Date: Jan 23, 2021 (Saturday)
Time: 9:00-11:30 am (EST)
Registration link: https://bit.ly/2K0TgTJ
Draft Agenda: all presentation topics are tentative.
Section 1: Presentation Host: Hao Li
- 9:00 – 9:05 am Introduction of CBA. Dr. Hang Lu, CBA President-Elect
- 9:05 – 9:35 am Opportunities and Career Development in the US FDA and USPHS as a Chemist. Commander Geoffrey Wu, Ph.D., Acting Deputy Director, OLDP, OPQ, CDER, FDA. (Click here to view the presentation)
- 9:35 – 10:05 am Project Management: a career option in pharmaceutical / biotech industry and not-for-profit organizations. Dr. Nora Yang, Chief Scientific Officer at Stratify Therapeutics, LLC. (Click here to view the presentation)
- 10:05 – 10:35 am Chance favors the prepared mind. Dr. Yun-Fu Hu, Chief Medical Officer at Genetron Health. (Click here to view the presentation)
- 10:35 – 11:05 am Overview of Employment-Based Immigration. Mr. Richard W. Chang, J.D., Partner, Wasserman, Mancini & Chang, P.C.
Section 2: Panel Discussion Host: Kevin Li
11:05 – 11:30 am including four speakers and two additional panelists
- Dr. Xin Xu, Principal Investigator and Director of Pharmacokinetics, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health
- Dr. Kevin Li, Executive Director of Regulatory Affairs and Head of US Regulatory Affairs, TopAlliance Biosciences, Inc., a subsidiary of Junshi Biosciences
Speaker bio:
Commander Geoffrey Wu, Ph.D., PMP, CPH, Acting Deputy Director, OLDP, OPQ, joined FDA’s OTR in 2010, has served as research scientist, science staff, chemistry reviewer, special assistant to the Office Director, staff supervisor (Division Director equivalent), Associate Director for Sciences and Communication (ADSC), acting Division Director, and acting Deputy Office Director. He is a scientist officer in the United States Public Health Service. Throughout his FDA tenure, he has been deeply involved, leading or co-leading regulatory review and research for Controlled Correspondence, ANDAs, and supplemental ANDAs and NDAs. Between 2013 and 2017, he served as a founding member on the OPQ Emerging Technology Team (ETT). He was a core member in multiple policy development efforts, such as emerging technology, continuous manufacturing, and comparability protocols. Dr. Wu has training and education in pharmacy, pharmaceutical science, protein chemistry, polymer chemistry, and process analytical technology. He has more than 20 peer-reviewed publications, and been invited to multiple national and international conferences to present or discuss the above related topics. His Ph.D. thesis from the University of Utah focused on self-assembly of hybrid hydrogels containing coiled-coils and drug-free macromolecular therapeutics to induce apoptosis by coiled-coiled mediated crosslinking of antigens.
N. Nora Yang, Ph.D., MBA, has twenty plus years of executive and scientific leadership experience in pharmaceutical, biotech, venture capital industries, and government. She is a leading expert on improving the efficiency and effectiveness of therapeutic development, particularly at the intersection of science and business. She currently serves as the Chief Scientific Officer at Stratify Therapeutics, LLC. Previously, she served as the Director of Portfolio Management and Strategic Operations at the National Center for Advancing Translational Sciences at the National Institutes of Health (NIH). She was recruited to NIH to develop novel public-private partnerships to establish new models of financing biomedical research that maximize benefits for underserved patient populations, while incentivizing industry partners and private investors. Under Dr. Yang’s management, the Therapeutic for Rare and Neglected Diseases (TRND) program portfolio at NIH created more than $2.5 billion dollars of commercial value within 8 years for its collaborating organizations and their investors. Prior to joining NIH, Dr. Yang led global teams for the successful development of novel therapies at Eli Lilly & Co and Amgen Inc. Her successful therapeutic development track record includes taking four (4) investigational drugs through successful New Drug Application (NDA) and Biologics Licensing Application (BLA) filings to global market launches and twelve (12) investigational drugs through Investigational New Drug (IND) filings to phase 3 clinical trials. Nora holds both a Master’s and a PhD degree in chemistry from the University of California, San Diego with her PhD research conducted at the Salk Institute for Biological Studies. She also holds a Master’s degree in management from Stanford University, Graduate School of Business.
