Despite uncertainty, high risk, and significant investment pressures impacting the cell and gene therapy landscape, those in the community gathered for the recent annual Cell & Gene Therapy International conference. And yet, the hallway conversations, visits to exhibitor booths, and engaging presentations and discussions gave the impression this community remains driven and dedicated to bringing these therapies to market and patients in need.
Enabling efficiency, propelling education, and sharing expertise as a community were strong themes echoed throughout the conference.
Let's take a closer look.
Efficiency
- Innovation is being pushed to its limits to improve manufacturing platforms to increase efficiency and applicability.
- Contract Development Manufacturing Organizations (CDMOs) are enhancing their processes and platforms to manufacture cell and gene therapies at a faster pace, and are working to harmonize and align materials, processes, and testing to generate safer medicines more efficiently.
Education
- Knowledge sharing was prioritized. From novel equipment used in manufacturing, to innovative testing methods and specifications, knowledge was shared with the audience enabling attendees to apply lessons learned to their products with the intent of avoiding arduous trial and error that can be costly and disruptive to development timelines.
Expertise
- Strong expertise was demonstrated across the conference, from presenters, panelists, and exhibitors promoting their products, to the audience asking intelligent, appropriately timed questions.
- Many experts shared their lessons learned or key points to consider when developing cell and gene therapy products. In particular, experts discussed the timing of selecting a CDMO, what to request and watch out for in the request for proposal process, when to prepare the sponsor organization and CDMO for a health authority inspection, and much more.
- Advice was shared about investing internally in areas to mitigate risk and delays, including in-process development labs for troubleshooting or pivoting in circumstances when a change in strategy is needed. Investing in an internal quality control-testing lab can also help mitigate delays.
Given the challenges and uncertainties in the field of cell and gene therapy, there was no doubt developers, scientists, regulatory professionals, medical professionals, and patients are still pushing these therapies forward. Still, there is tremendous potential with cell and gene therapies that the industry is only beginning to reveal.
As always, in times of uncertainty, change, and disruption, we come together to encourage efficient practices, share knowledge, and lend our expertise. That is what I proudly experienced at this conference.
I have been monitoring and advising cell and gene therapy companies on their regulatory affairs approach for the better part of my career. To learn more, please review our Insights page.