Conference Schedule
October 15, 2025
07:30
Registration Open
Welcome Breakfast and Networking
08:30
Opening Remarks from the Conference Chairs
James Donohue, Senior Digital Health Lead, Genentech
Anna Yang, Principal, Clinical Innovation & Technology Leader, Genentech
CONTENT BLOCK 1
The Future of Trials: Where Science, Humanity & Technology Converge
08:40
PANEL DISCUSSION
The Future of Clinical Trials: Where Science, Humanity & Technology Converge
Explore how AI, digital health, decentralized trials, and real-world evidence are transforming research, but why human-centered design, health equity, and trust remain foundational. Inspire the audience to challenge old models and build more inclusive, efficient, and meaningful trials.
Paulius Ojeras, VP Clinical Operations, Perceive Biotherapeutics
Michelle Longmire, Chief Executive Officer, Medable
Youssef Idelcaid, Head of AI Research Center - Drug Development, Gilead Sciences
Phil Johnson, Chief Commercial Officer, Evidation
Moderated by: Kimberly Barnholt, Executive Director, Data Systems & Evidence Generation, Genentech
09:05
CASE STUDY
Pragmatic Evidence Generation: Leveraging New Techniques
A deep dive into how trial approaches are evolving: integrating home health, wearables, mobile sites, and telemedicine while maintaining data integrity and patient engagement. Focus on real-world success stories and lessons learned.
Dr. Sachin Shah, Digital Biomarkers Lead,
GSK 09:20
CASE STUDY
Real-World and Emerging AI Use Cases for Improving Engagement in Clinical Trials
As clinical trials grow in complexity and geographic scope, successful execution increasingly hinges on engagement—of patients, investigators, and study teams. Artificial Intelligence (AI) offers transformative opportunities to streamline communication, personalize support, and optimize operations across the trial lifecycle. This session explores real-world and emerging AI use cases for improving engagement in clinical trials:
• For Patients: AI-driven personalization and behavioral insights can boost enrollment, retention, and adherence.
• For Investigators: Intelligent tools can reduce administrative burden and enhance decision-making at the site level.
• For Study Teams: Generative and agentic AI can coordinate trial logistics, detect risks early, and ensure protocol compliance.
Drawing from innovations in conversational AI, this talk offers a pragmatic view of how AI is not just automating clinical trials, but making them more human-centric.
Shun Zhang, Director of AI,
AstraZeneca 09:40
The Importance of Cognitive Assessment in Drug Development
Dr. Kenton Zavitz, Head of Clinical Affairs,
Cambridge Cognition
CONTENT BLOCK 2
Patient and Caregiver Perspectives at the Forefront
10:25
PANEL DISCUSSION
Redefining Patient Centricity: Voices from Participants & Caregivers
Real trial participants and caregivers share raw, personal experiences — what helped, what harmed, and what still feels performative. Discuss how patient advisory boards, return of results, financial burdens, and cultural respect can make or break trust.
This panel will bring together 3 patients and 1 caregiver to discuss their lived clinical trial experiences.
10:50
FIRESIDE CHAT
The Human Algorithm: Care Through Patient's Eyes
Take a deep dive into a patient’s journey: from trials to care.
Moderated by: Mandy Sodhi, Customer Engagement, Lead, Genentech
11:10
Beyond the Checklist: How AI is Transforming Patient Reporting and Experience
AI can enrich patient reporting by personalizing questions, capturing free-text narratives, and providing real-time insights. Yet challenges remain: bias, privacy, workflow burden, and regulatory acceptance. This talk explores how AI can move patient reports beyond checklists—balancing innovation with trust, inclusivity, and clinical relevance.
Saeid Shahraz, Director HEOR, Clinical Outcome Assessment Strategy and Analytics, Gilead Sciences
11:30
Future Proofing Clinical Sites: Voices from the Frontline
Dr. Mark McKenzie, Chief Medical Officer, EmVenio Research
11:50
PANEL DISCUSSION
From Burden to Benefit: Redefining the Participant Experience
Transform clinical trial participation from a burden patients endure into a meaningful experience they value. This session — ‘From Burden to Benefit: Redefining the Participant Experience’ — brings together leaders from both sponsor and vendor perspectives to share real examples and practical ways to make trials easier, more engaging, and more human-centered.
Daniel Swiercz, Associate Director, US Site Engagement | Global Program Lead, GSK
Natasha Massias, Solution Architect Director, Datacubed Health
Moderated by: Lauren Davis, Patient Advocacy Relations, External Affairs, Genentech
CONTENT BLOCK 3
AI, Data and Digital Health: Smarter, Faster, More Human
01:00
FEATURED FIRESIDE CHAT
Leading Transformation: A CEO’s Perspective on the Future of Research
Don’t miss this rare opportunity to hear directly from Genentech’s CEO, Ashley Magargee, as she shares her vision for the future of patient-centered research. In this fireside chat, Ashley will discuss how Genentech is pushing the boundaries of science while keeping patient trust and partnership at the core. Expect bold insights, fresh ideas, and a candid look at how leadership and innovation are reshaping clinical research for the decade ahead.
