I believe that strategic partnerships will still be the major relationship between Pharma and CROs. For some pharma and outsourcing companies, however, a shift back to smaller, more flexible, therapeutically-focused organizations will grow as well. We are already noticing this shift among pharma companies with a proliferation of smaller biotech companies focused on niche products and seeking more nimble, flexible CROs to meet their needs for targeted expertise, high quality and speed to market.
It is probable that there will be more diversity in the types of support that is available or requested – more ‘partnership’ and ‘in-sourcing’ approaches as well as consolidation of a more diverse range of services at a single provider.
Yes. The more big pharma adopts virtualization, the more they need to interact with CROs. Drug discovery and development outsourcing is also increasing and that requires a different relationship with CROs. Integrated drug development services will also increase, requiring a constant interaction between sponsors and CROs.
Currently for LC–MS bioanalysis, the relationship between pharma and CROs is quite mature. The frequent exchange of staff between pharma and CROs makes the partnership between CROs and pharma possible.
CROs will continue to deliver the quality data pharma cannot currently achieve internally. We will see continuous growth of preferred provider types of CROs, e.g., fewer CROs will be used by a particular pharma, even though other outsourcing models such as FTE agreement and pay per service models are still the most commonly used and probably most convenient approaches.
Operating models adopted by various organizations towards outsourcing still fundamentally fall into ‘tactical’ or ‘strategic’approaches. The tendency for larger organizations, such as the multi-national pharma companies, to build strategic alliances with similarly sized CROs is continuing to increase rather than decrease. Similarly, the size and diversity of the larger CROs is driving their need to increase the number of strategic alliances to protect and secure their capital investments.
This may well place a greater tension for smaller entities such as biotech start-ups or organizations with niche therapy technologies, particularly where these are in very early development or as more conceptual ideas. These organizations are also much more unlikely to have the breadth of expertise or technology access to cover all elements of even very early therapy developmental needs. The amount of capital expenditure that these innovators can deploy is much more likely to be limited and focused to achieve milestone goals that are more limited. For example, many smaller companies will have business objectives to take therapies only to certain stages of development such as achieving a Phase II proof of concept and then being able to partner or divest the asset. Thus, it is very possible that these organizations will tend to gravitate towards smaller niche providers to solve particular problems rather than build very strategic alliances where much of what could be provided is not of immediate or short term relevance.
Yes. I think that they would change from ‘fee-for-service’ to ‘partnership’ models. I think right now, more and more pharmaceutical companies are looking for long-term partnerships. It’s not just like ‘oh – you’re the CRO we’re like the pharmaceutical company’. They need to work together as a team.
Usually, even the CROs, bring part of their internal team. What we do for some of our clients, is to set up the lab for their projects and even send people to their lab to take care of their projects.
We call it a partnership.
Yes, outsourcing relationships are poised to become more collaborative, so this makes communication even more imperative. Also, companies are placing more regional studies so shipping samples across the world is not as common anymore. However, the number of labs in the same region of the application filing is more typical now.