Drug Metabolism Discussion Group

Discovery, Development, and Regulatory Strategy for Biologics and ADCs in Oncology and Immunology Program 8:00 a.m. Registration / Continental Breakfast / Vendor Exhibit 8:45 a.m. Introductory Remarks Arian Emami Riedmaier, PhD; Chair, NJ DMDG 9:00 a.m. The Evolution of First-in-Human Dose Selection for Biologics in Oncology and Beyond Haiqing Wang, PhD; Senior Director, DMPK, Alnylam 9:45 a.m. Mutants, Loners and Bad Influences (Systems Model of KRAS Pathway Describing Mechanism of Response in G13D CRC) Edward Stites, MD, PhD; Associate Professor of Laboratory Medicine and Pathology, Yale School of Medicine 10:30 a.m. Vendor Exhibit & Coffee Break 11:15 a.m. Mitochondrial Bioenergetic Health Index as a Biomarker for Kidney Injury Kiran Deshpande; PhD Candidate, Ernest Mario School of Pharmacy Rutgers, New Brunswick, NJ 11:45 p.m. Vendor Exhibit & Lunch 12:45 p.m. Immunogenicity Risk Assessments and Bioanalytical Strategy for IND Enabling Studies for Complex Biologics Sanjay Dholakiya, PhD; Principal Scientist, BMS 1:30 p.m. Developing Effective Drug Development Strategies for Biologics Samuel Chuang, PhD; Senior Director, Scientific Advisory Services, Charles River 2:15 p.m. Vendor Exhibit & Coffee Break 2:30 p.m. ADCs as Therapeutic Options: History, Resurgence and DXd Based ADCs from DSI Tushar Garimella, PhD; Executive Director, Clinical Pharmacology, Daiichi-Sankyo 3:15 p.m. Medicilon Strategy

Evening will include 20-minute talks by experts in the field, followed by Q&A and a networking session. Dinner and refreshments will be provided. List of speakers and topics: Speaker 1 - Pavan Vaddady: “Dose Optimization in Oncology Drug Development - A Summary of the IQ Initiative” Speaker 2 - Joga Gobburu: “How Are Strategic Decisions in Drug Development Enhanced by Exposure-Response Analyses?” Speaker 3 - Suzette Girgis: “Optimizing the Dose in Oncology - Insights from Quantitative Medicine” Speaker 4 - Birgit Schoeberl:  Title TBD   Ticket Pre-Sale= $45 until 9/9/24 Tickets After 9/9/24 = $100