Last year, at the American Biomanufacturing Summit, we sat down with some thought leaders from MedImmune, AstraZeneca, Pfizer, Takeda, Celgene, and Portola Pharmaceutical and asked them: “What do the Next Five Years Look Like in the Biomanufacturing Industry?”
Most agreed that it will be an exciting time with new product modalities improving patient care, but that these new product modalities will give rise to new challenges in capacity and raw material sourcing, as well as talent recruitment and management. We asked them to go further and tell us what key challenges organizations need to overcome to be successful in this period of unprecedented change.
Andy Skibo, EVP, Operations at MedImmune and RVP, Supply Biologics at AstraZeneca
Skibo says, “I think one of the things that’s going to drive success or failure is a really critical structure of clinical trials. Those drive successful outcomes, and failure to do that drives negative outcomes.”
Secondly, he says, companies in the biomanufacturing space need to get better at prioritization. “There’s only so much capital to go around, there’s only so many clinical trials you can fund. Picking the winners out of that, picking the must-haves out of that is something we have to get right.”
Rahul Singhvi, COO, Takeda Vaccines at Takeda Pharmaceutical Co.
Singhvi told us that one of the main areas for companies to focus on is making sure they are prepared to be able to supply these new modalities, as they demonstrate efficacy. “Whether it’s stem cells, regenerative medicine, or cell therapies, more and more of these modalities are showing a benefit to patients. So the question is are we ready from an industry standpoint to be able to serve patients with these modalities?” He says companies must make sure they have thought through both the production and supply chain aspects of these new modalities.
He also says, “you see with Industry 4.0 digitalization coming into manufacturing. I think our industry could benefit from that, and it would be the next wave in which the industry can become more productive and also reduce execution risk.” He expands on this, saying, “I’ve seen some early examples of what digital technologies can do and it can definitely improve our ability to serve patients. For example, we can have better training of our employees, we can do simulations of our facilities before they’re commissioned, we can use robotics in ways we’ve never thought about before. All of these types of ideas are going to be able to help us execute better and, ultimately, serve patients better.”
Paul Daly, CVP and Head, Global Quality, Celgene Corporation
Daly sees the biggest challenge will be recruiting. “I think it really will be, and I hate the term, a war for talent,” he says. “Everybody is counting on the same people because many of the companies are in the same phase of build for many of the biologics plants, and by some accounts, the requirements are an extra 35,000 people to work in the biologic supply chains and 7,000 of those are highly qualified engineers. Some of them are still at school, and when they’re coming through, all the companies are betting on those individuals joining their company.” While the market is still soft, he says, it’s getting harder and companies need to be prepared.
Basav Ghosh, Senior Director and Team Lead, Global Biologics Manufacturing Sciences, Pfizer
Ghosh, similar to Singhvi, tells us the biggest challenge is how to balance demand and supply and capacity. Especially given the incoming new modalities, she says companies will have to look different types of capacity. Overall, the biggest challenge she sees is having the flexibility to adapt to new types of business, new therapeutic areas, facilities, and manufacturing mindsets.
Andy Ramelmeier, SVP, Technical Operations Biologics, Portola Pharmaceuticals
Like Daly, Ramelmeier sees recruitment as a major challenge. “It may not be as big of an issue today,” he says, “but hiring people is going to be very hard. Just like any other aspect of your supply chain, this is a viable and limited resource and it will need to be managed better.”
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