Clinical trials are getting tougher
For those of you who wonder why the cost of getting a drug to market continues to grow each year, here’s what may be a piece of the puzzle: It’s getting harder to do clinical studies.
A report released Wednesday by the Tufts Center for the Study of Drug Development describes how clinical trials are getting more complex and harder to execute, and how it’s becoming more difficult to recruit and retain patients in these studies.
The report is a follow-up to a 2007 analysis performed by the center. The study looked at over 8,000 protocols from more than 75 pharmaceutical and biotechnology companies.
The report found, among other things, that the median number of procedures in a clinical trial increased by 49 percent, comparing the period of 2000-2003 with 2004-2007. Reflecting the rising complexity of trials, the number of eligibility criteria for entering patients into a study grew by 58 percent over that time, causing fewer patients to enroll in trials. The Tufts researchers also found that between 2002 and 2007, trials in oncology, immunology, and central nervous systems indications saw the biggest rise in procedures per trial.
Kenneth Kaitin, director of the center, says the increasing complexity comes from a number of factors, chief among them that the types of products being developed today tend to be geared toward more chronic and challenging indications. “Therefore the trials tend to be more complex,” he says.
The report, however, did not correlate the rise in complexity with any cost figures. How much does an average phase II trial cost today compared with, say, five years ago? How have the costs of a phase III or phase IV study changed? Kaitin says that as far as he knows there are no studies out there with those kinds of figures. There is an explanation, though: Companies are not very eager to share these numbers. Still, he says he strongly believes the overall increase in complexity goes hand in hand with higher costs.
SYLVIA PÁGAN WESTPHAL
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Oxford Bioscience Partners is losing one of its top general partners, Doug Fambrough, who has left his full-time role at the Boston venture firm to become chief executive of Dicerna Pharmaceuticals. Oxford is not currently investing in new companies, Fambrough says, and he told his partners in recent weeks that he could better serve the firm at Dicerna, which is an Oxford-backed company that is based in Watertown.
Fambrough, 41, plans to maintain a limited role with Oxford as a venture partner and will represent the firm on the boards of Solstice Neurosciences and Xencor. But his main focus now is Dicerna, the developer of gene-silencing drugs, which he cofounded in 2007 in his former role as general partner at Oxford.
Fambrough’s reduced role at Oxford is a blow to the firm’s talent pool, which has recently lost at least a few general partners, including Michael Lytton, who decamped early last year for a senior corporate development job at the Cambridge-based biotech powerhouse Biogen Idec.
RYAN MCBRIDE
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Waltham-based ImmunoGen said Thursday it has netted about $67.4 million through a stock offering. The company sold 9 million shares to investors at $8 apiece, for a gross of $72 million, then subtracted underwriting discounts and expenses. Underwriters of the deal have a 30-day option to buy another 1.35 million shares. The deal provides a big new cushion for ImmunoGen, which expects to burn through about $38 million to $41 million during the fiscal year ending June 30.
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San Diego-based Amylin Pharmaceuticals and its partners, Indianapolis-based Eli Lilly and Waltham-based Alkermes, said Thursday that the FDA has set a deadline of Oct. 22 to finish reviewing the application to start selling exenatide once weekly (Bydureon) for diabetes. The first application was filed in May 2009, and the FDA said in March that it wasn’t ready to be approved yet. Regulators aren’t requiring new clinical trials, although the companies said in March that issues remained around finalizing the prescribing information that guides physicians, along with a Risk Evaluation and Mitigation Strategy program, and “clarification of existing manufacturing processes.”
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Sanofi-Aventis, the French drug powerhouse that has one of its research sites in Cambridge, has agreed to contribute $500,000 over the next two years to a state program that provides financing to life sciences start-ups in Massachusetts, according to the Massachusetts Life Sciences Center, which administers the program. The program is one of several components of the state’s $1 billion life sciences initiative, a 10-year plan launched in 2008 to spur growth in the life sciences industry with grants, tax incentives, and loans to researchers and companies in the Commonwealth.
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Link Medicine has wrapped up its Series C round at $45 million, $5 million more than the $40 million the developer of drugs for neurodegenerative diseases said it would raise in the financing in September 2008, says Michael Fitzgerald, the company’s financial chief.
Cambridge-based Link has been pursuing new ways to treat Alzheimer’s, Parkinson’s, and other devastating neurological diseases.
This report was compiled by the editors of Xconomy, an online news website focused on the business of technology and innovation. For more New England coverage, visit www.Xconomy.com/boston. 
