Session 2: February 23-26, 2009 (San Francisco, CA)

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 California, San Francisco; and John Wagner, MD, PhD, Merck Research Laboratories

Session Chairs: David Jacobson-Kram, PhD, DABT, Food and Drug Administration; Bruce Mackler, PhD, JD, Independent Consultant; Malcolm Rowland, PhD, DSc, DSc, DPh, MSc, FRPharmS, FIMA, University of California, San Francisco; 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: New Therapeutics: Beyond Small Molecules on February 26.

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, Pharmacokinetics and ADME Principles Non-Clinical Toxicology
• Introduction to Pharmacodynamic Principles
• Planning for Successful Learn Phase
• 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 Pharmacokinetics
• 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 Pharmacokinetics Variability with Impact on Candidate Selection and Drug Development
• Pharmacogenomics and Pharmacogenetics in Drug Discovery and Development
• Experimental Models and Imaging
• The Use of Devices to Support Early Drug Development
  
  Frontiers Workshop
• Update on Hot FDA Issues in 2009
• Controversies in In Vitro Diagnostics
• Case Studies in Combination Products
• Vaccine Safety: An FDA Perspective
• Follow-on Biologics
• Perspectives on the Development of Medical Devices
• Challenges in Medical Device Development and Approval

Case Studies

• DPP-4
• Antibody X (Part I)

Teaching Faculty
Thorir Bjornsson, MD, PhD, Wyeth
Terrence F. Blaschke, MD, Stanford University
Mary Ellen Cosenza, PhD, DABT, RAC, Amgen
Andrew Farb, MD, Food and Drug Administration
David W. Feigal Jr, MD, MPH, Amgen
David Flockhart, MD, PhD, University of Indiana
Robert L. Garnick, PhD, Lone Mountain Biotechnology and Medical Devices
Michael Grundman, MD, MPH, Elan
Alberto Gutierrez, PhD, Food and Drug Administration
Michael Hale, MD, Amgen
David Jacobson-Kram, PhD, DABT, Food and Drug Administration
Diane Jorkasky, MD, Independent Consultant
William Kluwe, PhD, Novartis
Ismail Kola, PhD, Schering-Plough Research Institute
Christopher Lipinski, PhD, Melior Discovery
James S. MacDonald, PhD, Chrysalis Pharma Consulting
Malcolm Rowland, PhD, DSc, DSc, DPh, MSc, FRPharmS, FIMA, University of California, San Francisco
Andrea Sutherland, MD, MD, MPH, Food and Drug Administration
Nancy Sambol, PharmD, University at California, San Francisco
David Savello, PhD, Xenoport
Nancy A. Thornberry, PhD, Merck
John Wagner, MD, PhD, Merck
Nan Wu, MD, PhD, JD, Cooley Godward and Kronish LLP

The University of California, San Francisco, CA 94143, 415/476-9000
Copyright © 2009, The Regents of the University of California.