CAMBRIDGE, Mass., Feb. 24, 2026 /PRNewswire/ — Draper recently received an up to $26.7 million other transaction award (OTA) from the Advanced Research Projects Agency for Health (ARPA-H). The award supports the agency’s Computational ADME-Tox and Physiology Analysis for Safer Therapeutics (CATALYST) program, which will develop a new generation of in silico models of human physiology based on data from New Approach Methodologies (NAMs) to inform the drug development process.
Draper’s partners in the award are Revalia Bio, Inc., the Krishnaswamy Lab at Yale University, and LifeShare Network.
Modern drug development and approval pathways need leading-edge methods for accurately predicting safety profiles. Leveraging artificial intelligence and machine learning, CATALYST intends to develop computer models that mimic real human biology to predict safety and effectiveness for Investigational New Drug (IND) candidates, ensuring that only the most promising and safest medicines move forward to patients.
To overcome the limitations of existing human-based models, an integrated Human Data Stack will be developed utilizing four “layers” of human data that address different aspects of human biology. The four layers include patient data derived from Electronic Medical Records (EMR), macrophysiological data derived from donated human organs, detailed cellular and molecular level data from tissue and liquid biopsies, and microphysiological data from Draper’s PREDICT96 system that evaluates functioning human cells in a complex multi-cellular environment under physiologic flow conditions. Data from the four layers will be used to feed continuous learning models that leverage state-of-the-art AI/ML techniques to support patient-specific absorption, distribution, metabolism, excretion, and toxicity (ADME-Tox) prediction.
“Collectively, we believe an integrated Human Data Stack can be leveraged to develop a new class of Human Data Trial that can, in the near term, serve as a direct replacement to animal models under the current paradigm of drug development,” said Greg Tietjen, CEO, Revalia Bio. “More importantly, data from the stack can directly inform the development of the next generation of in silico models that leverage the latest AI/ML capabilities to be continuously learning every time data is generated in any layer of the system. These predictive models can become drug-specific companion models that move with a drug through each stage of development and support pharmacovigilance efforts post FDA approval.”
“A unique aspect of the integrated Human Data Stack is the blending of static, end point data—patient and biopsy data—with two separate dynamic experimental systems—the macro- and microphysiological data. In these layers, dynamic human experiments can be run to rapidly test hypotheses and refine our in silico models without risk to living patients,” added Tietjen.
“As part of an integrated Human Data Stack, Draper’s PREDICT96 system is able to provide a crucial layer of human data to support direct replacement of animal models, enabling faster and cheaper drug and medical countermeasure development,” said Katie Hulse, Distinguished Member of the Technical Staff, Draper.
Draper is a leader in microphysiological systems (MPS) used to model diseases and drug responses. In its 25-year history of MPS development, Draper has pioneered many groundbreaking advances, including long-term culture of mammalian cells in a microfluidic device, the first durable multi-organ system, the first multiplex instrumented MPS, and the first robust and reproducible operation of MPS in high containment.
The proposal’s research will use two specific human organ systems to provide proof of concept and lay a foundation for future expansion efforts. These organ systems are the human liver and kidney, the two primary filtering organs of the body that are susceptible to toxicity issues.
Subsequent research, if funded, will involve using the in silico models developed in Phase 1 towards generating predictive ADME-Tox data for use in Investigational New Drug (IND) filings with the FDA.
This research was, in part, funded by the Advanced Research Projects Agency for Health (ARPA-H). The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the official policies, either expressed or implied, of the United States Government.
About Draper
Draper is a non-profit research, development, and manufacturing company that solves some of the nation’s most important challenges. With more than 2,500 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 www.draper.com. Follow Draper on Linked In and Instagram.
About Revalia Bio
Revalia replaces animal models with scalable, AI-powered Human Data Trials built on living human organs — turning drug development into a high-velocity, data-driven engineering discipline, collapsing drug development from a 10+ year, $2B gamble into a <5-year, sub-$100M process. Learn more about Revalia Bio at https://www.revaliabio.com/.
About Krishnaswamy Lab
Krishnaswamy Lab at Yale University develops data geometric, topological, dynamic, deep learning methods for analysis, visualization and representation of big data, especially biomedical data. Learn more about Krishnaswamy Lab at https://krishnaswamylab.org/.
About LifeShare Network
At LifeShare Network, Inc, we believe in saving lives and inspiring hope. As a leading non-profit organization, our team fosters a strong commitment to serving donor heroes and their families. We ensure lifesaving gifts reach those in greatest need by collaborating with 159 hospitals in Oklahoma and transplant centers across the nation.
We are at the forefront of transplant research, innovation and education, made possible by our three subsidiaries: LifeShare Innovations, LifeShare of Oklahoma, and LifeShare Tissue Services, Inc, which all exist from community support of the LifeShare Foundation.
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