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Support for next-generation cell and gene therapies

NMDP biotherapies® and CIBMTR accelerate patient access to treatment

As your partner in delivering cell therapies, we are focused on meeting your needs so you can provide the best available therapy for patients. For some, that may be a cell therapy other than allogeneic or autologous transplant. It may be an emerging cell or gene therapy.

Through NMDP biotherapies®, we’re supporting the development of these therapies to help bring them to your patients sooner. And through the CIBMTR® (Center for International Blood and Marrow Transplant Research®), we’re collecting data on the long-term safety and efficacy of cellular therapies. This reduces the burden of duplicative data reporting for our transplant center partners.

Expanding cell therapy treatment options for all patients

 

NMDP biotherapies® builds on the experience and infrastructure we’ve developed over 30+ years of matching patients and donors and coordinating the collection and delivery of cells for your patients.

We partner with cell and gene therapy developers whose mission aligns with our own to expand access and treatment options for all patients. By supporting organizations with cell and gene therapies progressing through clinical trials or commercially available, we’re able to accelerate patient access to the best treatment for their disease.

If your center is already treating patients with cell and gene therapies, like CAR-T cells, you know how important timely, high-quality cell collection, manufacturing and therapy delivery is. That’s why we’re leveraging our supply chain and logistics experience to ensure high-quality, time-sensitive autologous and allogeneic cell therapy products are delivered to the patient.

But our support starts well before the first collection for a therapy. It starts with building, training and managing Collection Networks.

Collection Network onboarding and training

We’re building on our established relationships with our Network apheresis centers—including apheresis units in hospitals—to support high-quality cell collection for therapy manufacturing. Many of our Network centers are now part of the NMDP biotherapies® Collection Network.

This allows us to use standardized processes to minimize the resource burden on apheresis center staff for onboarding, auditing and training.

We are further reducing the resource burden on apheresis centers and cell therapy labs through our Quality System Audit Program (QSAP). This program can accelerate patient access to a therapy by:

  • Reducing the number of on-site audits at a center, and time spent preparing for each audit
  • Allowing multiple cell therapy companies to license a center’s quality system audit results
  • Reducing the amount of time required for a center to be qualified for collection because the audit is complete

If your apheresis unit is not yet part of our NMDP biotherapies® Collection Network or QSAP, contact our team at info@bethematchbiotherapies.com to discuss participation.

Case Study

The Challenge of Multiple Audits and Redundant Training

As UCLA Health’s participation in more CAR-T and other immunotherapy clinical trials grew, so to did the need for their cell collection and processing services.

Get an inside perspective on some of the challenges they encountered with multiple audits and training. And learn how standardized processes, like those NMDP(R) BioTherapies supports, can help alleviate the strain.

Advancing cell therapy research and development through partnerships

Through NMDP biotherapies®, we partner with more than 40 cell and gene therapy developers to advance clinical trials and support commercial product launches and ongoing delivery. These companies are at various stages of therapy development—from early clinical trials to FDA-approved products.

Some of these companies are developing therapies that have a potential impact on hematopoietic stem cell transplant, such as Poseida Therapeutics.

Poseida Therapeutics is the sponsor of P-BCMA-101—an autologous CAR-T clinical trial for patients with multiple myeloma. NMDP(R) BioTherapies provides apheresis center qualification, onboarding, training and ongoing support. In addition, we provide end-to-end supply chain management support from the collection of patient cells through transport and delivery.

NMDP biotherapies® also supports the development of cell therapies that treat post-transplant viral indications.

How will new cell and gene therapies impact the use of transplant?

Many cell and gene therapies being studied are for indications that have long been treated by allogeneic or autologous transplant. Watch this session from The ONE Forum® 2020 as a panel of industry experts explore the future use of transplant.

Long-term data collection and tracking

New cellular therapies—such as CAR-T—provide you with more treatment options and opportunities for a cure. With these new therapies comes a need to collect and track data, just as we have tracked transplant outcomes data for 50 years.

The CIBMTR has expanded its services to include data collection on more immunotherapies. The CIBMTR is our research collaboration with the Medical College of Wisconsin.

Two projects of note are the Cellular Immunotherapy Data Resource (CIDR) and the Cellular Therapy Registry.

As part of the Cancer Moonshot℠ initiative, the National Cancer Institute awarded the CIBMTR a grant to operate the CIDR. The CIDR collects data on long-term safety and the effectiveness of cellular therapies. The CIDR shares data and research results with clinicians, researchers, manufacturers, payers, regulators and the public.

The CIBMTR operates the Cellular Therapy Registry to collect data on immunotherapies for all cancers, including solid tumors. The CIBMTR is currently partnering with pharmaceutical companies to track 15-year follow-up data for CAR-T patients. These companies include Kite®, a Gilead Company and Novartis among others.

Through the partnership, transplant centers will only need to report to the CIBMTR. This reduces duplicative data reporting for our transplant center partners.

These programs wouldn’t be possible without the established partnerships with transplant centers who share our mission to improve access and outcomes for patients who receive cellular therapy.

Questions?

For more information about our partnerships with cell and gene therapy developers, visit BeTheMatchBioTherapies.com

To discuss how we can partner with your center to accelerate patient access to new cell and gene therapies, complete the form below and one of our team members will contact you soon.