Agenda is subject to change
Local Daylight Time
12:00 - 12:45
#R&D
#GenAI
Keynote - From Discovery to Patients: Innovation at the Speed of Trust
Innovation is reshaping pharma - from the way medicines are discovered to how safety is monitored and regulatory submissions are managed. This session brings together two global leaders, Dr. Aida Habtezion (former Chief Medical Officer at Pfizer, Adjunct Professor at Stanford) and Robert V. Brown (SVP, Digital at Pfizer), who sit at the crossroads of science, safety, and technology.
They’ll explore how emerging technologies like AI, real-world data, and digital platforms are shortening the bench-to-bedside cycle, the challenges of balancing speed with safety in highly regulated environments, and the leadership shifts needed to foster innovation. Expect practical insights on data trust, regulatory agility, and the collaborations that will define the next decade of healthcare innovation.
Robert V. Brown
Senior Vice President, Digital
Pfizer
Aida Habtezion
Former Pfizer CMO, Adjunct Stanford Professor
Sameer Lal (Moderator)
SVP, Enterprise Medical
Indegene
12:45 - 13:15
#MLR
MLR in the Age of AI: Balancing Innovation, Insight, and Integrity
As Medical, Legal, and Regulatory (MLR) review processes evolve, the promise of AI and data-driven technologies is reshaping how promotional materials are assessed. But will technology alone truly disrupt MLR? This session explores the nuanced interplay between automation and human expertise, in terms of enhancing content and MLR effectiveness, taking risk-based approaches, and what ethical and practical considerations arise when AI steps into the reviewer’s role.
Gareth Worthington
Global Head, Clearance - Medical and Commercial Operations
UCB
Heather Sun, PharmD
Sr Director, Medical Information & Review, Medical Affairs
Alnylam
Mohit Jain (Moderator)
AVP - Enterprise Medical Client Partnership and Advisory
Indegene
12:45 - 13:15
#DPRE
Where will AI move the needle in patient recruitment?
Patient recruitment remains one of the biggest challenges in clinical trials, with barriers ranging from designing an effective and agile protocol that reflects insights from real-world data, to identification and trial matching, and ultimately the last mile connectivity to research sites. This session brings together industry leaders to examine where AI can truly move the needle in the patient recruitment function. From filling the top of the recruitment funnel with qualified and interested patients while unlocking the “white space” between channels like EHRs, advocacy groups, claims data and behavioral data to reducing bottlenecks during the screening process, our experts will uncover practical, high-impact opportunities that could make patient recruitment more effective.
Angela Radcliffe
Clinical Research, AI, and Patient Engagement Expert
Craig Lipset
Co-Chair
Decentralized Trials and Research Alliance (DTRA)
Ram Yeleswarapu (Moderator)
SVP, Enterprise Clinical Solutions
Indegene
13:15 - 13:45
#MLR
Balancing Compliance and Creativity: Are We Over-Engineering Risk at the Expense of Innovation?
In today’s regulatory landscape, the tension between compliance and creativity is more pronounced than ever. Are we unintentionally choosing audit-proof over innovation-proof? This session brings together marketers, MLR leads, and creatives to explore how overly conservative approaches in promotional review can stifle innovation. We'll examine the cost of over-regulation, discuss where risk can be responsibly managed, and share strategies for bridging the gap between regulatory rigor and creative freedom—without compromising either.
Carlyn Martina-Mamber
Head of Medical Communications
Lantheus
Pankaj Chandak
Director of Regulatory Affairs & Product Labeling
Medtronic
Robert Liebman (Moderator)
VP, MLR Services, Enterprise Medical Client Partnership and Advisory
Indegene
13:15 - 13:45
#DPRE
From Innovation to Execution: Scaling Digital Clinical Trials Globally
Digital transformation in clinical research is no longer about ideas, it is about execution at scale. This fireside chat explores how digital trials are evolving across very different contexts, from offline eSource solutions enabling participation in Africa and LMICs, to advanced interoperability and analytics challenges in high-end US/EU hospitals. Together, the experts will discuss how to balance innovation with compliance, equity, and patient-centricity to truly scale digital clinical trials worldwide.
Avik Pal
Founder & CEO
CliniOps
Ram Yeleswarapu (Moderator)
SVP, Enterprise Clinical Solutions
Indegene
13:45 - 14:15
#CDM
AI-Powered Test Automation: Redefining Speed, Safety, and Efficiency in Clinical Trials
Clinical data management and biometrics teams face rising complexity from diverse data sources, evolving regulations, and tight timelines—resulting in slow test case creation, limited coverage, and restricted domain expert involvement in automation. Next-gen AI-driven test automation, powered by custom-trained LLMs and agentic functions, addresses these challenges by democratizing test creation, increasing coverage by 60–80%, and enabling shift-left testing to detect risks early and reduce costly rework. Acting as an intelligent assistant, AI accelerates test creation, empowers domain experts, and delivers faster, cost-efficient testing with lower risk exposure.
