Expanded service offering specializes in the design, implementation and oversight of cellular therapy clinical trials to speed patient access to life-saving treatments

MINNEAPOLIS, Minn. January 17, 2023 — NMDP BioTherapies, an organization offering solutions for companies developing and commercializing cell and gene therapies, today announced it is offering CIBMTR® (Center for International Blood and Marrow Transplant Research) Clinical Research Organization Services (CRO Services), which allows sponsors to significantly reduce the time required to launch and execute high-impact clinical trials. These CRO Services are a collaborative effort between NMDP BioTherapies and the CIBMTR, resulting in unique expertise and access to unparalleled resources, including research, sites, donors, partnerships, and scientific and operational expertise.

“NMDP BioTherapies and its partners have successfully supported bone marrow transplant and cellular therapy clinical trials for nearly 20 years,” said Erin Leckrone, Senior Director, Clinical Trials, at the CIBMTR. “Today, with our formal launch of CIBMTR CRO Services, the expertise and resources honed over decades of work by the leading experts are accessible to small to mid-sized biotechnology companies. These services, whether used in whole or as ad hoc support, will accelerate time-to-trial and bridge the transition from research to patients.”

CIBMTR CRO Services offer unique capabilities including:

  • Nearly 20 years of experience in transplant and cellular therapy trials and correlative study management, including therapeutically trained staff.
  • Established relationship with more than 225 domestic clinical sites.
  • Access to direct contact with patients and donors for research and clinical insights through on-staff transplant physicians.
  • Synergies with NMDP and NMDP Biotherapies for end-to-end clinical trial design, operations, and logistics support.
  • Built-out clinical infrastructure with a single Institutional Review Board (sIRB), dedicated Data Safety Monitoring Board (DSMB), master contracts, and 21 CFR part 11 compliant software.
  • A direct link to the CIBMTR outcomes database for more than 575,000 patients.

The new CRO Services provide turn-key solutions, including protocol development and approval oversight, project management, site selection, site start-up, data management, research sample/laboratory coordination, study monitoring, statistical analysis, patient-reported outcomes, and financial administration. Alternatively, companies can leverage the expertise of CIBMTR CRO Services for select services such as data analysis, surveys, site selection and management, and sample management.

About NMDP BioTherapies 

NMDP BioTherapies is the only cell and gene therapy solutions provider with customizable services to support the end-to-end cell therapy supply chain. Backed by the industry-leading experience of NMDP and a research partnership with the CIBMTR® (Center for International Blood and Marrow Transplant Research®), the organization designs solutions that advance the development of cell and gene therapies across the globe.

NMDP BioTherapies is dedicated to accelerating patient access to life-saving cell and gene therapies by providing high-quality cellular source material from the NMDP Registry, the world’s most diverse registry of more than 7 million potential blood stem cell donors. Through established relationships with apheresis, marrow collection, and transplant centers worldwide, the organization develops, onboards, trains, and manages expansive collection networks to advance cell therapies. NMDP BioTherapies uses a proven infrastructure consisting of regulatory compliance and managed logistics experts and cell therapy supply chain case managers to successfully transport and deliver regulatory-compliant life-saving therapies across the globe. Through the CIBMTR, NMDP BioTherapies extends services beyond the cell therapy supply chain to include long-term follow-up tracking for FDA-approved CAR-T therapies.

For more information, follow NMDP BioTherapies on LinkedIn or Twitter.

About the CIBMTR

The CIBMTR® (Center for International Blood and Marrow Transplant Research®) is a research collaboration between NMDP and the Medical College of Wisconsin (MCW). The CIBMTR collaborates with the global scientific community to advance hematopoietic cell transplantation (HCT) and cellular therapy worldwide to increase survival and enrich quality of life for patients. The CIBMTR facilitates critical observational and interventional research through scientific and statistical expertise, a network of more than 300 transplant centers, and one of the largest databases worldwide for clinical outcomes of cellular therapy, and a biorepository with tissue samples.

For more information on the CIBMTR, please visit www.cibmtr.org or follow the CIBMTR on FacebookLinkedIn, or Twitter.

About the Medical College of Wisconsin

The Medical College of Wisconsin brings together the most inquisitive minds in science, medicine, education and community engagement to solve the toughest challenges in health and society today. Academic medicine is at the core, where scientists, physicians and students work together with the community to ask the questions no one else is and fuel the continuous cycle of knowledge that’s shaping the future or medicine.

For more information, visit www.mcw.edu or follow the Medical College of Wisconsin on FacebookLinkedIn, and Twitter.

Media Contacts: 

Bonnie Quintanilla, bonnie@clarityqst.com
Phyllis Grabot, phyllis@clarityqst.com
(877) 887-7611