The shift in sponsors’ focus comes as large pharmaceutical companies are investing more money in longer partnerships with fewer CROs (contract research organizations) than they were in the past decade.
Joshua Schultz, VP of strategic partnerships at Parexel told us that based on a recent survey conducted by Parexel on strategic partnerships, the company found that 88 percent of industry executives said that one of the biggest issues is the type of oversight and governance required by a sponsor. The number of full-time employees that a sponsor has to devote to a partnership is crucial in determining how much it will cost to maintain a certain level of quality, he said.
Executives at the Avoca Quality Consortium Summit last month expressed similar concerns about the oversight of CROs. Only 41 percent of sponsors in the Avoca survey said they thought they could achieve quality without increased oversight.
Some suggested transferring more of the risk in a developing compound to CROs might change the dynamic. But Schultz said there’s only so much risk that can be off-loaded on a CRO as sponsors ultimately reap the profits and are liable for the risks of a compound. But CROs and sponsors need to align their incentives, including operational milestones, he added.
Mutual Investment
Another hot item was the amount of mutual investment for a partnership, which 84 percent of executives in the survey cited as an issue in selecting a partner. That investment includes the time and money it takes to integrate technological systems and databases between the companies, Schultz said.
He added that the survey showed sponsors that can allow a leaner oversight model can contribute to how executives make decisions in selecting CRO partners.
Schultz also said the gap between larger and smaller CROs is widening as major investments in IT and best practices in risk-based monitoring “are difficult to make if you’re a small- or medium-sized CRO, and these investments have enormous value.”
But in terms of CROs having to differentiate their work based on the size of a sponsor, Schultz said that the “volume of work and the type or scope of the work didn’t come up as a major driver for a partnership.”
Recent surveys show a rise in employee turnover at CROs might have a negative impact on the industry. But Schultz said that partnerships “allow for a more formal management of knowledge, enabling turnover dynamics to be mitigated.”