Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development – A Workshop
Background and Workshop Objectives
The drug development process faces challenges of efficiency and overall sustainability due in part to high research costs, lengthy development timelines, and late-stage drug failures. In response to these difficulties, as well as promising drug discovery opportunities offered by large-scale sequencing initiatives, the Forum on Drug Discovery, Development, and Translation (the Forum) and the Roundtable on Genomics and Precision Health (the Roundtable) held a workshop in March 2016, Deriving Drug Discovery Value from Large-Scale Genetic Bioresources. Speakers and participants discussed opportunities to reinvigorate the current drug development pipeline by utilizing information from genetic bioresources, a strategy that has realized some considerable successes in early-stage drug discovery. This follow-on workshop will examine later stages in the drug development pipeline, including the design and implementation of genetics-based clinical trials. Novel clinical trial designs that target genetically identified participants represent a potentially disruptive paradigm shift that could reduce costs associated with drug development, improve patient outcomes, and further realize the goals of precision medicine.
This one-day public workshop will examine and discuss successes, challenges, and best practices for effectively utilizing genetic information in the design and implementation of clinical trials to support the development of precision medicines, including exploring the potential advantages and disadvantages of such trials across a variety of disease areas. Topics covered could include strategies for including genetically focused populations in clinical trial design, logistical challenges in conducting genetics-based clinical trials, and mechanisms for engaging with and educating potential trial participants. Subject matter experts will be invited to participate in the workshop through presentations and discussions that will:
- Explore how clinical trials with genetically identified participants can enable more efficient and effective drug development and advance precision medicine.
- Highlight ongoing genetics-based clinical trials across a variety of diseases, examining best practices and lessons learned.
- Learn about the logistical challenges and successes associated with genetics-based clinical trial design.
- Examine possible mechanisms to engage participants and improve enrollment into clinical trials based on genetic characteristics.
This workshop will be webcast.