主题：CMC在ADC, 放射性药物，以及CGT开发中的关键作用 时间：5月8日21:00
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本期内容：
Join Bioverse webinar episode 9 to learn the essential role of chemistry, manufacturing, and control (CMC) in the global drug development and deal-making for ADC, radiopharmaceutical, and CGT. In this webinar, you would learn:
Review of recent debacles caused by laps in CMC
CMC’s essential role in the global drug development
CMC’s essential role in the global deal-making
Special concerns for ADC, Radiopharmaceuticals, or CGT
$川宁生物(SZ301301)$ $科伦博泰生物-B(06990)$ $中国同辐(01763)$ #ADC药物# #投资炼金季# #创新药时代来临#
嘉宾简介：
Jing Fan, PhD｜CEO of Hopstem Biotechnology
Dr. Jing Fan received her bachelor ‘s degree at Peking University, Ph.D in Neuroscience at UBC, and postdoctoral training at Johns Hopkins University. She has been elected as one of the ’30 Global Innovative talents of Chinese entrepreneurs’ in 2018, the 2022 Forbes list “TOP50 Women in Science and Technology in China”, the “Outstanding founder in biotechnology industry of 2022” BioCon Award, etc. Dr. Jing Fan has more than 20 years of experience in the fields of pluripotent stem cell and neural differentiation, CNS diseases drug discovery. She has published more than 10 academic papers and book chapters on top journals and led the Maryland Stem Cell Foundation project, and participated in major R&D projects such as NIH, Helis Foundation, etc. Since 2017, she has founded Hopstem, led the team to establish advanced CMC and development platform for iPSC-derived neural cell therapy products and raised more than 70 million USD. The global first-in-class human forebrain neural progenitor cell injection hNPC01 received IND clearance from FDA in 2024 and is undergoing a registered phase I clinical trial targeting chronic ischemic stroke in China.
Jimmy Li, PhD｜CEO of WuXi XDC
Dr. Jimmy Li is CEO of WuXi XDC and has over 20 years of experience in biologics research, development, and cGMP manufacturing. With his leadership, WuXi XDC has become premier\ CRDMO focused on ADC and other bioconjugates market, providing over 350 global clients with an integrated technology and one-stop service platform that extends from discovery, development, to manufacturing, quality control and regulatory filings. WuXi XDC has successfully brought many ADC projects to the Investigational New Drug (IND) filing stage with the platform timeline of 13-15 months or less, including all capabilities of mAb intermediate, payload-linker, bioconjugate drug substance and drug product development and manufacturing.
WuXi XDC has been recognized as "2023 Best CDMO Winner" by global industry and clients in the most influential "World ADC Awards". In Nov 2023, WuXi XDC successfully listed on the Main Board of Hong Kong Stock Exchange. Dr. Li joined the WuXi Biologics Group in 2011, after working in several US biotech companies including Genentech, Tanox etc.
Dr. Li holds B.S. degree from Tsinghua University, and Ph.D. degree from University of Maryland Baltimore County, majoring in Chemical and Biochemical Engineering.
Gary Li,PhD
Senior R&D leader and executive, Scientific advisor, Venture advisor
Ex-RayzeBio, BridgeBio, Ignyta, Pfizer, Johnson & Johnson
Dr. Li has over 20 years of multi-modality drug discovery, translational and early development experience at both strategic and operational levels. Most recently, as RayzeBio’s 3rd employee and SVP, he led Discovery Biology, Translational Medicine, and Portfolio Strategy from its inception. Particularly, he spearheaded the effort in establishing a rich portfolio spanning from novel targets to Phase III asset, the most innovative and comprehensive one in the targeted radiopharmaceutical industry. In addition, he played a key role in company building, fund raising, licensing and scientific communication. Soon after a successful IPO, RayzeBio was acquired by Bristol Myers Squibb for $4.1 billion in early 2024.
Before joining RayzeBio, Dr. Li was SVP, Translational Medicine at BridgeBio and its affiliate, QED Therapeutics, leading all aspects of Translational Research and Companion Diagnostics, which led to multiple global drug approvals. Prior to QED, he was VP of Oncology Research at Ignyta, where he built a highly productive research team from ground up and led multiple programs to NDA and IND milestones. Before Ignyta, Dr. Li held various scientific positions with increasing responsibilities at Pfizer and Johnson & Johnson, contributing to target ID/validation, drug discovery and multiple drug approvals.
Dr. Li earned his Ph.D. in Biomedical Sciences from the University of Pennsylvania. He is an inventor of multiple patents, and has published more than 50 peer-reviewed articles and delivered over 100 invited talks and meeting presentations. In addition, Dr. Li has served on multiple Scientific Advisory Boards and editorial boards.
Leon ‘Jun’ Tang, PhD ｜(BioVerse webinar host)
Leon ‘Jun’ Tang, is the founding partner of InScienceWeTrust BioAdvisory, a business development company focused on the East-West cross-border partnerships in the pharmaceutical industry. Dr. Tang is also the founder of InScienceWeTrust Community, which has more than 2,000+ members from Asian biotech community. He is also the c-founder and host of Bioverse webinar.
Dr. Tang serves as a scientific advisor to Mianus Capital, a boutique US-based healthcare PE/VC fund currently focused on ophthalmology. He is also an advisor to BioSpark, an Asian biotech professional’s association based in Massachusetts.
Previously, Dr. Tang was a senior director of BD Search & Evaluation at Shanghai Henlius Biotech, a public biotech listed on Hong Kong Stock Exchange, a biotech sell-side analyst at Barclays Investment Bank, and a senior manager/senior analyst at the philanthropic venture fund of Cancer Research Institute of New York.
Dr. Tang has published 50+ academic papers, some of which are in Nature Reviews Drug Discovery, Lancet Oncology, Science Translational Medicine, Nature Communications, Science Advances, PNAS, etc. Dr. Tang received his bachelor’s degree from Tianjin University, master’s degree from Nankai University, PhD from Icahn School of Medicine of Mount Sinai, and postdoctoral training at Memorial Sloan Kettering Cancer Center.