October 2010 – The CenterWatch Monthly : PDF
Anticipating disruptions from sponsor M&As and consolidations
Teresa Sligh, M.D., was working on compounds with Schering-Plough when the project mysteriously stopped. Then she found out about the Merck-Schering Plough merger. Sligh’s experience isn’t that unusual. One of the often overlooked consequences of the recent flurry of merger and acquisition (M&A) activity in the biopharmaceutical industry is a disruption in relationships between drug sponsors and their service providers.
During the past two years, as numerous mergers have resulted in delays and cancellations of planned clinical trial work, the turmoil inside drug companies has made it difficult for many investigative sites to even reach their contacts. As the dust begins to settle from the recent biopharmaceutical M&As, investigative sites and CROs now worry about fewer opportunities going forward. They’ve redoubled their business development efforts to build new relationships with the biopharmaceuticals in order to replace those contacts who took new jobs or left the industry as a result of a merger.
More sites launching early-phase units
Wherever one looked this summer, it seemed another investigator site was launching a small, early-phase unit. This hot site trend of summer 2010 could, once it gathers more steam, constitute a threat to the big CROs that currently dominate the early-phase market.
Why now, as the economy begins to show signs of improvement, are so many sites jumping into this new business line? A panoply of factors have come together to make early-phase work attractive right now, paramount among them the changing nature of drug development and how that has trickled down to the site level.
Indeed, the dearth of promising new drug candidates has been widely publicized. Add to that the economic slowdown that has hit the industry hard. As a result, late-phase work at the site level has slowed, leaving sites scrambling. Luckily, at the same time, sponsors began to look at cutting costs by sending more candidates into something of a staged mix of phase I and IIa trials as a way to test efficacy immediately after testing safety.
Eye On: Biogen Idec
The mission statement of Biogen Idec is to create new standards of care for unmet medical needs, particularly in the therapeutic fields of neurology, immunology, oncology, cardiopulmonary and hemophilia. Biogen Idec products are available in more than 90 countries for highly prevalent and disabling conditions such as multiple sclerosis, rheumatoid arthritis, Crohn’s disease and non-Hodgkin’s lymphoma.
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