jiwen zhang, ph.d.
Dr. Jiwen Zhang is heading the regulatory affairs group in GE Healthcare Cell Therapy and Regenerative Medicine business. Before joining GE, she had worked in the pharmaceutical industry at companies including Johnson & Johnson, Merck, Wyeth Pharmaceuticals, and Sanofi-Aventis. Dr. Zhang is currently leading various industry initiatives through Alliance for Regenerative Medicine, The Forum on Regenerative Medicine by the National Academy of Medicine, and International Standards Organization (ISO). Dr. Zhang obtained her Bachelor of Science degree in Biology from University of Science and Technology of China and her Ph.D. in Neuroscience from the joint program at Rutgers University and University of Medicine and Dentistry of New Jersey.
sven kili, MD
Dr Sven Kili is the VP and Development Head for the Cell and Gene Therapy division of GSK where he leads the teams developing ex-vivo Gene Therapies for a variety of genetic disorders. Prior to this, he was Senior Director, Cell Therapy and Regenerative Medicine for Sanofi (Genzyme) Biosurgery where he led the clinical development and medical affairs activities culminating in the granting of the first combined ATMP approval in the EU for MACI®. His team also prepared and submitted Advanced Therapy regulatory filings for Australia and the US, including health technology assessments and he was responsible for late stage developments for Carticel® and Epicel® in the US. Before joining Genzyme, Sven worked for Geistlich Pharma where, in addition to leading the cell therapy medical activities, he oversaw all UK regulatory functions and was the QPPV for the EU. Sven trained as an Orthopaedic surgeon in the UK and South Africa and since leaving full-time clinical practise has developed expertise Cell and Gene Therapy in clinical development, regulatory compliance, value creation, risk management and product safety, product launches and post-marketing activities. He sits on the board of CCRM in Canada, a Swedish Stem Cell company and is the chair of the CGTAC as part of the UK BIA. Additionally he still maintains his clinical skills in the UK NHS and serves as an ATLS Instructor in his spare time.
chris wiwi, ph.d.
Chris Wiwi is Director and head of Analytical Research & Development, part of the Cell Therapy Development and Operations (CTDO) team at Celgene, located in Warren, New Jersey. Chris leads analytical development and QC efforts for the advancement of Celgene’s novel cellular therapy candidates from research to clinical and commercial manufacturing. He also serves as the CMC lead for bb2121, an autologous anti-BCMA CAR T cell therapy that Celgene is developing in collaboration with bluebird bio for the treatment of multiple myeloma. Chris’ team is responsible for the selection, development and validation of analytical methods to assess cellular product identity, purity, safety, quality and potency. The QC Ops team, under Chris’ leadership, provides quality testing support for the cellular products manufactured at Celgene. Prior to joining Celgene, he worked in biologics at Schering-Plough and Merck as a leader in large molecule analytics. His teams led the development and validation of biomarker, pharmacokinetics and immunogenicity assays for multiple biologics programs. Chris received his B.S. in Biology from the University of Notre Dame, Ph.D. in Cell and Molecular Biology from Boston University and carried out postdoctoral research at Johnson & Johnson
richard mcfarland, Ph.d., m.d.
Richard McFarland, PhD, MD is the Chief Regulatory Officer Chief Regulatory Officer of armi/BioFabUSA. Prior to armi he was Associate Director of Policy for FDA/CBER’s Office of Tissues and Advanced Therapies and its predecessor office, the Office of Cellular, Tissue and Gene Therapies. In this position, he was heavily involved in policy development for tissue engineering, regenerative medicine, and alternatives to animal use in regulatory decision making. Dr. McFarland received his B.S., Ph.D., and M.D. from the University of North Carolina at Chapel Hill, and completed his anatomic/clinical pathology residency and immunopathology fellowship training at UT Southwestern in Dallas.
BOARD OF DIRECTORS
MARITZA MCINTYRE, American Society of Gene & Cell Therapy
MIKE KELLY, Biogen
WEN BO WANG, Cellular Dynamics Institute
KRISHNENDU ROY, National Cell Manufacturing Consortium
JIWEN ZHANG, GE Healthcare
ELENA KFOURY, Axiogenesis
SVEN KILI, GlaxoSmithKline
KURT GUNTER, International Society for Cellular Therapy
MICHAEL MENDICINO, Hybrid Concepts International
VIC MYER, Editas
CLAUDIA ZYLBERBERG, Akron Biotech
SHENG-LIN GIBSON, National Institute of Standards and Technology
MIKE ORRICO, AxoGen
JESSICA CARMEN, MaxCyte
RICHARD SNYDER, Brammer Bio
JASON WERTHEIM, Northwestern University School of Medicine
FRANCESCO PASQUALIINI, WYSS Institute Boston / Zurich
NAYNESH KAMANI, AABB
STEPHEN KENNEDY, Histogenics
MORRIE RUFFIN, Alliance for Regenerative Medicine
CHRIS WIWI, Celgene
RICHARD MCFARLAND, Advanced Regenerative Manufacturing Institute