Didier Dargent: The era of disruption has arrived

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This week's announcements on KYMRIAH (tisagenlecleucel) was "very important news for Australian patients and the country," says Didier Dargent, the Head of International Markets Cell and Gene for Novartis Oncology.

Mr Dargent, who spoke to BiotechDispatch during his short visit to Australia, said the company's investment in manufacturing KYMRIAH locally through a partnership with Cell Therapies helps meet the goal of being closer to patients across the region. 

"It could reduce the turn-around time for supply to patients and that would be a very good thing," he said.

Mr Dargent, who previously led the Novartis Oncology business in China, contrasted the "disruptive" nature of cell therapies with traditional pharmaceuticals.

"With the traditional model, you manufacture the product, in many cases millions of units, and then they are distributed. This is far more complicated. Nothing can start until an eligible patient has been identified. Once they are identified, the clock starts ticking. Their cells have to be taken - apheresis - and then sent to the manufacturing facility in a timely manner. 

"In the past, products were manufactured in anticipation. This is a totally new and disruptive model - a process we have to manage very closely, with the patient at the centre of that.

"Precision medicine like this is profoundly different because each treatment is about a single patient. Everything needs to be done in the best and most sophisticated way.  

"We are treating cells in this process - they are living things - and that is a huge responsibility. 

"It is also completely different for the hospital. The patient has to be diagnosed quickly with an equally quick decision on treatment. This impacts the organisation of the hospital - they need to have the bed available and meet GMP, regulatory and other quality requirements. They also need to be accredited to treat with KYMRIAH and manage potential side effects. This is a big change.

"The people involved in the process are also very highly skilled. This is very important. The process of apheresis is critical because the quality of the cells taken impacts the quality of the product.

"This is why we focus on creating centres of excellence - all countries face the same issues but we can work with them on creating a common platform across all centres. This helps ensure a consistent approach to quality.

"For us, as a company, it means working with payers, governments, regulators, hospitals and clinicians now and as the approach evolves over the next few years. People worry about time to market but they need to remember CAR-T therapy is very new. The technology is used to treat blood cancers now but this could move to solid tumours in the future."