Webinar Date:

• China Time: 9:00-10:30 AM, Saturday, May 14, 2022
• US EST Time: 9:00-10:30 PM, Friday, May 13, 2022
• US PST Time: 6:00-7:30 PM, Friday, May 13, 2022

Language: English, with Chinese simultaneous translation

Venue: Live Zoom Webinar

Webinar Agenda

Moderator：

• Dr. Li Yan, CMO, Brii Biosciences; Managing Director, USCACA

► 9:00-9:05 Chairman's Welcome Speech

• Jin LI, Shanghai East Hospital

► 9:05-9:50 Presentations:

• KEY ELEMENTS: Approaches, Experiences, and considerations for earlyphase go/no go
• Dr. Ramandeep Sharma, Senior Medical Monitor, Novotech

• Case Study: Clinical Development Strategy in Early Phase Oncology Trials
• Dr. Xiaoxia Yan, Vice President, Highthink

• Clinical Development of Disitamab Vedotin for Urothelial Cancer
• Dr. Jianmin Fang, Co-founder, CEO & CSO, RemeGen

• Decision Making in Early Oncology Clinical trials 
• Dr. Joseph Eid, Chief Medical Officer, Hengrui USA

► 9:50-10:30 Panel Discussion

• Dr. Jin Li, Shanghai East Hospital
• Dr. Li Yan, CMO, Brii Biosciences; Managing Director, USCACA
• Dr. Ramandeep Sharma, Senior Medical Monitor, Novotech
• Dr. Vivian Gu, Head of Clinical Development & Regulatory, CMO, Novotech China
• Dr. Xiaoxia Yan, Highthink
• Dr. Jianmin Fang, Co-founder, CEO & CSO, RemeGen
• Dr. Joseph Eid, Chief Medical Officer, Hengrui
• Dr. Jon Wigginton, Senior Advisor and Chairman SAB, Cullinan Oncology; Former Head of Immuno-Oncology Early Clinical Development, BMS

Speakers and Panelists Bio：

Li Yan, M.D., Ph.D.CMO, Brii Biosciences, Managing Director，USCACA

Dr. Yan is a seasoned drug developer. He held executive positions at GSK, Merck, and Johnson & Johnson, most recently, VP Global Oncology Head Unit Physician of GSK. He contributed to the development and approval of numerous medicines including Keytruda for China. He firmly believes in the power of global collaboration. He is a graduate of Peking University Medical College where he is an adjunct professor. He is an alumnus of Harvard Business School Enterprise Leadership program.

Dr. Jin Li, Professor of the Department of Oncology, Shanghai East Hospital

·2016-Present: Professor of the Department of Oncology, Tongji University East Hospital, Shanghai, China

·2003-2014: Professor and Director of the Department of Medical Oncology, Fudan University Cancer Hospital; Head, Clinical Study Unit of Fudan Cancer Hospital

·2000-2002: Post-Doc and visiting scientist in Yale Medical School, USA

·1997-1999: Associate professor in the Department of Oncology, Shanghai Changhai Hospital

·1989-1993: Attending and Lecturer in the Department of Obstetrics and Gynecology, Shanghai Changhai Hospital.

·1982-1986: Resident in Xichang Railway Hospital in Sichuan Province.

Dr. Ramandeep Sharma, Senior Medical Monitor – Novotech

Dr. Sharma has over 19 years professional experience in providing patient care and handling clinical research in the healthcare industry. He has hands-on experience in both clinical research domain as well as supporting commercial teams. Raman is well versed in ICH-GCP guidelines and has expertise in formulating clinical study protocols, CRFs, medical monitoring plans, causality assessment of AEs and conduct of investigator meetings. Furthermore, Raman has a flair for medical writing, having published 4 review articles in the last 2 years. He has extensive knowledge in handling all phases and functional areas of clinical trials for a range of therapeutic areas which include endocrinology, infectious disease, oncology, immunology, ophthalmology, rheumatology, haematology, as well as biosimilar clinical development studies. Raman’s impressive medical experience, communication style, and eye for detail makes him a valuable asset of Novotech clinical trial teams.

Dr. Shama obtained MBBS and M.D. (Pharmacology) from MS Baroda University, India.

Dr. Xiaoxia Yan, Highthink

Xiaoxia Yan, MD, is a Cardiologist in China. She has been the Vice President at Beijing Highthink Parmaceutical Technology Service CO., LTD since 2006. Dr. Yan has nearly 20-year clinical research experiences of CRO, successfully completed dozens of phase I, II and III clinical trials.

