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Breakthrough Therapies Face Unique Supply Chain Challenges

Live from the PDA Annual Meeting: Speed to market is so important in reaching patients without other options, but how do you build the supply chain with moving goalposts?

Mike Thien, Sc. D., is the Senior VP of Operations, Manufacturing Systems Design & Commercialization at Merck & Co., Inc. At the PDA Annual Meeting in San Diego, Thien explained that it’s not just the timeline that adds to the complexity, but that there are many uncertainties.
Mike Thien, Sc. D., is the Senior VP of Operations, Manufacturing Systems Design & Commercialization at Merck & Co., Inc. At the PDA Annual Meeting in San Diego, Thien explained that it’s not just the timeline that adds to the complexity, but that there are many uncertainties.

The first step of a typical journey is to pick a desired endpoint.

For breakthrough therapies, this goal-setting is especially tough. Manufacturers know they need to get product to patients as soon as possible to help those with time-sensitive conditions. Getting to market years sooner may mean saving thousands of lives.

But expediting drug development and commercialization comes with a number of challenges in that the goals—including how much to make—and manufacturing capabilities evolve rapidly.

Mike Thien, Sc. D., is the Senior VP of Operations, Manufacturing Systems Design & Commercialization at Merck & Co., Inc. At the PDA Annual Meeting in San Diego, Thien explained that it’s not just the timeline that adds to the complexity, but that there are many uncertainties. A legacy drug may have one, two or three indications. But with a breakthrough cancer drug, manufacturers aren’t necessarily sure how many indications a drug will have when it gets approved (the more patients it helps, the better, of course), so it’s difficult to figure out the supply needed to meet demand.

Thien asked, “Speed to market is so important in reaching patients without other options, but how do you build the supply chain?” Manufacturers must work to create a safe and secure supply chain step-wise, though it’s difficult to satisfy demand that can’t be predicted.

  • The manufacturer may start out with clinical trial manufacturing in-house that must be converted to a commercial facility.

  • External resources become critical. In Merck’s case for a breakthrough therapy, they added a trusted CMO in addition to the clinical-turned-commercial site near the start. As they got closer to approval, they found other indications and had to add another CMO to meet demand. Release testing and cell banks were external as well.

  • Operations such as packaging and labs may start out as outsourced resources and can be brought internally as time goes on.

Another challenge is launching one product form first, such as a lyophilized image, while bringing another facility forward to make a liquid image that will be in high demand in the future.

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