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Dark clouds for drug development.

As funding for the National Institutes of Health continues a decade-long trend of decline, corporate research is also shrinking. Recent layoffs and corporate restructuring reflect pharmaceutical companies' pulling back on drug discovery efforts, particularly for medications to combat dangerous, antibiotic-resistant "superbugs." The trend doesn't mean the end of research on anti-infective drugs. But it marks a significant slowdown in the effort to thwart an increasing medical problem. And it points to a more general issue in drug discovery and development: shrinking possibilities for blockbuster drugs to take off as clinical care turns its attention to personalized medicine.

A recent paper in Science describes the issue: "Although great strides were made in the 1990s [against fungal diseases that kill an estimated 1.5 to 2 million people each year], drug development has largely stalled since then," write David Denning and Michael Bromley of Britain's University of Manchester. In another report, Denning identifies "a critical need for new anti-fungal drugs, which is hindered by their slow development and increasing drug resistance to current weaponry in the fight against serious fungal infections."

A number of corporate research teams in the Boston-Cambridge area, a major hub for research on anti-infective drugs, have recently announced cuts of several hundred scientists and other staffers. The cuts stem from several causes, including consolidation of the industry through mergers and acquisitions and the narrowing of individual companies' research focus. And what's happening in Boston is being mirrored elsewhere in the United States and overseas. Late last year, for example, British big pharma GlaxoSmithKline announced plans to cut 900 jobs from its facility in Research Triangle Park, North Carolina--plans the company started implementing in March with the dismissal of 180 employees.

The problem isn't restricted to corporate research, though. Government support for academic research in the life sciences has plateaued since 2003, following a successful five-year effort to double the funding for the National Institutes of Health (NIH), the major funder of fundamental research on medical issues. Accounting for inflation, the plateau has meant an effective reduction of 20 percent in the NIH's budget. The result: one-eighth fewer research grants in 2014 than in 2004 and a drop of one-third in the R01-equivalent grants that support most independent laboratories.

A decline in drug discovery is not exactly new, and it is not limited to anti-infectives. In a global analysis published in Health Affairs in 2006, Duke University economists Henry Grabowski and Richard Yang found a reduction of about 50 percent in the annual rate of introductions of "new chemical entities" between 1982 and 2003. More recently, a study of data from the US Food and Drug Administration by analysts at wealth management company Sanford C. Bernstein showed a general decline in introductions of new drugs since the 1990s--the result, at least in part, of cutbacks in support for research. But while that continuing fall in academic and corporate research threatens drug discovery and development across the board, it causes the most concern to scientists working on infectious diseases.

That problem has also festered for some time. In 2008, for example, a report by the Infectious Diseases Society of America called for action to combat the threat presented by the development of antibiotic resistance in pathogens responsible for tuberculosis, pneumonia, and skin infections. The report pleaded for increased investments in R&D on antibiotics to bolster the diminished drug pipeline.

Analysts identify several reasons, beyond the reduction in federal funding, for the decline. The cost of introducing a new drug and successfully taking it to market has increased significantly over the past decade. So has the time span between discovery and introduction of a new drug. And as drug treatment becomes more targeted at small groups of patients rather than the general populations, the era of hugely successful blockbuster drugs seems to have ended. Mergers and acquisitions within the pharmaceutical industry--stemming in part from that realization--have also led to a reduction in the industry's overall productivity. For example, Amgen recently laid off 300 employees and closed a campus of Onyx Pharmaceuticals, which it purchased in 2013. French pharma Sanofi has announced plans to eliminate 100 positions, mainly in R&D, from Genzyme, a company that it bought in 2011.

Even without consolidation, some major pharmaceutical companies have pulled back on research related to infectious diseases. Companies such as AstraZeneca and Merck, for example, have cut positions in research on infective diseases as they have narrowed the focus of their research. That narrowing largely neglects anti-infective drugs. "Most major pharmaceutical companies are not investing in antifungals, preferring to focus on other, apparently more lucrative areas," Denning says.

Smaller biotechnology companies, meanwhile, are ensuring that they stay small by farming out much of their fundamental research, drug development, and clinical trial activities to clinical research organizations and contracting companies. That strategy insures against the need to lay off large numbers of employees from a drug project that fails in its late stages. But, of course, it reduces the intake of researchers.

The HEAL program of the Wildlife Conservation Society raises one more issue involved in the demise of infective drugs: environmental degradation that has led to a loss of biodiversity. Many of the most commonly used antibiotic treatments for infectious diseases, such as penicillin and tetracycline for bacterial infections, quinine and artemisinin for malaria, and avermectin for parasitic infections, are derived front natural sources. Indeed, more than half of the 100 most commonly prescribed medications in the United States originated in nature. The loss of biodiversity, the HEAL program claims, creates a barrier to the discovery of new antibiotics.

This situation "is hugely disruptive" to research, Michael Gilmore, who heads a microbiology laboratory at Harvard Medical School, told a March meeting of researchers in the field at the Broad Institute in Cambridge, Massachusetts. "There are few places focused on this problem in a significant way," he said. "As companies have given up the fight or have been taken over, you break that continuity."

What do industry, government, and academia need to do to remedy the situation? Quite a lot, according to Jon Lorsch, director of the National Institute of General Medical Sciences. "Re-optimizing the biomedical research enterprise will require significant changes in every part of the system," he wrote in a recent blog post. One suggestion: funding "smaller, more efficient research groups" that are more productive than larger outfits.

A report issued in January by the Federation of American Societies for Experimental Biology (FASEB) suggests possibilities in the academic arena. It urges NIH to complete plans already under development to give long-term grants to individuals and groups based on their track records rather than forcing them to continue seeking grants for specific projects. It also calls on universities to do more to prepare graduate students for careers beyond academic research. And several luminaries, notably former House of Representatives Speaker Newt Gingrich, have called for a doubling of the NIH budget. "The insights from genetics, personalized medicine and regenerative therapies could potentially lead to substantially longer and healthier lives for many," Gingrich wrote in the New York Times.

Analysts do see some signs of hope, particularly in the anti-infective arena. Denning and Bromley note that the US Food and Drug Administration has given new antifungal drugs the "orphan status" that allows them to move more quickly through clinical trials. And smaller biotechnology companies have begun to emerge in the anti-infective arena, often hiring researchers laid off by big pharma. Attacks on infective diseases from several directions should improve the understanding of the key risk factors. As a result, Denning notes, "stratification of patient groups will be possible, permitting more targeted clinical trials and ultimately leading to improved treatment regimens for patients."

DOI: 10.5437/08956308X5804001

MaryAnne M. Gobble, Editor

Peter Gwynne, Contributing Editor

Boston, Massachusetts
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Title Annotation:News and Analysis of the Global Innovation Scene
Author:Gwynne, Peter
Publication:Research-Technology Management
Date:Jul 1, 2015
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