Cell, gene therapy manufacturing takes center stage as Novartis, Amazon join forces
Tech giants have penetrated the realm of healthcare. Meanwhile, the biopharmaceutical industry has embraced the promise of digital drug development and medicine as it ushers in the era of telemedicine, wearables, cloud computing, machine learning and artificial intelligence. Novartis, which was one of the pioneering large drugmakers to hire a chief digital/technology officer in 2017, has now tied up with the widely used cloud platform Amazon Web Services to streamline its manufacturing, supply chain, and delivery operations.
The technology will be used to give Novartis scientists and researchers real-time visibility into the Swiss drugmaker’s manufacturing and distribution apparatus, enabling teams to track production lines, diagnose potential bottlenecks, detect risks to manufacturing and ramp up production of personalized treatments.
Novartis’ foray into cell therapies — as the manufacturer of Kymriah, one of two FDA approved CAR-T therapies — was clouded by initially underwhelming sales, as its expensive price tag and slow, complex autologous manufacturing process (marred by hiccups) slowed adoption. Eventually, the drugmaker swallowed a cell and gene therapy manufacturer in an attempt to unclog the commercial rollout. Meanwhile, Novartis also scored the landmark US approval for its gene therapy, Zolgensma, which costs a hefty $2 million per patient.
In a third-quarter earnings conference call in October, Novartis executives underscored their commitment to improving their manufacturing prowess in relation to cell and gene therapies. The company’s capacity to manufacture has gone up by 60% between the first and third quarters, it said.
“(W)e have with the cell and gene technology had to take some hit on our gross margins, particularly in oncology with CART therapy. Our aspiration is now to start to improve that and get that back up now in the coming year,” chief Vas Narasimhan said.
Late last month, Novartis told Reuters it had set aside $500 million to scale up its gene therapy manufacturing efforts.