Decision Time: Selecting a CMO Partner with Confidence

Posted by David Watt

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If you are like most managers responsible for green-lighting a CMO partnership, making the decision to choose one supplier over another can be career changing. Making these decisions confidently depends on how well the selection process narrows the field of prospects to a manageable group of strong contenders.

The due diligence required to assess potential prospects generally includes an invitation to respond to your RFP; a well-structured analysis and review of the submissions; a review of their process capabilities, capacity and availability; and similar background investigations to get to a qualified short list of prospects. You’ll want to make sure you’ve discussed the prospects’ audit history, citations and observations from the various regulatory bodies around the world, and you’ll want to take into account how well they communicated with you from your first contact. Do they show interest? Did they call you back? Responsiveness is critical.

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If you are a smaller pharmaceutical company, virtual company or a subsidiary with a specialized formulation or a more complex dose form, having a frank discussion with the appropriate group or groups within the CMO’s organization will help you understand the company’s technologies, how it functions and how you can best leverage the CMO’s formulation expertise or its process to your advantage.

If, for example, there is a specific piece of equipment required to manufacture your product, you have to consider what happens if one of these machines breaks down. If you’re manufacturing a product that’s selling billions of units a year and you only have one CMO to make it, it’s an obvious risk. In addition, does your prospective manufacturing partner’s equipment have the appropriate scale to handle your product’s batch sizes and long-term product demand requirements? Knowing that a prospective partner’s processes are up to date and demonstrate operational excellence will definitely support your positive decision in selecting a contract manufacturer.

If your due diligence reveals that your prospective CMO partners are generally equal, it’s time to investigate further. Consider the general commercial philosophy of your organization as well as price, cost, quality and supply chain concerns. The advent of ICH Q10 guidelines makes it more difficult to pursue an aggressive transfer or manufacturing strategy, so it’s vital you make the right choice to get your product to market successfully.

The best fit with a CMO is a seamless extension of your company. It comes from knowing the level of customer service and project management expertise you can expect regardless of the size of your company or the value of your contract. If you’re a small company seeking a relationship with a large CMO, you deserve the same attention to your contract and product as any client it serves.

A really good CMO selection has a lot to do with one’s industry experience and the gut feeling you rely on to make the toughest professional decisions. Most of the people on the selection committees I have worked on had at least 20 years’ experience in the business. When the ethics, quality, compliance history, experience and manufacturing capability are followed by competitive pricing and backed by service quality, this helps mitigate risk and that’s the key.

When it is decision time, you want to offer your board or your executive managers the best possible partner — a fit that you are comfortable with and the one that will help you succeed and hopefully advance you in your career.

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Topics: RFP, due diligence, CMO Partner

David is the Technical Director in the Business Development Department at WellSpring, and has over twenty years of pharmaceutical GMP experience in technical definition and evaluation of Contract Development and Manufacturing projects, both from provider and client perspectives. David has previously worked at Valeant, Medicis, Patheon and Syntex Pharmaceuticals. David is responsible for overseeing all technology transfer activities in the organization.

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