Outsourcing
‘We may have people who are more expert than our clients, who could be a large pharma company or another CRO. Although small, this makes us a strong partner’
Paul Clelow Sygnature Discovery, UK
must have the potential for benefits for both partners. Quoting a US sporting expression, he said that risk-sharing means that both partners are ‘putting more skin in the game’. But as Cottrell noted, the partners are generally looking for different benefits: ‘CROs are looking for quarterly revenues while Big Pharma is looking for long term goals.’ For the CRO, Foglesong believes it is less about royalties, ‘there is more emphasis on milestone payments – if the partners can determine what the success criteria are’. Zanze agreed that milestones can help with the shorter term goals of CROs, and Clewlow added that one approach could be to accept lower fees-for-service in favour of milestones, thereby limiting the risk sharing to the discovery stage. In the case where the companies involved are of a similar size, he pointed out that rather than risk sharing, they are probably looking at sharing their resources to achieve an agreed target that could then be offered to Big Pharma to take forward. However, Clewlow also pointed out that where companies are backed by venture capital, risk-sharing may not be attractive as fee-for-service contracts with CROs provide a quantifiable expense rather than the open-ended nature of milestones. Cottrell recognised that different types of incentives in terms of risk- sharing may encourage different behaviours and responses from the CRO, but what should they be? In response, Clewlow pointed out that the financial incentive is obvious but science is important to researchers, and the opportunity to be an equal partner in the discovery process is a major incentive. Zanze added that the incentives for the CRO should allow it to showcase its
44 Chemistry&Industry • November 2013
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expertise and motivate its own scientists. Selecting a partner
Selecting the best risk-sharing partner, according to Zanze, goes hand in hand with selecting the best project to partner, and agreeing the right type of contract. ‘It can be very obvious what level of experience is available,’ she added, noting that whether it is a one-stop- shop partner or collaboration with more than one CRO partner will depend on the project. Cottrell echoed that if it is a niche project then it is almost certain that the client will have to look for multiple partners. Trust is an important aspect of the
selection process, and having scientific teams that work well together augurs well for a successful project, according to Clewlow, but trust is needed that both sides have the same drivers and good reputations.
But how can that trust be developed? Clewlow highlighted his own experience that it can be established through initially working on a fee-for-service basis and then evolved into risk-sharing, and Cottrell agreed that the more mature risk-
Big Pharma can benefit from access to external expertise
shares have evolved from transactional relationships. Clewlow’s last comment, however, was that it is not possible to work with a CRO that is ‘betting the farm’ on a project.
Another form of risk-sharing that is gaining some momentum is through open innovation and also crowd sharing, with the latter now attracting attention in every sector of society from hobbies to hotels. James Tornos, director of scientific procurement at Pfizer, said this can offer a possible solution as the pharma sector goes through this major shift in how it works with outsourcing. Duncan Judd, principal of UK
discovery service consultant, Awridian, pointed out that open innovation can make a difference in therapeutic areas where there is a real lack of investment, including antibiotics, orphan drugs and diseases of the developing world, as well as in complex clinical trials. He also highlighted some examples of crowd sourcing in drug discovery, for example, one proposed by crowd sourcing expert Innocentive to generate hypotheses
for the male/female differences in the pathogenesis and presentation of Alzheimer’s disease from pre- symptomatic to late stage. But he noted that such proposals can be very generic, highlighting one from a ‘globally acting multinational organisation looking for proposals describing what should be the next big topic in drug discovery to be
The relationship between Big Pharma and contract research organisations is undergoing a major change
addressed by a pharmaceutical company in the next 10-20 years’. Jeff Marra, principal investigator at privately held Purdue Pharma in the US, pointed out that people who are members of groups on the internet through the Linkedin business sites are already effectively involved in crowd sourcing, asking questions and getting answers on, for example, process issues and possible sources of specific molecules. ‘Crowd sourcing offers a route to thousands of experts rather than tens of people in a focused way,’ he said, adding that it ‘has replaced the library as a route to answers’. He also pointed out that while it is possible to search for information electronically, using a crowd sourcing approach can provide the required information ‘and the other half of the story’. Crowd sourcing also has something
more to offer, according to Tornos, in terms of the loss of exclusivity through the rise of generics, and the need to reduce the cost of goods. Pfizer, he said, has put active pharmaceutical ingredients (APIs) into a crowd sourcing situation, posting API structures to CROs, with whom the company already had working experience, to see what they could suggest in terms of new process routes. Using this approach, the project took just eight weeks and avoided a lot of expenditure over a much longer time scale. ‘The winners were rewarded for their efforts,’ he said, adding that Pfizer will continue to develop this crowd sourcing process, evolving it to possibly give the winner a contract, for example. ‘It complemented our internal efforts and gained an intellectual focus on a new area of talent.’ This approach, however, does raise the issue of intellectual property (IP), and
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