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The Current Biomedical Research Environment Notwithstanding the efforts of the Markey Trust and other fund- ing entities to bridge the gap between rapid advances in our understanding of biological process and the translation of that knowledge into techniques for preventing diseases, concerns remain about the preparation and numbers of the workforce for conducting clini- cal research. Leon Rosenberg (1999) in the second annual Shannon Lecture at the NIH called on the NIH, the Howard Hughes Medical Institute, and other organizations concerned with scientific training to create and expand attractive training programs for medical students, M.D./Ph.D. students, postdoctoral fellows, and junior faculty. The NIH had already begun addressing the systemic and institutional issues surrounding the bed-bench gap before Rosenberg's charge, creat- ing in 1995 the NIH director's Panel on Clinical Research. The Panel, which included 14 physicians from academia and industry, released a report in 1998 (Nathan, 1998) calling for new programs, new resource allocations, and policy changes to encourage physicians to undertake ca- reers in patient-oriented clinical research. Both federal and private funders have responded to the Panel's recommendations. Immediately upon He report's release, the NIH created K-23 awards for mentored patient- oriented research career development and K-24 midcareer investigator awards in patient-oriented research (National Institutes of Health, 1998~. In the first two years these award programs attracted 452 research grant applications, the majority from M.D. investigators. In response to the call for new training programs in clinical research, the NIH K-30 awards pro. 32

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THE CURRENT BIOMEDICAL RESEARCH ENVIRONMENT 33 vice funds for curricular development at 55 institutions across the United States. In late 2001 the NIH announced its Clinical Research Loan Repay- ment program, which repays educational debts of investigators who are conducting patient-oriented research (National Institutes of Health, 2001~. Concurrently the collective investment in the career development of clinical researchers from the private sector has more than doubled since 1997. The total annual commitment has risen from $37 million to $78.5 million among a group of 11 private foundations and voluntary health agencies (Egan et al., 2002~. Most striking is the foundation group's re- sponse to the Panel's recommendations at the level of the new investiga- tor, where the annual dollar commitment has tripled since 1997 and now stands at $29.7 million per year. Foundation awards at this level have incorporated features designed to counteract the disincentives for physi- cian-scientists to enter careers in clinical research, such as loan repay- ment, more generous funding, longer award terms, and portability. The Howard Hughes Medical Institute announcement in [une 2001 specified that its next cohort of investigators would include only physician-scien- tists who were pursuing careers that integrated direct patient contact with biomedical research (Howard Hughes Medical Institute, 2001~. Despite the diversity and magnitude of these efforts, several areas still remain in critical need of support (Rosenberg and Ley, 2003; Zemlo et al., 2000~. Examples are additional research fellowships for medical stu- dents that involve debt prevention, recruitment of underrepresented mi- norities into clinical research careers, and training of Ph.D. researchers in translational research (Gray and Bonventure, 2002~. The federal government currently provides the built of funding for basic biomedical research at academic institutions. The President's fiscal year 2003 budget for the NIH, the largest source of such dollars, totals $27.3 billion (Government Printing Office, 2003~. Research-based pharma- ceutical companies invested $30.6 billion in R&D in 2001, but only about 5 percent of those dollars go to basic biomedical research and almost noth- ing goes into translational training programs. In 1999 about 73 percent of R&D expenditures at universities and colleges came from the federal gov- ernment, 9 percent came from industry, and 9 percent from philanthropy. Private philanthropists might wonder what can be accomplished with the substantially fewer private-sector dollars, but in fact, as noted by Kenneth Shine (American Cancer Society et al., 1998), "America's leadership in health science research can be greatly attributed to the creative synergism of public and private support of the research enterprise." While industry makes the greatest financial contribution, most of its support goes for the downstream development of products. Federal government funding, while the main source of money for biomedical research in universities, is largely for support of the research of individual investigators, with fewer

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34 BRIDGING THE BED-BENCH GAP dollars available for training or infrastructure investments, for risky re- search, for emerging areas of science often at the interfaces of fields, or for the training of translational researchers. Philanthropic dollars can pro- vide the risk capital for the biomedical enterprise by providing flexible dollars for innovation, for training in translational research, and for sup- porting undervalued or emerging areas of research. The Markey Trust provides one example of how charitable dollars can sunnort translational research. --r r