Bridging the Gap Between Preclinical and Clinical Evaluation of Therapeutic Candidates

July 30–31 and August 1, 2007, Natcher Conference Center Auditorium, Bethesda, Maryland

Agenda

Agenda

Goals:

Speed the translation of research discoveries from bench to bedside and back
Leverage investments in biomedical research to improve the drug development process
Reduce drug attrition due to safety concerns and/or lack of efficacy

Monday, July 30, 2007
7:00 am	Registration and Continental Breakfast
8:00 am	Meeting Introduction Dr. Min H. Song, National Cancer Institute, NIH
8:05 am	Opening Remarks Dr. Francis Collins, National Human Genome Research Institute, NIH
8:15 am	Keynote Presentation Cancer Biomarkers: Lessons from Kinase Inhibitors Dr. Charles L. Sawyers, Memorial Sloan-Kettering Cancer Center
Session 1: Toward More Predictive Preclinical Models
	Co-Chairs: Dr. Jack Reynolds, JAReynolds & Associates Dr. Richard Okita, National Institute of General Medical Scienses, NIH
9:00 am	Introduction to Session 1 Dr. Jack Reynolds, JAReynolds & Associates
9:05 am	Computational Genetics: Toward Understanding Our Drugs and Diseases Dr. Gary Peltz, Roche Palo Alto
9:40 am	Integrating Experimental, Text Mining and Analytical Prediction Methods in Drug Discovery Dr. Carolyn R. Cho, Pfizer Research Technology Center
10:15 am	Coffee Break
10:45 am	High-Throughput in vivo Assessment of Small Molecule Efficacy and Safety Dr. Randall T. Peterson, Massachusetts General Hospital
11:20 am	In Vitro-In Vivo Correlations for Induction Dr. Kenneth R. Korzekwa, AllChemie Inc.
11:55 am	NeuroAIDS: Bidirectional Translation of Molecular Targets in the Development of Novel Therapeutic Strategies Dr. Harris Gelbard, University of Rochester Medical School
12:30 pm	Lunch
Session 2: Early Clinical Evaluation of Pharmacokinetics and Pharmacodynamics
	Co-Chairs: Dr. David Jacobson-Kram, Center for Drug Evaluation and Research, FDA Dr. Bruce Littman, Pfizer Global Research and Development
1:20 pm	Introduction to Session 2 Innovative Dose-Ranging Designs in “Learn”: Three Case Studies Dr. David Jacobson-Krams, Center for Drug Evaluation and Research, FDA
1:25 pm	Theory and Applications of Scaling Mechanistic PK/PD from Animals to Man Dr. William J. Jusko, State University of New York at Buffalo
2:05 pm	Focus on the Molecule and its Target Dr. Jerry Collins, National Cancer Institute, NIH
2:45 pm	Coffee Break
3:15 pm	Use of Translational Biomarkers in Drug Development Dr. Margaret A. Read, Infinity Pharmaceuticals
3:55 pm	PET Biomarkers for Inflammation and the P-gp Efflux Transporter: Translation of Imaging from Animals to Humans Dr. Robert B. Innis, National Institute of Mental Health, NIH
4:35 pm	Evaluating Efficacy in Phase 0: Improving Phase 2 Survival Dr. Bruce Littman, Pfizer Global Research and Development
5:15 pm	Close of the day

