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September 2010

Dr. John McLane

Conducting a Clinical Trial in Europe from the Perspective of a U.S. Virtual Company

by Dr. John McLane
VP Clinical and Regulatory & COO, Clinquest

A common biotech business model is to have a lean and fast virtual organization. These organizations are established with experienced professionals who have a wide breadth of entrepreneurial experience and experience within the pharmaceutical, biotechnology or even medical device sectors. These organizations also have innovative products that are to be developed to the next inflection point, which is usually a step to reduce further developmental risk. The product can then be moved on toward regulatory development or licensed to a larger organization. Conducting early phase I or II (or a combination of both) clinical trials for the innovative product is often the mandate of these types of virtual companies. With limited human resources the organization must outsource many of the tactical and operational activities. For a clinical trial this will include the activities associated with manufacturing, distribution, regulatory, clinical operations, and safety evaluations.

The following is a case study of some of the key processes that a virtual biotech company located in the United States undertook to conduct a Phase II study in Europe. The company was a small four-person company that had acquired the license to a small molecule that had already been in a proof-of-concept, open label trial (with good results) at a University clinical setting in Europe. The active pharmaceutical ingredient (API) in the product was well known to be safe under its current use. For this study, the API was reformulated and had a changed delivery system (nasal) and was to be used in a new medical indication: migraine prophylaxis. There was good justification for the mechanism of action applicable to migraine prophylaxis. The principle physiology of migraine onset that might be affected by this API had been originally proposed in European universities. Investigative site costs tend to be lower per subject in Europe than in the United States; subjects in studies in Europe are not accustomed to high payments per subject and they frequently conduct studies with reimbursement received for time and travel costs only.

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