Companion Diagnostics

Strategies and Solutions to Streamline Development

Friday, February 15

8:00 am Morning Coffee

8:30 Chairperson’s Remarks

8:35 Successful Development and Commercialization of Precision Medicines: “It Takes a Village”

Hakan Sakul, Ph.D., Executive Director & Head, Diagnostics, Worldwide R&D, Clinical Research and Precision Medicine, Pfizer

9:05 Emerging Regulatory Trends in Drug-Diagnostic Co-Development

Erling Thor Donnelly, Ph.D., R.A.C., Director, Worldwide Regulatory Strategy, Pfizer, Inc.

9:35 From Biomarker to Companion Diagnostics: The Process Starts Early

Premal Shah, Ph.D., Director, Business Development, Genomic Health, Inc. (tentative)

10:05 Sponsored Presentations (Opportunities Available)

10:35 Coffee Break

11:00 PANEL DISCUSSION

Economic factors driving pharma’s decision-making regarding the companion diagnostic route, as well as the perspectives of the payer and regulator.

Moderator: Bruce Quinn, M.D., Ph.D., Senior Health Policy Specialist. Life Science & Government Strategy & Medical Coverage & Reimbursement, Foley Hoag

Panelists: Emily S. Reese, MPH, Pharmaceutical Health Services Research, University of Maryland School of Pharmacy

Larry J. Lesko, Ph.D., FCP, Professor, Department of Pharmaceutics, University of Florida College of Pharmacy

12:00 pm Luncheon Presentation I: Improving Patient Care through Companion Diagnostic Success: Biomarker Discovery to Global CommercializationChris Jowett, Global Commercial Head, Companion Diagnostics, Abbott MolecularThe business aspects of creating a successful companion product will be discussed. Phama and IVD manufacturers have the need to engage in efficient partnerships in order to drive specific but flexible and timely health care solutions that are patient focused. This talk will focus on collaborative partnerships that drive positive impact on patient care including models for successful development and market acceptance.

1:00 Luncheon Presentation II: (Sponsorship Opportunity Available) or Lunch on Your Own

1:45 PANEL DISCUSSION: Companion Diagnostics Post-Approval: Communicating Information to the Patient in a Global Environment

Remaining challenges of selling and marketing a companion diagnostic in the global marketplace and communicating information to the patient.

Moderator:Glenn A. Miller, Ph.D., Vice President and Head, Personalized Healthcare and Biomarkers, Strategy, Portfolio and Alliances, AstraZeneca Pharmaceuticals LP

Panelists: Richard E. Buller, M.D., Ph.D., Vice President, Translational Oncology, Pfizer, La Jolla

Walter H. Koch, Ph.D., Vice President and Head, Global Research, Roche Molecular Diagnostics

William Pignato, Global Head, Regulatory Affairs, Novartis Institutes for BioMedical Research, Inc.

3:20 Close of Conference

Day 1 | Day 2 | Day 3