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Thermo Fisher Scientific’s PPD Clinical Research Business Selected by BARDA to Support Phase II Platform Clinical Trial to Treat Acute Respiratory Distress Syndrome (ARDS)
WILMINGTON, N.C., December 21, 2023 — The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, has been selected by the Biomedical Advanced Research and Development Authority (BARDA) to implement the first BARDA-supported Phase II platform clinical trial to investigate multiple therapeutic options for the treatment of acute respiratory distress syndrome (ARDS). BARDA is part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).
ARDS is a life-threatening lung condition with multiple causes, including severe pneumonia and sepsis due to bacterial and viral infections such as influenza and SARS-CoV-2, that leads to high rates of death among hospitalized patients. Currently, no approved or licensed therapeutics are available to treat ARDS.
The primary objective of the BARDA-funded, hypothesis-generating study is to gather comprehensive clinical and biomarker data on the ARDS patient population to better inform future clinical studies and contribute to the development of targeted therapies for ARDS. Under this contract, the PPD clinical research business will implement a large Phase II clinical trial over three years. The clinical trial – a randomized, double-blind, placebo-controlled, multicenter Phase II platform trial – will evaluate the safety and efficacy of the three host-directed therapeutics at up to 60 U.S. sites, enrolling 600 hospitalized adult patients with ARDS. The drug candidates in the study will be announced in early 2024.
The PPD clinical research business will support the clinical trial with its deep capabilities and expertise in end-to-end platform clinical trials, seamless biomarker testing, and critical care, drug depot and laboratory services.
“There is an urgent, unmet medical need to better understand the clinical and biological features of ARDS to best treat people suffering from this often life-threatening condition,” said Sebastian Pacios, M.D., senior vice president and president, clinical research, Thermo Fisher Scientific. “We are privileged to contribute our expertise and innovative solutions to the development of effective treatments for ARDS. This opportunity has the potential to improve the outcome of ARDS patient health in the United States and around the world.”
The PPD clinical research business has more than three decades of experience delivering clinical research services and has conducted studies on a global scale across all trial phases and a broad array of therapeutic areas. During the past five years, it has conducted more than 175 respiratory studies, involving more than 40,000 patients at more than 10,000 research sites around the world.
For over 30 years, the business’ dedicated government and public health services group has successfully delivered clinical research services to various agencies, contractors and nonprofits in both prime contractor and subcontractor capacities within full compliance of all federal contracting requirements. In the past five years, the PPD clinical research business has supported more than 450 government-funded projects, including full-service clinical trials, statistical and data coordinating centers, clinical site monitoring centers, regulatory management centers, and clinical research operations and management support programs for BARDA, multiple National Institutes of Health institutes and centers, the Centers for Disease Control and Prevention and the U.S. Department of Defense.
This project, awarded to PPD Development, LP, has been funded in whole with Federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50124C00001.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.
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Randy Buckwalter
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