The PPD clinical research business of Thermo Fisher Scientific Inc., has been granted a five-year award to provide a Transplantation Statistical and Clinical Coordinating Center for the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. This center will offer a broad range of support services critical to the design, development, execution and analysis of NIAID transplantation clinical trials and research.
 
According to the United Network for Organ Sharing, more than 40,000 organ transplants were performed in 2022, setting an annual record, with total kidney transplants exceeding 25,000 for the first time. Meanwhile, the Health Resources & Services Administration within the U.S. Department of Health and Human Services notes that more than 100,000 people are on the national transplant waiting list for all organs combined.
 
While design of clinical trials in this field can be challenging, the PPD clinical research business will leverage its expertise to help sponsors develop successful, cost-effective studies that minimize site and patient burden. The center will provide services such as statistical design and analysis; clinical protocol development, implementation and study management; biospecimen tracking; manuscript publication support; study management team organization and maintenance; and collaboration with other stakeholders to plan, oversee, execute and analyze NIAID-sponsored transplantation research.
 
Thermo Fisher recently expanded its transplant diagnostics capabilities by opening its One Lambda Laboratories. The CLIA-licensed lab provides a suite of noninvasive, post-transplant testing services dedicated to improving long-term outcomes for transplant patients. The new lab will introduce a menu of breakthrough assays that can detect rejection from at-home urine samples, delivering results to clinicians with rapid turnaround, and potentially eliminating the need for an invasive biopsy. The lab also will offer research services to advance the development of new immunotherapies and immunosuppressive agents.
 
“The scope of clinical research supported by our transplantation center enables us to help advance NIAID-sponsored transplantation studies, the results of which are essential to minimizing or, more hopefully, removing barriers to the success of transplantation procedures and the complications of long-term immune suppression,” said David M. Johnston, Ph.D., senior vice president and president, clinical research, Thermo Fisher Scientific. “We welcome the opportunity to help design and implement effective and efficient clinical trials to move the science of transplantation forward.”