Industry Working Group Finalizes Cell-Collection Labeling Standards for Cell and Gene Therapies to improve patient safety | Deloitte US has been saved
By Steve Davis, managing editor, Deloitte Center for Health Solutions, Deloitte LP
Cell and gene therapies have shown promise in their ability to cure and heal patients rather than merely treat their symptoms. The emerging sector is growing so quickly that the development of some standards has lagged behind.
In February 2019, Deloitte launched the NextGen Therapies Industry Working Group (IWG) to provide a platform for Cell and Gene Therapy leaders to exchange perspectives, share best practices and develop solutions focused on improving the lives of cell and gene therapy patients. Later that year, as its first focused endeavor, the IWG brought together a group of cell and gene therapy companies, clinicians, quality and regulatory advisors, and technical-solution providers to drive alignment toward standardizing the minimum elements required for apheresis end-of-collection labeling. The voluntary group recently drafted and published a new International Council for Commonality in Blood Banking Automation (ICCBBA) standard.
The group, led by the Standards Coordinating Body, represents biopharma manufacturers, apheresis centers, regulatory advisors, and people with technical expertise. The organization’s goal is to share perspectives and to identify next steps for standardization across the CGT industry. The standardized labels are currently in the implementation phase.
CGT is an emerging area of therapeutic innovation and some processes and procedures have yet to be formalized. This includes the physical labels affixed to the blood-collection bags and the vials used to transport CGT materials and therapies for further manufacturing. Along with providing detailed information about the patient, CGT labels have to endure extreme temperature fluctuations (-190C to 37C) during production, storage, shipping, and use.1 An earlier standard was created for cells that stayed within a single hospital system, but biotech manufacturers needed additional data points for traceability.
Our 2020 report on optimizing the gene-therapy business model identified labeling as a time-consuming task with significant implications for operations and patient safety. Clinicians from treatment sites and academic institutions listed challenges that ranged from illegible, handwritten labels to labels that included extraneous and confusing information.
8 questions for bluebird bio and Deloitte
In close collaboration with the Standards Coordination Body, IWG set out to develop minimum requirements for CGT labeling (e.g., label size, material, layout, and minimum traceability data requirements). Jennifer Rabin, a specialist master in Deloitte Consulting LLP’s Life Sciences practice, led the formation of the working group. Prior to joining Deloitte two years ago, she was an oncology nurse at a large teaching hospital where she was involved in the apheresis center’s cell-collection program. Beth Gardner, senior director of global patient supply at bluebird bio, Inc., was one of the first industry representatives to join the group. The Cambridge, Mass.-based company develops autologous gene therapies for rare genetic disorders and cancer.
The Deloitte Center for Health Solutions (CHS) recently spoke with Beth and Jennifer about the working group, the importance of having standards for CGT cell-collection labels, and the next steps.
CHS: Why are labeling standards needed for cell and gene therapies?
Jennifer: Cell and gene therapy involves manufacturing a therapy from a patient’s own cells. The apheresis centers that collect those cells from patients were being inundated by requests from various sponsors and manufacturers. Some companies tried to reduce the burden on these centers by providing them with customized printers and labels for their products. That created additional challenges for nurses at centers that worked with multiple cell and gene companies.
Beth: We were hearing from staff at clinical locations that the processes bluebird bio required for its labels were a little different than the processes required by Company X or Company Y. They often asked why an accredited apheresis center needed to install a special label printer for every CGT manufacturer. We didn’t have a good answer. The working group allowed us to have honest conversations—across organizations—about how we could remove barriers while ensuring patient safety and traceability.
CHS: How is the labeling used in cell and gene therapy different from labels used for more traditional pharmaceuticals?
Beth: Labeling standards in biopharma are typically linked to lot numbers that allow materials to be tracked and traced. Labeling requirements for cell and gene therapies need to link back to the patient. Traceability has to be secure both for the hospital that is procuring the material from the patient, and for the processing done by the biotech manufacturer. We have to have readable information in a standard format to make sure there is no way to confuse the data.
CHS: What do stakeholders have to gain from standardized apheresis labeling?
Beth: The primary benefit is patient safety. That’s number one. Secondary benefits for sites and manufacturers mean they don’t have to install company-specific hardware and software to print labels, and they don’t have to train clinical staff on how to print the labels. Clinical staff won’t have to spend as much time navigating various printers, which means they have more time to spend with patients.
CHS: This is a highly competitive industry. Were you surprised at the level of collaboration?
Jennifer: When I think back to the very first meeting, everyone was so quiet that I felt like I was the only one talking. I didn’t know how much people would be willing to share their [non-intellectual property] thoughts and ideas. But as trust grew, collaboration evolved quickly. It was pretty great.
Beth: Agreed. In a competitive industry like biopharma, it was refreshing to see experienced people sharing information with those who had less experience so they wouldn’t repeat some of the same mistakes. The working group was a safe space where people felt comfortable asking complex questions or even very basic ones. People shared pictures of cell-collection label examples and then discussed specific elements of those labels. We talked about why some fields were needed and why others might not be necessary. It was also critical to get cross-CGT industry feedback from people who worked at apheresis centers, regulatory advisors, and representatives from technology organizations and manufacturers. It was humbling to realize that we may have each made assumptions about why specific information was needed on a label.
CHS: Did COVID-19 slow down this initiative?
Jennifer: The first public comment period was in March 2020—the same month the pandemic was declared. We worried that everyone would turn their attention to COVID-19. There was certainly some of that, but it didn’t deter our work. It can take five to 10 years to develop an industry standard. Being able to do that in a little more than a year is pretty awesome.
CHS: How was this group able to accomplish so much is such a short amount of time, and during a pandemic?
Beth: It’s pretty incredible looking back. Everyone in this group is a volunteer, but we are all passionate about this issue. Many of us have been working from home. For me, not having to spend three hours a day commuting meant I had more time to devote to this project.
CHS: You created gender-neutral names for the labels. How did that come about and why is it important for diversity, equity, and inclusion?
Beth: The label working group wanted to ensure that there were visual label examples within the standard document. The cell-collection label has a field for “Patient Name.” Early drafts of the document used the generic name “DOE, John William.” It’s a very traditional name, and I thought we could be more inclusive. I reached out to the person who leads our LGBTQ+ employee resource group and we brainstormed gender-neutral names. We landed on Charlie Alex. I reached out to ICCBBA and the IWG to see if our fictitious patient could be revised to Charlie Alex. The team universally supported revising our-label standard patient name to “DOE, Charlie Alex.” As a cis-gender woman leader within biotech pharma, I am thrilled to be an ally for my LGBTQ+ colleagues. Representation matters.
CHS: What are the next steps?
Beth: The working group has decided that 2021 will be a transition year for implementation. We had naively thought we could tell the apheresis centers that they could now use their own printers. But there are processes and procedures and audits that have to be updated at the sites, and software needs to be installed before they can do that. We are going to be spending a lot of time talking with staff at our sites, so we understand the timelines and their cell collection labeling capabilities. Ideally a large percentage of the sites will be able to print locally—leveraging their own equipment—by 2022.
Endnotes:
1. Critical considerations for packaging and delivery of gene therapy products, Cell & Gene, December 20, 2018
