BOSTON: Instem, a leading provider of SaaS solutions for preclinical R&D, today announced the appointment of Szczepan Baran, VMD, MS, as Chief Scientific Officer. In the role, Szczepan will lead scientific and AI strategy across in silico predictive modeling, translational safety analytics, and data-driven drug development solutions.

Building the Regulatory Infrastructure From the Inside Out

Szczepan spent the last decade building the regulatory infrastructure for AI-driven preclinical science, not from inside it, but at the table where the rules get made. At Novartis, he led Emerging Technologies. At VeriSIM Life, he served as Chief Scientific Officer. Currently, he co-chairs the FNIH Validation & Qualification Network (VQN), representing industry, the body setting evidentiary standards for New Approach Methodologies (NAMs) acceptance across the U.S. FDA and EMA. He co-founded and now co-chairs the 3Rs Collaborative's AI Initiative alongside the U.S. FDA, placing him at the intersection of AI, translational science, and the emerging evidence expectations shaping preclinical development.

At Instem, Szczepan’s role is to deepen the scientific layer across the business, embed AI into day-to-day preclinical execution, and help ensure that in silico modeling, translational safety analytics, and NAMs generate evidence built for regulatory scrutiny and submission readiness.

Turning the Inflection Point Into Infrastructure

"The pharmaceutical industry is at a real inflection point, not because AI is new, but because the scientific and regulatory infrastructure to use it responsibly is finally taking shape. Instem sits at the right point in the preclinical data lifecycle to turn that shift into submission-ready infrastructure for more patient-relevant drug development. That is what I am here to build," said Dr. Baran.

Expanding Instem's Scientific and Regulatory Footprint

The appointment comes as Instem expands its scientific and regulatory footprint. In March 2026, the company announced a five-year extension of its research collaboration agreement with the U.S. FDA through February 2031, continuing work through Leadscope on predictive toxicology models, curated safety databases, and regulatory decision-support tools.

“There is no shortage of AI messaging in this market. But what customers need is better science inside the workflow and better judgment at the point of decision. Szczepan has shaped the standards and partnered directly with the U.S. FDA on the qualification pathways our customers are now navigating. The opportunity to build the right infrastructure, whether for stronger GLP workflows today or NAMs adoption tomorrow, is now. We brought him in to help pull Instem and our customers ahead.” - Vik Krishnan, Chief Executive Officer of Instem

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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Fonte: Business Wire