ACDRS 2024 Session 2 - Learning Trials: From Discovery to First in Human

Date: 
Wednesday, March 6, 2024 - 8:00 am to Friday, March 8, 2024 - 4:00 pm
Location: 
UCDC, 1st floor meeting room

Full map

1608 Rhode Island Ave NW, Washington DC

This is Session 2 of 6. Must register for the entire 2024 Course and not per session.

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

Lecturers

Jennifer Allen, PhD

 Executive Director, Medicinal Chemistry, Amgen  
Margaret Faul, PhD Vice President, Vice President | Manufacturing & Clinical Supply and ATO Operations Site Head  
Gioia Guerrieri, DO DFAPA FASAM Physician, Digital Health Center of Excellence (DHCoE), Center for Devices and Radiological Health (CDRH), US Food and Drug Administration (FDA)  

Agi Hamburger, PhD

 Vice President, Drug Discovery, A2 Biotherapeutics  
Brandon W. Higgs, PhD Vice President, Translational Data Sciences, Genmab  
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  
Anindita (Annie) Saha Associate Director for Strategic Initiatives, DHCoE, CDRH, US FDA  

Gary Skiles, PhD

 Independent Consultant  
Paolo Vicini, PhD MBA Chief Development Officer, Confo Therapeutics  
Geoffrey Walford, MD Distinguished Scientist, Translational Medicine, Merck & Co., Inc  
Christina Webber, PhD Regulatory Science Program Manager, Division of Partnerships and Innovation, DHCoE, CDRH, US FDA  

Additional faculty - case study proctors

Charlie T. Gombar, PhD ACDRS Director
Jennifer S. Thompson, MD Global Clinical Program Lead, Therapeutic Area Inflammation, Boehringer Ingelheim
Christopher Vinnard, MD PhD MSCE MS Clinical Development Leader, Bill & Melinda Gates Medical Research Foundation

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
  • 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
  • Artificial Intelligence and Machine Learning in Translational and Early Clinical Applications