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Top 5 Things to Expect from Your Contract Manufacturing Organization (CMO)

If a CMO cannot return a phone call, you should be worried about your product. I recently learned of a colleague in a small biotech firm who had contracted with a CMO to supply product to clinical sites for them. She submitted the shipment request per the CMO’s instructions and then . . . silence.Commitment to Quality

Over a number of days and multiple attempts to contact the CMO with no response, the CMO finally verified receipt of the request. Once the product did eventually ship, my colleague experienced the same lack of communication regarding confirmation of the shipment to the clinical site, which led me to wonder: if a CMO cannot even provide this fundamental level of assistance, what does it indicate about their attention to more critical factors to success such as quality and innovation?

What should companies truly expect from their CMO? Here are a few values for consideration:

1. Quality

If the FDA can audit your vendor at any time, why can’t you? I am not necessarily promoting this, but I am suggesting that your vendor should have an “open door” policy and should encourage you to visit them prior to partnering. If they are confident in their own quality processes and documentation, they won’t hesitate to allow your company to perform the necessary due diligence.

2. Transparency

Unless the CMO you are partnering with is also an investor, your product is just that—yours! Thus, you should not only have access to all data and information regarding your product, but you should also be able to retrieve that information from your CMO at any time. Whether it be the results of an assay, confirmation of a shipment, or real-time storage temperature data for your product, it should be an email or a phone call away.

3. Responsiveness

As the industry grows toward operating more virtually, it is imperative to be in regular communication with your CMO. As a general rule of thumb, a CMO should respond to requests or inquiries within 24 to 48 hours. It is the most basic level of customer service that should be treated as the expectation—not an extra benefit—of working with your vendor.

While the entire drug development process can take years, the milestones involved, often very time sensitive, directly affect patients. For a patient who needs that life-saving new drug, a CMO’s effectiveness in responding to a shipment request makes a world of difference.

4. Innovation

SOPs are necessary for any organization and are particularly critical in the pharmaceutical industry, but no two projects or products are alike. Your product likely requires a unique solution, and a quality CMO should be willing to creatively collaborate to help you develop a novel plan that best fits your needs.

5. Agility

The pharmaceutical industry is inherently unpredictable as thousands of new drugs fail to reach the market each year, so anything you can do to help mitigate the risk involved in the drug development process is valuable. Creating a partnership with a CMO that is operationally flexible enough to change midstream when the unexpected happens can be a critical factor in predicting success.

Conclusion:

It is up to you to determine what you feel is acceptable from your suppliers, but if your expectations are higher than the level of service you are receiving, consider the following: when did the status quo become the norm, and why is this ok? Patients’ lives are at stake.

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Lesli Stasiek

Lesli Stasiek

Global Manger, Business Development and Marketing at BioConvergence LLC
Lesli leads the business development and marketing groups at BioConvergence, with a focus on identifying marketplace trends and targeting new business opportunities for the organization. She has held a number of sales roles in her career including positions at Eli Lilly & Company and AstraZeneca. Lesli received her BS from Purdue University’s Krannert School of Management and her MA from The Chicago School of Professional Psychology.