Amy Hines, BSN, RN, oversees the Be The Match BioTherapies® Collection Network, which includes apheresis centers, marrow collection centers and cell therapy labs. She talked to us about some of the challenges the Network is facing, how Be The Match BioTherapies can help build efficiencies and how the organization plans to save more lives internationally.
Can you tell us a little bit about your background and current role at Be The Match BioTherapies?
It’s hard to believe but I’m approaching 20 years in the cellular therapy field! My career in this field began as a stem cell transplant registered nurse at Spectrum Health/Helen DeVos Children’s Hospital in Grand Rapids, Mich., and included a wide range of positions over the next 12 years.
I joined the National Marrow Donor Program® (NMDP)/Be The Match® team in 2013, working closely with apheresis and marrow collection centers in the NMDP/Be The Match Network. As Be The Match BioTherapies was developing in late 2015, I began dedicating more time to the subsidiary, and started working with the team full-time in 2016.
As the director of Collection Network Management, I oversee the development of the Network and performance of apheresis and marrow collection centers and cell therapy labs in our Network. My team ensures that we are true advocates and supporters of the work our Network partners do in the cell and gene therapy space.
With the rapid growth of the cell and gene therapy industry, what are some of the challenges collection centers face?
This is a very exciting time — so many amazing and game-changing therapies are moving to clinical trials and commercialization. For all of these therapies, the initial starting material is a cellular product that needs to be collected, processed and shipped for further manufacturing.
Every clinical trial or commercial therapy will have its own protocol that lays out the specifications and requirements that must be met in order for the product to be manufactured. Here are a few key challenges:
First, there are collection capacity concerns, like having enough experienced staff, apheresis slots, cell therapy lab time, etc. These resources are already almost tapped out with the business-as-usual work that these centers have because the infrastructure hasn’t had the time to adjust. Right now, there are still many unknowns in the cell and gene therapy field when it comes to new therapies entering clinical trials or receiving commercial approval, and how much additional capacity will be needed and when. So organizations are unlikely to invest in expanding collection programs until they have a better understanding of program growth.
Second, as each therapy has its own protocol, the collection and cell therapy lab teams are being overwhelmed by repetitive audits and training, and are doing the best they can to remain compliant with multiple and varying protocol requirements.
Why is standardization essential to ease the burden on the collection centers?
Imagine a very busy academic medical center. The center may be managing 10, 20, even 30 or more protocols that require a cellular product as starting material. For those protocols that are not managed by the academic medical center, the facility will be required to successfully complete several time-consuming tasks before even collecting one product.
One of these tasks is to be audited by the cell and gene therapy company. This requires hours and hours of staff time, and most audits are fairly similar in scope. By standardizing the audit process through the use of a quality system audit program, like the one offered by Be The Match BioTherapies, one audit can cover all of these activities, and cell and gene therapy companies can license the audit results. This saves the centers time and stress, ensures quality and regulatory requirements are met, and helps cell and gene therapy companies move collection centers and cell therapy labs through the site qualification process more efficiently.
Compliance with protocol requirements is also at risk given the variability in collecting, processing, cryopreserving, labeling, documenting, and shipping. The increased number of protocols, each being only slightly different, increases the likelihood that highly-trained and skilled professionals could still confuse protocols, and this results in errors and deviations that may affect the successful manufacture of these invaluable products.
How does the Be The Match BioTherapies Collection Network Management create efficiencies and standardized processes for collection centers, cell therapy labs, and cell and gene therapy companies?
Our Collection Network Management program qualifies each site, collects and maintains up-to-date technical assessment information, and connects cell and gene therapy companies with the sites that meet the protocol criteria. Sites only need to gather the information for the technical assessment once and have one point of contact to report to when capabilities change. This approach saves time and resources for the cell and gene therapy companies, as well as collection centers and cell therapy labs.
We also streamline the training process during site qualifications and ongoing monitoring. We have existing relationships with collection centers and cell therapy laboratories across the U.S. and understand each site’s capabilities and limitations. With visibility to each center’s processes, we can efficiently establish areas of overlap between the center’s processes and the company’s protocols to help the company develop standardized training that focuses on the critical differences.
We also work with cell and gene therapy companies to develop job aids to assist collection center and cell therapy lab staff at the time of cell collection and processing, particularly for a therapy that the center collects for infrequently. Our team members are available to be onsite to support critical events, such as the first collection and shipment. The team also monitors collection activity at the site and provides refresher training, as needed.
Can you tell me about Be The Match BioTherapies’ expansion into international markets?
Just as our NMDP/Be The Match mission to save more lives through cellular therapy knows no geographical boundaries, neither does Be The Match BioTherapies’. It’s our mission to extend this call to action to any cellular therapy that has the potential to save more lives, no matter where that patient lives.
We have hired an international collection network manager, Petr Machalik, to develop strategies, foster relationships and manage partnerships in the EU and beyond to ensure that the support we provide collection centers in the U.S. is mirrored internationally. We are working with international Network partners to provide site audits, training and center support in many EU countries, and are continually adding Network partners to expand our reach and facilitate new cell and gene therapies for patients in need around the globe.
What’s the biggest change you’ve seen in the field of transplantation/cell therapy since joining NMDP/Be The Match in 2013?
Most definitely the rapid development of cellular therapies outside stem cell transplantation. It wasn’t that long ago that transplantation was the only choice of cellular therapy for many patients, but now patients and their physicians have more options. Patients and families are now able to have discussions with their physicians about these new therapies and be more involved in treatment decisions. This is incredibly exciting, as more and more treatments are truly personalized and targeted to the patient’s condition.