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Bridging the Valley of Death in Medicine

Head Writer

Preston Ge '17

· Preston Ge

There is no doubt that the United States excels at supporting basic biomedical research. In fiscal year 2015, the National Institutes of Health (NIH) invested over $30 billion annually through 50,000 grants, supporting over 300,000 researchers in both the US and elsewhere in the world. Despite fears of the US losing its edge in research, American researchers published nearly 40 percent of all papers published in biomedical research in 2009, a figure that has changed little over the years[1].

With the US’s track record in basic research, one might expect an equally impressive record in drug development. Yet, despite an ocean of biomedical research, new drug approvals remain a mere trickle. In 2014 alone, over a million papers were deposited into Pubmed, NIH’s database of biomedical research articles[2]. During the same year, only 44 drugs received FDA approval. While the quantity of research increases by the year, the number of drug approvals has declined and remained stagnant for nearly two decades[3]. Over the last decade, basic biomedical research has seen huge advances in bioinformatics, genome sequencing, gene editing, high throughput drug screening, and so on. Yet, these advances have thus fallen far short of their promise to revolutionize the treatment of human disease.

This gap between biomedical research and successful drug development is not a recent phenomenon. As early as 2004, it found itself in the crosshairs of then-NIH Director Elias Zerhouni, who termed it the ‘Valley of Death’[4]. Many believe that the main cause of this gap is a drop off in research funding for translational research, which bridges basic research and clinical research. The standard pipeline for drug development moves from drug discovery in basic research, to preliminary safety and dosage studies in translational research, and finally to drug efficacy and long-term safety evaluation in clinical trials. With research funding mainly going towards basic and clinical research, translational research has traditionally been the purview of the pharmaceutical industry[5]. Yet, with the increasing complexity of basic research and increasing regulatory demands, the pharmaceutical industry is hard pressed to continue this work alone.

Over the years, many initiatives have been tested and refined to help overcome the Valley of Death. In 2003, for example, the NIH established and provided $500 million in funding to a consortium of 60 Clinical and Translational Science Centers (CTSCs) at major universities and medical centers[6]. Many nonprofit organizations, such as the Michael J. Fox Foundation for Parkinson’s Research, the Cure Alzheimer’s Fund, and the Prostate Cancer Foundation have adopted novel goal-oriented and collaborative translational research strategies that differ from the open-ended, discovery-driven model of biomedical research[7]. Further efforts seek to forge new partnerships between the private sector and nonprofit research institutions, such as with the Johns Hopkins Alliance for Science and Technology Development and Drug Innovation Ventures at Emory (DRIVE)[8],[9].

These efforts appear to be working. The approval of 44 drugs in 2014 is the highest since 1996. Since bottoming out at 20 drug approvals in 2005 and 2007, there number of new drugs approved each year seems to be trending upward[10]. However, the fact remains that drug approvals are still lower than they were two decades ago, despite huge advances in diagnostic and drug discovery tools, far greater total research output, and much greater research funding. In short, the return on biomedical research is still far below what it used to be.

However, lack of funding for translational research is not a contributory factor to the Valley of Death. Clinical and basic research, which in the 1960s and 70s were tightly linked, are now widely disparate, with most basic research carried out by specialized PhD scientists who have never and never will treat patients.[11] Moreover, biomedical research is plagued by a festering reproducibility crisis: more than 70 percent of researchers have tried and failed to reproduce work by other scientists, with more than 50 percent failing to reproduce their very own work[12]. With such uncertainty surrounding the reliability of much basic research, it is difficult to chart a clear path forward in drug development. Ultimately, the efforts discussed above are insufficient for bridging the Valley of Death, simply because it is less a result of funding shortages and more a result of fundamental structural problems in biomedical research. Nothing less than a comprehensive overhaul of the very conduct and structure of biomedical research is necessary to close the Valley of Death.

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[1] Herper, Matthew. "The Most Innovative Countries In Biology And Medicine." Forbes. Forbes Magazine, 13 Mar. 2011. Web. 18 Sept. 2016.

[2] "Search Results." National Center for Biotechnology Information. U.S. National Library of Medicine, n.d. Web. 18 Sept. 2016. < http://www.ncbi.nlm.nih.gov/pubmed/?term=2014%3A2014>

[3] Munos, Bernard. "2014 New Drug Approvals Hit 18-Year High." Forbes. Forbes Magazine, 2 Jan. 2015. Web. 18 Sept. 2016.

[4] Eastman, Quinn. "Getting New Drugs through the 'valley of Death'" Emory News Center. N.p., 27 Jan. 2014. Web. 18 Sept. 2016.

[5] Butler, Declan. "Translational Research: Crossing the Valley of Death." Nature.com. Nature Publishing Group, 11 June 2008. Web. 18 Sept. 2016.

[6] Butler, Declan. "Translational Research: Crossing the Valley of Death." Nature.com. Nature Publishing Group, 11 June 2008. Web. 18 Sept. 2016.

[7] Bornstein, David. "Helping New Drugs Out of Research's 'Valley of Death'" The New York Times. The New York Times, 02 May 2011. Web. 18 Sept. 2016.

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