By Deborah Borfitz
May 5, 2008 | Whether they know it or not, most emerging biotech companies could use help exploring the means of arriving at their first clinical trial. Cash-strapped start-ups have a tendency to overlook the backend benefits of investing in standard operating procedures (SOPs) or the downside of relying solely on physician investigators for advice about how to intelligently design a protocol, says Stephen Fogelson, founder and president of Develotron LLC, a Worcester, MA-based clinical development consultancy. Their development plans also tend to be short on realistic timeline and budgetary details necessary to raise and sustain venture capital funding.
Develotron is itself a fledgling firm, though Fogelson is no newcomer to the drug development business. Up until last October, he was the chief clinical consultant at Clinquest, a product development organization in Hudson, MA. His expertise is in being creative and resourceful, both handy traits on projects that are technically complex or have tight budgetary constraints. “Some consultants get a little squirrelly with anything less than ‘best practices,’ but basic GCP [good clinical practice] can be achieved relatively cheaply when necessary.”
That being said, Fogelson’s mantra to the biotech sector is not to shortchange the end by the means. It may seem superfluous to develop SOPs if trial work is going to be outsourced to a clinical research organization (CRO), he says. But having a blueprint for oversight and contract functions could pay dividends down the road with regulators and partnering biopharmaceutical companies. Similarly, key opinion leaders may give elaborate free advice about what a product ought to do. But that might not represent the quickest path to the proof-of-concept stage unless it’s balanced with the perspective of industry about specific endpoints that require testing.
Early-stage biotech companies will often develop a generalized research strategy internally “without fully understanding all the operational implications of that choice,” says Fogelson. Develotron can do comparative analyses of the costs and timelines associated with different clinical development scenarios based on disease indication. A high proportion of trials fail to meet established timelines due to low patient enrollment, partly because of a failure to “set expectations” at the outset.
“My ideal client is a couple of years away from entering their first clinical trial,” says Fogelson. Preliminary clinical activities aren’t limited to protocol development, writing SOPs, and deciding what portion of the work will be outsourced. It might also include budget forecasting and analysis, systems analysis and development, and CRO selection and negotiation, as well as an assessment of product feasibility, staffing, infrastructure, and product production needs for each clinical trial phase and treatment arm. “I sometimes encourage clients to establish communication with the FDA [Food and Drug Administration] in advance of an IND [investigational new drug] submission and help bring in the expertise to ensure a good, productive dialogue.”
Develotron’s current client roster is composed of a small group of emerging, U.S.-based biotech firms seeking face-to-face interactions, says Fogelson, but relationships are being nurtured with more established companies primarily seeking project management assistance. Fogelson adds that he’s expanding his capabilities in the device development arena in response to growing demand.
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