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Chris Striffler Featured Expert on Personalized Medicine for Pharma Technology

OCTOBER 2018

Manufacturing personalised meds: what needs to change?

Personalised medicine offers the promise of customised treatments for individual patients and groups. But, in order to deliver these benefits, the pharma industry and supply chain will have to embrace dramatic changes in manufacturing methods. Abi Millar finds out more.

The age of personalised medicine – once discussed in purely hypothetical terms – is now very much upon us. With research advancing fast, cell and gene therapies are a therapeutic reality for some patients, and their numbers are climbing.

In the year up to July 2018, three new gene therapy products were approved by the US Food and Drug Administration (FDA). One study, by MIT, predicted that there will be 40 such products by the end of 2022. The FDA has also received more than 500 active investigational new drug applications involving gene therapies, with more than 100 in 2017 alone.

The promise is clear. Rather than playing a therapeutic guessing game – with no way of knowing for sure which patients will respond to which treatments – doctors will be able to prescribe the treatments that match the patient’s individual pathology.

A good example is autologous CAR-T treatments, in which the patient receives an infusion of their own genetically engineered immune cells. Touted as the next big thing in oncology, these therapies hold great promise for otherwise untreatable forms of cancer.

Of course, it is the clinical opportunities that are attracting the most attention. However, the movement towards personalised medicine has many other dimensions. It will also spell change for pricing structures, regulatory approaches, and manufacturing paradigms, meaning pharma companies will need to re-evaluate their ways of doing business.

How manufacturing needs to change
From a manufacturing and supply chain standpoint, personalised medicine brings some sizeable challenges – not least the need to move from large batch production to small runs of complex medicines. This applies whether you’re dealing with precision medicine (which may involve multiple treatment variants) or autologous treatments (which have a patient population of one).

“With precision medicines, it’s a much more complex model with more products, and with a lot size of one it’s a complete shift away from large batch production,” says Chris Striffler, supply chain services leader at Clarkston Consulting. “It’s almost like what companies do in their clinical trial stage, when they have short runs of lab-based manufacturing.”

This has important ramifications for business models. Traditionally, the pharma supply chain has relied on a ‘push’ model, in which demand is forecast ahead of time, and the inventory ‘pushed’ out via wholesalers. Personalised medicine requires a much more patient-centric approach.

“With an autologous CAR-T treatment, you don’t even start your production till you have a patient, so it’s a huge shift into a make-to-order environment,” says Striffler. “Even in the precision medicine space, where you may be manufacturing stock, the introduction of partner diagnostics comes into play.”

To read the full article,  read Manufacturing personalised meds: what needs to change?