Tuesday, July 31, 2007
7:00 am	Registration and Continental Breakfast
Session 3: Biomarkers for Assessment of Responses to Therapies
	Co-Chairs: Dr. Carl C. Peck, University of California San Francisco Dr. Min H. Song, National Cancer Institute, NIH
8:00 am	Introduction to Session 3 Introduction to Biomarkers for Assessment of Responses to Therapies Dr. Carl C. Peck, University of California San Francisco
8:15 am	Intravascular Ultrasound Assessment of Atherosclerosis Progression and Regression Dr. Steven E. Nissen, Cleveland Clinic Foundation
8:55 am	Implementing Mechanism-Relevant Biomarkers for Assessing Upstream and Downstream Responses to Aurora A Inhibition Dr. Mark Manfredi, Millennium Pharmaceuticals Inc.
9:35 am	Biomarkers for Early Prediction of Acute Kidney Injury Dr. Prasad Devarajan, Cincinnati Children’s Hospital Medical Center
10:15 am	Coffee Break
10:45 am	Predicting Responses of Cancer using PET Imaging Dr. Richard L. Wahl, Johns Hopkins Medical Institutions
11:25 am	Biomarker Applications in Drug Development: Predicting Response and Risk of Adverse Events Dr. Nicholas Dracopoli, Bristol-Myers Squibb
12:05 pm	Lunch
12:55 pm	Featured Presentation Public-Private Partnership: The NIH/FDA/PhRMA/FNIH Biomarkers Consortium Dr. Barbara Mittleman, Office of the Director, NIH
Session 4: Tools and Approaches for Personalizing Medicine
	Co-Chairs: Dr. Deanna L. Kroetz, University of California San Francisco Dr. Dan M. Roden, Vanderbilt University Medical Center
1:40 pm	Introduction to Session 4 Dr. Dan M. Roden, Vanderbilt University Medical Center
1:45 pm	Linking Drug Responses to Genomic Variability: the Pharmacogenetics Research Network Dr. Dan M. Roden, Vanderbilt University Medical Center
2:15 pm	Pharmacokinetic and Pharmacodynamic Consequences of Drug Transporter Pharmacogenetics Dr. Deanna L. Kroetz, University of California San Francisco
2:45 pm	Coffee Break
3:15 pm	Use of Genetic Biomarkers for Efficacy Stratification in Clinical Development Dr. Daniel K. Burns, GlaxoSmithKline Pharmaceuticals
3:45 pm	Whole Genome Association Studies in Neuropsychiatry: Safety of Existing Medicines and the Identification of New Therapeutic Targets Dr. David B. Goldstein, Duke University
4:15 pm	A Review of Regulatory Tools and Activities that Lead to Personalized Medicine Dr. Michael Orr, Center for Drug Evaluation and Research, FDA
4:45 pm	Close of the day
Wednesday, August 1, 2007
7:00 am	Registration and Continental Breakfast
Session 5: Optimization of Clinical Trial Designs for Efficient Drug Development
	Co-Chairs: Dr. Robert Temple, Center for Drug Evaluation and Research, FDA Dr. Donald A. Berry, University of Texas MD Anderson Cancer Center
8:00 am	Introduction to Session 5 Dr. Donald A. Berry, University of Texas MD Anderson Cancer Center
8:05 am	Innovative Statistical Designs for Clinical Trials Dr. Donald A. Berry, University of Texas MD Anderson Cancer Center
8:45 am	Innovative Approaches to Integrate Decision Making Across Disease and Drug Platforms – Metabolic Syndrome and the PPAR Platform Dr. Eiry W. Roberts, Eli Lilly & Company
9:25 am	Qualification and Acceptance of Biomarkers, Surrogate Endpoints and Diagnostics Dr. Stephen A. Williams, Pfizer Global Research and Development
10:05 am	Coffee Break
10:35 am	Use of Enrichment Designs to Promote Efficiency Dr. Robert Temple, Center for Drug Evaluation and Research, FDA
11:15 am	Innovative Dose-Ranging Designs in “Learn”: Three Case Studies Dr. Michael Krams, Wyeth Pharmaceuticals
11:55 am	Lunch
Session 6: Treatment of Diverse Diseases that Share Common Targets and Pathways
	Co-Chairs: Dr. Mark J. Ratain, University of Chicago Dr. Robyn J. Barst, Columbia University
12:45 pm	Introduction to Session 6 Dr. Mark J. Ratain, University of Chicago
12:50 pm	Kinase Inhibitors for the Treatment of Cancer Dr. Mark J. Ratain, University of Chicago
1:30 pm	Novel Therapeutic Agents for Pulmonary Arterial Hypertension: Role of Signaling Inhibitors Dr. Robyn J. Barst, Columbia University
2:10 pm	Coffee Break
2:40 pm	Tyrosine Kinase Pathways in Rheumatoid Arthritis Dr. William H. Robinson, Stanford University
3:20 pm	Multi-targeted Kinase Inhibitors as Topical Therapies for Posterior Segment Ocular Disease Dr. John Doukas, TargeGen, Inc.
4:00 pm	Targeting Mitochondrial Hyperpolarization of T-Cells for Treatment of Systemic Lupus Erythematosus Dr. Andras Perl, State University of New York at Syracuse
4:40 pm	Wrap-up Dr. Min H. Song, National Cancer Institute, NIH
4:45 pm	Close of the Workshop

Additional information can be obtained by contacting Dr. Min Song at songm@mail.nih.gov.

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This page last reviewed: March 19, 2008