
Monday, May 18
Registration and Morning Coffee
Organizer's Welcome Remarks
SCALING AI INNOVATION
Chairperson's Remarks (Sponsorship Opportunity Available)
AI-Enabled Patient Voice Integration in Digital Protocol Design


Patient perspectives have long informed clinical trial design, but AI now makes this process scalable. This session explores how AI-driven tools capture and analyze patient insights across larger populations, informing endpoint selection, digital protocols, and trial workflows. Panelists will share strategies for leveraging AI to enhance trial relevance, engagement, and outcomes while maintaining scientific rigor and regulatory compliance.
Clinical Trial Optimization in Practice: Leveraging Data and Technology to Drive Operational Impact


The clinical operations environment is becoming increasingly challenging in the execution of clinical studies. Industry-wide, the clinical trials landscape is becoming more saturated, leading to delays and growing execution risks across late-phase clinical study portfolios. This session will illustrate these challenges and demonstrate how Merck is mitigating risk through the use of data, technology, and process improvements to better serve patients.
Best Practices for AI Implementation

AI is transforming clinical trials, but successful implementation requires careful planning and execution. This session explores best practices, strategies, and approaches for integrating AI into trial design, operations, and data management. Panelists will discuss practical lessons on workflow adaptation, team training, regulatory considerations, and measuring impact to ensure AI adoption drives efficiency, data quality, and meaningful clinical outcomes.
Sponsored Presentation (Opportunity Available)
Grand Opening Coffee Break in the Exhibit Hall
AI TO TRANSFORM CLINICAL DEVELOPMENT
Chairperson's RemarksÂ
Mitchell Denker, Head, Data Strategy and Products, R&D Data Science and Digital Health, Janssen Pharmaceuticals , Head, Data Strategy and Products , R&D Data Science and Digital Health , Janssen Pharmaceuticals
Transforming End-to-End Clinical Development through AI

AI is rapidly transforming clinical development, and we are approaching a future where frontier AI models will outperform humans in complex reasoning tasks. To have the maximum impact on improving patient outcomes, AstraZeneca is applying AI across oncology R&D to help deliver on its bold ambition of one day eliminating cancer as a cause of death.
Leveraging AI to Transform Site Engagement in Clinical Trials


In this session, we will be speaking about our foundational work to reduce tech burden for clinical trial sites, the use of AI to boost productivity and operational excellence for our internal teams, and our roadmap for further AI integration to a frictionless Site Engagement.
Sponsored by: From Start-Up to Scale: Lessons Learned from Widespread Deployment of AI-Driven Technology for Cancer Clinical Trial Operations


Scaled deployment and adoption of AI-enabled technology requires careful integration with clinical and operational workflows. Delivering value is multifactorial and includes deep understanding of site capabilities and specific trial context. We will share insights gained regarding factors affecting LLM performance, resourcing, change management, and impact measurement, and will review two case studies where approaches have produced measurable operational improvements. We conclude with practical lessons for clinical development leaders deploying AI technology at scale.
Sponsored by: Talk Title to be Announced

Speaker to be Announced , Trialbee
Operationalizing AI in Clinical Trials: From Strategy to Scalable Impact


This presentation will share Moffitt Cancer Center’s journey in embedding AI into clinical trials operations, highlighting real-world use cases, implementation strategies, and measurable outcomes. Drawing from initiatives such as EHR-to-EDC integration, AI-enabled prescreening, and CPOE deployment, it will offer a practical roadmap for scalable AI adoption aligned with institutional goals.
Luncheon Presentation: Sponsored by: LUNCHEON PRESENTATION: Revolutionize Clinical Trials Financial Management with Agentic AI


