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Generative AI Tools
Move from Proof-of-Concept to Production in Regulated Environments
May 18, 2027 ALL TIMES EDT
The Generative AI Tools symposium explores how life sciences organizations are building and operationalizing GenAI applications, agents, platforms, and workflows in complex, regulated environments. Topics include system architecture, workflow and product design, agent orchestration, enterprise platforms, research infrastructure, integration, validation, security, compliance, and human oversight. Through production deployments and practical case studies, attendees will learn how to move beyond prototypes, integrate GenAI into existing systems and workflows, automate time-intensive processes, establish trust and auditability, and build scalable, production-ready AI solutions across R&D, clinical, regulatory, and operational environments.
Preliminary Agenda

FROM PROTOTYPE TO PRODUCTION: BUILDING AND SCALING ENTERPRISE GENAI

Do We Really Need Another GenAI Tool? Managing AI Sprawl at Enterprise Scale

Photo of Manasi Ghogare, Senior Technology Product Manager, Digital Health, Takeda Pharmaceutical Co., Ltd. , Sr Tech Product Mgr , Digital Health , Takeda Pharmaceutical Co Ltd
Manasi Ghogare, Senior Technology Product Manager, Digital Health, Takeda Pharmaceutical Co., Ltd. , Sr Tech Product Mgr , Digital Health , Takeda Pharmaceutical Co Ltd

The democratization of GenAI enables teams to rapidly create agents and conversational experiences, but decentralized development can produce duplicative capabilities, fragmented architectures, inconsistent governance, and accumulating technical debt. This session explores how disciplined enterprise architecture reviews, product management frameworks, capability reuse, and agent stewardship can create scalable GenAI ecosystems that preserve experimentation while systematically identifying, governing, evaluating, and retiring redundant GenAI solutions.

Panel Moderator:

PANEL DISCUSSION:
Beyond the Pilot: What It Really Takes to Scale Generative AI in Life Sciences

Nagaraja "Sri" Srivatsan, CEO, Endpoint Clinical, Inc. , CEO , Endpoint Clinical, Inc.

Panelists:

Christopher Colucci, Vice President, IT & Clinical, Clinical & Commercial & Enterprise Systems, Insmed, Inc. , VP IT , Clinical & Commercial & Enterprise Systems , Insmed Inc

TRUSTED AI IN PRACTICE: VALIDATION, GOVERNANCE, AND REGULATED DEPLOYMENT

A Verified Analysis Fabric: Pre-Registered, Independently Checked AI-Agent Analysis in a Clinical-Stage Cell Therapy Program

Photo of Vivek Kaimal, PhD, Executive Director, Head of Genomics, Bioinformatics & Data Science, Translational Sciences, Allogene Therapeutics , Exec Dir, Head of Genomics & Bioinformatics , Translational Sciences , Allogene Therapeutics
Vivek Kaimal, PhD, Executive Director, Head of Genomics, Bioinformatics & Data Science, Translational Sciences, Allogene Therapeutics , Exec Dir, Head of Genomics & Bioinformatics , Translational Sciences , Allogene Therapeutics
Photo of Saurav Mahanti, Vice President, Information Technology, Allogene Therapeutics , Vice President, Information Technology , Allogene Therapuetics
Saurav Mahanti, Vice President, Information Technology, Allogene Therapeutics , Vice President, Information Technology , Allogene Therapuetics

AI agents can now carry a translational single-cell analysis from raw sequencing data to a finished figure, but their errors are silent: a wrong result looks identical to a right one. We present a working pattern from an exploratory analysis in an allogeneic cell therapy program: a pre-registered plan rehearsed on public data, agent-driven execution, and three independent agents with deliberately different information attempting to break the result, with the human expert designing every check.

Explainable and Auditable Generative AI for Medical Device Complaint Investigations

Photo of Michael Paull, PhD, Data Engineer, Global Device Develoment & Engineering, Takeda Pharmaceutical Co. Ltd. , Data Engineer , Global Device Dev & Engineering , Takeda Pharmaceutical Co Ltd
Michael Paull, PhD, Data Engineer, Global Device Develoment & Engineering, Takeda Pharmaceutical Co. Ltd. , Data Engineer , Global Device Dev & Engineering , Takeda Pharmaceutical Co Ltd

Medical device complaint investigations are often repetitive and time-consuming. To improve consistency and efficiency, we developed a Generative AI system that executes a structured investigation process modeled on subject matter expert decision-making. The system combines large language models with deterministic controls, creating an audit trail at every step and enabling explainable, auditable investigations. In operational use, the approach reduced complaint handling effort by approximately 50% while standardizing investigation outputs.

Proposed Title from AI Co-Scientist to Connected Drug Intelligence: Advancing Trustworthy AI for Drug Development

Photo of Lawrence Callahan, PhD, Chief Scientist, Autopoiesis Sciences , Chief Scientist , Autopoiesis Sciences
Lawrence Callahan, PhD, Chief Scientist, Autopoiesis Sciences , Chief Scientist , Autopoiesis Sciences

Proposed Abstract:
This presentation explores the next phase of trustworthy AI in drug development, integrating AI-driven scientific reasoning with structured substance information through the Global Substance Registration System (GSRS). Emerging applications include AI-generated substance summaries and real-time drug labeling to advance connected drug knowledge, preclinical safety assessment, and regulatory intelligence. The discussion highlights development progress, data standardization challenges, validation requirements, and opportunities for industry collaboration to improve scientific reliability and decision-making.

