Clinical Development Highlights
Date: April 27, 2024 @ 9:00 am – @ 3:00 pm
Location: 1633 Old Bayshore Hwy #280, Burlingame, CA 94010
Introduction:
What does it take to bring clinical evidence to obtain market approval? This workshop is designed to gain a “big picture” of the entire drug development process from IND to NDA/BLA. It will highlight regulatory requirements, the framework for robust study design, medical monitoring and benefit & risk assessment, and elements of clinical operations and CRO program management. Key principles and concepts will be illustrated with case studies. This workshop will provide an opportunity for CABS members who are interested in expanding professional networks to clinical development for career development, industry partnerships or strategic collaborations.
Presentation Titles and Speakers:
1. Presentation Title: Brief introduction of clinical development
Speaker: Wei Dong, MD, PhD, VP and Head of Drug Safety at Denali, 2010-2011 CABS President
2. Presentation Title: Regulatory overview: the journey from IND to NDA/BLA including case examples
Speaker: Wen Liu, PhD, VP of Regulatory Affairs, Lyell Immunopharma
3. Presentation Title: Statistical considerations in clinical trial designs
Speaker: Jing Yi, PhD, Head of Data Science and Global Development Team Leader, CARGO Therapeutics
4. Presentation Title: Clinical operations and CRO program management
Speaker: Angela Wang, Commercial Director at Novotech
5. Presentation Title: Clinical Monitoring Priorities and Responsibilities
Speaker: Harry Liu, MD, MPh, MBA, Executive Director, Clinical Development, ALX Oncology
6. Presentation Title: The science and practice of drug safety
Speaker: Wei Dong, MD, PhD, VP and Head of Drug Safety at Denali, 2010-2011 CABS President
List of Speakers:
Wei Dong, MD, PhD
VP and Head of Drug Safety at Denali
2010-2011 CABS President
Wen Liu, PhD, VP of Regulatory Affairs, Lyell Immunopharma
Jing Yi, PhD, Head of Data Science and Global Development Team Leader, CARGO Therapeutics
Harry Liu, MD, MPh, MBA, Executive Director, Clinical Development, ALX Oncology
Angela Wang, Commercial Director at Novotech,
Organizing committee:
Wei Dong, MD, PhD, VP and Head of Drug Safety at Denali, 2010-2011 CABS President
Liping Meng, PhD, Senior Scientist II at Gilead Sciences, Co-chair of CABS Science & Technology Committee
Yan Wang, PhD, Director at ChemPartner, Co-chair of CABS Science & Technology Committee
Jessica Sun, PhD, Executive Director, In Vivo Pharmacology at Terremoto Biosciences, 2024-2025 CABS President
Exclusive Sponsor:
NovoTech
Bio of Speaker:
Wei Dong is the VP and Head of Drug Safety at Denali Therapeutics where she builds and leads safety and pharmacovigilance organization. She oversees the scientific, operational and product strategy aspects of global safety during clinical development and prepare the organization as a whole to address future marketing authorization applications and multinational postmarketing safety requirements. Wei brings extensive R&D experience in global drug development to improve patient care. She held executive leadership roles in Genentech and Roche in the areas of drug safety, epidemiology and Asia Pacific product development contributing to the approval of multiple breakthrough medicines. Most recently she served as the VP and Head of Safety at Corcept Therapeutics building up its safety team and ensuring successful regulatory inspections. Wei obtained her MD from Shanghai Medical University and PhD in Epidemiology from the London School of Hygiene & Tropical Medicine, University of London. She lectured at UCL Medical School, U.K., and was an Assistant Professor of Epidemiology and Community Medicine at Mount Sinai School of Medicine before joining the industry. Wei is a long-term supporter of the CABS vision and community and has served as the CABS Present 2010-2011. )
Jing Yi is the Head of Data Science, Global Development Team Leader for CRG-022 at CARGO Therapeutics since May 2023. Jing has over 17 years of industry experience with a proven record in oncology clinical development and medical affairs, and in functional and cross-functional leadership.
Jing has been involved in many successful global regulatory interactions and approvals, including Avastin across various tumor types. She has built and led multiple high performing cross-functional teams and initiatives. Prior to joining CARGO, Jing spent over 2 years at Erasca as the Senior VP of Data Science and PTL of ERAS-601 program. Jing was the Global Development Team Leader for Tecentriq at Roche/Genentech prior to joining Erasca, where she led a cross functional team and was accountable for the overarching strategy, development and implementation of cancer immunotherapy in Lung and Head/Neck Cancers. She also managed a group of medical directors and clinical scientists. Prior to her cross-functional leadership role, she was the biometrics lead of multiple molecules and managed a group of statisticians who supported many pivotal studies at Roche/Genentech. Jing received her PhD. in Statistics from the University of California, Berkeley.
Angela Wang has extensive business development, investment, product management, and research experience in the biotech industry. As the China Commercial Director at Novotech, her focus is to bridge the needs of biopharma companies in North America/Europe with China. This involves guiding clients through regulatory, clinical, and commercialization strategies.
Angela previously held Sr. Director of Business Development position at ClinChoice, Director of Investments and Operations at several venture capital firms as well as various senior product management and marketing roles at ThermoGenesis, Thermo Fisher Scientific, and Abaxis.
Angela received her MBA from Rensselaer Polytechnic Institute and B.S. in Cell Biology from Wuhan University. Angela is based in the San Francisco Bay Area.
Wen Liu is a seasoned regulatory affairs professional in biotech. She has been serving as the VP of regulatory affairs at Lyell immunopharma since 2021, a clinical stage cell therapy company with genetic reprogramming technologies for oncology. Prior to joining Lyell, she joined Genentech in 1998 as a scientist in research after acquiring her PhD. In 2004, she transitioned to clinical regulatory affairs and over time has established as a leader in regulatory strategy and filings for groundbreaking oncology therapies. At Genentech/Roche, she was instrumental in the successful development and approval of major oncology therapies worldwide as a global regulatory affairs leader. At Lyell, she continues to drive regulatory excellence to bring transformative therapies to clinic.
Harry Liu is currently an Executive Director Clinical Development in ALX Oncology, where he is the clinical lead for the head and neck cancer programs. Prior to ALX Oncology, he had worked in Genentech and Amgen, and taken leadership roles in clinical development and clinical safety functions. Harry received his medical degree from Norman Bethune University of Medical Sciences, MPH in Epidemiology from UC Berkeley, and MBA from UCLA Anderson school.
Lunch will be provided. Limited seats. RSVP is required. Please register as early as possible.
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