has led AGC Biologics to record highs in new business acquisition, securing contracts with many of the world’s most renowned pharma companies. Mr. Womack earned an Executive Management Certification from Harvard Business School, a Master of Science degree in Organization Development from Chapman University, and a Bachelor of Science degree in Education from Southern Illinois University.