Roundtable Part 5: Did the COVID-19 pandemic slow the development of cell and gene therapies? If so, what can industry do in the future to reduce the likelihood of this happening again? What has industry learned over the last three years?

The Pandemic created an unprecedented situation halting a massive number of clinical programs. The ramifications of these delays are likely never going to be fully understood, but surely derailed approval and commercialization of viable candidates in the clinic. From that, the industry has and will learn to adapt. Re-evaluation of supply chain strategies, diversity of product portfolios, and facets of the workplace dynamic will continue in the future. I believe the industry will challenge the status quo more than ever before.

Although the industry had experienced a temporary slowdown in CGT due to the pandemic and due to other trial related issues, this is no longer the case. Instead Eurofins BioPharma Product Testing is seeing a surge in the contract laboratory as new products are being pursued. Contract testing is back in high demand in the CGT space as manufacturers address the quality and safety needs of products.

First and foremost, CDMOs and vendors need to partner. What we have seen, due to what has happened to the global supply with COVID, is that everyone has run out of raw materials and components. It is so critical for every process we do to establish partnerships with the suppliers of those raw materials, and then to project out and forecast — looking at ways we can hold those raw materials without them expiring. If you don’t have those types of relationships, then you may be dealing with lead time that causes us, as a CDMO, to not be able to start on time.

The impact of the COVID-19 pandemic was far reaching, requiring a unified effort from the public health and manufacturing communities on a national and international level to find solutions to the challenges presented in continuing ongoing clinical trials toward successful completion.

During the pandemic we were committed to working with product developers and academia to develop strategies and solutions to the challenges that arose – and we will apply the lessons learned to future actions.

History has taught us that adversity often results in accelerated change, innovation, and new discovery. This is a unique strength of the FDA – to be prepared to respond through planning and designated resources, and to apply what we have learned previously rather than to simply be reactive.

We also recommend that you contact organizations such as the Biotechnology Innovation Organization (BIO), American Society of Gene & Cell Therapy (ASGT), and the International Society for Cell & Gene Therapy (ISCT) to obtain further information centric to the focus of this question.

Following the initial “knee-jerk” reaction to the pandemic, where everything pretty much came to a halt – the cell and gene industry recovered quickly and rapidly made up lost ground in the development and delivery of new therapies. The industry proved its resilience to the issues with logistics and supply chain and developed new, creative solutions to stay on track. As a result, the industry has emerged stronger than before and has learned from the pandemic. Companies now have a much more robust business continuity ethos and have built significant redundancy in the processes. Many developers have optimized their supply chain risk profiles by using alternative suppliers, decentralized distribution and storage as well as broadening their internal skill base to cover resource shortages. Overall, the pandemic was a difficult period for cell and gene therapy, but it has created a far more resilient industry that would now be far better equipped to manage supply chain challenges in the future.

Supply chain issues caused by the pandemic, and other global disruptions since, have led to inconsistencies in the ability to source key raw materials, consumables and requisite release testing. Long lead times and stock outs can impact the ability to schedule batches, which can in turn delay production, product release, or both. During this period, many discovery and early stage organizations experienced difficulty as COVID-19 vaccines and late stage therapies were prioritized. To mitigate future risk, many companies have secured secondary supply sources, extended their buying horizons, and increased their inventory of critical materials. Some have also integrated supply of key materials into their own operations, as with pDNA supply as mentioned earlier, and developed improved business analytics to identify and track potential supply risks earlier, giving them more time to respond to potential issues. A positive outcome emerging from the last three years comprises a strategy adopted by some therapy manufacturers toward platform process and testing standardization. By aligning and streamlining materials and processes, producers of therapies may be more responsive both in favorable as well as challenging times, assuring therapeutic supply to the clinic and the market.