Yun-Fu Hu, Ph.D., RAC, ASQ CQA, has served as Chief Medical Officer at Genetron since April, 2020. Dr. Hu brings over two decades of experience in regulatory and managerial capacities related to medical devices and pharmaceutical industries. Dr. Hu had more than ten years of service at US Food and Drug Administration (“FDA”), where he had served as Deputy Director and other positions at Division of Molecular Genetics and Pathology, Office of In Vitro Diagnostics and Radiological Health, Center for Device and Radiological Health. During his tenure at FDA, Dr. Hu supervised a staff of scientists, engineers, consumer safety officers and medical officers in premarket reviews and post-market compliance of IVD products and LDTs for genetic testing, molecular cancer diagnostics, companion diagnostics, radio dosimetry, digital pathology and artificial intelligence devices. Some of the notable authorizations by Dr. Hu’s group at FDA include: the first NGS-based LDT as CDx (Foundation Medicine FoundationFocus CDxBRCA); the first NGS-based CDx kit (ThermoFisher Oncomine Dx Target Test); the first NGS-based LDT for tumor profiling (MSK-IMPACT) and later on FoundationOne CDx); the first liquid biopsy test for NSCLC (Roche Cobas EGFR Mutation Test v2); and FDA’s only two approved cancer screening tests in the last decade (Exact Sciences’ Cologuard and Epigenomics’ Epi ProColon). He was a member of the steering committee to stand up the FDA’s Oncology Center of Excellence (OCE) under the 21st Century Cures and served as the Center’s first Acting Associate Director of In Vitro Diagnostics.
Prior to joining FDA, Dr. Hu has more than ten years of product development experience in diagnostic and pharmaceutical industries, including his prior employments at GlaxoSmithKline and Becton Dickinson Diagnostic Systems.
Richard W. Chang, J.D., is a partner at the law firm of Wasserman, Mancini & Chang, an “AV” rate firm that is also one of the oldest immigration law firms in the country. Richard W. Chang received his Juris Doctorate (JD) and his International Law Certificate at the Columbus School of Law at the Catholic University of America. He graduated from the University of Illinois at Urbana-Champaign (UIUC) with a Bachelors degree in History – East Asian Concentration. Richard W. Chang was one of the authors of the Asian Pacific American Coalition (APAC) Cultural Center Proposal at UIUC that helped the Asian Pacific American (APA) student groups land a $30,000 grant for APA programs. He is a former Vice-President for Communications for the Asian Pacific American Bar Association (APABA) in Washington DC. Richard W. Chang co-founded the DC Chapter of the National Association of Asian American Professionals (NAAAP-DC) in 1998. He is a former board member of the Asian American Action Fund (AAA-Fund), Richard Chang was a contributing author for the Taiwan-AIT article in “The Visa Processing Guide” published by the American Immigration Lawyers Association (AILA). Richard was the co-host of the Free Immigration Law program on World Today Comcast Cable Channel 678 in Montgomery County, Maryland since 1997. He was named one of America’s Best Lawyers in 2020 & 2021 in Immigration by Best Lawyers at Bestlawyers.com (U.S. News and World Reports). He was also named as one of the Top 100 Northeast Lawyers (Immigration Category) by Amtrak’s ARRIVE Magazine and AVVO (Nov/Dec 2011)
Panelist Bio:
Xin Xu, Ph.D., is a Principal Investigator and Director of Pharmacokinetics at National Center for Advancing Translational Sciences (NCATS), NIH. Prior to joining NCATS, she had over 20 years of industrial experience in drug metabolism and pharmacokinetics. Dr. Xu has extensive experience in IND and NDA filings of novel therapeutics, ranging from small molecules to biologics, such as monoclonal antibody, nanobody, engineered human protein, protein-drug conjugate and gene therapy. Dr. Xu obtained her B.Sc. degree from School of Pharmacy, Peking University Health Science Center, Beijing, China. She earned her Ph.D. degree in Pharmacokinetics from Faculty of Pharmacy, University of Toronto, where she also did her post-doctoral training in controlled release formulations. Dr. Xu has authored 239 publications (119 journal papers/ book chapters, and 120 conference presentations/abstracts). She is the co-inventor for five patents.
Kevin Li, Ph.D., is the Executive Director of Regulatory Affairs and Head of US Regulatory Affairs at TopAlliance Biosciences, a subsidiary of Junshi Biosciences. Prior to TopAlliance, Dr. Li was a director of regulatory affairs at AstraZeneca BioVentures and the head of regulatory affairs at Centus Biotherapeutics, a joined venture between AstraZeneca and Fujifilm Kyowa Kirin Biologics. In that role Dr. Li has directed the regulatory affairs group for the preparation and defending of global marketing applications for Equidacent® (a proposed biosimilar to Avastin), leading up to the final approval by European Union in September 2020. Prior to AstraZeneca, Dr Li was a product quality reviewer at Office of Biotechnology Products (OBP) and Office of Life Cycle Product at CDER/FDA, responsible for reviewing the chemistry, manufacturing and control (CMC) section of Abbreviated NDA (ANDA), investigational new drug (IND) and biologic license applications (BLA) for biologics and drugs. Before that, Dr. Li was an analytical scientist at MedImmune, with responsibilities range from method development to project and people management. Dr. Li received his undergraduate degree from Peking University and Ph. D. from University of Illinois at Urbana-Champaign.
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