Track 3: Executive Summit:
Drug-Diagnostic Co-Development
 

Day 1  |  Day 2  |  Day 3  

Final Agenda 

Monday, May 2

1:00-2:00 Main Conference Registration

2:00-2:10 Welcoming Remarks from Conference Director

Julia Boguslavsky, Executive Director, Conferences, Cambridge Healthtech Institute

 

Biomarkers as Decision-Making Tools 

2:10-2:15 Chairperson’s Opening Remarks

Nicholas C. Dracopoli, Ph.D., Vice President, Centocor R&D, Johnson & Johnson

2:15-2:45 Can Biomarkers Explain Why Drugs Fail? The Impact of Measuring Target Engagement, Downstream Effects and Preselecting Patients on Meeting Clinical Endpoints

Nicholas C. Dracopoli, Ph.D., Vice President, Centocor R&D, Johnson & Johnson

2:45-3:15 How Biomarkers Can Improve Clinical Drug Development and Drug Approval

Pravin Jadhav, Ph.D., FCP, Team Leader, Division of Pharmacometrics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

3:15-3:45 Applied Biomarkers: Where We Need More Research and Where We Don’t

Felix W. Frueh, Ph.D., President, Medco Research Institute, Medco Health Solutions, Inc.

3:45-4:15 The Yin and Yang of Biomarkers

Stefan Scherer, M.D., Ph.D., Global Biomarker Head, Product Development Oncology, Genentech

Personalized healthcare (PHC) is built on the premise that laboratory tests can accurately predict the response of individual patients to a particular treatment. The recent stakeholder behaviors, from regulators to payers and patients, physicians and pharmaceutical and diagnostic industry, suggest that the pursuit of therapeutic stratification will become a standard in oncology drug development. Among the growing number of examples for individualization of cancer therapy, Avastin and Herceptin will be presented as case studies for translation of results from pre-clinical research into a successful targeted therapy in a selected patient population and to demonstrate the associated challenges.

4:15-5:15 Opening Reception in the Exhibit Hall with Poster Viewing

 

Day 1  |  Day 2  |  Day 3