Academia and early-stage biotech companies are more frequently looking to fill holes in their expertise and preclinical capacities through the use of CROs, according to a commentary in Nature Reviews Drug Discovery .
“CROs that we have been working with, both large and small, are increasingly interested in providing services to academia and biotech,” Rachel Lane, co-author of the commentary and assistant director of scientific affairs for the Alzheimer's Drug Discovery Foundation (ADDF), told Outsourcing-Pharma.com.
The field of Alzheimer’s research in particular “is seeing a shift to academic scientists conducting more early stage discovery” programs where funding is more restricted and “every part of the preclinical process cannot be done in an academic lab.” Assay development, for instance, can often be taken care of by smaller CROs, Lane said, whereas larger CROs can be more collaborative and consultative while handling more generic studies.
"The way we've chosen what CROs we want to work with comes down to flexibility in terms of differed payment," Curtis Keith, chief scientific officer of the Blavatnik Biomedical Accelerator at Harvard University, told us.
Lane said the Nature commentary was a high-level recap of a closed-door, one-day panel meeting on the best ways academic researchers can use CROs.
The ADDF, whose funds are divided to about 80% academic researchers and 20% start-up companies, has built a database of CROs and their specialties that researchers funded by the foundation can use for help, Lane said.
The CROs listed in the database include a number of smaller, more-specialized companies, such as AMRI, Charles River, QPS and Afraxis. Some, such as Afraxis and Axxam, offer packages of discounted services available to ADDF investigators, according to a review of the database. Custom assay development, compound characterization and toxicology are offered as discounted services.
Within the field of dementia and Alzheimer’s research, scientists are always “very interested in connecting” with peers, “even if they aren’t going to use them” as a partner or service provider, because “they like to discuss methodology. Scientists in CROs will often provide free guidance upfront and a lot of scientists tap into that resource and lay down plans for their future programs,” Lane said.
Covance, MPI Research and AMRI are also listed as CROs offering consulting services to ADDF investigators in the database.
“We want to better connect our investigators with CROs,” Lane said, adding that often times “there’s a specific CRO for a program, though the scientists need to make that call” on what CRO to select.
In the commentary published Monday, the authors, who were all panellists at the one-day meeting, said the decision to outsource to a CRO “should be driven by factors that include: the need for expert guidance in drug discovery science; technical expertise beyond in-house capabilities; key platform technologies; lack of development experience; time and cost efficiency; and the regulatory requirement for good laboratory practice (GLP) and good manufacturing practice (GMP).”
Despite the advantages of the network of CROs, “identifying the right CRO and keeping the project on track is challenging,” the authors write in the commentary. “Undertaking appropriate due diligence and effective management of a CRO partnership is crucial to the project's success.
“Ultimately, our key recommendations are as follows: first, the formation of interdisciplinary teams that include experienced consultants and project managers; second, the development of a clear project plan before initiating the programme; and third, appropriate due diligence and management of CROs with structured, open and frequent communication between all partners,” the authors conclude.