Partnering for drug discovery success
Science is about solving big problems and today’s extremely high-tech tools and innovative partnering are providing incredible opportunities to meet that goal.
Next-generation business models are emerging through collaborative networks to support frontier science and innovation, address the early drug development gap and help move a good idea through the rocky terrain that separates upstream research on promising genes, proteins and biological pathways from downstream drug candidates.
Alliances with CRO/CMOs are becoming an integral part of R&D approaches as they contribute to building key scientific evidence for drug development programs for clinical success. CROs often have infrastructure to handle work that used to be the domain of basic science laboratories within Big Pharma. CROs also have highly-skilled workers—many began their careers in Big Pharma—in indispensable areas with deep clinical exposure.
Kathryn Chapman, Executive Manager of The Milner Therapeutics Institute, and Charles McOsker, Senior VP of Technical Operations at BioMotiv, talk about what it is like working in this space, how CROs fit into it and ways in which these collaborations can expand. Also participating in the discussion was Swati Prasad, Senior Manager of Business Development and Scientific Alliances at Charles River, who works closely with both Milner and BioMotiv.
What is the most significant challenge you face in moving drug candidates forward?
KC: If the therapeutic area of a target is directly relevant to our pharmaceutical partners, the challenge is getting more data, the right data and making sure that it is human relevant data. If it is generally outside the scope of Pharma, then the challenge is access to independent funding to do the chemistry and clinical trials.
CM: Certainly, one of the challenges is identifying funding to do what many government funding agencies consider to be applied research. The level of funding and even more importantly the lack of expertise available to many academic investigators on how to take exciting foundational research and turn it into a candidate that can be developed is a huge challenge for academic investigators.
How does partnering with CRO’s work and vice versa?
KC: We are doing two things. We are partnering academics throughout the University of Cambridge with CROs. This happens when there is enough data for an academic to think about applying for more applied, translational grant funding. We have 36 affiliated companies and about 70% of them are CROs. They range from companies working on a single thing, such as an ion channel assay, to ones like Charles River that work across the board. We see them as absolutely essential to drug development.
CM: For those studies that help move a project along toward commercialization our strong preference is to use CROs. We try to use a relatively small number of CROs who we work with extensively.
SP: From the CROs perspective, we also work as consultants for our academic and biopharma partners, and provide inputs on how to de-risk their scientific and proof-of-concept programs. A lot of times we’re engaged quite early and they look forward to our ideas and our experiences on how a particular candidate can be developed. We also have an integrated drug discovery (IDD) team which encompasses a wide range of therapeutic areas and internal disciplines and expertise, including in vitro biology, synthetic and medicinal chemistry, structural biology, in vivo pharmacology, and subsequently, pharmaceutics and process chemistry. The IDD has delivered over 70 candidates to various biopharmaceutical partners and is a successful format.
CM: That’s an important point. For the past 1 ½ years we have been working with the IDD group on two major projects and it truly does work as a collaboration. It has provided us with valuable confirmation and new ways of thinking. The consultancy piece is, I think, somewhat unique and we have even taken it a bit further. A CRL advisor on one of our projects sat alongside our investigators and participated in the planning process, which let us integrate CRL’s capabilities and expertise in real-time, rather than engaging in the usual back-and-forth discussions on ‘can you do this?’.
Are there other gaps CROs can fill in the drug discovery process?
KC: When we go to pharmaceutical companies, the first bit of data they need is human data or clinical data. We are doing a lot of stuff right now with Big Data, such as genomics or transcriptomics that come from human datasets but also from experiments in the lab. I really think there is a role for CROs in some of their data curation, data interrogation and analyzing of the data, but with a drug development perspective, that an academic lab doesn’t necessarily have the time, resources or expertise to do.