CIBMTR® Launches Rapid Clinical Site Selection and Activation, Resulting in Faster Trial Enrollment for Cell and Gene Therapy Trials

Leveraging Master Contracts with Clinical Centers of Excellence, CIBMTR Launches a Dedicated Site Startup Team. Expert Physician Insight Leads to Fewer Obstacles Navigating IRB, DSMB and Regulatory Review

The CIBMTR CRO Services team will be presenting at the Association of Clinical Research Professionals (ACRP) 2024 Annual Meeting in Anaheim, May 3–7

NMDP BioTherapies announced today that CIBMTR CRO Services now offers a rapid clinical site selection and activation service, resulting in faster trial enrollment for cell and gene therapy (CGT) trials. By leveraging data from its 675,000+ patient clinical outcomes database, CIBMTR can quickly identify, vet and select transplant centers based on patient population, diversity and competing trials.

“At hand-off to our dedicated site startup team, we leverage our deep relationships with transplant centers to get your CGT trial activated and enrolling quickly, which enables sponsors to reduce the time required to launch and execute high-impact clinical trials,” notes Erin Leckrone, Vice President, Clinical Trials. “In addition, expert CIBMTR physician review enables endpoint efficiencies and mitigates barriers, allowing a refined protocol to progress more quickly through IRB, DSMB and regulatory body approvals.”

CIBMTR CRO Services’ team of clinical trial experts will be sharing their insights, experiences and strategies aimed at accelerating trial implementation and execution through two presentations, (i) fostering a clinical research associate (CRA) culture of excellence and (ii) critical data oversight structures at the upcoming Association of Clinical Research Professionals (ACRP) 2024 Annual Meeting.

Here's a glimpse of what attendees can expect:

• Title: A CRO Training Program for Overcoming Workforce Development Roadblocks
  
  
  
  Presenters: Kathleen Kane, Alisha Mussetter, Kassandra Nealon
  
  
  
  Date & Time: Monday, May 6, 2024, 10:30-11:30 a.m. PT
  
  
  
  Content: This session offers actionable strategies for enhancing clinical research training programs, drawing from the success of a CRA training program implemented by a small contract research organization. Attendees will learn how to foster a culture of excellence and growth within their teams.
  
  

• Title: Understanding Roles & Responsibilities in a World of Increasing Data Complexity
  
  
  
  Presenter: Kathleen Kane
  
  
  
  Date & Time: Sunday, May 5, 2024, 10:15-11:15 a.m. PT
  
  
  
  Content: In an era marked by increasing data complexity, this session explores foundational data oversight concepts crucial for successful clinical investigations. Kathleen will discuss the importance of clearly defining roles and responsibilities across multidisciplinary stakeholders.

CIBMTR 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.

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 Facebook, LinkedIn, 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 Facebook, LinkedIn, and Twitter.

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