R&D Policy

FasterCures fosters patient-centric policies and practices that enable greater patient participation in drug development and regulatory decision-making. 

We work with patient advocates, investors, policymakers, researchers, and other life science leaders to: 

Support federal investment in research

FasterCures champions federal investment that fuels promising scientific discovery and supports the development and delivery of treatments and cures. This includes ensuring that the National Institutes of Health (NIH), which funds approximately $30 billion of research annually, can continue to support groundbreaking programs and young investigators and have policies in place that will allow it to develop partnerships and pursue transformative ideas.


Advance regulatory capacity and processes

Enhancing capacity at and resources available to the Food and Drug Administration (FDA) is a key component to improving and continuously modernizing the medical research environment. Working across sectors, FasterCures advocates for an FDA that is fully equipped with the resources and expertise it needs to keep pace with the changing technology and that is able to apply 21st century scientific principles to regulatory practices and policies. We also seek to optimize the use of patient perspective data in regulatory decision-making, particularly as it pertains to weighing the benefits and risks of new medical products.


Expand patient engagement

FasterCures believes that for the medical research system to work, it has to be patient-focused and patient-driven. We educate legislators about the social and economic value of medical research and advocate for more widespread, collaborative, and effective use of patient data – including biospecimens, clinical encounter data, and patient preference information – across the discovery, development, and delivery continuum.


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How we've impacted policy

Advocated for passage of the 21st Century Cures Act (H.R. 6) by the U.S. House of Representatives

  • Through the 18 months it took to get this uniquely bipartisan bill off the ground, FasterCures educated legislators and stakeholders about the value and imperative of infusing patient perspectives across the medical product continuum.  
  • FasterCures Executive Director Margaret Anderson testified in a roundtable convened by the U.S. House of Representatives Energy and Commerce Committee as part of the 21st Century Cures initiative, and FasterCures Founder and Chairman Michael Milken joined in a televised roundtable alongside NIH Director Francis Collins, U.S. Health and Human Services Secretary Sylvia Burwell, and (then current) U.S. FDA Commissioner Margaret Hamburg.

Educated regulators about the importance of enhancing the science of patient input as a means of stimulating innovation

  • In July, 2015, FasterCures participated in both the Medical Device User Fee Amendments (MDUFA) and Prescription Drug User Fee Act (PDUFA) reauthorization public meetings. Our comments highlighted the importance of enhancing the science of patient input to ensure that patient perspectives can be effectively integrated into product development while also informing regulatory approval decisions.
  • FasterCures continues to work with regulatory leaders to engage patients in ways that are purposeful, reciprocal, dynamic, and transparent.  

Had a positive impact on the effectiveness of the NIH’s Intramural Research Program through work led by FasterCures Board Member and Nobel Laureate David Baltimore

  • This task force examined tangible ways to fully optimize NIH’s $3 billion Intramural Research Program. In January 2009, the group presented recommendations designed to strengthen this vital program. As of January 2013, three of the five recommendations the group presented have been acted on, the most significant of which involved allowing external scientists access to the NIH’s Clinical Center.

Provided significant support for the effort to create the National Center for Advancing Translational Sciences at the NIH

  • Held a Capitol Hill briefing, June 25, 2013, "Science, Cures and All the Stuff In Between," where we hosted more than 100 congressional staffers, patient advocates, academics and drug developers to discuss the importance of federal support for translational research.
  • Developed a series of publications that spotlights the importance of translational research in the therapeutic development process, models of collaboration in early-stage R&D, and major challenges and possible solutions.

Been an effective advocate for increased resources at the FDA

  • FasterCures supports FDA’s efforts to improve drug development by implementing innovative pathways to expedite cures to patients as well as accelerate clinical trials laser-focused on patient outcomes.
  • We seek to foster a regulatory framework that incorporates patient perspectives into benefit-risk assessments.
  • Given the mounting pressures facing the FDA from globalization, statutory requirements, and regulatory science initiatives with limited resources, FasterCures supports the recognition of funding FDA as a national priority.

Educated legislators and advocates about the value of biomedical research and the critical role federal agencies play in the R&D ecosystem

  • Through our Capitol Hill briefingsFasterCures brings together leaders and decision-makers from across sectors in medical research to acknowledge that medical research matters and to encourage the leaders to make research a priority for the national policy agenda and to join us in this fight for cures.
  • The Celebration of Science brought together 1,000 leaders in medical research, bioscience, patient advocacy, industry, philanthropy, and public policy, including the Majority Leaders of the U.S. Senate and House on the same stage in support of the same goal. As one of our speakers noted, “Disease doesn’t care which party you prefer.”