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  1. Advancing Regulatory Science

Importance of a Strong Regulatory Science Culture and Infrastructure: Strategic Plan for Regulatory Science

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Implementation Strategies for the Strategic Plan for Regulatory Science

This report has outlined a number of priority areas where FDA believes advances in the underlying regulatory science will catalyze innovation in regulatory review as well as product and methods development. Each scientific emphasis area presented in this plan represents opportunities to drive a new and important research agenda using a variety of means, from enhancing the FDA internal research program to expanding informal external collaborations and participation in formal consortium models. By identifying key scientific challenges and implementation plans within each priority area, FDA is providing a guide for its regulatory science efforts and a focal point for research and development activities beyond the walls of the agency. It should be noted that while FDA is a science-based agency that does and will continue to directly support regulatory science research, it is not primarily a funding agency. FDA is, however, an agency that has scientific staff spanning diverse disciplines from food science to engineering to medicine, who are making important contributions to the biomedical, tobacco, toxicology, and foods science research enterprises. The sections below briefly describe some of the potential avenues for fostering a strong regulatory science culture, improving the scientific infrastructure, and promoting and engaging in the regulatory science research agenda laid out in this plan.

Partnerships with Government Agencies

Currently FDA is actively collaborating with several government agencies and departments to provide guidance, co-sponsor, collaborate, or partner to promote regulatory science programs. These relationships include the formation of an NIH-FDA leadership council, which launched its first Regulatory Science Requests for Applications (RFA) under which four regulatory research programs are currently being supported, as well as ongoing and active participation in the design, development and approval of projects that are part of the NIH Biomarkers Consortium.

FDA is continuing to explore expansion of efforts with NIH as well as new efforts with other agencies to promote and support regulatory science research and development. A critical component of the FDA science strategic plan will be implemented through enhanced collaborations between FDA and other agencies, domestic and international, both to leverage funding for supporting outside research but as importantly to establish new collaborative intramural research projects where expertise from each agency can be brought to bear on regulatory science research projects.

Staff Scientific Training and Professional Development

In addition to the proactive regulatory science efforts outlined in this plan, it is essential to maintain the capacity and in-house scientific and technical expertise needed both to evaluate increasingly complex and innovative products and technologies and to respond rapidly and effectively to public health emergencies. A strong in-house science base and a network of collaborations is necessary to help support FDA success in addressing these public health challenges, and FDA is supporting various mechanisms where staff have opportunities to increase their knowledge and skills, thereby strengthening the Agency’s science base. FDA staff training and professional development is enhanced by participation in scientific and professional meetings and conferences where experts present their most current research and through collaborations and relationships, both formal and informal, with academic institutions that provide FDA with access to cutting edge science through courses, workshops, and seminars. Academic collaborations also support faculty coming to the FDA to impart their knowledge, in addition to FDA staff participating in academic activities and initiatives to bring knowledge back to the agency. Additionally, every year the Commissioner's Fellowship Program brings talented young scientists with cutting edge experience in academia, industry, and government to FDA every year to work with FDA scientists and learn about regulatory science and review.

Direct Funding Mechanisms

The FDA product Centers and Offices, such as the Office of Critical Path Programs within the Office of the Commissioner are currently engaged in direct support of relevant scientific programs in the form of grants, cooperative agreements, or contracts. These programs supply both research support and in many cases collaborative engagement with and guidance from scientists across the agency. Recent examples include RFAs to fund cooperative agreements for regulatory science programs in the areas of reproductive toxicology and biomarker qualification, and for a pilot program to potentially support a regional academic collaboration with a Center for Excellence in Regulatory Science and Innovation (CERSI) to support regulatory science research, training, scientific exchanges, and professional development. Moving forward, FDA will continue to engage selectively in direct funding mechanisms to seed important areas of science noted in this strategic plan. FDA’s limited funds, however, will generally need to be targeted for
initial pilots or start up funds that will be used to leverage resources from other sources, such as other government agencies, industry through consortium models, or philanthropy. FDA will continue to identify key areas for investments through issuance of competitive solicitations and will work to partner, in particular with the NIH, to directly support as much of the regulatory science agenda as feasible.

Public-Private Partnerships

Public-Private Partnership (PPP) models are a key component of the implementation strategy for FDA regulatory science. PPPs are one mechanism that can be used to leverage FDA resources by working collaboratively with both public and private partners, to achieve the agency’s mission as well as that of the partners. PPPs may take many forms and can range widely in size and scope. In addition, PPPs provide a means to leverage funds from academic institutions, FDA, other government agencies, and industry to support regulatory science priority areas as defined in this plan.

FDA can collaborate with partners from a wide range of other organizations including, but not limited to, patient advocacy groups, professional societies, charitable foundations, industry members, trade organizations, and academic institutions. FDA PPPs can be designed around the strategic priorities set forth herein and constructed in ways that advance the regulatory science research efforts of FDA in an efficient and cost-effective manner. Because these partnerships will be science-driven, aimed at advancing regulatory science, and structured to uphold the principles of transparency, fairness, inclusiveness, scientific rigor, and compliance with Federal laws and FDA policy, they are a valuable tool to achieving the Agency’s mission of advancing regulatory science. Currently FDA is engaged in several PPPs including the Clinical Trials Transformation Initiative and MDEpiNet Initiative.

One unique vehicle for establishment of PPPs is the Reagan-Udall Foundation (RUF), a non-profit foundation established by Congress for the purpose of advancing the regulatory science that FDA needs to accomplish its mission. RUF was designed to be a vehicle for bringing an array of resources and perspectives to bear on high priority FDA regulatory science projects. RUF can create consortia of patient groups, industry, academia and FDA scientists to design and implement regulatory science research.

Moving Forward

The headlines are replete with examples of the critical scientific role the Agency plays in addressing crises, such as contaminated heparin, melamine in pet food, outbreaks of food borne illness, and questions about vaccine safety, seafood safety, or readiness for pandemic influenza. A strong FDA science infrastructure provides the essential foundation for ensuring scientific excellence and integrity in all of our regulatory and public health decisions and activities. Successful engagement of other scientific communities in academia, industry, and government will be essential to attainment of FDA goals. FDA scientists must work in an environment that fosters creative thinking, promotes scientific multidisciplinary interaction and collaboration, offers opportunities for learning, ensures both scientific excellence and integrity, and provides access to state-of-the-art laboratory and computer technologies. The agency will develop creative ways to use technology to expand opportunities for training and collaboration, leverage external expertise and infrastructure through collaborative mechanisms to broaden the range of research possibilities, and provide joint training opportunities with external partners. It will also maximize the impact of our regulatory science investments by publishing in peer-reviewed scientific and medical journals and communicating research findings to the public by using Internet tools, such as its existing web site at www.fda.gov as well as some of the newer Web 2.0 tools available, to the maximum extent possible. In addition, to ensure the regulatory science remains up to date, FDA will periodically use the FDA Science Board and other outside scientific expertise to aid in identifying and prioritizing research efforts and to provide input on the relevance, quality, and productivity of the Agency’s regulatory science programs. A successful regulatory science program will translate key findings into FDA guidance and communications, both informal and formal, that reflect the latest scientific understanding as it relates to regulatory policy and decision making.

Table of Contents: Strategic Plan for Regulatory Science

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