Challenges and Opportunities for Clinical Development in China
Thursday, October 13th, 11:00am -12:15pm
China is broadening its clinical trials infrastructure and improving safety, presenting new, innovative opportunities for clinical R&D. In this session, seasoned representatives from major CROs and drug development companies will discuss their experiences in China in key areas such as site selection, IRB approval processes, and content requirements to initiate trials in China. Experts in designing clinical studies conducted in China will address their experiences with the use of clinical data in China, and talk about what conducting studies in China means in terms of global development.
Moderator:
- Joanne Jiang, PhD, MBA, Co-Founder, VP, Business Development and Project Management, Fountain Medical Development
Panelists:
- Nathaniel Brown, MD, Chief Medical Officer and SVP, Clinical Development, Presidio Pharmaceuticals
- John Z. Gong, PhD, MD, SVP and Chief Technology Officer, JOINN Laboratories
- Bing Yan, MD, MBA, Head of Clinical Development Asia & China Vaccines Lead, Emerging Markets, Pfizer, Inc.
Who's Who
|
Nathaniel Brown - Dr. Nathaniel Brown MD is Chief Medical Officer at Presidio Pharmaceuticals, in San Francisco, CA, Previously he held positions as Chief Medical Officer at Idenix Pharmaceuticals, and for 7 years he was the Hepatitis Section head at GlaxoWellcome/GlaxoSmithKline. During his pharmaceutic career Dr Brown has led global product registration programs for AZT for children with HIV, lamivudine and telbivudine for patients with hepatitis B, lymphoblastoid interferon for hepatitis C, and atovaquone for pneumocystis pneumonia. Dr Brown was the global leader for the lamivudine and telbivudine clinical trial programs for hepatitis B, which included prominent involvement of clinical sites in China, leveraging China’s clinical expertise in this area. For the telbivudine global registration trials, China was the lead country. China-generated clinical data were favorably reviewed by the U.S. Food and Drug Administration and by the European Medicines Agency, and played a major part in telbivudine’s successful product registrations in North America, Europe, China, and worldwide. During the past 20 years Dr Brown has served in various advisory roles to pharmaceutic and biotech companies, foundations, and government agencies (NIH and FDA). Prior to his pharmaceutic career Dr. Brown held full-time faculty positions in clinical infectious diseases at Cornell Medical College and U.C.L.A. School of Medicine. Dr. Brown studied Molecular Biophysics and Biochemistry at Yale University and received his M.D. degree from Georgetown University School of Medicine. He has authored over 180 scientific publications and has received leadership awards from the Hepatitis B Foundation and the American Liver Foundation. |
|
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. |
|
Joanne Jiang - In 2007, Dr Jiang co-founded Fountain Medical Development, a contract research organization (CRO) offering a full range of ICH GCP compliant clinical research services for multinational clients conducting clinical research in China, Hong Kong, Korea and Taiwan. As a key contributor of the co-founding team, Dr Jiang has created an organization that is the leading regional service provider in Asia, providing clinical development solutions for global quality new drug development. Dr Jiang has worked in the pharmaceutical industry for 14 years. She started her career in preclinical pharmacology area at Bayer pharmaceutical and Eli Lilly, working as research scientist, lab head and project leader. She further developed expertise in drug development and project management through her tenure as global project manager since year 2000. From year 2000 to 2007, at Aventis and then Daiichi Sankyo, she managed drug development and life cycle management projects, encompassing phase I to phase IV clinical studies. During her 7 years of leading clinical development teams, she has conducted global trials with study sites in US, Europe and Asia.
She especially focused on clinical trial planning and management, integrating marketing plans and regulatory strategy that enables optimal trial design, which in turn delivers best NDA filing quality and timeline. Dr. Jiang also has working knowledge of building and managing high performing project teams that deliver break-through results. Dr. Jiang was an Executive Council for Sino-American Pharmaceutical Association. She is also a member of Project Management institute and Drug information association. |