FAST Congress
Archived Content

Implementing Personalized Medicine


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Friday, September 21

7:30-8:15 am Morning Coffee or Sponsored Breakfast Presentation (Opportunity Available)

Contact Ilana Quigley at or 781-972-5457

Regulatory Strategies for Drug-Diagnostic

8:30-8:35 Chairperson’s Opening Remarks

8:35-9:00 Companion Diagnostic Co-Development and Regulatory Considerations

Donna Roscoe, Ph.D., Senior Scientific Reviewer, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation, Division of Immunology and Hematology Devices, U.S. Food and Drug Administration

Highlighting several recent examples of the co-approval process, this talk will address regulatory expectations, recommendations, and lessons learned from the current perspective of the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) in the FDA’s Center for Devices and Radiological Health (CDRH).

9:00-9:25 XALKORI Rx/Dx Regulatory Challenges, Collaborations and Life Cycle Considerations

Erling Donnelly, Ph.D., Director, Worldwide Regulatory Strategy, Pfizer

9:25-9:50 Drug and Diagnostic Company Partnership: Regulatory Considerations

Christine Gathers, M.S., RAC, Senior Director, Global Regulatory Affairs, Diagnostics, Eli Lilly and Company

Drug development is challenging on its own, but the co-development of drug and diagnostic increases the complexity several fold.  The drug company must partner effectively with a diagnostic company to deliver meaningful data in an efficient manner to support the contemporaneous regulatory review of drug and diagnostic. There are a number of essential regulatory considerations for co-development that pertain to partnering such as partner selection, clinical trial design, regulatory interactions, labeling and registration. Effective partnering is critical to the success of realizing personalized medicine.

9:50-10:15 Regulatory Approval Process Integrating Sequencing in Personalized Medicine

Giselle Sholler, M.D., M.Sc., Associate Professor; Co-Director, Pediatric Oncology Translational Research Program, VAI/TGen; Haworth Family Director, Innovative Therapeutics Clinic, Helen DeVos Children’s Hospital; Chair, Neuroblastoma and Medulloblastoma Translational Research Consortium

10:15-11:15 Coffee Break in the Exhibit Hall with Poster Viewing

Personalized Medicine Reimbursement and

11:15-11:20 Chairperson’s Opening Remarks

11:20-11:45 Clinical and Economic Challenges Facing Personalized Medicine

Joshua P. Cohen, Ph.D., Senior Research Fellow, Tufts Center for the Study of Drug Development

This presentation examines the clinical, economic, and regulatory challenges that face developers of and payers for personalized drugs and companion diagnostics. We review and summarize clinical, regulatory and economic (reimbursement) issues with respect to eight, high profile personalized medicines and their companion diagnostics. We found that Medicare beneficiary access to physician-administered (Medicare Part B) drugs is relatively unfettered, with a fixed patient co-insurance percentage of 20%. More reimbursement restrictions are placed on self-administered (Medicare Part D) drugs, which translates into higher and more variable cost sharing, more use of prior authorization and quantity limits. There is a lack of comprehensive reimbursement of companion diagnostics, even in cases in which the diagnostic is on the label and recommended or required by the Food and Drug Administration. Lack of evidence linking diagnostic tests to health outcomes has caused payers to be skeptical about the clinical usefulness of tests. An increase in (personalized) comparative effectiveness research may help to close the evidence gap. Furthermore, a less ambiguous regulatory framework for co-development of therapeutics and diagnostics may provide a boost to personalized medicine.

11:45-12:10 Evidence-Based Evaluation of Specialty Pharmacy Targeted Drugs and Companion Diagnostics — An Evolving Process

Margaret Piper, Ph.D., M.P.H., Director of Genomics Resources, Technology Evaluation Center, Blue Cross Blue Shield Association

The Blue Cross Blue Shield Association Technology Evaluation Center (TEC) produces evidence-based assessments of the clinical effectiveness and appropriateness of a given medical procedure, device or drug. The TEC Specialty Pharmacy (SP) Program conducts evidence reviews related to specialty pharmaceutical agents. TEC assessments and SP reviews are available to BCBS plans solely for informational purposes, and do not constitute coverage determinations or recommendations. Recently, TEC has considered companion diagnostic tests for newly approved targeted drugs, and has reviewed the associated drugs. The process has identified several important limitations and gaps in knowledge.

12:10 Close of Conference

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