“The trend in oncology research continues towards targeted therapies,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health. “This test is an example of the important role companion diagnostics play in determining that the safest and most effective treatments are promptly delivered to patients living with serious and life-threatening diseases,” according to an FDA news release from August 2011.
Case studies to be discussed CHI’s conference:
Integrating Companion Diagnostics into Clinical Drug Development:
Hakan Sakul, Ph.D., Executive Director & Head, Diagnostics, Worldwide Research & Development, Clinical Research and Precision Medicine, Pfizer, Inc.
Fully integrating a diagnostic test into crizotinib pivotal trials, leading to a simultaneous submission of a drug-diagnostics combination, presented many challenges as well as opportunities in the development of crizotinib for treatment of NSCLC patients.
Speed of Drug Development by Incorporation of a Companion Test: Crizotinib Case Study
Keith Wilner, Ph.D., Senior Director, Oncology Clinical Development, Pfizer, Inc.
The use of a diagnostic test to appropriately identify a patient population expected to benefit from crizotinib treatment led to smaller clinical trials in NSCLC to meet the primary statistical endpoints as well as a greater chance of successful trials.
Simultaneous Approval of a Therapeutic & Companion Diagnostic: Crizotinib Case Study
Erling Thor Donnelly, Ph.D., R.A.C., Director, Worldwide Regulatory Strategy, Pfizer, Inc.
The simultaneous submission and approval of Pfizer's crizotinib and Abbott Molecular's anaplastic lymphoma kinase (ALK) break-apart FISH companion diagnostic presented unique clinical and regulatory challenges, requiring novel approaches as well as close collaboration between Pfizer, Abbott, CDER, and CDRH.
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