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In Bay State, trying to do more trials with patients can be a test of patience

Boston Globe
By Scott Kirsner | October 24, 2005

Why don't Massachusetts biotech and medical-device companies conduct more of their clinical trials in Massachusetts?

It's the kind of question around which committees, institutes, and working groups are formed. But so far, this particular grain of sand hasn't yielded a pearl.

	“We're trying to engage all the key stakeholders, and we want this to be a sustainable effort, not a one-time summit.”
MTC Executive Director Mitchell Adams commenting on the subject.

It seems obvious everyone would benefit from a life-sciences ecosystem that enabled local companies to do at least some portion of their patient testing locally. Drug and device companies wouldn't have to travel so far afield to manage their trials; doctors would get an opportunity to work at the cutting edge of medicine; and patients, points out Tom Moore, associate provost for clinical research at Boston University, would ''get a chance to test new potential therapies."

But in today's global economy, work shifts to wherever it can be done most efficiently and inexpensively, and that means that many local companies run trials in other parts of the country or the world.

''The cost pressures that are hitting everyone in healthcare are hitting biotech as well," says Michael Astrue, interim chief executive of Epix Pharmaceuticals, a Cambridge company that develops contrast agents for medical imaging. ''But timeliness is also important. You don't want to lose three months because your trial is running slowly, because that's three months in the market you lose."

Of course, when life-sciences companies conduct trials, they tend to go where the experts are -- eminent specialists who can help design a study and lend their prestige to the trial when they publish the results. In later-stage trials that involve hundreds of patients, companies gravitate to centers that treat large volumes of patients suffering from the same malady. (And most big trials involve multiple sites.) But when life-sciences companies have a choice, they often run into high costs and institutional unresponsiveness in Massachusetts.

''For a smaller company that is venture-backed, it's really a cost-driven decision that's made," says Tom Sommer, president of the Massachusetts Medical Device Industry Council. ''They're looking at the cost of performing these trials here, or in Texas, Michigan, Colorado, or around Europe." There is, sadly, no hometown discount extended to local companies trying to develop a drug or device. Given the chance to run a cheaper clinical trial elsewhere, Sommer says, ''clinical affairs specialists from companies around here get on planes and go to other venues."

Running trials doesn't generate profits for hospitals, observes Alison Taunton-Rigby, a veteran biotech executive who serves on the board of the Massachusetts Biotech Council. ''That's why Mass. General doesn't bend and help you," she says. ''It's not a profit center, and they don't need the prestige."

Attitude and red tape also can be factors. Individual doctors must step forward to help conduct trials, and the hospital structure around them needs to facilitate making those trials happen smoothly.

At Boston University, Moore helped streamline the process by which trials are reviewed to ensure that they're ethically and medically sound. Boston University's internal review board would examine a trial and give an answer in 50 to 60 days, Moore says. But through an arrangement with an outside, for-profit review organization, the school can now give industry-sponsored trials the ''go" or ''no-go" in just over 20 days. ''We've seen an increase in the volume of trials done here," he says, though it's not necessarily attributable to that change. (He's careful to emphasize that the speed doesn't compromise the quality of the review.) Moore and others say they aren't aware of other academic hospitals in Massachusetts that have expedited things similarly.

There have been earlier efforts to dial up the number of trials taking place in Massachusetts. The issue came up at the 2003 Life Sciences Summit at Harvard Business School, which gathered leaders from academia, industry, and government. But a task force set up to address the issue lost momentum after Robert Pozen stepped down as the state's secretary of economic development later that year.

Another effort to address the issue may be getting underway at the Massachusetts Technology Collaborative. ''We're trying to engage all the key stakeholders," says executive director Mitchell Adams. ''And we want this to be a sustainable effort, not a one-time summit." Adams has received a grant from the Boston Foundation to form a Life Sciences Collaborative, which he says will tackle clinical trials as part of its mission.

Initiatives and collaboratives are just swell. But what's even better are individuals who care about moving the needle, will bang the drum, and are willing to find and track the right metrics. (I couldn't find good consolidated data, for instance, on the number of trials being conducted in Massachusetts, and number of patients enrolled.)

It would help to have Ranch Kimball, the current secretary of economic development, and Mitt Romney involved, helping to poke life-sciences executives and hospital leaders in the ribs. Adding a hospital exec to the board of the Massachusetts Biotech Council wouldn't hurt either, to keep the lines of communication open.

(Policy chief Stephen Mulloney told me there hasn't been one on the board there for three or four years; Moore serves on the board of the medical-device council.)

Patient advocates, too, need to make it clear they and their confederates are eager to get as many trials going in Massachusetts as possible -- and that they'll help marshal participants.

''We could do a lot more," says Chris Colecchi, vice president for research and ventures at Partners HealthCare System. He was formerly head of clinical trials at Mass. General. ''There could be a lot more interactions between local companies and academics here." He says his office helps coordinate about 500 clinical trials a year, a number that is ''fairly consistent, probably pretty flat, but not declining."

One idea at Partners is to extend trials out into community clinics and hospitals -- which could expand the number of doctors and patients involved, and make it easier for patients to participate.

''It's in everybody's interests for the whole biomedical complex locally to be as large and diverse as possible," says Astrue at Epix Pharmaceuticals. ''The companies are more than willing to work with the hospitals to try to advise them on ways to be industry-friendly. I give a lot of credit to Paul Levy," Astrue continues, referring to the chief executive of Beth Israel Deaconess Medical Center. ''He has reached out to me personally to try to get advice on how to get it done better. But I've never heard from any other place."

Unfortunately, the issue hasn't yet risen high enough on any individual's priority list -- or that of a trade group.

Taunton-Rigby led a committee within Mass. Biotech that tried to address the question of increasing clinical trials. But, she says, ''We backed away from that issue. People don't see enough benefit to trying to do something about it. The attitude is 'It's a problem, but let's keep doing what we're doing.' "

Scott Kirsner is a contributing editor at Fast Company.