ACDRS 2021 Session 2: Learning Trials: From Discovery to First in Humans

Monday, April 19, 2021 - 10:00 am to Friday, April 23, 2021 - 3:00 pm

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, Consultant


Cynthia A. Afshari, PhD

Vice President, Global Head Toxicology and Nonclinical Safety, The Janssen Pharmaceutical Companies of Johnson & Johnson

Kevin Beaumont

Director DMPK, Oncology R&D, AstraZeneca
Ashley Boam, MSBE Director, Office of Policy for Pharmaceutical Quality, US Food and Drug Administration

Agi Hamburger, PhD

Vice President, Drug Discovery, A2 Biotherapeutics

Dean Hickman, DPhil

Vice President, Preclinical and Translational Sciences, Arclight Therapeutics
Marian Iwamoto, MD PhD Associate Vice President, Translational Pharmacology, Merck & Co., Inc
Diane K. Jorkasky, MD FACP Consultant to Pharma
Saileta Prabhu, PhD Vice President, Global Head, Clinical Biomarker Innovation & Development, Takeda
Malcolm Rowland, PhD Adjunct Professor, School of Pharmacy, University of California, San Francisco

Hansjorg Sauer, MS PhD JD

Deputy General Counsel for Intellectual Property, Biotechnology Industry Organization

David Savello, PhD

Partner, NDA Partners LLC

Gary Skiles, PhD

Michael V. Templin, PhD DABT Director, Senior Principal Scientific Advisor, Charles River
Paolo Vicini, PhD MBA Chief Development Officer, Confo Therapeutics

Additional faculty - case study proctors

Siddique Abbasi, MD MSc FACC Executive Medical Director, Global Development Lead, Amgen
Kemal Asik, PhD Clinical Scientist, Ophthalmology, Genentech
Yelizaveta Babayan, PhD  Principal Research Scientist, CMC Global Regulatory Affairs, Eli Lilly & Company
Patrick Burnett, MD PhD FAAD Chief Medical Officer, Arcutis Therapeutics
Jamie Connarn, PhD Clinical Pharmacokinetic & Pharmacometrics Lead, Bristol Myers Squibb
Dinko Rekić, PhD Global Project Leader, AstraZeneca  (Sweden)
Robert Schuck, PharmD PhD Deputy Director (Acting), Division of Translational and Precision Medicine, Office of Clinical Pharmacology, Office of Clinical Pharmacology, US FDA
Patrick Twomey, MD MBA Medical Safety Director, Genentech


  • 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