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The Institute of Medicine (IOM) Forum on Drug Discovery, Development, and Translation (the Forum) provides a unique opportunity for stakeholders to meet and discuss issues of mutual interest in a neutral setting. It includes leaders from private sector sponsors of biomedical and clinical research; federal agencies sponsoring and regulating biomedical and clinical research; foundations; the academic community; consumers; and federal and private health plans. The range of issues the Forum addresses includes the full drug development pipeline—from drug discovery and regulatory approval to translation of research into clinical practice. The Forum convenes several times each year to identify and discuss the most important issues within its purview. To supplement the perspectives and expertise of its members, the Forum also holds public workshops and symposiums to engage a wide range of experts, members of the public, and the policy community in discussing specific issues of concern in the science and policy of drug development.

The past year has been one of extraordinary opportunity and challenge in pharmaceutical innovation. Advances in genomic science, systems biology, and cell-based technologies have led to exciting new avenues of biomedical research and drug discovery, and have given us glimpses of the “personalized” future of medicine. Despite these advances, the pathway from basic science to new therapeutics faces challenges on many fronts—the regulatory process, the translational science workforce, the high costs of clinical trials, and many others. As a result, we have seen a gradual decline in new drug therapies entering the market, and shifts in both research capital and talent to new centers of biomedical innovation in Asia and Europe. Despite the high stakes, the public is largely unaware of these trends and their potential impact. As we move forward, it will be important for the public, policy makers, and the scientific community to understand the scientific issues and appreciate the consequences of policy decisions related to pharmaceutical innovation. The Forum looks forward to prompting and fostering these important discussions. 

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INITIATIVES FOR 2008-2009

Discussion Series
In the fall of 2007, the Forum launched a series of Biomedical Science and Policy discussions. The Discussion series serves as an opportunity to inform the Forum, and engage the public and the policy communities on critical issues and public concerns related to drug development. Past discussions have included Patient Perspectives on Drug Development, A Conversation with Tony Fauci of NIH’s NIAID, Comparative Effectiveness, and Science at FDA. The Forum plans to host several additional discussions on a variety of relevant topics in 2008-2009. Click here to see a list of upcoming events.

Workshop: New Funding Models for Drug Development
In June 2008, the Forum will hold a public workshop to discuss innovative models for funding and advancing development of drugs for rare or neglected diseases. Speakers and participants at the workshop will (1) outline changes in the translational research process that have taken place over the past ten years; (2) discuss new models for funding translational research and new technologies; and (3) examine regulatory, legislative, and institutional policy tools currently in place to help advance therapeutic development for rare or neglected diseases. Click here for more information.

Workshop: Safety Biomarkers
The Forum is committed to advancing the FDA’s critical path initiative through its continual review and discussion of emerging safety science technologies and methodologies. As a follow-up to the Forum’s Emerging Safety Science workshop in April 2007, the Forum is hosting a workshop on Safety Biomarkers in October 2008. The broad objectives of this workshop will be to consider whether genomic technologies can be used to anticipate off-target drug effects earlier in the development process, to evaluate the progress of industry and the critical path initiative in the development of safety biomarkers, and to discuss what collaborative efforts will be needed to speed development of clinically relevant biomarkers. Click here for more information.

Symposium: Multidrug-Resistant Tuberculosis
Medicines are urgently needed to treat a host of life-threatening and debilitating diseases of the developing world. Although many such drugs are within reach, their development and use has been impeded by barriers that include a lack of financial incentives, problems associated with international enforcement of intellectual property rights, a lack of infrastructure for drug development and distribution, inadequate epidemiological data and reporting systems, and an inadequately trained clinician workforce. To address this issue, the Forum will explore strategies for encouraging the development of new drugs for neglected diseases, consider research priorities and opportunities for capitalizing on existing basic research, and explore promising public–private partnerships that could help meet this critical need. The first activity under this initiative will be a symposium on multi-drug-resistant tuberculosis. To prepare for the symposium, the Forum commissioned an authored paper by Partners in Health in association with Harvard University. Under the leadership of Jim Kim and Paul Farmer, a team of researchers will examine a range of MDRTB global scale-up challenges, including adequate diagnostics and implementation models, in addition to access to quality assured drugs. More information will be available in the coming months.

Workshop: Translational Workforce
During the Forum’s 2007 workshop Challenges for FDA: the Future of Drug Safety, participants recognized that within the field of translational medicine, there is a growing deficit of a trained workforce capable of embracing and driving the emerging biomedical research revolution. Lack of integrated training programs and adequate funding is contributing to this deficit. In 2008 the Forum will explore opportunities to stimulate national interest in the creation and financial support of programs to equip researchers with an integrated skill set ranging from molecular mechanistic science and systems biology to clinical science and epidemiology. More information will be available in the coming months.

Workshop Series: Precompetitive Collaboration in Biomedical Research and Drug Discovery
The completion of the Human Genome Project has created extraordinary opportunities to transform modern medicine. Cutting edge technologies for realizing this potential are emerging at a fast pace, with new developments in systems biology and bioinformatics pointing the way. In a major new initiative over the next two years, the Forum will explore ways to accelerate development of new drugs through increased collaboration between universities, industry and government. A series of workshops will address distinct stages in the drug development pathway—target identification, lead optimization, pharmacology and toxicology, clinical development, and pharmaceutical regulation—in order to identify obstacles and opportunities within each. For each stage, opportunities and challenges associated with collaboration in precompetitive space will be addressed—including intellectual property, conflict of interest, human capital, and financial issues. More information will be available in the coming months.

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