The Role of Nonprofit Institutes in Pharmaceutical Development

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When I describe to friends and colleagues what I do for a living, I typically get a response like, “So, you are really no different than a pharmaceutical company.” Exactly. And not at all.

SRI International has played a major role in the development of therapeutics for a wide range of diseases over the years through partnerships with the federal government, private companies, and through our own drug discovery program. By my count, SRI has assisted in moving about 150 compounds from the discovery stage into clinical trials. Well over a dozen of these drugs have reached the market.

SRI Biosciences provides the full spectrum of drug discovery and development expertise in what we have trademarked as “Idea to IND®” service. If you toured our labs you would indeed see activities that so closely resemble those of a “Big Pharma” facility, you would be hard-pressed to tell the difference between SRI and a Bayer or Merck facility.

But the difference is not in what we do, but why we do it. As a collection of large, mostly publicly owned companies, “Big Pharma” is ultimately focused on increasing shareholder value—and thus providing quarterly profits and dividends for investors—and rightly so. Profit these days means drugs for arthritis, blood thinning, hypertension, cholesterol lowering, diabetes, erectile dysfunction, and cosmetic improvements (think BOTOX® and Rogaine).

By contrast, SRI often addresses the “neglected and orphan” drug needs of the world. There isn’t much money to be made in malaria, even though it affects half a billion mostly poor people and kills over a million a year. Likewise, pharma isn’t rushing to find a cure for Niemann-Pick Type C, a progressive neurologic disease with only about 500 cases per year worldwide that is always fatal, usually about the time a child reaches his or her teens.

Traditional pharmaceutical companies simply can’t afford to spend the $1 billion or more it takes to bring a drug all the way to market when the affected population is too poor to buy the drugs, or too small to make a dent in the investment. I wish it wasn’t so, but that is the reality of our economy. As someone with a few pharma stocks in his retirement funds, I think this is a pretty sensible approach, but as a citizen of the world, I’m outraged!

This is where organizations like SRI fill the gap, not a trivial task by any means. Putting together a program even to take a drug into early clinical trials can cost $3 million to $10 million, which is far beyond the reach of many moderately well-funded foundations. But like the famous inventions of Rube Goldberg, SRI has stitched together coalitions that include the National Institutes of Health, private philanthropy, disease foundations, state governments, and a host of other interested parties.

By cobbling together a team of players dedicated more to curing the disease than getting rich, we have helped advance a number of promising therapeutics. Halofantrine, still used in parts of the world for the treatment of malaria, was initially discovered using U.S. Army funding. Pralatrexate, for T-cell lymphoma, was moved to the marketplace through a coalition of SRI, two other nonprofits and a small pharmaceutical company (Allos Therapeutics). Other programs have advanced to the clinic by SRI, starting with NIH money then transferring to other nonprofits such as Medicines for Malaria Venture or the Drugs for Neglected Diseases Initiative.

Doesn’t sound so hard, right? Wrong. As federal money gets tighter and NIH grant pay lines go down, we have to scrape harder for the funding to support this kind of work. Often we invest our own money into programs as seed funds, hoping to generate enough data to win the next step of funding from a government or foundation.  It would be so much easier (and lucrative) to just go to work for Pfizer and develop the next Viagra®.

Why do I find my work so satisfying? About 10 years ago, I got together with a group of friends over the holidays and everyone was asking each other what they had done the previous year. One had arranged an IPO for a new tech startup.  Another acquired a small company as part of a merger.  One created an online division for his company. I said, “I moved a malaria drug into clinical trials where it is currently saving 10,000 lives a year in Mali.” Not many people get to measure the success of their work by the thousands of lives saved. This is why SRI pioneers in the “orphan and neglected” needs of the world. And it’s why I come to work each day.

Dr. Mirsalis, a board certified toxicologist, is managing Director of SRI Biosciences.  He is principal investigator on two large contracts with the National Institute of Allergy and Infectious Diseases for the preclinical development of drugs for a broad range of infectious diseases.

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