The increased focus on precision medicine holds tremendous promise to more effectively target treatments to those individuals most likely to have a benefit. However, there are a number of regulatory science challenges to ultimately develop and utilize personalized medicine technologies and approaches. The objective of this 3rd annual Forum is to bring together federal agencies, industry, foundations and academic institutions, to help identify and address some of the key topics and opportunities for regulatory science to advance precision medicine. Ultimately, the goal is to advance precision medicine by identifying and addressing regulatory science gaps, informing regulatory decision-making, and developing educational resources.
The Regulatory Science to Advance Precision Medicine Working Group has finalized the following topic for the 2019 Fall Forum:
Digital health, focusing on the opportunities and challenges for improving and utilizing digital measures as Real World Evidence to advance precision medicine. This includes diverse sources of digital biomarkers that are more functional measures of health and are increasingly captured in a real world setting. The Forum will focus on identifying regulatory science gaps and needs, while examining areas of emerging science, regulatory considerations, ethics and privacy, and data storage and use.
There is no cost to attend the Forum, which is sponsored by the University of Rochester Clinical and Translational Science Institute (CTSI) and the PhRMA Foundation.
Registration is required, as space is limited. If you would like to register or have any questions, please contact Scott Steele (Scott_Steele@URMC.Rochester.edu) or Joan Adamo (Joan_Adamo@URMC.Rochester.edu).