Kim McCleary lores
Kim McCleary
Managing Director, FasterCures
Bioscience and Health
Kim McCleary is managing director at FasterCures, leading the charge on key programmatic areas including FDA and how it evaluates risk and benefit for patients, and medical innovation and how we determine value and reimbursement.
read bio

FasterCures responds to Senators’ Innovation Report

By: Kim McCleary
February 25, 2015

2015 has begun with a burst of health policy initiatives, from the release of the U.S. House of Representatives Energy & Commerce Committee’s 21st Century Cures discussion documentto President Obama’s announcement of the Precision Medicine Initiative as part of the administration’s FY16 budget request. Onthe Senate side of the Capitol, the Health, Education, Labor and Pensions(HELP) Committee, under the leadership of Chairman Sen. Lamar Alexander (R-Tenn.) and Ranking Member Sen. Patty Murray (D-Wash.), is gearing up to launch its own exploration of ways to better align public policies to accelerate promising therapies through the pipeline to patients.


As a first step, on Jan. 29, 2015, Alexander and HELP Committee member Sen. Richard Burr (R-N.C.) released a report, “Innovation for Healthier Americans: Identifying Opportunities for Meaningful Reform to Our Nation’s Medical Product Discovery and Development.” The senators describe their objective in the introduction:

“Science has never held greater potential to improve the quality of life and outcomes for America’s patients. In order to fully realize this exciting potential, we must identify, candidly assess, and confront existing factors that may be stifling efforts to innovate.” 

The 37-page report synthesizes data from a wide range of sources and includes correspondence between the Committee and the U.S. Food and Drug Administration (FDA).

Alexander and Burr invited feedback on the report, an invitation to which FasterCuresresponded. Our comments focus on three areas in which we believe more tightly coordinated action could lead to substantial improvements in the biomedical ecosystem:

1. Transitioning FDA’s traditional model of patient engagement with designated patient representatives to an evidence-based model that can effectively integrate the whole patient experience – including unmet medical needs, risk tolerance, and outcome preferences – into regulatory decision-making.

2. Applying learnings from FasterCures’ analysis of nearly 400 consortia through our “Consortia-pedia” program to enhance the many important public-private partnerships in which federal agencies, particularly FDA and the National Institutes of Health (NIH), are involved to increase their effectiveness and output.

3. Strengthening mechanisms to foster inter-agency collaboration between NIH and FDA in developing regulatory science tools, such as biomarkers and clinical outcome assessments, with the appropriate regulatory standards from the earliest stage of research. This includes bolstering jointly supported regulatory science training to ensure that our nation’s regulatory agency has a workforce with appropriately diverse scientific training to improve the development, review, and oversight of new drugs, biologics, and medical devices.

With new ideas springing from both the legislative and executive branches, plus a new cycle of user fee agreement negotiations getting underway later this year, we continue to believe the best solutions will come from open dialogue and collaborative action. Please share your ideas about how to accelerate science and regulation with policymakers and withFasterCures.


Opportunities to provide feedback: