The Clinical Trial Innovation Summit will return to Genentech Headquarters in South San Francisco on October 15th!

PanAgora Pharma and Genentech are collaborating again to present the 2nd Annual Clinical Trial Innovation Summit on October 15, 2025 on Genentech's South San Francisco campus. This year's conference agenda will focus on how life sciences organizations are building more human-centered clinical trials by improving patient engagement, experience, retention, and recruitment.

The 2025 edition of the Clinical Trial Innovation Summit will focus on 3 core theme blocks throughout the one-day event, including:

The Future of Trials: Where Science, Humanity & Technology Converge
Patient and Caregiver Perspectives at the Forefront
AI, Data & Digital Health: Smarter, Faster, More Human

• Collaboration as a Catalyst for Innovation

Join 25+ speakers and 200+ senior-level clinical research, operations, and trial design leaders this October 15th at Genentech's Campus in South San Francisco!
 
Location
Genentech SSF Campus
1 DNA Way
South San Francisco, CA 94080

Date & Time
October 15, 2025
08:30am - 5:30pm PST
Networking Reception to Follow


HOST SPONSOR
CTI SUMMIT THEMES FOR 2025

THEME 1: The Future of Trials: Where Science, Humanity & Technology Converge

Discover how AI, automation, digital health technology, and decentralized models are reshaping research with trust, ethics, and human-centered
design at the heart of innovation.

THEME 2: Patient and Caregiver Perspectives at the Forefront

Beyond the buzzwords with real stories from patients and caregivers and
actionable tools for co-creating trials to ensure success.

THEME 3: AI, Data & Digital Health: Smarter, Faster, More Human

Explore the real-world impact of emerging technologies - from multimodal patient data integration and wearables to digital twins - and how to balance innovation with regulatory, ethical, and operational realities.

THEME 4: Collaboration as a Catalyst for Innovation

Learn how cross-sector collaboration can unlock solutions for hard-to-reach populations, improve site sustainability, return results to participants, and ultimately drive research that matters.



SpeakING FACULTY & ADVISORS
Ashley Magargee

Chief executive officer

GENENTECH
Nikheel Kolatkar

VP, US Medical

GENENTECH
Anna Yang

Principal, Clinical Innovation and Technology LEADER

GENENTECH
James Donohue

Sr. Digital Health Lead

GENENTECH
Rozanno Gonzales

Principal, Clinical Innovation and Technology LEADER

GENENTECH
Shun Zhang

DIRECTOR OF AI

ASTRAZENECA
Laura O'Donnell

Sr. Director, Head, Global Site EngagemenT 

GSK
Paulius Ojeras

VP, Clinical OPERATIONS

PERCEIVE BIOTHERAPEUTICS
Lisa Moneymaker

CHIEF STRATEGY OFFICER

Medidata
Austin Speier

CHIEF STRATEGY OFFICER

CLICK THERAPEUTICS


Katrina Paz

DIRECTOR, CLINICAL PROGRAMMING

DENALI THERAPEUTICS
Thomas Switzer

Head, Digital Health, gRED

GENENTECH
Natasha Massias

Solution Architect Director

DATACUBED HEALTH
Mandy Sodhi

Customer Engagement, Lead

GENENTECH
Rasika Kalamegham

Head, US Regulatory Policy

Genentech
Mark McKenzie

CHIEF MEDICAL OFFICER

EMVENIO RESEARCH
Alfred Woo
CHIEF PRODUCT OFFICER

ALIVECOR
Judy Lee
PRINCIPAL TRIAL LEADER

GENENTECH
Dr. Kenton Zavitz

Head OF CLINICAL AFFAIRS

CAMBRIDGE COGNITION
Michelle Longmire

CEO

MEDABLE
Iraj Hosseini

DISTINGUISHED SCIENTIST, DIRECTOR, PHARMACOLOGY tEAM

GENENTECH
Lauren Davis

PATIENT ADVOCACY RELATIONS, EXTERNAL AFFAIRS

GENENTECH
Sachin Shah

Digital biomarkers lead

GSK
Saeid Shahraz

DIRECTOR, HEOR

GILEAD
Kwame Marfo

VP OF PRODUCT

UNLEARN.AI
Dudley Tabakin

Ceo

vivosense
Phil Johnson

CHIEF COMMERCIAL OFFICER

EVIDATION
Daniel Swiercz

Associate Director, US Site Engagement | Global Program Lead

GSK
Kimberly Barnholt
EXECUTIVE DIRECTOR, EVIDENCE GENERATION

GENENTECH
Darshan Kulkarni
REGULATORY & COMPLIANCE ATTORNEY FOR LIFE SCIENCES

THE KULKARNI LAW FIRM
Jane Myles

Program Director

DTRA
Youssef Idelcaid

Head of AI Research Center - Drug Development

GILEAD
Jacqueline Thong

GENERAL MANAGER, US

DEEP MEASURES
Archana Sah

Founder & CEO

AS PHARMA ADVISORS
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


10:00
Networking Break





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


12:10
NETWORKING LUNCH



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


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CTI SUMMIT VENUE

Genentech SSF Campus
The Clinical Trial Innovation Summit will be held at the Genentech South San Francisco campus. The South San Francisco campus is large, hilly, and consists of over 40 buildings housing scientific research, manufacturing operations, and various business functions.

Address:
Genentech 
1 DNA Way
South San Francisco, CA 94080

Learn more here: Genentech SSF Campus Overview

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