aforementioned fields, covering areas such as CMC and strategic regulatory affairs, R & D, commercial, and product & technology due diligence activities.  During his FDA appointment, Michael worked primarily in what is now the Office of Tissues & Advanced Therapies (OTAT), where he performed regulatory submission review and provided guidance to sponsors for cell therapy products, devices and combination products.  Michael is currently a representative on multiple Alliance for Regenerative Medicine (ARM) and International Society for Cellular Therapy (ISCT) committees (including Co-Chair of ARM’s Science & Technology Committee).  Michael is a Co-founder and the Chair of the Board for SCB.    

jiwen zhang, ph.d.

PRESIDENT

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

Vice president

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.

treasurer

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

 

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richard mcfarland, Ph.d., m.d.

secretary

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