Digital Biomarkers in Motion: Advancing Translational Relevance Through Continuous Monitoring and AI
Event Details:
Takeda Pharmaceuticals
125 Binney Street| Cambridge, MA 02142
Monday, June 23 | 9:00 AM – 5:00 PM
Hosted by Allentown and The Jackson Laboratory
Featured Speakers:
CeCe Brotchie-Fine, DBe, CPIA | Novartis
Srinivas Rao, MBA, DACVP, PhD, MS, DVM | Sanofi Biopharma
Brian R. Berridge, DVM, PhD, DACVP | Digital In Vivo Alliance (DIVA)
Natalie Bratcher-Petersen, MS | Digital In Vivo Alliance (DIVA)
Noah Ditto, MS | The Jackson Laboratory
Sarah Rovezzi | Allentown
Szczepan Baran, VMD, MS | Baran Cafe and Tech4Pets
Summit Overview
The 2025 Preclinical Digital Innovation Summit spotlights how digital technologies and cross-sector collaboration are transforming preclinical research. The focus is on using continuous digital biomarkers and in vivo monitoring to produce richer, more translatable data from animal models. By capturing behavior and physiology in real-time within home cages, these tools enhance data quality and animal welfare. This digital shift bridges preclinical and clinical outcomes, improving human response prediction and expediting the delivery of safer therapies.
The summit also responds to evolving regulatory and ethical priorities. Sessions will examine how validated digital endpoints and AI analyses can meet safety standards while reducing animal use. Aligning preclinical metrics with clinical endpoints and leveraging data science supports a future-ready approach to toxicology, pharmacology, and operations.
Attendees will explore practical strategies, regulatory frameworks, and the alignment of digital preclinical and clinical measures. Through expert talks, panel discussions, and hands-on demos (including the Envision™ platform), participants will gain actionable insights to integrate digital biomarker technologies into their research.
Summit Theme
The summit explores how digital transformation in preclinical research—through automated behavioral and physiological monitoring, AI-driven analytics, and home cage technologies—creates more translatable, reproducible, and humane research models. Key focus areas include:
- Implementing scalable digital biomarker technologies that capture continuous, objective data
- Aligning preclinical digital endpoints with clinical measures for improved translation
- Navigating regulatory frameworks while advancing 3Rs principles
- Establishing industry standards for verification, validation, and clinical qualification of digital measures
Key Takeaways for Participants
- Practical Implementation Roadmap: Understand the timeline from technology selection to first study.
- Regulatory Navigation Strategies: Learn how digital endpoints align with FDA Modernization Act 2.0 and current guidance on animal research.
- Translational Digital Biomarker Framework: Master the principles of reverse translation—taking validated clinical digital endpoints back to preclinical models to enhance predictive validity and reduce late-stage drug development failures.
- Technology Verification and Clinical Validation: Gain practical frameworks for establishing technology verification, analytical validation, and clinical validation - the critical V3 framework needed for regulatory acceptance and scientific credibility of digital biomarkers.
- Vivarium Operational Transformation: Learn how digital technologies reduce manual observations, enable automated health alerts, minimize handling-related stress, and integrate with existing husbandry workflows while improving staff efficiency and animal welfare outcomes.
- 3Rs Advancement Through Technology: Discover how continuous monitoring enables earlier intervention, reduces animal numbers through improved study design, and refines welfare assessment through objective, 24/7 monitoring capabilities.
- Ethical AI Framework for Preclinical Innovation: Learn practical approaches to implement ethical guardrails for AI-driven preclinical research, including addressing algorithmic bias in animal model selection, ensuring transparency in automated decision-making, and establishing governance structures that protect both scientific integrity and animal welfare while accelerating translational success.
About the Speakers
CeCe Brotchie-Fine, DBe, CPIA
Executive Director of Ethics | Novartis Pharmaceuticals
With over 20 years of experience in the pharmaceutical research field, Dr. CeCe Brotchie-Fine has held roles from animal husbandry to research administration and ethics oversight. She began her research journey working in the nutrition laboratory of the Smithsonian’s National Zoological Park assisting with projects to better understand the metabolism of the Mojave Desert Tortoise (Gopherus agassizii). A Certified Professional in IACUC Administration, CeCe first became involved with IACUC administration while working for a small start-up biotech company and quickly developed a passion for research ethics, animal welfare and regulatory compliance, which drove her to pursue a career in biomedical research oversight. Previously, CeCe was the Associate Director & Head, Animal Welfare Compliance at Novartis Institutes for BioMedical Research in Cambridge, MA, serving as IACUC Chair and leading several global animal welfare initiatives.
Currently, she is the Executive Director of Ethics in the Ethics, Risk and Compliance function for R&D at Novartis Pharmaceuticals, where she provides bioethics guidance across the business. With equal enthusiasm for teaching, CeCe has been an invited speaker and course instructor for undergraduate and graduate programs and enjoys connecting with those new to the field of drug discovery and research. She has received a B.S. in Animal Science from the University of Massachusetts, M.A. in Psychology from Lesley University, M.S. in Bioethics from Columbia University, and Doctor of Bioethics (DBe) degree from Loyola University Chicago.