Join this session to explore how Agentic AI accelerates every step of your financial workflow—from protocol ingestion to budgeting, contracting, payments, and analytics. Learn how an AI-powered unified platform eliminates disparate silos, automates manual processes, and delivers measurable business value. Explore real-world AI use cases where your team's role shifts from doing to reviewing, enabling faster decisions and ensuring patient and site success.
Refreshment Break in the Exhibit Hall
PLENARY SESSION
Keynote Opening Remarks
Marina Filshtinsky, MD, Executive Director, Conferences and Portfolio, Cambridge Healthtech Institute , Executive Director, Conferences , Cambridge Healthtech Institute
Chairperson's Remarks (Sponsorship Opportunity Available)
KEYNOTE PRESENTATION:
Validating Generative AI for Clinical Development

The development of robust AI for clinical development is limited by scarcity of large-scale annotated datasets and clear frameworks for real-world translation. This talk will present examples of clinically validated generative AI that enhances clinical-trial efficiency, evidence generation, and patient outcomes. The discussion will conclude with a regulatory-science perspective on emerging challenges and necessary standards for validating and approving complex, AI-enabled medical devices for safe and effective patient care.
Chairperson's Remarks (Sponsorship Opportunity Available)
KEYNOTE FIRESIDE CHAT:
Investing in the AI-Driven Future of Clinical Development



AI is transforming every stage of clinical development, generating unprecedented investment activity across venture capital and pharmaceutical corporate venture arms. This plenary panel brings together a cross-section of investors to discuss where capital is flowing, what technologies show the strongest near-term value, and which business models are most likely to endure. Attendees will gain a clear view of how investors are prioritizing innovation in clinical development and what signals they are watching to guide future deployments of capital.
Interactive Breakout Discussions
INTERACTIVE DISCUSSIONS
Interactive Breakout Discussions (IN-PERSON ONLY)
Interactive Breakout Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each breakout will be led by a facilitator who keeps the discussion on track and the group engaged. Please visit the Interactive Breakout Discussions page on the conference website for a complete listing of topics and descriptions. Interactive Breakout Discussions are offered in-person only.
TABLE 1:
Translating Healthcare AI Success into Clinical
Pratik Shah, PhD, Professor, Pathology & Laboratory Medicine, Electrical Engineering & Computer Science, and Biomedical Engineering, University of California , Professor , Pathology & Laboratory Medicine, Electrical Engineering & Computer Science, and Biomedical Engineering , University of California
TABLE 2:
AI-Ready Clinical Data
Kristian Hammond, PhD, Professor, Computer Science, Northwestern University; Director, The Center for Advancing Safety of Machine Intelligence (CASMI) , Professor , Computer Science , Northwestern University
TABLE 3:
KPIs of AI Adoption and ROI
Subha Madhavan, PhD, Vice President and Head, AI/ML, Quantitative and Digital Sciences, Pfizer Inc. , Vice President and Head, AI/ML, Quantitative and Digtal Sciences , Pfizer
TABLE 4:
Regulatory Landscape for AI in Clinical Development
Kevin Bugin, PhD, Head, Regulatory Policy and Intelligence, Amgen , Head , Regulatory Policy and Intelligence , Amgen
M. Khair ElZarrad, PhD, MPH, Vice President, Regulatory Policy, BridgeBio; Former Deputy Director Office of Medical Policy, Center for Drug Evaluation & Research, FDA CDER , Vice President , Regulatory Policy , BridgeBio
TABLE 5:
Applying AI at the Site Level
Jimmy Bechtel, Chief Site Success Officer, Society for Clinical Research Sites (SCRS) , Chief Site Success Officer , Society for Clinical Research Sites (SCRS)
TABLE 6:
AI-Powered Patient Recruitment and Retention
Anastasia Christianson, PhD, Pharma Industry Data Science Leader , Pharma Industry Data Science Leader
Michelle Everill, Vice President, Global Trial Optimization, Alnylam Pharmaceuticals , VP, Global Trial Optimization , Alnylam Pharmaceuticals
TABLE 7:
Leveraging AI in RBQM
Brian Barnes, Director, Risk Management Strategy, Global Clinical Development Operations, BioNTech US , Director, Risk Management Strategy , Global Clinical Development Operations , BioNTech US
Networking Reception in the Exhibit Hall
Dinner Short Course Registration
*Separate registration required. See short course page for details.
DINNER SHORT COURSE: AI Implementation in Practice: A Hands-on Short Course (Bring Your Laptop)
INSTRUCTORS:
Jonathan Crowther, PhD, Head, Operational Design Center, Merck KGaA, Darmstadt, Germany
Prasanna Rao, Chief Products and Innovation Officer, SaamaÂ
This interactive workshop will provide a practical overview of key considerations for implementing AI in clinical operations and beyond. Topics will include ethical implications and regulatory updates such as the EU AI Act, a clear explanation of AI APIs and how they function, and best practices for effective prompt engineering. Attendees will gain valuable insights into common pitfalls to avoid strategies to successfully integrate AI tools in a regulated environment.​
Tuesday, May 19
Executive Think Tank: How Should We Prioritize AI Investments in Clinical Research?
"Bytes and Bites" in the Exhibit Hall
Join your colleagues for coffee and a quick bite before diving into another day of sessions.
AI-PROMPTED CHANGE MANAGEMENT
Chairperson's Remarks (Sponsorship Opportunity Available)
From Tools to Transformation: Rebuilding the Clinical Trial Ecosystem With AI