Key session takeaways:
1. Democratized Automation – See how AI empowers domain experts to create robust automated test cases through intuitive, no-code interfaces.
2. Early Risk Mitigation – Learn how shift-left testing identifies risks sooner, reducing rework and accelerating timelines.
3. Unified Intelligence – Discover how AI consolidates testing assets for rapid adaptation to evolving requirements and ensures cross-technology compatibility.
Gregory Ambra
C-Suite Advisor, Data Analytics Expert, Life Sciences
Nasrin Bidarkund (Moderator)
Senior Manager, Biometrics
Indegene
13:45 - 14:15
#Medical Writing
#R&D
#GenAI
Lessons from Merck's journey from GenAI Pilots to Production
As generative AI rapidly reshapes the life sciences landscape, Merck KGaA has taken a bold step to embed GenAI into one of the most content-heavy and compliance-driven areas like R&D medical writing. Through structured initiatives such as Project GAME Plan and Project Horizon, Merck has demonstrated how to move from experimentation to scaled implementation. This session will highlight how Merck prioritized use cases, established governance, and built user trust to ensure adoption across global teams. The discussion will also explore how these lessons extend beyond medical writing - providing a blueprint for regulatory, safety, and other enterprise functions seeking to harness AI responsibly and at scale.
Keyur Brahmbhatt, PhD, MBA
Head of Data Digital and IT (DDIT) Business Partnering for RQS
Merck Healthcare R&D
Nikesh Shah (Moderator)
VP - Safety and GenAI Solutions
Indegene
14:15 - 14:45
#Patient Advocacy
Smart Care: How Pharma Can Meet Patients in the Age of AI
AI is revolutionising healthcare and holds enormous potential for improving patient outcomes - from faster drug discovery to smarter clinical trials. But what about its potential to truly connect with patients? In this session, a leading patient engagement expert and advocate will explore the opportunities for using AI in patient engagement, education, and information. Discover what pharma needs to know to harness patient-centred AI responsibly and collaboratively, and learn how to work with patients for impact that lasts.
Trishna Bharadia, BA(hons), MFPM(hons)
Patient Advocate & Patient Engagement Consultant
The Spark Global
Lisa Chamberlain James (Moderator)
Senior Partner
Trilogy, An Indegene Company
14:45 - 15:30
#Medical Writing
#Regulatory Affairs
Honing Your Tetris® Skills: Resourcing Strategies for Medical Writing Groups
Managing medical writing resources often feels like a high-stakes game of Tetris® - fitting the right people, skills, and timelines together under constant pressure. In this session, Matthew C. Robillard and Kim Jochman, moderated by Julia Forjanic Klapproth, will explore practical strategies for balancing capacity and demand, optimizing team structures, and leveraging outsourcing and technology effectively. The discussion will share real-world approaches to overcoming bottlenecks, building flexibility, and ensuring quality without burnout - helping medical writing groups align resources with organizational goals more effectively.
Kim Jochman, PhD, RAC
Senior Director, Medical Writing & Disclosure
Merck
Matthew C Robillard
Senior Director, Strategic Medical Writing
AbbVie
Julia Forjanic Klapproth (Moderator)
Senior Partner
Trilogy, An Indegene Company
15:30 - 16:15
#Market Access
Global Ripple Effect of the U.S. Most Favored Nation Policy: Payer Perspectives
The United States proposed Most Favored Nation (MFN) pricing approach is more than a domestic lever, it’s a shockwave with global consequences. What begins as a U.S. policy experiment inevitably reverberates through Europe, challenging payer strategies, budget frameworks, and cross-border reference pricing. This panel brings together senior payer voices from the U.S., U.K., and Germany to dissect how MFN could reshape incentives, disrupt established norms, and accelerate transatlantic shifts in access and affordability. Moderated by William Lobb and Nekshan Dalal, the session will highlight perspectives from three pivotal health systems and expose the trade-offs payers face.
Dr. Harald Herholz
Ex-Physician | GBA Member | QA Head, Doctors Association
James Mahon
NICE advisor and member of Evidence Review Group (ERG)
Jeff Dunn
President and CEO
Cooperative Benefits Group (CBG)
Nekshan Dalal (Moderator)
Director - Pricing, Reimbursement and Market Access
Indegene
William Lobb (Moderator)
Vice President- Strategic Initiatives, PRMA
Indegene