Details
- Type Event
- Date -
- Time -
- Location 1608 Rhode Island Ave NW, Washington DC 1608 Rhode Island Ave NW, Washington DC
About
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