laborative initiatives offer numerous lessons for developing a standard mechanism for regulatory science. Several successful models of collaborative networks already exist, such as the Tufts Center for the Study of Drug Development, DC-based UCSF Center for Drug Development Science, European Center for Pharmaceutical Medicines, European Innovative Medicines Initiative, and further analysis of these initiatives can be useful in developing an implementation plan for building regulatory science within FDA.

  • Leverage informatics and existing network capabilities. Various industry sectors have devoted considerable resources to development of surveillance, which could be leveraged through cross-sector and cross-disciplinary partnerships.

  • Educate the public. Public education is an important component to raise awareness and understanding about the complexity of clinical research and the drug development process, and about the need for a strong regulatory science to support drug development. There is a general lack of understanding, by not only the public but also by academia, about the roles of NIH and FDA, respectively, in supporting regulatory science for drug development. Patient advocacy voices are a key element in providing models and input for energizing the public about the need for enhanced regulatory science.

  • Actively engage public policy community. The public policy community is a strong force for enacting reform and should be considered a partner in the efforts to boost regulatory science. As demonstrated by improvements in HIV/AIDS therapies and cancer care, an effort as substantial as the establishment of a regulatory science infrastructure cannot succeed without the understanding and support of the public policy community. FDA and other stakeholders will need to involve and communicate effectively with patient advocates, policy makers, and the public in its endeavors to move forward with this effort.

  • Secure sustainable support for regulatory science. Although FDA’s FY 2011 proposed budget includes an allotment for regulatory science activities, establishing a regulatory science infrastructure will not happen overnight and will require steady funding, workforce, and leadership for realization.

Many workshop participants acknowledged that simultaneously developing in-house expertise, taking advantage of available funding mechanisms, and coordinating with external experts will be a massive undertaking. Building a regulatory science infrastructure will require tremendous commitment, resources, and an agreed-upon blueprint to be successful.

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