Purpose
This workshop will offer a platform for experts to discuss the needs of complementary approaches to understand complex questions focused on biological mechanisms to advance human health and opportunities, to use National Institutes of Health (NIH)–funded model resources and physical infrastructure, to validate new approach methodologies (NAMs), and to improve overall predictability of models for human diseases.
Background
Biomedical researchers rely on a combination of innovative methods, models, and technologies to answer complex questions about human health and disease. The use of any given approach is driven by its ability to support rigorous and impactful science and answer the research question under study. Scientific advancements in the last decade led to the introduction of precision animal models, which are carefully designed and engineered to mimic specific human genetic variations and disease characteristics. While animal research remains necessary for addressing the complexity of human biology, rapid advances in technology are catalyzing the development and use of complementary NAMs (which include in silico, in chemico, and in vitro models). NAMs hold tremendous promises for increasing the tools available to achieve the NIH mission and potentially improve significantly the effectiveness of model use in several research areas in the future. Among examples of noticeable application of NAMs is regulatory testing, which includes safety and toxicity testing of pharmaceuticals and chemicals. Non-animal approaches are also being used in the approval process for drugs and vaccines in humans and the testing of the safety of commonly used chemicals. Application of NAMs in general biomedical research areas, such as basic science or preclinical testing, requires significant further development and validation. While some NAMs aim to replace animal testing, others are used in a complementary way with animal studies to gain better insights and solutions to scientific questions, thereby reducing and refining the overall use of animals in research. Given the current state of technology development, realizing the broad utility of NAMs in biomedical research will require sustained investment in shared infrastructure and community resources—such as robust validation frameworks, interoperable data standards and platforms, reference datasets, training, and coordinated access to specialized capabilities—to support their proper incorporation and wide application.
Day One will concentrate on the strategic and translational integration of NAMs and animal models in biomedical research. Discussions will address the complex incorporation of emerging technologies into studies of human disease progression, including the shared infrastructure needed to support adoption (e.g., data standards, interoperable platforms, and validation resources).
Day Two will pivot on the technological frontiers of NAMs that reshape biomedical discovery, focusing on strategies and validation of combined multi-system integration. Sessions will also emphasize how technologies will drive adoption and maximize impact on human disease research, with an interest in identifying infrastructure gaps.
Office of Research Infrastructure Programs (ORIP) POCs
Please contact the ORIP staff listed below for more information about the workshop.
Day One
Oleg Mirochnitchenko
Yongjun Sui
Day Two
Monika Aggarwal
Jeffrey Spector
Day One
List of Presenters and Panelists
Ashutosh Agarwal, Ph.D., University of Miami
Manuel Amieva, M.D., Ph.D., Stanford University
Murat Cirit, Ph.D., Javelin Biotech
Melissa Haendel, Ph.D., The University of North Carolina at Chapel Hill
Michael Helmrath, M.D., Ph.D., University of Cincinnati, Cincinnati Children’s Hospital Medical Center
Bridgett Hill, M.S., General Dynamics Information Technology
Nicole Kleinstreuer, Ph.D., Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), NIH
Donald Ingber, M.D., Ph.D., Wyss Institute, Boston Children’s Hospital, Harvard Medical School
Scott Lowe, Ph.D., Memorial Sloan Kettering Cancer Center
Carolina Lucchesi, Ph.D., American Type Culture Collection
Oleg Mirochnitchenko, Ph.D., ORIP, DPCPSI, OD, NIH
Diana Monsivais, Ph.D., Baylor College of Medicine
Stephanie Murphy, V.M.D., Ph.D., ORIP, DPCPSI, OD, NIH
Brenda Ogle, Ph.D., University of Minnesota
Sergiu Paşca, M.D., Stanford University
Jason Spence, Ph.D., University of Michigan Medical School
Takanori Takebe, M.D., Ph.D., Cincinnati Children’s Hospital Medical Center
David Tuveson, M.D., Ph.D., Cold Spring Harbor Laboratory
John Wikswo, Ph.D., Vanderbilt University
Joseph Wu, M.D., Ph.D., Stanford University School of Medicine
Wolfram-Hubertus Zimmermann, Prof., Dr., Institute of Pharmacology and Toxicology, University Medical Center Göettingen
List of Organizing Committee Members
Thomas Bell, M.S., Ph.D., National Disease Research Interchange
Kelly Chandler, Ph.D., Office of Research on Women’s Health (ORWH), DPCPSI, OD, NIH
Christine Happel, Ph.D., National Center for Advancing Translational Sciences, NIH
Helena Hoegberg-Durdock, Ph.D., National Institute of Environmental Health Sciences (NIEHS), NIH
Qing Lin, Ph.D., National Heart, Lung, and Blood Institute, NIH
Scott Lowe, Ph.D., Memorial Sloan Kettering Cancer Center
Oleg Mirochnitchenko, Ph.D., ORIP, DPCPSI, OD, NIH
Christine Nadeau, Ph.D., National Cancer Institute (NCI), NIH
Malgorzata Ochocinska, Ph.D., Office of Strategic Coordination, DPCPSI, OD, NIH
Rebecca Roof, Ph.D., National Institute of Neurological Disorders and Stroke (NINDS), NIH
Jason Shepherd, Ph.D., The University of Utah
Yongjun Sui, Ph.D., ORIP, DPCPSI, OD, NIH
Alice Tarantal, Ph.D., University of California, Davis
Elizabeth Worthey, Ph.D., The University of Alabama at Birmingham
Other Acknowledgements
Susan Chandran, ORIP, DPCPSI, OD, NIH
Day Two
List of Presenters and Panelists
Gary An, M.D., Professor, The University of Vermont
Anthony Atala, M.D., Wake Forest University School of Medicine
Randolph Ashton, Ph.D., University of Wisconsin–Madison
Anna Bremser, Ph.D., Genentech Inc.
