Completed
Topics
While early co-development successes have demonstrated the potential for a genomic-based approach to drug discovery and development, certain questions remain, including the processes for partnering, the economic viability of co-development for diagnostics, payer reimbursement for companion tests and off-label use of these drugs, the substitution of non-FDA approved tests, the challenges in changing technologies for an existing companion diagnostic, the need for multiple tests for ever smaller diagnostic tissue specimens, and many others. The Roundtable on Translating Genomic-Based Research for Health hosted a workshop to examine the challenges of and potential solutions for co-development of molecular tests and targeted therapeutics.
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Workshop
·2014
Many drug developers have examined new strategies for creating efficiencies in their development processes, including the adoption of genomics-based approaches. Genomic data can identify new drug targets for both common and rare diseases, can predict which patients are likely to respond to a specifi...
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Description
An ad hoc planning committee will plan and conduct a public workshop to examine and discuss challenges and potential solutions for the co-development of targeted therapeutics and companion molecular tests for prediction of drug response. The goal of the workshop will be to feature presentations and advance discussions among a broad array of stakeholders which may include in vitro diagnostic test companies, pharmaceutical companies, regulators, pathologists, providers, patients, and public and private payers. The planning committee will develop the workshop agenda, select and invite speakers and discussants, and moderate the discussions. An individually-authored summary of the workshop will be prepared by a designated rapporteur in accordance with institutional policy and procedures.
Collaborators
Committee
Robert McCormack
Chair
Debra Leonard
Co-Chair
Philip J. Brooks
Member
Elizabeth Mansfield
Member
Victoria M. Pratt
Member
Ronald Przygodzki
Member
Derek T. Scholes
Member
Pamela L. Swatkowski
Member
Sponsors
Department of Defense
Department of Health and Human Services
Other, Federal
Private: For Profit
Private: Non Profit
Staff
Adam Berger
Lead
Major units and sub-units
Health and Medicine Division
Lead
Institute of Medicine
Lead
Board on Health Sciences Policy
Lead