The Next Generation of Cell and Gene Therapies | Deloitte US has been saved
By Hussain Mooraj, principal, NextGen Therapy practice lead, Deloitte Consulting LLP
I recently had the privilege of moderating an online panel discussion at the Financial Times Live Global Pharmaceutical and Biotechnology Conference. The esteemed panel of cell and gene therapy executives included Matthew Durdy, CEO of Cell & Gene Therapy Catapult; Dick Sundh, head of ACE (Australia, Canada, Europe) at Kite Pharma; Jo Brewer, senior vice president of Allogeneic Research at Adaptimmune; and Richard Scott, CMO of Genomics England. Below is a synopsis of our discussion. I’ve also added my thoughts based on what the cell and gene therapy (CGT) industry has seen during the past decade of its evolution.
During the session, we discussed the current state of—and future vision for—the CGT industry. We looked across research and development (R&D), manufacturing, and commercialization. We debated changing differentiators in a dynamic market, shifting business models and innovative collaborations, and the talent and technology aspects of maintaining momentum in an emerging field of R&D. The takeaways from the panel discussion touch on all aspects of the CGT industry and provide great food for thought for leaders in this space.
Rethinking competitive differentiators
In the beginning, manufacturing was a source of advantage. Over time, companies have seen that it takes a lot of work, is expensive, and is resource-intensive. Is manufacturing still a competitive advantage? The operational process was seen as another source of advantage: a company’s internal way of operating in a hospital environment using its own digital-enablement capabilities. Today, many providers are asking for standardization. Is the operational process still a competitive advantage?
The CGT industry is seeing new sources of competitive differentiators. Historically, manufacturing had to be done in-house because of the unique technology, processes, and skillsets required. Today, CGT services have evolved so that companies can develop their manufacturing strategies using the facilities from one vendor, the talent from another, and the systems and licenses from yet another. This scenario creates options in the marketplace that can add to competitive advantage.
Regulatory caution
It is still early for the field to understand the long-term impact of gene-edited cells, how they grow within patients, and how they cure diseases. Regulators have become hyper-cautious, especially as the market seems to pivot toward the allogeneic side, and rightly so, as risks for side-effects increase. Additionally, manufacturing nuances continue to pose a challenge for CGT organizations owing to inherent biological variability between manufactured batches. Therefore, close collaborations with the regulators will likely be vital in developing consistent approaches and eventually standards of practice that are commonly accepted and employed.
Business model innovation & standardization
Innovation is upending existing business models. We are seeing contract development and manufacturing organizations (CDMOs) act as venture capitalists or technology innovators. Public/private partnerships and new levels of collaboration across the value chain are becoming the norm. Some companies have even begun to envision a factory model for apheresis centers. All these efforts are resulting in new approaches and business models. However, standardization should not be ignored. As unique collaborations surface, the industry should collectively look at standards development. Standardization can offer scalability while reducing the time and costs of development, manufacturing, and commercialization.
Navigating the digital divide
Technologies have the potential to drive costs down while also speeding up processes. More collaboration among CGT stakeholders could help companies understand where, when, and how to harmonize delivery to patients. In the future, common systems that help patients and clinicians identify targets and access available products might simplify the connection between patient and therapy. Still, some changes are likely needed. On its current trajectory, the CGT industry could overwhelm health care providers with a digital and operational burden. Driving standardization and consolidation of digital capabilities will likely be essential to operate successfully.
Talent
At this point, many CGT organizations are pressed to develop internal talent due to high demand and the small number of experienced resources. Some organizations have attracted individuals from other industries, but this strategy often requires extensive retraining. In either case, an investment in people is essential for success. Talent acquisition is the first challenge, but retention is often a more significant concern. The small number of experienced individuals—combined with the high cost of training—is creating a talent deficit. Options such as hiring talent with clean-room experience from other industries or establishing apprentice programs should be considered. Mission and purpose can help hiring managers retain the right resources.
For any CGT product, the longer-term value will likely be found in the product’s efficacy. At the end of the day, it likely boils down to two moments of truth: (1) was the product available to the clinician and the patient at the point of care in a timely manner, and (2) did the product bring about the promised outcome?
The burgeoning CGT industry is focused on sophisticated medicines. Complexity permeates the entire development, manufacturing, and commercialization process. At the same time, there is a considerable opportunity for CGT stakeholders (manufacturers, providers, regulators, patients, and investors) to share experiences and collaborate in new and more meaningful ways. In doing so, we can begin to develop a shared understanding of the challenges we face and begin to build the standards of practice that can fuel progress and speed the maturation and growth of the entire industry.