Colleen Clancy, Ph.D., University of California, Davis
Robert Damoiseaux, Ph.D., University of California, Los Angeles
Jennifer Elisseeff, Ph.D., Johns Hopkins University
Benjamin Freedman, Ph.D., University of Washington (Day 2 Workshop Chair)
Lisbet Geris, Ph.D., University of Liege, Belgium
Daniel Geschwind, M.D., Ph.D., University of California, Los Angeles
Linda Griffith, Ph.D., Massachusetts Institute of Technology
Kimberly Homan, Ph.D., Genentech Inc.
Christopher Hughes, Ph.D., University of California, Irvine
Albert Hwa, Ph.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH
Raphael Isokpehi, Ph.D., Office of Data Science Strategy (ODSS), DPCPSI, OD, NIH
Georgette Jones, Ph.D., NCI, NIH
Robin Kawazoe, ORIP, DPCPSI, OD, NIH
Angela Koehler, Ph.D., Massachusetts Institute of Technology
Reinhard Laubenbacher, Ph.D., University of Florida
Douglas Lauffenburger, Ph.D., Massachusetts Institute of Technology
Brian Paegel, Ph.D., University of California, Irvine
María Rodríguez Martínez, Ph.D., Yale University
D. Lansing Taylor, Ph.D., University of Pittsburgh
Martin Trapecar, Ph.D., Johns Hopkins University
Alexander Tropsha, Ph.D., The University of North Carolina at Chapel Hill
Michael Wells, Ph.D., University of California, Los Angeles
Joseph Wu, M.D., Ph.D., Stanford University
List of Organizing Committee Members
Monika Aggarwal, Ph.D., ORIP, DPCPSI, OD, NIH
Anthony Atala, M.D., Wake Forest Institute for Regenerative Medicine
Julia Bachman, Ph.D., NINDS, NIH
Kelly Chandler, Ph.D., ORWH, DPCPSI, OD, NIH
Yong Chen, Ph.D., ORIP, DPCPSI, OD, NIH
James Cherry, Ph.D., National Institute of Allergy and Infectious Diseases, NIH
Colleen Clancy, Ph.D., University of California, Davis
Tiziana Cogliati, Ph.D., National Eye Institute, NIH
Robert Damoiseaux, Ph.D., University of California, Los Angeles
Benjamin Freedman, Ph.D., University of Washington (Day 2 Workshop Chair)
Linda Griffith, Ph.D., Massachusetts Institute of Technology
Helena Hoegberg-Durdock, Ph.D., NIEHS, NIH
Albert Hwa, Ph.D., NIDDK, NIH
Raphael Isokpehi, Ph.D., ODSS, DPCPSI, OD, NIH
Georgette Jones, Ph.D., NCI, NIH
Jonathan Kulwatno, Ph.D., National Institute of Biomedical Imaging and Bioengineering, NIH
Reinhard Laubenbacher, Ph.D., University of Florida
Douglas Lauffenburger, Ph.D., Massachusetts Institute of Technology
Xiang-Ning Li, M.D., Ph.D., ORIP, DPCPSI, OD, NIH
Ananda Roy, Ph.D., OD, NIH
Jeffrey Savas, Ph.D., Northwestern University Feinberg School of Medicine
Jeffrey Spector, Ph.D., ORIP, DPCPSI, OD, NIH
Alexander Tropsha, Ph.D., The University of North Carolina at Chapel Hill
Joseph Wu, M.D., Ph.D., Stanford University
Other Acknowledgements
Cecilia Fox, ORIP, DPCPSI, OD, NIH