After 15-year China and international regulatory, medical affairs strategy planning experiences, Dr. Yan has gained abundant RA practical experiences, which has enabled her to successfully submitted dozens of INDs for her clients, and participated hundreds of project defenses and review conferences.

Dr. Jianmin Fang, Co-founder, CEO & CSO, RemeGen

Dr. Jianmin Fang is the co-founder, CEO and CSO of RemeGen; the founder and Chairman of the Board of Directors of MabPlex International, and a Professor at School of Life Science and Technology, Tongji University. Dr. Fang has over 20 years of experience in biopharma R&D and has successfully led multiple innovative drug programs from discovery through commercialization. He has over 50 drug-related invention patents and is the inventor of the marketed drugs telitacicept, disitamab vedotin, and conbercept. Dr. Fang obtained a Ph.D. in biology from Dalhousie University, Canada, and received post-doctoral training in Harvard Medical School.

Dr. Vivian Gu, Head of Clinical Development & Regulatory, CMO, Novotech China

Dr. Gu has over 20 years of clinical research experience at multinational pharmaceutical companies (MNCs) such as BI, AZ, and BMS. She has also worked as the head of Clinical Operations for MNCs for 16 years. Prior to joining Novotech China, she was a Senior VP of a leading biotech company in China. Over the years for being in the leadership position providing high quality clinical trial services, she has accumulated extensive knowledge and experience across broad therapeutic areas and indications. With her rich experience in clinical operations, medical and regulatory affairs, she has deep understanding of the regulatory pathways and clinical development needs of biotech companies.

Dr. Gu has obtained her medical degree in Clinical Medicine from Fudan university, previously known as Shanghai Medical University before her practice as an internal medicine doctor for 8 years at a top tier hospital in Shanghai, China.

Dr. Joseph Eid, Chief Medical Officer, Hengrui USA

Dr. Eid is a medical oncologist and hematologist with more than 20+ years’ experience in academic medicine and in the biopharmaceutical industry, in both clinical development and medical affairs. Dr. Eid has experience with phase 1-4 programs, including small molecules, monoclonal antibody, and immuno-oncology. Regulatory expertise including IND, BLA, and NDA filing. He possesses strong leadership skills and multiple achievements in matrix organizations.

​Dr. Eid was most recently the Sr. Vice President and Head, Global Medical Affairs at BMS, leading a global organization responsible for supporting better health outcomes for patients and the safe and appropriate use of medicines through understanding the current and future needs of patients and medical care. The organization he lead included market based medical, HQ medical teams, and centers of excellence for collaborative science, medical information and publications.

​Prior to BMS, Dr. Eid worked at Merck for 8 years in roles of increasing responsibility. Dr. Eid also worked at Roche for 5 years in their clinical science teams. He was an Assistant Professor at the Rutgers Robert Wood Johnson Medical School for close to 8 years. Dr. Eid holds a Doctor of Medicine degree (MD) from Saint Joseph, Faculty of Medicine, Beirut-Lebanon.

Dr. Jon Wigginton, Senior Advisor and Chairman SAB, Cullinan OncologyFormer Head of Immuno-Oncology Early Clinical Development, BMSCullinan Oncology

Dr. Wigginton currently serves as Senior Advisor and Chairman, SAB at Cullinan Oncology. Previously, he served as Chief Medical Officer at Cullinan Oncology. Prior to that, Dr. Wigginton was Chief Medical Officer at MacroGenics, where he led the company’s evolution of a fully-integrated, clinical-stage cancer immunotherapy organization. This included the translation of ten new molecules into the clinic, and early phase and/or proof-of-concept studies with bispecific molecules, checkpoint inhibitors, Fc-optimized antibodies and antibody drug conjugates. Previously, he served as the Therapeutic Area Head, Immuno-Oncology, Early Clinical Research at Bristol- Myers Squibb. There, he oversaw early clinical development of the BMS Immuno-Oncology portfolio, served in a governance role for discovery research in immuno-oncology, and co-led the BMS International Immuno-Oncology Network (II-ON). These efforts included studies defining proof-of concept for both anti-PD-1 and anti-PD-L1 antibodies in patients with a variety of solid tumors, and for the anti-PD-1/anti-CTLA-4 combination in patients with melanoma.

During his academic career, Dr. Wigginton served as Head of the Investigational Biologics Section, Center for Cancer Research, NCI, where he led an integrated basic, translational and clinical research effort focused on cytokine-based combination immunotherapy in preclinical models and early clinical studies. Dr. Wigginton also served previously as President of the Society for Immunotherapy of Cancer (SITC). Dr. Wigginton received his M.D. and B.S. in Biology, with distinction, from the University of Michigan.

Organizer:

Co-organizer