Interview with Bart DeCorte: Outsourcing – how to choose the right CRO?

Drug-discovery outsourcing in the pharmaceutical industry has changed dramatically in the past 20 years. While the last century was mostly dominated by large pharmaceutical companies that executed all science within the walls of their organization, drug-discovery outsourcing has now become an integral part of the execution of research and early development (R&D) in biotech companies and large pharmaceutical organizations alike.

Earlier this year, Bart DeCorte, VP of Business development at MercachemSyncom, captured that remarkable transformation in a perspective article in the Journal of Medicinal Chemistry. In this interview he elaborates.

When I started my career at Johnson & Johnson (J&J) in 1993, the concept of outsourcing in drug discovery was almost nonexistent. In today’s world, many drug-discovery programs in larger pharma and biotech companies rely on external partnerships.

As most readers of the J. Med. Chem. are involved in some way in external partnerships, I wished to share my perspective on how the industry has changed, and the lessons I learned as both the client and the provider.

In 2007, I served as a medicinal chemistry consultant to a drug-discovery initiative at J&J. In partnership with an academic institution, we explored chemical modifications of natural-product building blocks. I soon realized the value of coupling internal medicinal chemistry expertise with the synthetic creativity of an academic group.

Later, I started a natural-product-based drug-discovery program, as a virtual venture, that combined the generation of novel natural-product-derived chemical matter with broad opportunistic biological profiling. All science was executed through external partnerships.

When I first started looking into which CRO would be the best fit, I probably focused too much on the immediate needs of the work. I did not think long term nor sufficiently consider my needs a year or two down the road. However, I soon found out it is equally important that your partner has the capabilities and expertise to take your project beyond initial requirements.

It is important to select a partner willing to think with you and even challenge your ideas. Even if you are lucky enough to find synthetically feasible starting points in your program, once the chemistry becomes more complex, a partner with good problem-solving skills is critical

As I touch on in the article, any prospective client should reflect on intellectual property protection, employee turnover, data integrity, safety and personnel policies, to anticipated duration of the partnership, scalability of capacity and geographic location. The relative importance of these criteria will vary from client to client, but they should nevertheless be considered upfront.

Cost is always an important consideration. While it is easy to obtain an FTE rate from any CRO, it is harder to gauge what you will receive for it. My recommendation to any client is to share your goals and expectations with the CRO under CDA and ask the CRO to provide you with an estimate of the resources they expect to need to reach the goal (cost and timeline).

The global coronavirus pandemic continues to affect the client-provider partnerships. Many US-based biotech and pharma clients have reduced their in-house chemistry activities dramatically and now rely even more on CROs. As a result, existing client-CRO relationships are often stronger. For those clients looking for new CRO partners, site visits may be impossible given current travel restrictions, which will most likely not be lifted in the months to come. Clients should feel comfortable asking for recommendations from existing partners as an alternative.

Drug-discovery and development organizations will most likely continue to rely on CRO partners to execute their drug-discovery programs. Before signing, clients should do their homework and reflect on the attributes they are looking for in a CRO. The success of any drug-discovery undertaking will depend greatly on the people who execute the science. The right partner can mean the difference between success and failure.

Related article from J. Med. Chem.:
https://doi.org/10.1021/acs.jmedchem.0c00176

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