James Donohue, Senior Digital Health Lead, Genentech
Jenny Fisher, Sr. Principal, Digital Business Lead, Oncology, Genentech

Executive leaders discuss where AI, digital biomarkers, decentralized trials, tokenization, digital twins, and software-enabled research have delivered measurable value—and where expectations have outpaced reality. Explore the keys to effective collaboration across industry, technology, and research organizations needed to turn emerging innovations into scalable, sustainable impact.

Peter St. Wecker, Clinical Development Lead, Neurology, UCB
Phil Johnson, GTM Leadership - Life Sciences, SpaceXAI
Dr. Francisco Beca, Chief Medical Officer, QuantHealth
Mukul Virmani, Director, Clinical Data Science, AI Research Center, Gilead Sciences

Moderated by: Luca Finelli, VP, Global Head of Digital Endpoints and Patient Centered Solutions, Roche

• Risk-based monitoring exists because we couldn't review everything. Agents can.
• Oversight moves from periodic review to continuous reasoning — agents investigate signals, not just flag thresholds.
• Trust comes from auditability, not autonomy. Humans still own the judgment calls.

Dr. Michelle Longmire, MD, Co-Founder and CEO, Medable

Hala Borno, Founder and CEO, Trial Library

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 4 patients to discuss their lived clinical trial experiences.

Moderated by Rozanno Gonzales, Clinical Innovation and Technology, Genentech

Jin Lee, Founder, CURE NDD

This presentation will explore how sites are adapting workflows, staffing, and technology to support modern clinical research.

Laura O'Donnell, Sr. Director, Head, Global Site Engagement, (Former) GSK

• What are the biggest barriers sites faces in starting trials faster, and where could sponsors make the greatest difference?
• What do you wish pharma sponsors understood better about the day-to-day realities of running clinical trials at a site?
• Which technologies have actually improved patient recruitment, retention, or trial execution—and which have created more burden than value?
• If you could change one thing about the sponsor–site relationship to make trials more efficient and patient-centric, what would you change?

Lauren Dickey, Clinical Research Supervisor, UCSF
Colin Sauder, Chief Scientific Officer, Adams Clinical
Brian Scates, Clinical Application Manager, UC Davis Health

Moderated by: Laura O'Donnell, Sr. Director, Head, Global Site Engagement, (Former) GSK

Executive vision for the next generation of clinical research and why responsible innovation requires patient trust, collaboration, and measurable outcomes.

Luca Finelli, VP, Global Head of Digital Endpoints and Patient Centered Solutions, Roche

This panel will explore how connected devices can transform safety monitoring from periodic snapshots into continuous insight—helping sponsors improve patient safety, strengthen data quality, and de-risk clinical development. This panel will address what it takes to move from promise to practical, scalable implementation.

John Rootenberg, Principal Director, Digital Safety & Decision Support, Genentech
Sebastian Jayaraj, Sr. Director, Digital Health Oncology, Hematology, & Cell Therapy Lead, BMS
Frank Padron, General Manager, BioPharma, Alivecor

Moderated by: Rajesh Ghosh, Group Director Digital Safety & Decision Support Technologies, Genentech

This presentation will look into the current subspace of PRO among other phenomics data sources and discuss opportunities and challenges in the era of AI.

Saeid Shahraz, Director, HEOR, Clinical Outcome Assessment Strategy & Analytics, Gilead Sciences

Thomas Bengtsson, Executive Director, Product Development (Oncology, Digital Endpoints), Genentech

This discussion will explore combining digital biomarkers, EHRs, PROs, imaging, genomics, and real-world data into continuous evidence generation.

Thomas Bengtsson, Executive Director, Product Development (Oncology, Digital Endpoints), Genentech
Saeid Shahraz, Director, HEOR, Clinical Outcome Assessment Strategy & Analytics, Gilead Sciences

Connecting patient journeys across studies while preserving privacy. Discussion of tokenization, federated learning, and trusted data ecosystems.

Carrie Nielson, Director, Epidemiology and RWE, Gilead Sciences
Rekha Coalson, Medical Data & Analytics Engineer, Genentech
Anju Parthan, PhD, Sr. Director, HEOR & RWE, Oncology, Corcept Therapeutics
Vidhya Parameswaran, Director, Real World Evidence, Kiniksa Pharmaceuticals

Moderated by Kim Barnholt, Executive Director, Data and Clinical Innovation, Genentech

FDA, legal, and industry perspectives on AI governance, digital endpoints, tokenized data, digital biomarkers, and decentralized oversight.

Anita Modi, Co-Founder and CEO, Peer AI
Matt DeFina, SVP of Regulatory Policy, Canal Row Advisors

Moderated by: Anne Madej, Regulatory Science, Genentech

Clinician-reported outcomes remain the gold standard for efficacy in psychiatric trials, yet rater bias and variability continue to undermine signal detection despite decades of training, certification, and oversight programs. This talk presents Automated COA Quality System (ACOQS) a system of large language models developed by Definium that transcribes audio-recorded Hamilton Anxiety Scale (HAM-A) interviews and independently scores each item. Trained on roughly 1,500 Phase 2 interviews, the model closely matched central rater scores (mean difference 1.57 points; r = 0.98) and is now deployed across an ongoing Phase 3 program, where it reviews every recorded assessment. The session will describe how the system flags discordant assessments for independent clinician review, supports longitudinal monitoring of rater performance, and informs eligibility decisions without altering study data, illustrated with real-world case examples. It will close with a look ahead at the promise and regulatory hurdles of using LLMs as a primary endpoint measure, and their potential role in measurement-based care.

Todd Solomon, PhD, Senior Director, Clinical Development, Definium Therapeutics

This panel discussion will share innovations in reaching rural, indigenous, low-literacy, and under-resourced communities for research participation, with concrete tools and partnerships.

Meg McKenzie, Director, Population Sciences, Genentech
Lloryn Hubbard, Director, Clinical Trial Diversity, Daiichi Sankyo
Shamekka Marty, CEO and Founder, Beyond the Game Health
Jin Lee, Founder, CURE NDD

Moderated by: Archie Yellow-Duke, Sr. Medical Director, US Medical Population Science & Health, Genentech

Interactive closing discussion where patients, investigators, sponsors, regulators, and technology leaders design the ideal clinical trial of the future using the day’s insights

James Donohue, Senior Digital Health Lead, Genentech
Jenny Fisher, Sr. Principal, Digital Business Lead, Oncology, Genentech

James Donohue, Senior Digital Health Lead, Genentech
Jenny Fisher, Sr. Principal, Digital Business Lead, Oncology, Genentech