Building a resilient cell and gene therapy industry in the face of COVID-19

The disruption to daily life from our collective preventative measures against the global SARS-CoV-2 outbreak is obvious to most. Many industries are being held back and we will likely see long-term or permanent effects from the shifts happening with social interaction in and out of the workplace. What may not be so obvious in the engrossing commotion over the COVID-19 danger is the increased vulnerability to patients with previous and ongoing unrelated medical treatments. The visualization below helps show why COVID-19 is taking up so much attention and what other medical issues are competing for care:

<div class="flourish-embed flourish-bar-chart-race" data-src="visualisation/1712761" data-url=""><script src=""></script></div>

The increased prioritization of resources toward fighting COVID-19 has left other medical issues in an abnormally challenging environment. It is especially precarious for cancer patients and the cellular therapy industry that supports cancer treatment development. In this space, however, the extreme caution given to COVID-19 is not unwarranted. One of the primary T-cell therapy treatment toxicities, cytokine release syndrome, also occurs in a subset of COVID-19 cases.1 This raises alarm bells for companies and regulators alike.

A study conducted at Mount Sinai Health System (MSHS) in New York City reported significantly increased intubation for COVID-19 patients who also suffered from cancer, and significantly higher mortality for COVID-19 patients under 50 years old who also suffered from cancer.2 Given the emergent timeline of this outbreak and suggestions of increased risk for cancer patients, current treatments and new therapy trials have been quickly altered in an attempt to limit exposure to SARS-CoV-2. The FDA and other regulators around the globe have encouraged these changes, even allowing for protocol changes to be implemented before review and final approval.3

This flexibility is necessary to salvage as many clinical trials as possible. The National Cancer Institute (NCI) recently reported that accrual to NCI-funded treatment clinical trials has dropped by half, a trend that is expected to continue.4 Some commercial pharmaceutical companies, like Bristol Myers Squibb (a major player in the cellular therapy space), have made the decision to suspend new and ongoing clinical trial enrollment.5

With patients and companies deciding to forego experimental treatment, there will be a gap in future therapy approvals. This gap will likely result in depressed projections for pharmaceutical companies and the material suppliers that support the industry. The pre-clinical environment is also experiencing drag with research and development companies around the world implementing precautionary measures like working from home and skeleton staffing on-site.

This slowdown in evaluation and development brings up many concerning unknowns about the future. The uncertainty and continued protraction of near-term global timelines for opening travel and business has many of us asking questions like: How long will it be until a majority of companies regain full functionality? What will the long-term effect be for the current population of cancer victims? What will happen to the security of current biopharmaceutical supply chains if demand lowers to a level that endangers material suppliers? How do we best integrate precaution and regulatory guidance into our operations moving forward? Are we now properly prepared for more of the same or a similar situation in the future?

Though we may never return to a world that was identical to the one before this pandemic, there are positive impacts being made now that will continue long into the future. Efficiency and safety improvements are being made throughout society including cleaning procedures and personal hygiene. Regulators and businesses are adapting to a new remote working environment and learning how to be flexible in their approach/strategy to continue business. Supply chain analysts are calculating and discussing how to truly mitigate risk. Some of those conversations include secondary sourcing with a multi-regional geographic approach, and how to re-shore the manufacture of key components such as raw materials, personal protective equipment (PPE), and lifesaving medicines to the United States.

Here at Akron, we are leveraging our global footprint to de-risk the supply of critical ancillary materials used in the cell therapy industry. Also, to assist with COVID-19 initiatives, Akron is continuing to supply key cytokines such as Inferferon to partners developing novel treatments to fight this virus. While all of this is happening, like many other companies, Akron is asking many of the questions that everyone is asking surrounding the impact to the industry. We all know that a resolution will not be immediate, but ancillary material companies such as Akron and the cell therapy companies and researchers we supply must continue to work together to meet demand and ensure clinical trials move forward. While many aspects of our lives may be on hold, cancer is not.

Once the immediate challenges have been mitigated or resolved, the fight must not end – we still need to come together as a community to resume research, clinical trials, and commercial development quicker than ever before to decrease the lag time between the discovery and diffusion of new cancer and orphan-designated therapy options to patients. We believe that our community will emerge from this pandemic with an even stronger sense of purpose and urgency, ensuring that we create the resilience in our supply chains, manufacturing processes, and clinical programs to accelerate the development of new, lifesaving treatments.

  1. Saini K, de las Heras B, de Castro J, Venkitaraman R, Poelman M, Srinivasan G, Saini M, Verma S, Leone M, Aftimos P, Curigliano G, Effect of the COVID-19 pandemic on cancer treatment and research., The Lancet Haematology (2020), doi: org/10.1016/S2352-3026(20)30123-X
  2. Miyashita H, Mikami T, Chopra N, Yamada T, Chernyavsky S, Rizk D, Cruz C, Do Patients with Cancer Have a Poorer Prognosis of COVID-19? An Experience in New York City., Annals of Oncology (2020), doi: org/10.1016/j.annonc.2020.04.006
  3. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency – Guidance for Industry, Investigators, and Institutional Review Boards
  4. At NCI, A Robust and Rapid Response to the COVID-19 Pandemic. Norman E. Sharpless, M.D. Apr. 17, 2020
  5. A Message to Clinical Trial Investigators on Bristol Myers Squibb’s Response to COVID-19. Samit Hirawat, M.D. 20, 2020.