According to its Strategic Partnerships 2013 report, CRO Parexel – whose model is focused on alliances and has partnered GSK, Pfizer and Merck & Co. amongst others – said 85% of pharma executives it interviewed believe strategic partnerships have had a positive impact on the CRO-sponsor relationship.
However, as the partnership cliff approaches for some long-term strategic alliances between Pharma and CROs, questions of what happens now were put to Pfizer, Novartis, Amgen and Baxter, as well as providers inventive and PPD in a packed room in Vienna, Austria.
One factor Pharma was united on was the importance of oversight when dealing with a CRO. Pfizer’s VP of Clinical Trial Support & Compliance, John Oldtman, told the room how in the regulator’s eyes it is Pharma and not the CRO who is accountable for all trials. “Risk-based data, global analysis, we can do this and oversee it,” he said. “Oversight is key.”
“There is a need to have reasonable levels of oversight,” Adrian Otte continued for Amgen, adding the highest risk to a sponsor-CRO relationship lies with “rogue CRAs.”
“If we don’t have a tight connection we will miss a lot,” he said. “These are the things that bring down companies.”
Increased relationships, decreasing numbers
Chairing the panel was BBC journalist Kirsty Wark who asked Oldtman, what model his company had chosen for its clinical trials outsourcing.
From once having seventeen functional service providers (FSPs), the Pharma Giant has moved to the to just two full service companies carrying out over 20,000 studies in a transitional move that leveraged costs he described as “really fun.”
Similarly, VP Clinical Development BioScience at Baxter, Barbara Valenta-Singer, said her company had seen a shift from twenty different FSPs just seven years ago to currently working with just four, admitting Baxter wants to move to just one partner with the possibility of another small contract to service any extra niche requirements.
Though Novartis has not historically outsourced a great deal of its clinical work, this is changing mostly due to its product portfolio, said Global Head Development Strategic Sourcing, Paula Gildert.
The Swiss Giant wants to “embrace partners who have the power to do better” and the shift to outsourcing “has been a rollercoaster” with the firm now having a mixture of partnering models. Regarding renewal of its three-year strategic alliances, Gildert told the room Novartis had assessed two partners in September and, after looking predominantly at the CRO’s quality and on-time fulfilments “they will be renewed and renewed on merit.”
She said Novartis was still learning to deal with such relationships having “behaved badly” with its partners by not setting them up for success.
In what was starting to sound like a “confessional,” as Wark put it, Valenta-Singer too admitted Baxter disliked the FSP model and had not treated its partners in a correct way in the past. “A CRO should be a partner,” she said.
Resource not partners
However, Amgen’s Otte had a more candid view, telling Wark “CROs are businesses and therefore are all looking for the most advantageous conditions” in differing deals with different customers.
He added Amgen is coming up to renewal of a six year contract with a FSP, with KPIs judging whether an extension will be granted. “It keeps the relationship fresh,” he said, and rebutted Wark’s comments as not so much “putting a gun to [the CRO’s] head” but rather “having the gun ready.”
In a later session, the strategic partnership approach was questioned further by AstraZeneca’s Andy Parrett who brought the role of a CRO back down to Earth saying they are just a resource to provide a service to Pharma, though drew the line at Wark’s tongue-in-cheek suggestion CROs were “slaves” to the industry.
Representing PPD, Viv Page told the room CROs needed more flexibility as Pharma changes its approach to partnering. A strategic alliance is “a big step up on the level of trust,” she said, and therefore sponsors should have access to a CRO’s senior management.
inVentiv’s Senior VP Business Development Mike Ryan, added CROs were in an evolutionary position, offering better and cheaper models as the pharma world struggles with regulatory changes, patent cliffs and rising R&D costs. “CROs have to listen to what pharma wants and be ready.”