THE FUTURE OF SCIENTIFIC DISCOVERY: HUMAN JUDGMENT AND AI-DRIVEN R&D

PLENARY KEYNOTE PRESENTATION:
When AI Becomes the Scientist's Partner: Human Judgment and the Future of R&D

Photo of Santha Ramakrishnan, PhD, Vice President, Head, R&D Data Strategy and Governance, Bayer Pharmaceuticals , VP, Head, R&D Data Strategy and Governance , Bayer Pharmaceuticals
Santha Ramakrishnan, PhD, Vice President, Head, R&D Data Strategy and Governance, Bayer Pharmaceuticals , VP, Head, R&D Data Strategy and Governance , Bayer Pharmaceuticals
Photo of Anu Sharma, Senior Principal Scientist/Senior Director, MRL BARDS Epidemiology RWE Capabilities and Analytics, Merck & Co., Inc. , Senior Principal Scientist and Senior Director , MRL BARDS Epidemiology RWE Capabilities and Analytics , Merck
Anu Sharma, Senior Principal Scientist/Senior Director, MRL BARDS Epidemiology RWE Capabilities and Analytics, Merck & Co., Inc. , Senior Principal Scientist and Senior Director , MRL BARDS Epidemiology RWE Capabilities and Analytics , Merck

As AI agents evolve from research assistants into active partners in scientific discovery, what becomes the scientist's unique contribution? How can researchers challenge AI-generated conclusions, recognize overlooked opportunities, and preserve scientific judgment? Senior biopharma leaders will explore how human-AI collaboration is transforming R&D decision-making, operating models, workforce capabilities, and accountability, while examining the leadership and organizational strategies needed to harness increasingly autonomous AI systems for scientific innovation and patient impact.

CHANGING THE TRAJECTORY OF DISEASE: FROM PREDICTION TO INTERVENTION

PLENARY KEYNOTE PRESENTATION: Can we Predict Disease before it Happens? Mapping and Redirecting Biological Trajectories

Photo of John Quackenbush, PhD, Professor of Pediatrics and Human Genetics, University of Chicago; Professor Emeritus of Computational Biology and Bioinformatics, Harvard T.H. Chan School of Public Health , Professor of Pediatrics and Human Genetics , University of Chicago
John Quackenbush, PhD, Professor of Pediatrics and Human Genetics, University of Chicago; Professor Emeritus of Computational Biology and Bioinformatics, Harvard T.H. Chan School of Public Health , Professor of Pediatrics and Human Genetics , University of Chicago

Biomedical research has generated increasingly large, rich, and multidimensional datasets, yet we still often study disease by dividing people into discrete categories: healthy or diseased, responder or non-responder, case or control. Biology, however, does not operate in static states. Disease develops along a continuum, shaped by changing regulatory programs and influenced by aging, biological sex, genetics, epigenetics, and environmental exposures.

As our data and computational capabilities advance, an important opportunity is emerging: moving beyond cataloging molecular differences to reconstructing how biological systems change over time. Gene regulatory networks, pseudo-time modeling, and change-point analysis can help identify critical regulatory switches that move a biological system from one state to another and reveal drivers of disease that may be missed when we focus only on individual mutations, genes, or biomarkers.

These approaches are beginning to provide insight into why individuals exposed to similar risks can follow very different disease trajectories, why biological sex can influence disease susceptibility and treatment response, and how aging may reshape the path toward chronic disease. Identifying these transition points may also uncover new therapeutic targets and opportunities to intervene before disease becomes firmly established.

The ultimate vision is a predictive theoretical biology: The ability to understand where an individual is biologically, anticipate where that trajectory may lead, and identify opportunities to redirect it. Moving from describing disease after it occurs toward predicting and ultimately altering its course could transform how we approach target discovery, therapeutic development, and precision medicine.

PLENARY KEYNOTE PRESENTATION: From Data to the Individual: Connecting the Pieces to Deliver Precision Medicine

Photo of Elizabeth Worthey, PhD, Director, Center for Computational Genomics & Data, University of Alabama Birmingham , Director , Ctr for Computational Genomics & Data , Univ Of Alabama Birmingham
Elizabeth Worthey, PhD, Director, Center for Computational Genomics & Data, University of Alabama Birmingham , Director , Ctr for Computational Genomics & Data , Univ Of Alabama Birmingham

Delivering precision medicine requires more than sophisticated technologies or increasingly complex datasets. Understanding individual patients, particularly those with complex diseases and post-infectious syndromes, demands integration of genomic, molecular, clinical, environmental, and longitudinal information. This presentation explores how connecting fragmented expertise, data, and computational capabilities can bridge the gaps between discovery, biological understanding, and clinical action, advancing a more collaborative, integrated approach to individualized diagnosis and treatment.


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Conference Tracks

T1: Data Platforms & Storage Infrastructure