Ask DEL BioPharma LLC: Selecting a CRO/CMO involves multiple considerations that are applicable to any component of the drug discovery/development process.  From the perspective of API manufacturing, it is critical to understand the following:

By Dan Levy- dan@delbiopharmallc.com
  • A company is looking to build a partnership with a CRO for the development of a new drug. This decision is a complex one and can play a significant role in the success for the company. What are the top 3 considerations that the company must make in their selection process to ensure that they will make the right choice?

DEL BioPharma LLC

 

Selecting a CRO/CMO involves multiple considerations that are applicable to any component of the drug discovery/development process.  From the perspective of API manufacturing, it is critical to understand the following:

  • Compound-specific expertise – There are many choices for contract labs and all will express interest in capabilities across chemical space.  However, some aspects of organic chemistry are more specialized.  Examples include carbohydrate chemistry, stereoselective synthesis, nucleic acids, heterocycles and peptides.  If an API development candidate is a sugar derivative, a contract lab with carbohydrate-specific expertise is likely a better fit compared to one that generally produces aromatic heterocycles.  Similarly, while most CROs/CMOs can produce amides as intermediates or required functional groups incorporated into an API, a peptide-based API is best prepared by a CRO/CMO that specializes in this sector.  For these reasons, DEL BioPharma LLC maintains relationships with a broad network of contract labs that are capable of addressing synthetic challenges across all chemical space.
  • Quality and regulatory track record – QA/QC and regulatory affairs are critical to success in generating material useful for various stages of clinical development.  Contract labs that are not able to maintain and demonstrate tight adherence to quality and regulatory guidelines will place development efforts at high risk for clinical holds imposed by regulatory agencies.  Such holds extend timelines and costs for development efforts.  Therefore, knowledge of CRO/CMO audit track records is essential in maintaining a quality network of potential partner organizations capable of meeting clinical needs.  This is a key area for which compromise should never be an option.
  • Internal culture favoring collaborative relationships – Partnerships are always more productive than “hired-hand relationships”.  If mutual trust, receptiveness to client input and an ability to generate novel ideas are all present between a CRO/CMO and a client company, timelines are generally reduced, costs are generally reduced and problems are generally tackled from a collegial perspective.  In a “hired-hand” scenario, the CRO/CMO is less likely to feel like a true development partner and is less likely to be fully invested in the success of the project.  All CROs/CMOs should be paid fairly for their efforts.  However, it is the nature of the relationship between the CRO/CMO and sponsor company that provides the incentive from the CRO/CMO to provide exactly what is agreed upon or to provide a little extra in the interest of reaching a successful outcome.  Change orders should be expected but their frequency can be minimized.

 

One item not listed above is contract cost.  While budgetary considerations are critical to project success, a competitive bidding process generally opens doors for reasonable price negotiation.  Furthermore, an efficient CRO/CMO that is more costly but adheres to a shorter timeline may be the best fit for a project over the lowest priced contract.  Therefore, pricing should generally be the last item for consideration in the CRO/CMO selection process.

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About the Author and BIOCOM CRO Board Member

Dan Levy- dan@delbiopharmallc.com DEL Bio Pharma |