Ashley Magargee, Chief Executive Officer, Genentech
Moderated by: Nikheel Kolatkar, VP, US Medical, Genentech
01:30
PANEL DISCUSSION
Unlocking Digital Biomarkers: What Works, What Doesn’t, and What’s Next
As clinical trials increasingly tackle integrating wearable sensors and digital health technologies, we find ourselves at a pivotal moment, where innovation meets complexity. Today’s conversation brings together leaders from across the digital biomarker ecosystem to explore how we can move from promise to practice.
Dudley Tabakin, Chief Executive Officer, Vivosense
Sachin Shah, Digital Biomarker Lead, GSK
Moderated by Tom Switzer, Head, Digital Health, gRED, Genentech
01:55
CASE STUDY
Clinical Operations Reinvented: Agentic AI Transforms How We Run Trials
Discover how agentic AI is transforming clinical trials from manual coordination to intelligent, self-driving, and highly efficient operations. This session will share a real-world case study, highlighting opportunities, lessons learned, and key considerations for the successful adoption of AI teammates in clinical development.
Paulius Ojeras, VP Clinical Operations, Perceive Biotherapeutics
02:10
The Human-Centric Trial: Advancing ECGs with AI-Powered Remote Monitoring
Alfred Woo, Chief Product Officer, AliveCor
02:30
PRESENTATIONS + JOINT Q&A
AI-Driven Insights from Multimodal Patient Data
This discussion will explore two separate 10-minute presentations focused on combining patient sensor data, EHR data, PROs, genomics and more for integrated trial insights, followed by a joint Q&A session.
Iraj Hosseini, Distinguished Scientist and Director, Pharmacology Team Lead, Genentech
Kwame Marfo, VP of Product, Unlearn.AI
Followed by Joint Q&A Session
02:55
AFTERNOON COFFEE BREAK
CONTENT BLOCK 4
Collaboration as a Catalyst for Innovation
03:15
FIRESIDE CHAT
A New Era for Clinical Trials: Software-Enhanced Drug(TM) Treatments
As the pharmaceutical industry evolves toward more holistic, patient-centered care models, Software-Enhanced (SE) Drugs are emerging as a powerful strategy to differentiate products, improve outcomes, and extend therapeutic value. In this joint session, Medidata and Click Therapeutics will introduce the core concept of Software-Enhanced Drugs and explain the impact on clinical trials.
Lisa Moneymaker, Chief Strategy Officer, Medidata
Austin Speier, Chief Strategy Officer, Click Therapeutics
03:35
Avoid Product Market [Mis]Fit:
Approaching Site Engagement like the Fastest Growing Silicon Valley Start-Ups
• Why PMF Matters for ClinOps: True competitiveness comes from fit
• Customer Obsession: Win by knowing your Site customers better than anyone else
• Personalization at Scale: Unlocking potential with AI as the multiplier
Laura O'Donnell, Sr. Director, Head, Global Site Engagement, GSK
03:55
FIRESIDE CHAT
The Regulatory Pulse: AI, Decentralization & Data Use in 2025
Regulatory experts discuss hot topics: AI-driven decision support, digital endpoint validation, decentralized oversight, and the evolving role of real-world data.
Darshan Kulkarni, Regulatory and Compliance Attorney for Life Sciences, The Kulkarni Law Firm
Jacqueline Thong, General Manager, US, DEEP Measures
Moderated by: Rasika Kalamegham, Head of US Regulatory Policy, Genentech
04:15
PANEL DISCUSSION
Reaching the Unheard: Engaging Hard-to-Engage Populations
This panel discussion will share innovations in reaching rural, indigenous, low-literacy, and under-resourced communities for research participation, with concrete tools and partnerships.
Judy Lee, Principal Lead US Trial Information and Compassionate Use, Genentech
Jane Myles, Program Director, Decentralized Trials and Research Alliance, DTRA
Archana Sah, Founder and CEO, AS Pharma Advisors
Moderated by Rozanno Gonzales, Clinical Innovation and Technology, Genentech
04:40
WORKSHOP
Agentic AI Prompt Workshop
James Donohue, Senior Digital Health Lead, Genentech
Anna Yang, Principal, Clinical Innovation & Technology Leader, Genentech
04:55
Closing Reflections
James Donohue, Senior Digital Health Lead, Genentech
Anna Yang, Principal, Clinical Innovation & Technology, Genentech
Rozanno Gonzales, Principal, Clinical Innovation and Technology, Genentech
APÉRO / NETWORKING RECEPTION TO FOLLOW