Draper announced it is prepared to partner with the FDA and other government agencies to advance the use of microphysiological systems (MPS) and in silico computer models as an alternative to animal testing in the discovery, evaluation and regulatory approval of treatments and vaccines.
CAMBRIDGE, Mass., April 24, 2025 /PRNewswire-PRWeb/ -- Draper today announced it is prepared to partner with the U.S. Food and Drug Administration (FDA) and other government agencies such as the National Institutes of Health (NIH), the Defense Threat Reduction Agency (DTRA), the Biomedical Advanced Research and Development Authority (BARDA), the Defense Health Agency (DHA) and the Department of Veterans Affairs (VA) to advance the acceptance and use of microphysiological systems (MPS) and advanced in silico computer models all focused toward accelerating the discovery, evaluation and regulatory approval of treatments and vaccines.
This is in support of the FDA's announcement on April 10, 2025, that it plans to gradually phase out animal testing requirements for monoclonal antibodies and other drugs. The new approach will employ a range of testing methods, including computational models of toxicity and cell lines using artificial intelligence (AI) and organoid testing in laboratory settings with MPS, also known as organ on a chip. The FDA collectively refers to these as New Approach Methodologies (NAMs).
In addition to reducing animal experimentation, the FDA aims to lower research and development (R&D) costs, and ultimately, drug prices, while ensuring safer therapies reach patients faster.
Roger Odegard, Draper's Biodefense/Accelerating MCM Development portfolio lead said, "Draper is aligned with the FDA's decision to reduce its dependence on animal testing and to utilize the results and insights that NAMs can deliver in the drug testing and evaluation process. With over 20 years of experience developing MPS-based solutions and advanced models for biodefense applications, we fully understand the role in vitro human tissue testing and data intelligence will have when evaluating the safety and effectiveness of drugs, vaccines and antibody-based treatments. And, as a non-profit engineering innovation company, Draper is uniquely positioned to work at the intersection of government, industry and academia to move this initiative forward."
"The FDA's roadmap creates an important opportunity to expand the role of microphysiological systems and related technologies," said Jeffrey Borenstein, Laboratory Fellow at Draper. "Organ models have been around for a while, but their role has been limited to essentially research devices that are incompatible with the pharmaceutical workflow. We at Draper are developing systems that are designed to integrate seamlessly into the drug development workflow, and we have demonstrated in vitro in vivo correlation across a range of high impact applications in disease modeling and safety science. The time for MPS is now, and we are uniquely positioned to meet this moment."
Draper innovations in the MPS space have resulted in a class-leading, high-throughput, tunable organ-on-chip (OOC) microenvironment that can generate physiologically relevant responses in human organ tissue models to accelerate drug discovery, toxicity screening and efficacy testing for therapeutics and vaccines. Draper's flagship MPS architecture – PREDICT96 – has an instrumented microfluidic culture plate (MCP) in the standard 384-well plate footprint that supports 96 individual OOCs or arrayed multi-organ systems simultaneously, with sensors to monitor individual OOCs.
Draper began its MPS development in the early 2000s to improve the understanding of how chemical, biological, radiation and nuclear (CBRN) threats affect the human body and to predict the safety and effectiveness of drugs, vaccines, and antibody-based treatments. Draper advancements in the field have resulted in solutions that leverage human tissue platforms (MPS), immune system models, molecular and cellular assays, omics-based technologies, and advanced analytical methods. These innovations enable in-depth assessment of threat agents and medical countermeasure (MCM) interventions.
In its 25-year history of MPS development, Draper has achieved multiple industry firsts: first to culture mammalian cells in a microfluidic device, first durable multi-organ system, first multiplex instrumented MPS, and first robust MPS in high containment.
Draper has ongoing sponsored work with the Defense Threat Reduction Agency (DTRA) (ETHOS) and the Biomedical Advanced Research and Development Authority (BARDA) (for COVID-CBRN and Filovirus research) that are aligned with FDA's long-term goals and objectives. Additionally, Draper maintains business relationships with world-renowned experts at the nation's leading universities, industry partners, the DoE National Labs, Federally Funded Research and Develop and Centers (FFRDCs), and Contract Research Organizations (CROs) to support FDA's long-term investments and objectives.
Draper is committed to supporting MPS advancement through R&D and innovation, establishing best practices and data standardization, all geared toward accelerating MCM development and testing through a broad team of world-renowned experts. As a non-profit engineering innovation company, Draper is committed to participating in the workgroups and consortia outlined in the FDA's roadmap to reduce animal testing over the next five years.
About Draper
Draper is a non-profit research and development company that solves some of the nation's most important challenges. With more than 2,000 employees working in collaboration across 12 locations, Draper delivers transformative, mission-driven solutions that successfully meet our customers' requirements. These efforts focus on four critical mission areas: Strategic Systems, Space Systems, Electronic Systems, and Biotechnology Systems. To extend our legacy into the future, the Draper Scholars program engages with the next generation of innovators while DraperSPARX™ seeks to partner with startups and small businesses that can further our mission. To learn more about Draper, visit http://www.draper.com.
Media Contact
Michael Shirer, Draper, 617-258-2464, [email protected], https://www.draper.com
SOURCE Draper
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