Gene and Cell Therapy Developers Are Getting Creative to Keep Programs on Track During the Pandemic

Gene and Cell Therapy Developers Are Getting Creative to Keep Programs on Track During the PandemicJeanette Young, senior consultant for analytical services at BioTechLogic talks with Tonia Becker, Life Sciences Editor, Macon Raine 

As it became clear that the COVID-19 pandemic would not be a short-lived disruption, gene and cell therapy companies adjusted their approaches to keep programs on track as best as possible. In particular, lab work has required reconfiguration to facilitate needed social distancing.

I was fortunate to have the opportunity to speak with Jeanette Young, senior consultant for analytical services at BioTechLogic. Jeanette has spent years working alongside her colleagues and clients in the lab. Lately, however, she has been working with clients to adjust processes and procedures for the demands of the times. 

Are your clients experiencing any concerning program delays due to the pandemic?

Jeanette: Clinical trials have experienced the most significant delays. Patients haven’t been able to get to the medical facilities conducting the trials or are simply reluctant to do so. Also, in many cases, there has been a slowdown in getting material to the clinics for administration. 

I did have a client that had to discard millions of dollars’ worth of material. It was in the middle of a run—not a good stopping point—when shutdowns started happening in its area, and there was concern that a contractor who had been on-site might have been infected with COVID-19. The company’s leadership shut down the facility out of an abundance of caution, and the entire company quarantined at home for a couple of months. The client found new ways to do things remotely and spent time working that way rather than letting work grind to a halt.

I have another client that is in the midst of authoring a BLA. It shifted focus and worked on areas of the BLA it had planned to focus on a bit later in the filing process. They found ways to move forward, so there was no significant impact to its overall timeline. This is not the ideal way of working, but everyone has been forced to get creative.

Has there been a slowdown in the delivery of contract services?

Jeanette: A lot of my clients contract out their analytical lab work. There has been a sizable slowdown in contract labs responding to proposals for new work. The work itself has slowed down as well. In normal times, it is common for contract labs to be backlogged. But now, they must reduce the number of workers in their labs and consequently have had to adjust their schedules. Many labs are running certain types of tests on specific days, which makes the process challenging if your analysis requires interdisciplinary work. Because of this scheduling segmentation, it is often difficult to complete interdisciplinary work in real-time. 

How are companies working to handle ongoing disruptions as we move through the pandemic?

Jeanette: I think everyone is realistic. Based on evidence from historical pandemics, infection rates and the corresponding disruption tend to ebb and flow.  Many companies are figuring out new ways to move forward on their path toward commercialization—to get their clinical trials back on track and file their BLAs. 

Multiple clients are now executing shifted schedules; when team members don’t have to be in the lab conducting hands-on work, they are asked to work from home. Workers coming into the lab on a given day are asked to practice social distancing, wear masks, use hand sanitizer, and regularly wipe down everything. 

Many companies are looking at the twenty-four hours in a day more creatively to space workers and keep the work on track. For instance, they are altering schedules—some analysts are going in early in the morning, and others are coming in later in the day so there’s no overlap. 

These changes have certainly resulted in changes in the approach because less interaction occurs among team members, but everyone is striving to get the work done while staying as safe as possible.

How are clients handling work where a lot of collaboration is necessary? 

Jeanette: Validations are big collaborations because you always have multiple analysts involved. Whereas we used to have in-person conferences where we would go through the protocol and answer questions, these discussions now happen on Zoom or Skype. 

We send a lot more email correspondence and documentation to make sure protocols are well understood. Recording who is doing what portion of the assay on which days has been critical. It has always been necessary to have schedules and assign the work; however, with less in-person interaction, documented communication has needed to become more regimented. 

How have you adjusted the approach to your work to best help your clients?

Jeanette: Hands-on training has been especially challenging. Companies are rightfully restricting consultants and third-party contractors on their campuses. In the past, I have spent countless hours in the lab with clients helping them with the work and training as needed. You can’t observe as you normally would when training, so we’ve had to make changes to our approach.

I’ve handled this by making myself available to analysts to answer questions as they arise. I am often fielding urgent correspondence like calls, texts, and video communications in addition to responding to less urgent issues via email. We are all doing what we must in the moment to get the work done.