Preparing for success in modernizing the science behind the development and regulation of medical products
ACDRS 2021 Session 2: Learning Trials: From Discovery to First in Humans
Date:
Monday, April 19, 2021 - 10:00 am to Friday, April 23, 2021 - 3:00 pm
Location:
virtual/online
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
Lecturers
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 |
Consultant |
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 |
Topics
- 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