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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
Published on: December 11, 2016
An industry statistician's perspective on PHC drug development
Contemporary Clinical Trials
|May 8, 2013
Summary
Drug development costs are rising due to failed trials. Focusing on targeted treatments with predictive biomarkers offers a more efficient path for personalized healthcare (PHC).
Area of Science:
- Biopharmaceutical industry
- Clinical trial design
- Personalized medicine
Background:
- Drug development is increasingly costly and time-consuming, with high failure rates in traditional clinical trials.
- A significant portion of this cost is attributed to lengthy, expensive, and unsuccessful drug trials.
- The pharmaceutical industry faces challenges in optimizing return on investment for drug development.
Purpose of the Study:
- To review industry approaches and challenges in drug development strategies that incorporate predictive biomarkers.
- To outline concepts of co-development for novel therapeutics and diagnostics.
- To present guiding principles for personalized healthcare (PHC) development.
Main Methods:
- Review of industry perspectives on drug development strategies.
- Discussion of co-development concepts for therapeutics and diagnostics.
- Examination of statistical, strategic, regulatory, and operational challenges in PHC development.
Main Results:
- Incorporating predictive biomarkers into clinical programs offers a strategy to improve drug development efficiency.
- Co-development of therapeutics and diagnostics is essential for targeted treatments.
- Personalized healthcare (PHC) development requires new strategies and approaches.
Conclusions:
- Targeted treatments with predictive biomarkers can enhance clinical benefit in specific patient populations.
- The co-development of novel therapeutics and diagnostics is crucial for the success of personalized medicine.
- Addressing statistical, strategic, regulatory, and operational challenges is key for effective PHC drug development.
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