Last year, at the American Biomanufacturing Summit, we sat down with some of our thought leaders to ask them where they see the industry going in the next five years. It was clear that major changes are on the horizon. It will be an exciting time, with new product modalities improving patient care, but giving rise to new challenges in capacity and raw material sourcing, as well as talent recruitment and management. Read on for insights from thought leaders at MedImmune, AstraZeneca, Pfizer, Takeda, Celgene, and Portola Pharmaceutical.
Andy Skibo, EVP, Operations at MedImmune and RVP, Supply Biologics at AstraZeneca
Skibo spoke at the summit on the topic of Achieving Clarity on Global Capacity in an Evolving Picture. Of the next five years, he told us, “I think it’s a period of unprecedented change and what we’re going to see is an incredible number of product approvals and launches, and that will bring with it uncertainty – that will bring with it this much capacity, half that capacity, 5x that capacity…”
Rahul Singhvi, COO, Takeda Vaccines at Takeda Pharmaceutical Co.
Singhvi addressed that audience with the topic Using Collaboration and Alliance Models to Break Beyond Development Silos and Bring New Medicines to Market. He sees that therapies like checkpoint inhibitors for oncology are going to remain very big in the next five years, and adds, “What I see is the modalities that are coming through – the cell therapies, the regenerative medicine – are going to become mainstream in the bio industry, in addition to what we normally see now, in terms of the large monoclonal antibodies and other therapeutic protein types of therapies.”
Paul Daly, CVP and Head, Global Quality, Celgene Corporation
Daly spoke at the summit on Examining the Quality Oversight of CAR-T Clinical Manufacturing and the Challenges of Moving Into Commercial Operations. He predicts, “as you look out for the next five years, there will be exciting potential in the development pipelines.” He adds that Celgene is expanding rapidly, and building a lot of capabilities in the US, “utilizing the talent we have here to bring 26 molecules over five years through phase 3.” He says, “it’s a particularly exciting time in areas like CAR-T (Chimeric Antigen Receptors) and the challenges around those, because they are absolutely meeting an unmet patient need – the people on the fourth line of oncology therapies – and this is really a breakthrough and something the whole industry should be proud of.”
Basav Ghosh, Senior Director and Team Lead, Global Biologics Manufacturing Sciences, Pfizer
Ghosh, who spoke about Examining Scientific Interventions to Improve the Vaccine Supply Chain, tells us that, in her opinion, “in the next five years the industry will move towards more personalized medicine, particularly with the gene therapy and cell therapy areas. There’s also another growth area, which is the biosimilars, and we will see a lot of it in the new industry as both Big Pharma and many small companies are getting into biosimilars, bringing a new group of generics to market.”
Andy Ramelmeier, SVP, Technical Operations Biologics, Portola Pharmaceuticals
Ramelmeier was part of a panel on Examining Methods to Address the Skills Gap and Build Global Manufacturing Capacity through Talent Development. Like the others, he sees tremendous growth with new products and new product modalities coming out. He says that this growth will require new capacity and technology to manage that and says, “it is a very exciting time to be in the industry as we’re really going to have to be more resourceful and look for innovative ways to manage this, because what has worked in the past may not work in the future, as we deal with this growth, particularly around the new products.”
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