AI adoption in Clinical Trials is stuck in low impact pilots. The real opportunity is not better tools, but a fundamentally different ecosystem. This talk explores how next gen technology can reshape protocols, site-selection, data flow and decision making across the ecosystem. Drawing from frontline experience, we will move beyond incremental pilots to what it actually takes to deliver faster, simpler and more scalable clinical development.
AI in Clinical Trials: Building Skilled Teams

AI is transforming clinical trials, but its success depends on skilled, prepared teams. This session explores strategies for training clinical operations, data, and trial management teams to effectively use AI tools. Panelists will discuss best practices for upskilling staff, integrating AI into workflows, and ensuring data quality, compliance, and trial efficiency while fostering collaboration and adoption across teams.
AI Governance at the Site: Practical Frameworks Sites Need Now

As AI adoption accelerates in clinical research, sites face growing pressure to implement new tools while navigating unclear governance frameworks, limited training, and fragmented technologies. At the same time, sites are increasingly evaluated by opaque AI-driven algorithms for feasibility, selection, and performance. This presentation explores the site perspective on AI governance, operational integration, and trust—and why meaningful AI transformation in clinical trials depends on genuine partnership and successful implementation at the site level.
Sponsored by: From Static Plans to Living Scenarios: How AI Changes Behavior in Trial Planning


AI can transform trial planning by being designed to change decisions, not just predict outcomes. We will discuss AI's role in upstream planning, showing how planning-stage intelligence can highlight tradeoffs, clarify assumptions, and improve cross-functional decision-making without replacing human judgment. We'll share design lessons on embedding AI into planning loops, limiting its autonomy, and driving behavioral change in clinical development teams.
Responsible Use of AI in Clinical DevelopmentÂ

AI offers transformative potential for clinical development, but its adoption must be responsible, ethical, and compliant. This session explores best practices for integrating AI into trials, addressing data quality, patient safety, regulatory expectations, and organizational readiness. Panelists will share practical strategies for leveraging AI effectively while maintaining scientific rigor and ensuring trust across teams, regulators, and stakeholders.
Agentification of Life Sciences: Why Clinical Research Needs Agents—Not More Dashboards

As clinical research teams chase faster timelines and earlier submissions, dashboards alone are no longer enough. This session explores the agentification of life sciences—how agentic AI systems can actively orchestrate trial design, operations, and regulatory authoring to compress critical paths. We will examine where agents deliver real acceleration today, and the governance, oversight, and validation guardrails required to scale speed without compromising regulatory trust.
Sponsored by: Talk Title to be Announced


