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Clarkston Partner, Janel Firestein Featured on GEN

Durham, NC | November 3, 2020

Partner at Clarkston Consulting,Janel Firestein quoted on precision medicines and reorganizing supply chains. An excerpt from the article is included below:

Precision medicines, such as cell therapies, remain expensive to manufacture and hard to access by patients. For example, Kymriah, the first chimeric antigen receptor (CAR) T-cell treatment approved in the United States, can have price tags as high as $475,000. Unfortunately, precision medicines are expensive to develop and manufacture, and the costs are ultimately borne by taxpayers and patients, according to “The State of Personalized/Precision Medicine” a report issued last year by GlobalData.

Today, companies are developing new models to lower the costs of manufacturing and bring drugs to more patients. Among them are companies developing new business models and services, innovative equipment for on-site manufacturing in hospitals, and improved formulation technology.

Reorganizing Supply Chains

A key challenge for companies is scaling up the delivery of precision medicines, notes Janel Firestein, partner and life sciences industry leader at Clarkston Consulting. Companies supplying precision medicines are harvesting material for patients in a hospital or clinic, and then freezing or shipping it fresh to a contract manufacturing organization (CMO), contract development and manufacturing organization (CDMO), or other manufacturing entity.

“What we’re seeing with a lot of our clients leveraging contract manufacturers is they’re contracting for specific slots,” she says. “They have x number of slots per week or month, and the scalability of that is hard.”

Precision medicines are manufactured in small batches in accordance with genetic, environmental, and lifestyle factors, that is, for patients in subpopulations that meet certain well-defined criteria. (The subset of precision medicines known as personalized medicines are even more specific; that is, they are developed uniquely for each individual patient.) If a patient doesn’t pass prescreening at the scheduled time, Firestein warns, the manufacturing slot for the patient’s treatment is lost unless the manufacturer can find another eligible patient.

Conversely, if the company is working across multiple CMOs in different countries, it needs to schedule slots in a predictable way. “You need to know which slots are open,” Firestein points out. “You need to leverage automation and artificial intelligence to give a manufacturing view to physicians at the patient hub, so they know which dates are available and can ensure the patient’s cells are viable upon receipt at the manufacturing plant.”

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