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Policy Issues

Policy Issues

As a hub for catalyzing innovations in translational science, NCATS works closely with partners in the regulatory, academic, nonprofit and private sectors to identify and overcome hurdles that slow the development of effective treatments and cures. Through these partnerships, NCATS also focuses on policy issues important to and affecting translational sciences.

As a hub for catalyzing innovations in translational science, NCATS works closely with partners in the regulatory, academic, nonprofit and private sectors to identify and overcome hurdles that slow the development of effective treatments and cures.

Effective and thoughtful navigation through translational policy issues is vital to the success of NCATS. To succeed in our mission, the NCATS Office of Policy, Communications and Strategic Alliances (OPCSA) is working with partners to prioritize key issues and specific policy goals, likely to include the following:

Models for Precompetitive Collaboration

NCATS aims to re-engineer the translation process by bringing together expertise from the public and private sectors in an atmosphere of collaboration and precompetitive transparency. Through partnerships that capitalize on the respective strengths of each, NCATS works with government, academia, philanthropy, patient advocates, and biotechnology and pharmaceutical companies to overcome translational roadblocks and offer solutions to detect, treat and prevent disease.

Translational Research Policy

Through collaborative efforts, NCATS will work through policy roadblocks in strategic areas including therapeutic target validation, medicinal chemistry, pre-clinical toxicology, efficacy testing, virtual drug design, clinical trial design and post-market events. Because of its role within the U.S. Department of Health and Human Services, NCATS can partner with its sister agency, the U.S. Food and Drug Administration, in synergistic ways to advance regulatory science.

Intellectual Property for Collaborative Projects

Patenting and licensing are used to help ensure new technologies are developed fully and commercialized to advance public health, but they can sometimes be seen as impediments to moving collaborative science projects forward. NCATS intends to consider thoughtfully when patent protection is necessary to commercialize further a technology and ensure that barriers are not created in precompetitive research areas. Working closely with other NIH offices, NCATS hopes to pursue creative licensing arrangements with a variety of partners that will best develop NCATS technologies to address public health needs.

Ethical Issues in Clinical Trials

Clinical trials, whether “first in man” or for a new indication of an existing therapeutic, are generally intricate, costly and challenging to implement. NCATS will explore limitations of the Federal Policy for the Protection of Human Subjects (the Common Rule) in areas of consent, IRBs, data sharing and de-identified samples.

Looking Forward

OPCSA works closely with institutes and centers at NIH that are already deeply engaged in the translation process to conduct policy development and analysis that support the mission of NCATS. OPCSA plans to host workshops, conferences and seminars via multi-stakeholder working groups and teams, which will inform such outputs as issue briefs, white papers and scholarly publications. 

NCATS is catalyzing the development of new paradigms for translational science and will embrace the same mission to innovate around policy roadblocks to new therapies. By leveraging the extensive expertise of our network of collaborators and building new relationships with colleagues from the public and private sectors, NCATS aims to speed the delivery of new drugs, diagnostics and medical devices to patients.

Contacts

Penny Burgoon, Ph.D.
Director
Office of Science Policy

Dorit Zuk, Ph.D.
Director 
Office of Policy, Communications and Strategic Alliances


IOM Releases Report on CTSA Program

IOM Report Cover

On June 25, 2013, the Institute of Medicine (IOM) released its findings after reviewing the Clinical and Translational Science Awards (CTSA) program.

Statement from the NCATS Director

FAQ About the IOM Report

IOM Report

IOM Website

Working Group


Building an NCATS’ Policy Research and Analysis Agenda

On Dec. 11, 2012, NCATS convened a one-day workshop to discuss issues and obtain advice on proactively building a solid policy research and analysis agenda to inform translational research within the scope of the Center’s mission. This meeting provided an opportunity to collaborate with key stakeholders in the regulatory, academic, nonprofit and private sectors to obtain views on how policy research and analysis can inform translational research and to identify barriers in translation that could benefit from policy research and analysis. A summary of the workshop is available.


Presidential Report Highlights Drug Discovery

On September 25, 2012, the President's Council of Advisors on Science and Technology released its latest report: Report to the President on Propelling Innovation in Drug Discovery, Development, and Evaluation. The report highlights NCATS and its New Therapeutic Uses program.