Kim Hawkins, Global Head of Clinical Project Operations & Dossier Delivery, Sanofi , Global Head , Clinical Project Operations & Dossier Delivery , Sanofi Grp
Coffee Break in the Exhibit Hall
FIT-FOR-PURPOSE AI IN CLINICAL DEVELOPMENT: A NECESSITY, NOT A CHOICE
Chairperson’s Remarks
The Missing 20%: How AI Microservices Turn Vendor Platforms into a Clinical Ops Ecosystem


The “perfect†clinical operations vendor platform does not exist and probably never will. Even leading suites cover only ~60–80% of real-world needs once governance steps, audit evidence, edge cases, and post-acquisition system realities enter the room. Organizations typically respond by force-fitting the platform, and end up paying twice: Process debt (manual workarounds, shadow processes, spreadsheet sprawl), and integration debt (fragile point-to-point connections, duplicated data, inconsistent metrics). In this session, we propose a different operating model: Core Platforms + Niche Capability Vendors + a thin, reusable Microservices Layer. The outcome: fewer workarounds, more consistent data, and teams spending time on decisions that improve trial delivery and ultimately patient impact.
Panel Moderator:
PANEL DISCUSSION:
Fit-for-Purpose AI in Clinical Trials

Panelists:



Transition to Lunch
LUNCHEON PRESENTATION:
Luncheon Presentation: Sponsored by: Talk Title to be Announced

Speaker to be Announced , PhaseV Trials Ltd
PLENARY SESSION
Keynote Opening Remarks

Chairperson’s Remarks (Sponsorship Opportunity Available)
KEYNOTE PRESENTATION:
The Next Leap: What AI Means for How We Work and What We Build

Artificial intelligence is transforming every industry it touches, and clinical research is no exception. Generative AI tools like ChatGPT are rapidly becoming powerful partners in the work of designing, running, and accelerating clinical trials. In this talk, we’ll cut through the hype and look directly at how these systems can help us today—streamlining protocol development, speeding recruitment, reducing documentation overload, strengthening safety monitoring, and unlocking faster insights from the data you already collect. We’ll also take a quick look at what’s coming. As AI systems become more capable and more adaptive, they will reshape how trials are planned, executed, and evaluated. The question is no longer if this shift is coming, but how we prepare for it. And because clinical trials carry real stakes for patients and science, we’ll focus on what must be done to integrate AI responsibly, ensuring transparency, data integrity, regulatory alignment, and trust. This is about empowering trial teams with tools that make research faster, clearer, and more effective—while keeping humanity at the center of every decision.
Panel Moderator:
KEYNOTE PANEL DISCUSSION:
Navigating the AI Era: Strategic Reflections from FDA Former Regulators and Technologists

Panelists:



Close of Conference
For more details on the conference, please contact:
Marina Filshtinsky, MD
Executive Director, Conferences
Cambridge Healthtech Institute
Phone: (+1) 781-972-5496
Email: mfilshtinsky@healthtech.com
Iris Goldman
Conference Producer
Cambridge Healthtech Institute
Email: igoldman@healthtech.com
For sponsorship information, please contact:
Companies A – E
Ilana Quigley
Director, Sales
Cambridge Healthtech Institute
Phone: (+1) 857-636-2334
Email: iquigley@healthtech.com
Companies F – N
Katelin Fitzgerald
Senior Manager, Business Development
Cambridge Healthtech Institute
Phone: (+1) 781-247-1824
Email: kfitzgerald@cambridgeinnovationinstitute.com
Companies O – V
Jon Stroup
Lead Business Development Manager
Cambridge Healthtech Institute
Phone: (+1) 781-972-5483
Email: jstroup@healthtech.com
Companies W – Z
Patty Rose
Vice President, Sales
Cambridge Healthtech Institute
Phone: (+1) 781-972-1349
Email: prose@healthtech.com
For media and association partnerships, please contact:
Andrew Hall
Marketing Manager
Cambridge Healthtech Institute
Email: ahall@healthtech.com

















