Regulatory considerations, strategy and best practices for choosing a quality CMO

Regulatory considerations, strategy and best practices for choosing a quality CMO
by Brandon Boyd
Industry Strategist & Segment Lead for Generics, Clarivate Analytics
Life Sciences Connect

Historically, the relationship between a sponsor and a CMO has been mostly transactional – one side manages items like regulatory filings and the other simply manufactures a specific product for a fee.  Today, however, said Bryan Coleman of the EAS Consulting Group, the market and regulatory environment require a much higher degree of collaboration and partnership between sponsor and CMO.  A key reason for this, he said, is the evolving requirements from the U.S. FDA, which now expects joint accountability.  Practically, this means close coordination and a plan around quality assurance between the manufacturing partners. Coleman spoke in a session at this spring’s CPhI North America 2018 conference in Philadelphia

 

The market and regulatory environment require a much higher degree of collaboration and partnership between sponsor and CMO.”

– Bryan Coleman of the EAS Consulting Group

In order to be successful in CMO selection, sponsors should consider several important factors, Coleman said.  First, the sponsor company’s leadership should think carefully about the type of partnership they want and how that will be translated into responsibilities on each side.  Second, they should be “brutally honest” about their expectations of their chosen CMO; today’s regulatory and market environment leaves very little room for gaps in understanding.  Third, the sponsor should approach a potential collaborator just as if it were acquiring the other company.  Due diligence should be conducted to a significant degree.  Finally, accept that you don’t know everything and work to define what is unknown.

Coleman provided an example: If manufacturing with a new technology, such as hot melt extrusion, don’t expect your experience with other technology, like simple tablet compression, to translate over completely.  All of these factors speak to the need to have a plan – a governing set of services and controls around functions like manufacturing, testing, compliance, methods qualification, stability, etc. to ensure commercial success.

 

Check and balance

The approach that sponsors should then take when evaluating and selecting a CMO can be broken down into a few critical activities, Coleman said.  The due diligence work should be carried out by a small team of subject matter experts from across functions.  In addition to the input of this SME team, an “honest broker” – an internal resource without a vested interest in financial outcome and work load – is an indispensable check and balance to the process.  Additionally, and as part of the “brutal honesty,” the sponsor must define clear metrics for success: capacity available at the CMO, experience with the specific technology or manufacturing process, cost, timing, etc.  Tied to these metrics is risk tolerance – how much variability or uncertainty can you accept?  Combining these qualitative and quantitative attributes together then leads to a scoring matrix.  For example, ranking the attributes on a numerical scale and then using the sum value to guide team discussion and ultimately decision making.

Furthermore, once such a system has been used to select a CMO partner, and efforts turn to planning and execution, it becomes a shared responsibility to establish a quality agreement, Coleman said.  In fact, the FDA makes clear this expectation in its guidance to CMOs.  Basically, both parties must align and have a clearly defined plan around cGMP, prescribing the specific “what” and “how” for matters of quality and compliance in their contracted manufacturing activities.  Failure to construct this quality agreement, and to then execute on the responsibilities it sets out, creates risk not only to commercial success but could lead to serious regulatory consequences for both sponsor and CMO.

 

Selecting a high quality CMO can be challenging just on the basis of experience or capabilities, and now regulatory expectations add to that challenge by defining new layers of shared responsibilities.”
– Bryan Coleman of the EAS Consulting Group

Selecting a high quality CMO can be challenging just on the basis of experience or capabilities, and now regulatory expectations add to that challenge by defining new layers of shared responsibilities, Coleman said.  The best strategy for sponsors is to establish well-defined metrics for partner selection and then set clear expectations around roles and responsibilities with a selected CMO.  The key thing to remember is that nothing is merely transactional – both sides share accountability in the partnership.

 

This article is excerpted from “Key issues in pharma manufacturing: Choosing a CMO, the journey of a molecule and the history of contract services,” a report from the Clarivate Analytics team covering CPhI North America. To download the full report, click here.

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