T-SCCC will support initiatives seeking to ensure success of organ transplants for patients

The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, 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 in the United States. 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, the non-profit serving as the nation’s transplant system under contract with the federal government, 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 ever. 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.

Research advances continue to expand understanding of the biological mechanisms of solid organ transplant rejection and acceptance, yielding significant improvement in one-year survival rates and quality of life. While design of clinical trials in this field can be challenging, the PPD clinical research business has the tools and expertise necessary to help sponsors develop successful, cost-effective studies that minimize site and patient burden.

Thermo Fisher’s PPD clinical research business has three decades of experience successfully delivering clinical research services to governmental agencies, contractors and nonprofits. The business has conducted therapeutic, vaccine and medical device studies on a global scale across all trial phases and a broad array of therapeutic areas. During the past five years, it has conducted nearly 150 studies in transplantation and related indications, involving more than 7,000 patients at more than 2,200 research sites around the world. More broadly, Thermo Fisher’s transplant diagnostics business offers advanced solutions to help improve quality of life for transplant patients.

“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.”

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.

The results of that research are essential to minimizing or removing barriers to short- and long-term success of transplantation procedures by reducing the morbidities associated with pharmacological immunosuppression, inducing transplantation-immune tolerance and improving understanding of the immunologic response to allotransplantation.

In June, Thermo Fisher expanded its transplant diagnostics capabilities by opening its One Lambda Laboratories. The CLIA-licensed laboratory 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, while easing the burden on the patient by potentially eliminating the need for an invasive biopsy. The lab also will offer customers research services to advance the development of new immunotherapies and immunosuppressive agents.

The NIAID project will be funded in whole with federal funds from NIAID, the National Institutes of Health and the Department of Health and Human Services under cooperative agreement U01AI178756. The content of this announcement is solely the responsibility of Thermo Fisher Scientific and does not necessarily represent the official views of the National Institutes of Health.