Forum on Drug Discovery, Development, and Translation: Annual Report 2009 (2010)

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Initiatives for 2010 A series of work group meetings will be held through 2010, in which information will be exchanged and analyzed, and strategies discussed. Regulatory Science FDA Community Updates: Premarket Drug Safety and The Forum will hold a public workshop in February 2010 to the Benefits and Risk of Pharmaceuticals examine the state of the science of drug regulation and to As a part of the Forum’s broader Biomedical Science and consider approaches for enhancing the scientific basis of regu- Policy Discussion Series, the third FDA Community Update latory decision making. Individuals from the federal govern- will examine progress made in the premarket drug safety sys- ment, pharmaceutical industry, academia, industry, and pa- tem since the release of the IOM drug safety report and the tient groups will discuss the strengths and weaknesses of the passage of the FDA Amendments Act of 2007. The series will current regulatory science framework, and consider a range of also consider the challenges and policy issues that remain. A strategies for improving regulatory science, such as develop- fourth FDA Community Update will brief Washington policy- ment of a scientific discipline of regulatory science, increased makers on the agency’s progress in communicating benefits collaboration between regulatory and academic researchers, and risks of pharmaceuticals to the medical community. The and enhancement of the regulatory science infrastructure. meeting will follow a 2006 Forum workshop on the same topic and the creation of new FDA advisory committees dedi- Transforming Clinical Trials in the United States cated to risk communication and transparency issues. In 2010, the Forum will continue its discussion on how clini- cal trials can be improved to enhance feedback to a learning The Growing Threat of Multidrug-Resistant health care system. The meeting will examine the need for a Tuberculosis national infrastructure for clinical trials that will help to close In March and May of 2010, the Forum plans to hold MDR the gap between clinical research and clinical practice. It will TB workshops in South Africa and Russia. The workshops will also consider alternative approaches and proposals for such bring together local and global experts, as well government an infrastructure, and consider strategies for improving the leaders, to open dialogue on overcoming the rising threat of organization and design of clinical trials across different set- MDR TB. Similar workshops in China and India are in develop- tings and clinical areas. ment. The goal of these in-country meetings is to bring atten- tion to the growing problem of MDR TB worldwide, and to Conflict of Interest consider alternative global strategies for transmission control, Following the 2009 IOM report on conflict of interest, the drug procurement, diagnosis, and treatment. Forum began the development of a public workshop to explore approaches to implementing the IOM’s recommen- Drug Failures Analysis dations in ways that promote openness and collaboration The Forum established a precompetitive collaboration to among academia, industry and government. A key aspect better understand drug failures, explore the establishment of of this workshop is a comparative analysis of approaches to standards for data collection and analysis, and to ultimately managing conflicts in the United States and elsewhere, and a foster better decision-making with respect to research and background paper is being commissioned in order to provide investments in drug development. While a number of IOM a baseline of information on international standards and activities are exploring precompetitive collaboration from a best practices in managing conflict of interest. A workshop is conceptual and policy framework, this is an operational col- planned for the Fall of 2010.     laboration through which member companies have begun to share and analyze information in order to understand the root causes of late-stage attrition. 10