ACDRS 2026 Session 2: Learning Trials: From Discovery to First in Humans

Must be registered in advance to attend.

Topics

• PK, pharmacodynamics (PD) and absorption, distribution, metabolism, and excretion (ADME)
• Discovery chemistry
• Discovery of biologics
• Chemistry, manufacturing, and control (CMC)
• Selection criteria for therapeutic monoclonal antibodies
• Strategies and approaches for preclinical to clinical translation
• Artificial intelligence in drug discovery and development
• Strategies for predicting human PK, exposure-response, and safety
• Determinants of human PK variability
• Guidelines and Beyond for nonclinical toxicology
• Strategies for successful toxicology investigations
• Devices to support early drug development

Speakers

• Brian Arey, Executive Director, PhD MS, Pharmacological Sciences and Screening Technologies, Discovery Biotherapeutics and Lead Discovery and Optimization, Bristol Myers Squibb (BMS)
• Stephen Carl, PhD, Scientific Director, BMS
• Bruce A. Ellsworth, PhD, Global Head of Oncology Chemistry, Novartis
• Brandon W. Higgs, PhD, Chief Data Officer, Diagnostics, Danaher Corporation
• Diane K. Jorkasky, MD FACP, Consultant to Pharma
• Jacqueline Kinyamu-Akunda, DVM PhD,  Vice President, Toxicology, Incyte
• Lois D. Lehman-McKeeman, PhD ATS, Vice President, Pharmaceutical Candidate Optimization, BMS
• Michael Maitland, MD PhD, Vice President, Clinical Development, Path
• Giuliana Montenegro, MBA, Executive Director, Precision Medicine Portfolio Planning, GSK
• Andrew Parsons, PhD, Senior Director, Process Development, Amgen
• Saileta Prabhu, PhD, Senior Director, Clinical Pharmacology, Regeneron
• Paolo Vicini, PhD, Chief Development Officer, Confo Therapeutics
• Scott Wasserman, MD, Chief Medical Officer, Kailera Therapeutics
• Zheng Yang, PhD, Principal, DMPK and PK/PD Modeling Consulting, Excelsius LLC