ACDRS 2023 Session 2 - Learning Trials: From Discovery to First in Human

Wednesday, March 29, 2023 - 8:00 am to Friday, March 31, 2023 - 4:00 pm
UCDC, 1st floor meeting room

1608 Rhode Island Ave NW, Washington DC

This is Session 2 of 6. Must register for the entire course and not per session.

Session Co-chairpersons:
Paolo Vicini, PhD, MBA, Chief Development Officer, Confo Therapeutics
Gary Skiles, PhD, Independent Consultant


Jennifer Allen, PhD

Executive Director, Medicinal Chemistry, Amgen
Ashley Boam, MSBE Director, Office of Policy for Pharmaceutical Quality, US Food and Drug Administration
Patrick Collins, PhD Director, Functional Genomics, 23andMe
Margaret Faul, PhD Vice President, Vice President | Manufacturing & Clinical Supply and ATO Operations Site Head

Agi Hamburger, PhD

Vice President, Drug Discovery, A2 Biotherapeutics
Diane K. Jorkasky, MD FACP Consultant to Pharma
Jacqueline Kinyamu-Akunda, DVM PhD Senior Scientific Director, Nonclinical Safety, Janssen
Lois D. Lehman-McKeeman, PhD ATS Vice President, Pharmaceutical Candidate Optimization, Bristol Myers Squibb
Saileta Prabhu, PhD Senior Director, Clinical Pharmacology, Regeneron
 Bill Richards, PhD Vice President, Target & Drug Discovery, 23andMe

Hansjorg Sauer, PhD JD

Deputy General Counsel and Vice President, Intellectual Property, Biotechnology Industry Organization

Gary Skiles, PhD

Independent Consultant
Paolo Vicini, PhD MBA Chief Development Officer, Confo Therapeutics
Geoffrey Walford, MD Distinguished Scientist, Translational Medicine, Merck & Co., Inc

Additional faculty - case study proctors

Jaspreet Arora, PhD Associate Director, Formulation Development
Sean Downing, PhD Senior Director of Biomarker Development and Technologies, Center of Excellence for Biomarker and Bioanalysis Sciences and Technologies, Takeda Pharmaceuticals
Maria Flynn, PhD Senior Pharmaceutical Quality Assessor, Application Technical Lead, Division of Immediate and Modified Release Products II, Office of Lifecycle Products, Office of Pharmaceutical Quality, Center for Drugs & Evaluation Research, US Food and Drug Administration
Charlie T. Gombar, PhD ACDRS Director
Jennifer S. Thompson, MD Global Clinical Program Lead, Therapeutic Area Inflammation, Boehringer Ingelheim


  • Pharmacokinetics (PK), pharmacodynamics (PD) and absorption, distribution, metabolism, & 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
  • Intellectual property 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
  • Functional genomics approaches for drug discovery