Wednesday, October 24th, 3:30-4:55pm
Learn how to navigate the complexities of the European and U.S. regulatory landscapes. What are the barriers to entry in these markets and how can companies gain market access? Regulatory and legal experts will explore the similarities & differences between the U.S., Chinese & European regulatory systems.
- Alan Morrison, Vice President, Regulatory Affairs, Amgen
- Jasemine C. Chambers, PhD, JD, Deputy Administrator for External Affairs, United States Patent & Trademark Office (USPTO)
- Gang Wang, PhD, Assistant Country Director, China Office, US Food and Drug Administration (US FDA)
- Yang Wei, Deputy Director General, Drug Registration, State Food and Drug Administration (SFDA)
Jasemine C. Chambers, PhD, JD
As Deputy Administrator, Dr. Chambers assists the Administrator in providing policy advice to the Director of the U.S Patent and Trademark Office (USPTO) on matters relating to intellectual property (IP) protection and enforcement, and IP-related trade issues, including proposed legislation and international activities. She also oversees the day-to-day operations of a 100-member organization that comprises the Policy Division, the Office of Governmental Affairs, the Global IP Academy, the IP Attaché Program, and the Office of the Chief Economist.
Dr. Chambers’ previous appointments at the USPTO include serving as Director of Technology Center 2900 where she oversaw the examination of design patent applications and as Director of Technology Center 1600 where she oversaw the examination of biotechnology and pharmaceutical patent applications. In 2000, she became the first Asian female to be appointed to the USPTO’s Senior Executive Corps.
Dr. Chambers was instrumental in developing policy and practice related to the examination of gene sequences, stem cells, transgenic animals and gene therapies, as well as in developing examination guidelines and examiner training materials on the utility, written description and enablement requirements for biotechnological inventions. She represented the USPTO in meetings of the Trilateral Biotechnology Working Group and worked on harmonizing examination practices. Dr. Chambers also served as the USPTO's project coordinator in the creation of the Patent Cooperation Treaty Search and Examination Guidelines that was subsequently adopted by the World Intellectual Property Organization in 2004.
A former law clerk to Chief Judge Randall Rader of the U.S. Court of Appeals for the Federal Circuit, Dr. Chambers has served on detail assignments at the White House Office of Science and Technology Policy, and the Department of State’s Office of IP Enforcement. Prior to joining the USPTO, she was a Postdoctoral Fellow at the Duke University Medical Center, and a Senior Staff Fellow at the National Institutes of Health.
Dr. Chambers received a PhD in Molecular Biophysics from the Florida State University, and a JD with honors from the George Washington University Law School. She is a member of the Maryland bar and the District of Columbia bar, and is admitted to practice before the U.S. Supreme Court and the U.S. Court of Appeals for the Federal Circuit.
Alan Morrison, Vice President, leads Amgen’s International Regulatory Affairs & Safety functions of approx. 300 staff both in the UK and across more than 30 local affiliate offices worldwide. As well as part of the Global Regulatory Affairs & Safety leadership, Alan is also key member of Amgen’s cross-functional International Management Committee, which sets and guides the International business overall strategic direction.
Alan joined Amgen in 2004, having previously held a number of regulatory affairs and safety positions at a number of companies including Baxter Bioscience.
Alan is currently Chairman of the BioIndustry Association’s Regulatory Affairs Group and acting on a number of trade association committees related to biotechnology / biopharmaceuticals.
Gang Wang, PhD
Dr. Gang Wang is currently the Assistant Director for the US FDA China Office in Beijing. At this position, he holds the responsibilities for regulatory issues, policy analysis, capacity building and collaborative programs related to drugs and biologics.
Prior to taking this position, Dr. Wang was a senior reviewer, lead inspector and an Expert Biologist in the Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, FDA. His main responsibilities included reviewing and evaluating the CMC and CGMP issues of various biological license applications and supplements for biological drug products and conducting pre-licensure and pre-approval inspections of domestic and international manufacturing facilities for biological drug products. Dr. Wang is a peer-reviewed expert on CGMP and manufacturing of biological drugs, including vaccines, blood-derived products, cellular and gene therapy products, and stem cells.
Dr. Wang received his BS in biochemistry from Nanjing University in China and PhD in pharmacology and toxicology from Dartmouth Medical School in the U.S. He conducted his postdoctoral training in cancer immunotherapy at the National Cancer Institute in the National Institutes of Health. He was an Assistant Professor and Principal Investigator at the University of Texas M.D. Anderson Cancer Center prior to joining FDA in 2005.
Mr. Yang Wei has been serving as the DDG of the Drug Registration Department of the SFDA since December 2008. Prior to this, he worked for the Jilin provincial Food and Drug Administration for 10 years, serving in numerous positions, including Director of Drug Safety, Director of Drug Registration, and Director of the General Office, among others.
Previously, he was the head of the Changchun Pharmaceutical Manufacturing Machinery Plant from 1996 to 1998. He has also worked at the Jilin Medicine Industry Institute.
Born in May 1962 in Jilin Province, DDG Yang graduated from Changchun Chinese Medicine College in Changchun, Jilin Province with a major in Chinese traditional medicine.