Anil Kane Executive Director & Global Head of Technical & Scientific Affairs, Pharma Services
THERMO FISHER SCIENTIFIC
"Techniques, technologies, and some areas of innovation where small biotechs may not have the breadth and depth of investing are now expected out of CDMOs."
What have been the main highlights for Thermo Fisher in 2023?
Thermo Fisher has invested heavily in advanced capabilities and capacity to meet our customers’ evolving needs. Medicine continues to advance and new technologies, such as cell and gene therapies, mRNA therapies, and innovative treatments, are increasing in demand. The company’s focus is to be a reliable supply chain player, enabling our pharma partners to bring effective medicines from discovery to commercialization. We continue to innovate and expand our capabilities in biologics, sterile drug product manufacturing, viral vector services, advanced therapies such as cell and gene therapy, and clinical supply chain services to help the biotech and pharma sectors in bringing their molecules to patients. Can you touch upon the latest investments made by Thermo Fisher in the field of R&D and innovation?
The company has expanded our capabilities to support the accelerated demand for our global sterile drug products and biologics manufacturing, increasing the scale of our operations as well. Thermo Fisher has expanded our capabilities in the Asia Pacific region and can now support our pharma partners in sterile drug product manufacturing from our new Singapore facility. The company’s Italian site in Monza recently received GMP approval for RNA-based products, enabling us to support our partners not only from a drug substance perspective but also from a drug product perspective. These are mRNA-based products including LNPs that have shown success in a variety of indications beyond oncology and immunotherapy.
Our new cell therapy development and cGMP manufacturing collaboration center at the University of California in San Francisco helps our partners to accelerate advanced cell therapy for difficult-to-treat conditions including cancer, different immune conditions, etc. Thermo Fisher’s newly constructed 300,000-square-foot viral vector manufacturing facility in Plainville, Massachusetts was commissioned in 2023 and supports taking complex viral vectors through development and clinical phases to commercial manufacturing. Beyond these new technologies, we have also supported our partners with their sterile drug products, prefilled syringes, and clinical supply chain services. How do you forecast the challenges and opportunities ahead for CDMOs?
CDMOs are playing an increasingly important role. More than 50% of products developed and commercialized are being outsourced, and outsourcing is here to stay and will only grow. The relationship between pharma and CDMOs is evolving, and expectations and partnership models are changing. The expectation is now that CDMOs must deliver transformational value, have access to cutting-edge technologies, have critical data-driven insights, have access to advanced materials, have innovative manufacturing processes, and also invest in resources and skilled individuals in different fields of science. In terms of partnership models, decades ago, we saw more transactional models or a fee-for-service model between a contract development partner and a pharma sponsor. Today, this is evolving to a different level of partnership where the CDMOs are required to bring in innovation as well and are not just an extended arm of support for clinical manufacturing or conducting clinical trials. Techniques, technologies, and some areas of innovation where small biotechs may not have the breadth and depth of investing are now expected out of CDMOs. What is your analysis of the main trends ahead for the pharma industry in 2024?
Today, a lot of effort is put in to make medication administration easy for patients, not only from an oral solid format perspective but also from a sterile injectable format perspective in the form of prefilled syringes.
Digitalization is also a major trend. It may be in the supply chain or analyzing data, bringing in predictive modeling to help us make science-based therapy decisions, whether it is in operations or manufacturing. We are going to see AI and machine learning being applied to utilize data more effectively, enabling data-driven decisions. Thermo Fisher continues to look at digital enablement, which is a fundamental component of pharma 4.0, helping to transform the industry and bring cost-effective operations into play. What is Thermo Fisher’s growth strategy in 2024?
There have been tremendous learnings coming out of the pandemic, and with the challenges mostly behind us, we look forward to a strong start to 2024. Thermo Fisher will continue to listen to our pharma partners’ needs, investing, innovating and growing with them, as we are all in it together.