Appendix C


Statement of Task

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.



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OCR for page 75
Appendix C Statement of Task An ad hoc planning committee will plan and conduct a public work- shop 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 stake­ olders h which may include in vitro diagnostic test companies, pharmaceutical com- panies, 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 indi- vidually authored summary of the workshop will be prepared by a desig- nated rapporteur in accordance with institutional policy and procedures. 75

OCR for page 75