Strategic insights from complex, high-dimensional healthcare data, fostering integrated analytics and strengthening the organization’s competitive edge in precision medicine.
1. Regulatory workflows are complex but structured.
The presentation highlights that regulatory processes—spanning data management, authoring, reviewing, publishing, and health authority queries—are intricate yet follow consistent patterns. They are highly collaborative, interdependent, and mission-critical to bringing therapies from candidate nomination to market
2. AI is powerful but needs context and precision.
While AI excels at understanding and summarizing information, it struggles with reasoning and lacks domain-specific (drug development) context. Effective use of AI in regulatory work requires clear task definition—large enough to matter, but small enough to manage
3. Human-AI collaboration transforms regulatory efficiency.
When applied thoughtfully, AI can make regulatory work up to 100× faster without compromising quality—reducing months of effort to hours. Studies with Takeda and partnerships with Parexel demonstrate how AI can accelerate timelines, elevate human expertise, and make portfolio knowledge computable across programs
Lindsay Mateo
CCO
Weave Bio
Weave Bio
Website: https://www.weave.bio/
Weave Bio is an AI-native company reimagining how life science organizations navigate regulatory work. Through its core product, the Weave Platform, Weave brings intelligence, structure, and collaboration to every stage of the regulatory process.
The Weave Platform connects people, data, and technology in a unified workspace that combines AI-powered drafting, source-linked data, and configurable workflows. By keeping experts firmly in the loop, it transforms complex, manual regulatory work into transparent, traceable, and collaborative processes.
Built for biotech, pharma, CROs, and regulatory consultants, Weave supports the full regulatory lifecycle—from early development through submission—helping teams move faster, maintain quality, and scale with confidence.
Learn how AI models enhance physics-based simulations to predict molecular interactions and optimize drug design.
Discover the synergy between machine learning and classical methods to accelerate screening and improve the accuracy of drug discovery.
Sreyoshi Sur
Former Scientist, Molecular Engineering & Modeling
Moderna
Explore how AI enhances biomarker discovery by analyzing large datasets to uncover novel biomarkers for disease diagnosis and therapeutic efficacy.
Learn how integrating digital biomarkers with AI improves the interpretation of data from wearable devices and traditional lab-based biomarkers for better patient stratification and treatment personalization.
Moderator
Nikolaos Patsopoulos
Biomarker Development Therapeutic Area Lead
Novartis Institutes for BioMedical Research (NIBR)
Jack Geremia
CEO
Matterworks
Satarupa Mukherjee
R&D Leader, AI/ML (Digital Pathology)
Roche
Virginia Savova
Senior Director, Head Cell-Targeted Precision Medicine
AstraZeneca
Matterworks
Website: https://www.matterworks.ai/
Matterworks is unlocking predictive biology through an AI-powered platform that immediately uncovers actionable discoveries hidden in LC-MS raw data. Our Large Spectral Model (LSM) has been trained on billions of proprietary raw LC-MS spectra across diverse applications. Built on this foundation, the Pyxis query system leverages the LSM to rapidly identify biomolecules without disparate, time-consuming, and laborious downstream processes.
Available in application-specific configurations, Pyxis transforms conventional manual processing into immediate AI-driven results, expanding the breadth and speed of biomarker discovery, upstream bioprocess optimization, and downstream process development.
Matterworks brings together expertise in AI, software engineering, and analytical chemistry to bridge the gap between raw data and phenotypic endpoints hidden in the dark matter. By developing our AI-powered platform for rapid biomolecule discovery, identification, and concentration determination, we are creating the new standard for researchers, data scientists, and industry leaders to uncover previously unattainable insights and accelerate decision-making across discovery and development.
Examine how AI models are being developed, validated, and governed to meet regulatory expectations, with practical insights into documentation, auditability, and lifecycle management to ensure safe, transparent, and compliant deployment in GxP environments.
Guides strategic IT decisions by clarifying trade-offs between cloud and on-premise solutions, to align infrastructure strategy with agility, security, and compliance objectives.
Explore practical strategies for scaling AI implementation across clinical development pipelines, enabling faster trial execution, smarter protocol design, and improved patient recruitment while aligning with evolving regulatory expectations.
Maria Florez
Senior Consultant
Tufts
- Explore how AI models predict protein 3D structures from sequences, enabling insights into folding pathways and functional conformations
- Examine foundational models that reveal protein–protein interactions and guide design of innovative drug candidates
Miles Congreve
Chief Scientific Officer
Isomorphic Labs
- Learn how AI-driven approaches integrate multiomics data, including genomics, proteomics, and transcriptomics, to identify potential drug targets and disease biomarkers for complex diseases.
