Lisa Henderson
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In last month's editorial, I wrote: "As the lines continue to blend between what is a biotech and what is a pharma, and even
what is a CRO." I was alluding to future business models and a potential for CROs to become true partners in the development
of a drug through financial risk. But after attending IIR's Partnerships conference and listening to a panel on "Leveraging
Relationship Structures to Optimize Sponsor–CRO Collaborations," I've changed my mind. It appears that no one relationship
model, in the many CROs and sponsors can have, stands out. The full-service CRO model, however, is out. And true copartners
toward the financial viability of a drug's development is not a viable solution either.
The panel, moderated by Kenneth A. Getz, MBA, senior research fellow at Tufts Center for the Study of Drug Development as
well as founder and chairman of CISCRP and Clinical Trials Insights columnist to this publication, included: John Hubbard,
PhD, FCP, global president of ICON Clinical Research; Jeffrey Kasher, PhD, vice president and chief operating officer, global
clinical development, Eli Lilly; Charles Morris, MD, vice president, worldwide clinical research, Cephalon; Daniel Perlman,
chief executive officer and chairman of RPS; and R. Adrian Otte, MD, BCH, vice president, global development operations, Amgen.
Led by Getz, the discussion reflected on data from a survey of Applied Clinical Trials readers—an article based on the results begins on page 42—about outsourcing. Getz described the different relationship types
between sponsor and CRO: functional service providers, transactional single service providers, transactional multi-service
providers, preferred recurring functional providers, and alliance providers, and how all models are in use to varying degrees.
The reason: Dr. Otte pointed to the dissatisfaction with the full-service model based on lack of standardization and portability.
Dr. Morris added, "If everybody is using a mixed model, why? Because they don't know which one is best. We have constraints
just like the larger sponsors. The really small guys have to be thinking of this [which model to use with a CRO] going in."
Risk ridiculous
Kasher said that his company is still trying to manage the types of relationships needed. However, he added, "I find the risk-sharing
model ridiculous. My business is getting molecules to market. The CRO's business is getting the science and development right."
He finished with: "Blurring of lines is not good...it is two separate companies."
Dr. Hubbard described the different types of risk that the CROs and the sponsors already assume. "There is delivery risk and
there is operational risk," he said. Adding product risk into the mix, he warned, would be very difficult for all parties.
It was Perlman's realistic statement about potential legal issues around a true financial partnership that sent the risk-sharing
model to pasture. "If the lawyers get involved and there is a drug failure after the CRO got paid? We [indicating the CRO
industry as a whole], not even the largest CRO, is large enough to handle it."
