Digital Health Innovation in Highly Prevalent Chronic Disease

November 2018

On November 7, 2018 the Harvard-MIT Center for Regulatory Science and Biotechnology Innovation Organization (BIO) partnered on a workshop that explored opportunities for digital innovation to address some of the challenges faced in highly prevalent chronic disease clinical trial development. Opinion leaders from biopharma, technology companies and academia discussed the benefits of digital technologies in clinical trials and patient care, regulatory gaps and opportunities for digital innovation, and issues around aggregation of data from multiple sources.

Workshop Outputs

The discussions were synthesized in a summary report accessible to roundtable participants.

Innovative Approaches to Clinical Biomarker Validation

October 2018

On October 25, 2018 the Harvard-MIT CRS in collaboration with the Program On Regulation, Therapeutics and Law (BWH) co-hosted a one-day conference on approaches to collecting and sharing clinical trial data and the implications of these approaches for validating clinical biomarkers. The invited speakers included leadership from the FDA, Cochrane Collaboration, (a new patient-level clinical trial data- sharing platform), and CancerCommons (a not-for-profit network of patients, physicians, and scientists that helps cancer patients to identify and select optimal treatment).


Workshop Outputs

Key points from the meeting were published in a series of opinion pieces in a special issue of the Journal of Law, Medicine & Ethics on September 2019.

Duke-CRS Anticancer Drug Development Workshop

September 2018

On September 28-29, 2018, Harvard-MIT Center for Regulatory Science and Duke University co-hosted a 2- day workshop around anticancer drug development. The discussion in the first day focused on how patient advocates can work more effectively with all stakeholders in the research process – industry, academia, government and technology – to ensure that the patient voice is incorporated across all conversations and decision making. The second day featured an advanced clinical development workshop discussing the specific strategies leading to successful development pathways for new anticancer agents. Viewed as a training opportunity for early career investigators and fellows, the event engaged experts from academia, government agencies and biopharma in discussions around drug development, approval and value for new cancer therapies.

Workshop Outputs

Over 80 participants from across academia, industry, and patient advocacy joined in this educational session to learn about the drug development process. This was a fantastic opportunity for postdoctoral fellows and junior investigators to connect with patients and patient advocates and learn how their research might have real world impact on patient outcomes.