- Explore how AI models synthesize cross-omic data and real-time multiomic information to uncover novel biological mechanisms, identify potential biomarkers and enable precision medicine.
Moderator
Raju Pusapati
Vice President, Life Sciences
Solix Technologies Inc.
Dr. Raju Pusapati is a biologist and drug discovery scientist with a distinguished 15+ year career spanning top-tier institutions like Genentech, Exelixis, and emerging biotech ventures. Trained at Harvard and Genentech, his expertise lies in translating basic cancer biology—including the discovery of novel signaling pathways and resistance mechanisms—into viable clinical candidates.
As a project leader and biology lead, he has a proven track record of steering oncology programs from target validation and lead identification through to Go/No-Go decisions, with publications in top-tier journals such as Cancer Cell and Nature Chemical Biology. His hands-on experience encompasses the full spectrum of pre-clinical work, including biomarker strategy, PK/PD, and managing complex internal and external collaborations.
In his current role as Vice President of Life Sciences at Solix Technologies, Dr. Pusapati leverages this deep industry background to bridge the gap between biology and technology. He leads the charge in adopting Solix's CDP and Enterprise AI platforms, empowering life sciences companies to unlock data-driven insights and accelerate therapeutic innovation. He brings this unique, dual perspective to the panel “AI and Multi-omics Integration for Enhanced Target Identification and Validation".
Kiran Nistala
Head, Functional Genomics
Alkermes
Harris Bell-Temin
Director, Proteomics
Johnson & Johnson Innovative Medicine
Arthur Liberzon
Director, AI Research Lead for Omics, Oncology Data Science
AstraZeneca
Solix Technologies
Website: https://www.solix.com/solutions/solix-eai-pharma/
Solix powers AI-driven drug discovery with a platform built for the real data challenges of pharma and biotech. From early research to clinical execution, we unify siloed data, apply scalable AI and automation, and enable governed, audit-ready intelligence that accelerates therapeutic programs. Our semantic data layer, cloud-native architecture, and purpose-built life sciences apps reduce time-to-insight, improve reproducibility, and future-proof compliance, without forcing teams to “rip and replace” existing systems. With 20+ years in industry, 100+ petabytes of scientific and clinical data processed, and deployments across leading biopharma, Solix enables organizations to move faster, collaborate better, and compete with confidence in a world where data is the molecule.
Moderator
David Champagne
Senior Partner
McKinsey & Company
David Champagne is a Senior Partner at McKinsey and leads McKinsey’s global Scientific AI practice to help clients in the life sciences industry and beyond drive the next frontier of R&D productivity with AI. The practice covers a broad range of AI capabilities across Biology, Chemistry, Materials and Physics. David brings together teams of scientific experts from McKinsey’s industry practices with deep technology expertise from QuantumBlack, to develop strategies, blueprints and roadmaps for the technology-driven transformation of product discovery and development processes in industries where science is at the core of innovation.
Melissa Landon
Head, Commercial & Business Development, AI & Automation
MilliporeSigma
Dr. Melissa (“Mel”) Landon leads Commercial and Business Development for AI and Automation at Millipore Sigma, the Life Science business of Merck KGaA. With 20 years of experience of building cutting edge platforms across pharma and tech, Mel’s current work focuses on scaling intelligent automation and AI solutions that bridge scientific innovation with commercial value. She brings to this role a cross-disciplinary background spanning life sciences, technology partnerships, and enterprise transformation. Prior to joining MilliporeSigma, Melissa served as Chief Strategy Officer at Cyclica, an AI-enabled tech bio company (acquired by Recursion in 2023). Melissa completed her PhD in Bioinformatics at Boston University and performed postdoctoral studies in biochemistry and X-ray crystallography at Brandeis University.
David Hallett
Chief Scientific Officer
Recursion
Morten Sogaard
Senior Vice President & Head, Astellas Innovation Lab
Astellas Pharma
Peter Clark
Vice President, Digital Chemistry & Design
Novo Nordisk RDUS
MilliporeSigma
Website: https://www.sigmaaldrich.com
Together with our colleagues, customers and stakeholders, we impact life and health with science. Before researchers can make scientific breakthroughs, they must have access to state-of-the-art tools, services and expertise to perform experiments and engineer new products. That’s where we come in.
We offer one of the broadest portfolios in the industry for scientists, best-in-class products for pharmaceutical development and manufacturing, and a fully integrated service organization to support CDMO and contract testing across traditional and novel modalities.
Our vision is a world where our innovative products, services and digital offerings help create solutions for people globally and a sustainable future for generations to come.
The life science business of Merck KGaA, Darmstadt, Germany, operates as MilliporeSigma in the US and Canada. Merck KGaA, Darmstadt, Germany is a global science and technology company with around 60,000 employees in more than 66 countries.