Session 2: January 7-10, 2008
Learning Trials: From Discovery to FIH
Session Co-Leaders: David Jacobson-Kram, PhD, DABT, Food and Drug Administration; Malcolm Rowland, PhD, DSc, DSc, DPh, MSc, FRPharmS, FIMA, University of Manchester; and John Wagner, MD, PhD, Merck Research Laboratories
Session Chairs: Bruce Burlington, MD, Independent Consultant; David Feigal, MD, MPH, Elan; Gerald Galluppi, PhD, Biogen Idec; David Jacobson-Kram, PhD, DABT, Food and Drug Administration; and John Wagner, MD, PhD, Merck Research Laboratories
Prioritizing areas of therapeutic interest and target product profile. Principles for target identification, understanding of combinatorial chemistry and drugability of new compounds. Exploring possible new drugs by means of preclinical safety and efficacy testing. The choice and the predictive value of animal testing for toxicity data as well as the principles of ADME, the possibilities and opportunities of computer assisted modeling on the way to proof of concept. The procedures and databases for pharmacovigilance and pharmacoepidemiology surveillance. Pharmaceutical engineering and choice of formulation.
Frontiers in Drug Development and Regulatory Science Series: Relating Current Issues about Medical Devices and Biological Products to Drug Development on January 10.
Lectures
- Drug Discovery and Early Development: A Strategic Overview with a Focus on the Learning and Confirming Paradigm
- From Idea to Drug Candidate—Identifying and Validating Unprecedented Targets
- Discovery Chemistry: Building the Right Drugable Properties into the Molecule
- CMC Considerations for Selection of a Successful Drug Candidate (Drug Substance & Drug Product)
- Introduction to Drug Metabolism, PK and ADME Principles Non-Clinical Toxicology
- Introduction to Pharmacodynamic Principles
- Planning for Successful Learn Phase
- Biostatistics as Applied to Drug Discovery and Development
- Intellectual Property in Drug Discovery and Development
- The Regulatory Framework: Focus on the Safety Drivers for IND and CTA Submission Strategies
- The Role of Modeling and Simulation in Candidate Selection
- Strategies for Predicting Human PK
- Selection Criteria for Successful Biologics
- Preclinical Drug Development Strategies for Small Molecules
- Preclinical Drug Development Strategies for Large Molecules
- Overcoming Roadblocks to IND Initiation and Nontraditional INDs
- Determinants of Human PK Variability with Impact on Candidate Selection and Drug Development
- Pharmacogenomics and Pharmacogenetics in Drug Discovery and Development
- The Role of Biomarkers and Surrogate Endpoints in Drug Discovery, Drug Development and Regulatory Decision-Making
- Experimental Models and Imaging
- What is Needed to Support the Early Development of Devices?
Frontiers Workshop - Controversies in In Vitro Diagnostics
- Case Studies in Combination Products
- Overview of Clinical Trials in Alzheimer's Disease (AD)
- Imaging and Biomarkers Support Disease Modification in AD
- Vaccines
- Follow-on Biologics
Teaching Faculty
Leslie Benet, PhD, University of California, San Francisco
Thorir Bjornsson, MD, PhD, Wyeth
Bruce Burlington, MD, Independent Consultant
David Feigal, MD, MPH, Elan
David Flockhart, MD, PhD, University of Indiana
Gerald Galluppi, PhD, Biogen Idec
Michael Grundman, MD, MPH, Elan
Steven Gutman, MD, MBA, Food and Drug Administration
David Jacobson-Kram, PhD, DABT, Food and Drug Administration
Diane Jorkasky, MD, Pfizer
William Jusko, PhD, University at Buffalo
William Kluwe, PhD, Novartis
Ismail Kola, PhD, Schering-Plough Research Institute
Christopher Lipinski, PhD, Melior Discovery
James MacDonald, PhD, Schering-Plough
Michael Mayersohn, PhD, University of Arizona
Karen Midthun, MD, Food and Drug Administration
David Savello, PhD, Xenoport
Daniel Schultz, MD, Food and Drug Administration
Bruce Stein, RPh, PhD, JD, Patent Law Consulting
Kathryn Stein, PhD, MacroGenics
Julie Stone, PhD, Merck
Nancy Thornberry, PhD, Merck
Thomas Tozer, PharmD, PhD, University of California, San Diego
John Wagner, MD, PhD, Merck
Stephen Williams, MD, PhD, Decisionability LLC
Stanley Young, PhD, National Institute of Statistical Sciences
