Instem, a global leader in SaaS solutions for life sciences R&D, today announced a 5-year extension of its Research Collaboration Agreement (RCA) with the U.S. Food and Drug Administration (FDA).
(Q)SAR models must be continually updated and validated to remain relevant as new compound classes and chemistries advance through pharmaceutical drug development. At the same time, computational toxicology approaches are becoming increasingly important as regulators shift toward adoption of the 3Rs principles (Replacement, Reduction, and Refinement) and away from the use of animals in drug safety assessments. The RCA, ongoing since 2011 and now extended through February 2031, will see Instem and the FDA continue their collaborative research utilizing the Leadscope platform to advance predictive toxicology models, expand curated safety databases, and enhance regulatory decision-support tools.
“At Instem, we focus on staying at the forefront of scientific, technological, and regulatory developments to help our clients achieve and maintain alignment as they bring life-changing therapies to market,” said Vik Krishnan, CEO of Instem. “Our continued collaboration with the FDA underscores this commitment and highlights the value we bring to both industry and regulators in advancing confident, data-driven safety assessments.”
Leadscope: Collaborative Research Advancing Predictive Safety and Regulatory Science
Instem’s decades of scientific rigor and sustained focus on high-quality predictive (Q)SAR models spanning preclinical, in vitro, in vivo, and human safety endpoints have naturally aligned our work with expectations of regulatory authorities, including the FDA. Our continued investment in regulatory-aligned modeling solutions supports consistent safety assessment and smoother decision-making across global regulatory frameworks.
Leadscope Model Applier™ and related Instem solutions are continually updated and aligned with evolving regulatory and scientific needs. The platform has long been part of collaborative research efforts with FDA in drug safety assessments, reflecting the partnership’s role in advancing regulatory science and decision-making tools. Through Leadscope, Instem provides clients with a predictive modeling solution that de-risks regulatory review, improves cost- and time-efficiency in early development, and accelerates the development of life-changing therapies.
Regulatory Disclaimer
The RCA described above does not constitute or imply endorsement, recommendation, or approval by the U.S. Government, the Department of Health and Human Services, the U.S. FDA, or any of their employees or organizational units of Instem or any Instem products or services.
About Instem
Instem is a leading supplier of SaaS platforms across Discovery, Study Management, Regulatory Submission, and Clinical Trial Analytics. Instem applications are in use by customers worldwide, meeting the rapidly expanding needs of life science and healthcare organizations for data-driven decision making, leading to safer and more effective products.
Founded in the United Kingdom in 1969, Instem has deep roots internationally across North America, EMEA, and APAC. Instem maintains a commercial and technical presence throughout these regions and takes pride in localized support for its diverse client base. Instem has been an ARCHIMED company since 2023.
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Contacts
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Mike Thurogood, VP Global Marketing: mike.thurogood@instem.com
