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Development and Maintenance of a Preclinical Patient Derived Tumor Xenograft Model for the Investigation of Novel Anti-Cancer Therapies
Published on: September 30, 2016
Drug development and clinical trials--the path to an approved cancer drug
Eric H Rubin1, D Gary Gilliland
1Merck Research Laboratories, 351 North Sumneytown Pike, North Wales, PA 19454, USA. eric_rubin@merck.com
Abstract:
Advances in our understanding of cancer biology have led to the discovery of a spectrum of new therapeutic targets. However, despite remarkable progress in the identification and characterization of novel mechanisms of the oncogenic process, the success rate for approval of oncology drugs remains low relative to other therapeutic areas. Innovative preclinical and clinical approaches, such as the use of advanced genomic technologies, as well as branched adaptive clinical trial designs, have the potential to accelerate the development and approval of highly effective oncology drugs, along with a matching diagnostic test to identify those patients most likely to benefit from the new treatment. To maximize the effectiveness of these new strategies, close collaboration between academic, industry, and regulatory agencies will be required. In this Review, we highlight new approaches in preclinical and clinical drug development that will help accelerate approval of drugs, and aim to provide more-effective treatments alongside companion diagnostic tests to ensure the right treatment is given to the right patient.
Insights
New strategies in cancer drug development, including advanced genomics and adaptive trials, aim to improve oncology drug approval rates. Collaboration is key to delivering targeted cancer therapies with companion diagnostics to the right patients.
Area of Science:
- Oncology
- Drug Development
- Genomics
Background:
- Cancer biology advances reveal numerous therapeutic targets.
- Oncology drug approval rates lag behind other therapeutic areas despite progress.
Purpose of the Study:
- To review innovative preclinical and clinical strategies for accelerating oncology drug development and approval.
- To emphasize the role of companion diagnostics in personalized cancer treatment.
Main Methods:
- Review of advanced genomic technologies in preclinical research.
- Discussion of branched adaptive clinical trial designs.
- Highlighting the need for inter-agency collaboration.
Main Results:
- Innovative approaches can potentially increase the success rate of oncology drug approvals.
- Companion diagnostics are crucial for identifying patient populations likely to benefit from new treatments.
Conclusions:
- Accelerated drug approval requires integrating novel preclinical and clinical strategies.
- Effective cancer treatment relies on a collaborative approach to match patients with targeted therapies and diagnostics.
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