LIVE PANEL featuring speakers from Amgen, Regeneron, & Modella AI/AstraZeneca
The latest generation of cancer therapies, including antibody-drug conjugates and bispecifics, is testing the limits of biomarker strategies, and success depends on far more than target expression at the cell. The tumor microenvironment, spatial biology and cancer cells morphological changes matter just as much, sometimes shaping how a therapy or payload actually works. Yet these signals are extremely hard to quantify by conventional pathology and can be easily missed.
AI-powered digital pathology and multimodal approaches are beginning to change that across stratification, biomarker discovery, and response monitoring: surfacing which H&E and IHC features are genuinely predictive, making existing biomarker scoring more robust and reproducible, and unlocking exploratory readouts that cannot be produced manually.
The field is maturing from promise to practice, and this panel of experts will assess where it stands today. The panel will examine where AI digital pathology and multimodal models are already delivering measurable value and where they are still developing. They will explore the standard that translational teams set before trusting an AI-derived biomarker and ask what it really takes to move from a working model to a clinically deployable test, and ultimately a companion diagnostic.
Key learnings:
- Where AI on H&E and IHC is delivering measurable value in drug development today, and where it is still maturing.
- How digital pathology is being applied across ADCs, IO, and bispecifics for stratification, biomarker discovery, and response monitoring.
- The bar pharma translational teams set before trusting an AI-derived biomarker: robustness, reproducibility, regulatory readiness, clinically deployable test, including the CDx path.
Meriem Sefta,
CEO & Co-founder,
Waiv
Meriem Sefta is Co-founder and Chief Executive Officer of Waiv, where she sets the company’s scientific and strategic direction. She holds a PhD in computational and cancer biology from Institut Curie, as well as a dual master’s in engineering from MIT and Polytechnique, bringing a combined engineering and research background rooted in the molecular biology of cancer. She built and led the diagnostics business at Owkin, which spun out as Waiv in 2026 with $35 million in financing co-led by OTB Ventures and Alpha Intelligence Capital. As CEO, she drives Waiv’s mission to turn digital pathology and multimodal clinical data into clinically validated precision tests that improve outcomes for cancer patients worldwide.
Mike Montalto,
Vice President of Precision Medicine,
Amgen
Mike Montalto, Ph.D., is Vice President of Precision Medicine at Amgen, where he leads efforts to advance biomarker-driven approaches that help inform drug development across the continuum of drug development from early stage discovery through registrational clinical trials, across all therapeutic areas. He is an industry leader in translational and precision medicine, digital pathology and the application of AI to biomarker discovery. Prior to joining Amgen, Dr. Montalto served as Chief Scientific Officer at PathAI and Vice President of Translational Sciences at Bristol Myers Squibb, where he led teams advancing biomarker science, digital pathology, and AI-enabled approaches. Dr. Montalto serves on the Executive Committee of the FNIH Biomarkers Consortium and the editorial board of the Journal of AI in Precision Oncology and is a member of the Friends of Cancer Research Digital Pathology and AutoRECIST Working Groups. He is also a former President and board member of the Digital Pathology Association.
Jill Stefanelli,
President & CEO,
Modella AI/AstraZeneca
Jill Stefanelli, PhD is a Cofounder and CEO of Modella AI, recently acquired by AstraZeneca. Prior to Modella AI, Jill served as the President, Board Member, and Chief Business Officer of Paige AI, where she led the company’s strategic partnerships with life science companies and biomarker strategy in pathology. Prior to that, Jill also served as the Senior Vice President and Head of Partnerships at Invitae / ArcherDX, where she led the global Companion Diagnostic partnerships and alliances with pharmaceutical companies.
Jill’s experiences also include serving as the Clinical Commercial Development Lead at Life Technologies, Genomics Specialist at Roche Diagnostics, and in science and microbiology roles with USDA APHIS and Sandia National Laboratories. Jill obtained her Ph.D. in Molecular Medicine and Diagnostic Pathology at the College of Veterinary Medicine, Kansas State University.
Jennifer Davidson Hamilton,
VP & Head, Precision Medicine,
Regeneron
Jennifer Davidson Hamilton, Ph.D. is Vice President and Head, Precision Medicine at Regeneron Pharmaceuticals, Inc. Dr. Hamilton has over 25+ years of research and development experience in the biopharmaceutical industry. She leads a team of specialists in Biomarker Sciences (including digital sensor-based technologies), Clinical Laboratory Operations, Bioanalytical Quality and Clinical Diagnostics; applying Biomarker and Precision Medicine strategies across all therapeutics areas and modalities through all phases of development.