Srinivas Rao, MBA, DACVP, PhD, MS, DVM
R&D US Country Lead, Global Head – Translational Models, Global Research Platform | Sanofi
Dr. Srinivas S. Rao is an innovative R&D executive leader with extensive global experience spanning the United States, France, Germany, China, and the UK. He currently serves as the R&D US Country Lead and Global Head of Translational In Vivo Models (TIM) within Sanofi’s Global Research Platform. Based in Framingham, Massachusetts, he is responsible for Sanofi’s translational research infrastructure, overseeing the development and integration of in vivo and computational models that bridge early-stage scientific discovery with clinical development.
Throughout his career, Dr. Rao has advanced numerous therapeutic candidates—including small molecules, large molecules, gene therapies, and vaccines—from preclinical discovery into human studies. He has a strong track record of leading complex, cross-functional projects from vision through execution. As a strategic change agent, he combines scientific and business acumen to drive operational excellence and deliver creative solutions across diverse R&D challenges.
Dr. Rao is recognized for his ability to lead large scientific organizations through cultural and operational transformation. He brings high energy, natural enthusiasm, and a strong sense of purpose to his work, consistently enabling teams and aligning scientific resources, personnel, and financial investments to accelerate the delivery of innovative medicines to patients.
He actively represents Sanofi’s scientific leadership within broader scientific, industrial, and policy communities. His scholarly contributions include co-authoring studies such as a recent publication on CRISPR/Cas9 knockout mouse models for phenylketonuria.
Brian R. Berridge, DVM, PhD, DACVP
Chair of the Digital In Vivo Alliance | DIVA
Dr. Brian Berridge is the Chair of the Digital In Vivo Alliance and the Principal Consultant at B2 Pathology Solutions LLC. Prior to his retirement from the NIH in 2023, he was the Scientific Director of the Division of Translational Toxicology and Associate Director of the interagency National Toxicology Program at the National Institute of Environmental Health Sciences. Before he joined NIH, he served as Head of Animal Research Strategy at GlaxoSmithKline.
Brian is a veterinarian and is board-certified as a veterinary pathologist. He received a PhD in Veterinary Pathology from Texas A&M University. Brian spent 17 years in the pharmaceutical industry as a toxicologic pathologist with specialty expertise in cardiovascular pathology and translational animal research. He is the former Chair of the pharma industry’s IQ Consortium 3Rs Leadership Group where he also served as the Lead for the Microphysiological Systems Working Group. While at the NIH, he was a member of the NIH Advisory Committee to the Director’s Animal Research Rigor and Reproducibility Working Group. Brian is currently a member of the Advisory Committee to the Division of Earth and Life Studies at the National Academies and the Stakeholder Advisory Group for the EU’s Horizon 2020 Predictive Toxicology Project.
Natalie Bratcher-Petersen, MS
Manager of the Digital In Vivo Alliance | DIVA
Natalie is the Head of Partnerships at TLR Ventures where her primary responsibility is managing the Digital In Vivo Alliance (DIVA). an organization dedicated to advancing digital measures for preclinical in vivo research through collaborative development, validation, adoption, and regulatory acceptance. With a foundation in cognitive and behavioral sciences, Natalie brings over 20 years of experience in the pharmaceutical industry, where she initially focused on rodent in vivo neuroscience models before transitioning to animal welfare science. In this role, she led a pioneering global 3Rs program, championing innovative approaches to responsible and ethical animal-based research. Natalie is deeply motivated and dedicated to inspiring teams toward collaborative success. She excels in spearheading initiatives and is committed to promoting rigorous, reproducible research practices. At DIVA, Natalie’s mission is to cultivate a community centered on digital in vivo technologies, fostering a culture of collaboration with a vision for elevating scientific standards and improving research animal welfare.
Szczepan Baran, VMD, MS
Founder of Tech4Pets and the Principal of Baran Cafe
Dr. Szczepan Baran is a veterinarian-scientist and expert in digital health innovation, currently serving as Principal at Baran.Cafe, a consulting firm focused on transforming pharmaceutical and veterinary drug development through AI, digital measures, and data-driven approaches. He is also a Research Associate at KU Leuven’s Department of Biosystems, where he leads translational projects integrating digital technologies into preclinical and clinical research frameworks.
As the founder and Chief Barks and Purrs Officer at Tech4Pets.healthcare, Dr. Baran advances veterinary care by developing digital health solutions tailored to companion animals. He previously served as Chief Scientific Officer at VeriSIM Life, guiding AI-driven predictive platforms to enhance drug development outcomes. Throughout his career, Dr. Baran has pioneered the implementation of digital biomarkers, AI, and microphysiological systems (organ-on-chip technologies) to bridge gaps between preclinical research and clinical trials.
His expertise uniquely encompasses both the preclinical validation and clinical integration of digital measures, supporting more accurate disease modeling, real-time monitoring, and improved translational outcomes. Dr. Baran actively collaborates with regulatory agencies, industry consortia, and academic institutions, contributing significantly to ethical, efficient, and innovative biomedical research practices.