BIO China: Health & Regulatory Issues Panel

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Balancing Biosimilar Expansion and Innovation – China’s Regulatory Landscape for Large Molecules

Thursday, October 13th, 1:30pm -2:45pm

China’s expansion and improvement of health coverage for its population through health reform has considerable implications for the biosimilars market.  Numerous Chinese companies are in this market segment, as are an increasing number of western companies.  Likewise, China is taking dramatic steps to support the development of innovative molecules.  How does China's regulatory system balance the development of both an expanding biosimilars segment along with innovative biotech development? What are key differences between the US, EU, and Chinese approaches?  What are key global regulatory and market trends that impact biosimilars development?  The regulation of both innovator and follow-on biotechnology products in the US, Europe, and China will be discussed by leading experts. 

Moderator:

  • Shaoyu Chen, Managing Director, China Food & Drug Practice, Covington & Burling LLP

  Panelists:

  • John Z. Gong, PhD, MD, SVP and Chief Technology Officer, JOINN Laboratories
  • Li Jie, Director, China, Worldwide Regulatory Strategy, Pfizer, Inc.
  • Wassim Nashabeh, Ph.D, Global Head, Technical Regulatory Policy & Strategy, Genentech, a member of the Roche Group
  • Li Weiping, Regulatory Affairs Director, Xian-Janssen Pharmaceutical Ltd.

   Who's Who


 

Shaoyu Chen - Shaoyu Chen is a member of the firm’s Food and Drug practice group and the managing director of its China food and drug practice.  Mr. Chen has over 10 years experience in food and drug law, including serving as assistant chief counsel at the United States Food and Drug Administration Office of Chief Counsel, as senior counsel at Amgen Inc., and as chief compliance counsel for GE Healthcare China.  Mr. Chen represents pharmaceutical, biotechnology, medical device, food, dietary supplement, and cosmetic companies in matters before the China SFDA, the U.S. FDA, and other government agencies.  He regularly assists clients on legal and regulatory issues related to SFDA and FDA oversight, including those pertaining to preclinical research, clinical trial, marketing approval, advertising and promotion, manufacturing GMP, pharmacovigilance, import and export, and compliance with Foreign Corrupt Practices Act and China Anti-Unfair Competition Law.

John Z. Gong - Dr. Gong joined JOINN Laboratories in March 2008 with ten years of US FDA regulatory experience in new drug development. He served as a Toxicology and Pharmacology Reviewer in the FDA's Center for Drug Evaluation and Research (CDER) and conducted primary and critical reviews of numerous IND and NDA applications for both small molecules and biologics. These reviews covered various areas such as pharmacology, PK/PD, ADME, and toxicology studies. Since joined JOINN, Dr. Gong actively promotes and implements international standards at JOINN, leading to the AAALAC accreditation in 2008, and US FDA inspection in July 2009. JOINN’s study reports have been accepted to support clinical trials in the U.S. afterwards. Dr. Gong is a member of the Drug Safety Evaluation Committee of the Chinese Pharmaceutical Association and an ad hoc specialist of AAALAC. Dr. Gong received his Ph.D. in Toxicology from New York University in 1996 and a medical degree from Beijing Medical College in 1984.

Wassim Nashabeh, PhD - Dr Wassim Nashabeh received his Ph.D. in Analytical Chemistry from Oklahoma State University in 1993, and his post-doctoral fellowship from “Barnett Institute of Chemical and Biological Analysis” at Northeastern University where he developed new approaches for the separation of closely related recombinant protein variants. Thereafter, he joined PerSeptive Biosystems as a Senior Scientist from 1994-1996, where he co-developed new schemes for antibody modification with fluorescent and enzymatic labels for use in micro-fabricated chips based immunoassays.

In 1996, Dr Wassim Nashabeh joined Genentech (A member of the Roche Group) as a Scientist and had since held several positions of increasing responsibilities including Associate Director, Methods validation group, Director Quality Control Clinical Development, Director in the CMC Regulatory Affairs Group, Sr. Director of CMC Policy & Strategy and most recently as Global Head, Technical Regulatory Policy & Strategyfor the Roche Pharma Medicines Group. His current primary responsibilities include the development of global innovative regulatory strategies, as well as the development of key positions on a variety of subjects of significant impact to Pharma Technical Operations. Dr Nashabeh chairs the Pharma Technical External Interactions Steering Committee (PT-EISC) with responsibility for the oversight of all external outreach activities with global health authorities, industry associations and scientific organizations on technical matters.

Dr Nashabeh is the author/co-author of over 30 scientific publications, reviews and patents in the field of separation science and biotechnology. Wassim is a member of the Expert Working Group for the International Committee on Harmonization representing the BIO organization on Quality topics (currently Q11 and Q3D). Wassim is also a member of the Board of Directors of CASSS (an International Separation Science Society), co-founder and chair of the “International Symposium of CE in the pharmaceutical and Biotechnology Industries”, a permanent committee member of the CMC strategy forum conference series, co-founder of the CMC Forum Europe Conference Series as well as a member of the program committee for the WCBP conference series. Dr Nashabeh has co-chaired several biotechnology forums and events that focused on a variety of CMC related issues over the last 10 years including “Lifecycle approach of Setting Product Specifications”, “Changing paradigms for process validation”, “Design of Stability Studies”, “Quality by Design for Biotechnology Products” and “Comparability for Biotech Products”.