- FasterCures praises efforts to modernize FDA drug review programs (February 2018)
- FasterCures Comments on the FDA’s Patient-Focused Drug Development Discussion Documents (February 2018)
- FasterCures commends bipartisan support of FDA Reauthorization Act (August 2017)
- FasterCures Comments on the Proposal to Create an Office of Patient Affairs at FDA (June 2017)
- FasterCures Congratulates Scott Gottlieb’s Confirmation as FDA Commissioner (May 2017)
- Public Comments »
In the News
- Health Citizenship: A New Social Contract To Improve The Clinical Trial Process (May 2018)
- Make Match Day a Movement Toward Health Citizenship (March 2018)
- Kim McCleary provides insight into how patient groups approach the drug pricing issue (March 2018)
- Kim McCleary and Kristin Schneeman outline key medical R&D Issues to watch in 2018 in Health Affairs (January 2018)
- The intersection of tech and life science at Partnering for Cures featured in WRAL column (December 2017)
- In the News »
One of the most exciting changes that we’ve been collectively advancing at FasterCures is the push to bring patients into the spotlight and to use their perspective more fully in all that we do in R&D.
The U.S. Food and Drug Administration (FDA) has recently brought much of this work into motion, and we at FasterCures have been thrilled to see the change that their actions have embodied and to serve as partners in the process.
Our team has long supported efforts to enhance patient-focused drug development (PFDD) and the implementation of the patient perspective across the R&D pipeline. FasterCures participated in several PFDD meetings, as well as in stakeholder meetings for the Prescription Drug User Fee Act and Medical Device User Fee Amendments. Throughout these efforts, we have advocated for the advancement of patient input.
May 2018: The Research Acceleration and Innovation Network (TRAIN) E-News
Under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V) in 2012, the U.S. Food and Drug Administration (FDA) initiated the Patient-Focused Drug Development Initiative (PFDDi). Over the course of the five-year commitment, FDA has collected input from 2,500 patients during PFDDi meetings, which have informed the regulatory decision-making process. To expand the value of participant input, the FDA initiated a process for patient groups to host externally-led PFDDi meetings that the FDA is open to participating in. These meetings are structured largely the same as the FDA-sponsored ones, giving FDA staff the opportunity to gather patient input from a broader group of disease areas.
Tanisha Carino, Ph.D., the respected senior executive with more than two decades of experience in academia, government, and the private sector, is joining the Milken Institute as executive director of FasterCures, the center devoted to saving lives and improving the medical research system. More »
- Innovators in Medical Research head to San Francisco for Milken Institute Partnering for Cures; Program focuses on patient-centered solutions and the impact of technology on biomedical research
- FasterCures to Further Accelerate Biomedical Innovation with $3 Million Grant from Helmsley Trust (March 2017)
- Partnering for Cures to Bring Together Hundreds of Medical Research Leaders Nov. 13-15 in New York (Nov. 2016)
- NIH Director Francis Collins to receive FasterCures’ Partner of the Year award (Oct. 2016)
- Science Translational Medicine Article Tracks Emerging Field of Science of Patient Input (April 2016)