DPHARM: Disruptive Innovations Agenda 2025 Page 1

Track D. The Power of Patient Insights, Novel Prescreening ID Mechanisms, Change Management, Site Adoption Barriers, and Strategies for Digital Biomarker Adoption

Track Chair:

Patrick Gee Sr, PhD, JLC, Patient Advocate, Founder & Chief Executive Hope Dealer, iAdvocate, Inc

2:10PM - 2:25PM

REGENERON | The Power of Systemic Patient Insights to Inform Trial Design and Address Patient Burden

Speaker:

Tara Gipp, Director Global Trial Optimization, Patient Engagement, Regeneron Pharmaceuticals Inc

2:25PM - 2:40PM

BOEHRINGER INGELHEIM | Addressing Site Innovation Adoption Barriers with Change Management

Speaker:

Wouter Däniels, MSc, Patient & Site Engagement Lead, Boehringer Ingelheim

2:40PM - 2:55PM

BIOGEN | Deploying Novel Prescreening ID Mechanisms to Drive Impactful Patient Recruitment

Speaker:

Katie King, MSHS, Associate Director, PCE DU Lead AD, Patient Centricity & Engagement, Global Clinical Operations, Biogen

2:55PM - 3:10PM

BAYER | The Future Adoption of Digital Biomarkers through Proactive Engagement

Speaker:

Julien Kroll, Strategic Lead, Digital Health and Real World Science, Bayer

Showing Events in 1 Track from 03:10pm to 03:50pm

Afternoon Networking Break

3:10PM - 3:50PM

Afternoon Networking Break

Graciously Hosted By:

Showing Events in 1 Track from 03:50pm to 04:50pm

Afternoon General Session

3:50PM - 4:50PM

Pharma and Solution Provider Collaborations on Advancing Clinical Trials

Showing Events in 1 Track from 05:00pm to 06:25pm

DPHARM Idol Disrupt 2025

5:00PM - 6:25PM

DPHARM Idol Disrupt 2025

DPHARM Idol 2024 Winner Where They Are a Year Later:

Brandon Li, Co-Founder and Co-CEO, Power

DPHARM Idol Disrupt Host:

Valerie Bowling, Executive Director, The Conference Forum

DPHARM Idol Disrupt Judges:

Mohammed Ali, R&D Head of Business Performance & Analytics, CMO Office, Astellas

Esther Dyson, Author, "Term Limits"

Rozanno Gonzales, MS, Clinical Innovation and Technology Leader, Genentech

Bill Illis, Head, Technology and Collaboration, Novartis

Hassan Kadhim, Head of Business Engagement, Clinical Operations and Clinical Development, Vertex Pharmaceuticals

Julien Kroll, Strategic Lead, Digital Health and Real World Science, Bayer

Sarah Krüg, Executive Director / CEO, Cancer101 / Health Collaboratory

Yvonne McLean Florence, MDiv, Patient Advocate and 2023 Elevate Ambassador, National Coalition for Cancer Survivorship

Siân Ratcliffe, PhD, SVP, Head of Quantitative Sciences & Development Operations, Biogen

Doug Schantz, SVP, Clinical Operations, AskBio

Gina Schweizer, MS, MBA, Vice President, Head of Strategy, Operations and Analysis & Reporting, Genmab

Mark Travers, PhD, MBA, Former VP, Head Global Clinical Trial Operations, Regions and Regional Operations, Merck & Co., Inc.

Donna Usiskin, Chief Strategy Officer, New Enterprise Ventures

Showing Events in 1 Track from 06:30pm to 07:30pm

Grand Reception

6:30PM - 7:30PM

Grand Reception

Showing Events in 1 Track from 07:00am to 08:05am

Registration

Showing Events in 1 Track from 08:05am to 08:25am

Patient Keynote

8:05AM - 8:25AM

Patient Keynote

Keynote Guest Patient Speaker:

Victoria Gray, Advocate and First CRISPR Gene Therapy Recipient for SCD, NA

Moderated with:

Charlotte Moser, MD, PhD, MBA, Chief Medical Officer, Parexel

Showing Events in 1 Track from 08:25am to 09:35am

Day One – Morning General Session

8:25AM - 8:55AM

Expanding Your Global Footprint for Clinical Research: Readiness to Pivot

Moderator:

Janelle Sabo, PharmD, SVP, Clinical Research Capabilities, Eli Lilly and Company

Panelists:

Nikki Amaratunge, VP, Clinical Development Operations, Head of Clinical Site Management, AbbVie

Marta Arias-Salgado, VP, Global Head GCTO Regions and Regional Operations, Merck Research Labs

David Carruthers, VP, BioPharmaceuticals and Global Head of Clinical Operations, AstraZeneca

Melika Davis, SVP, Global Head, Clinical Operations, BeOne Medicines

Peyton Howell, MHA, Chief Executive Officer, Parexel

8:55AM - 9:25AM

AI Powered Real-Time Industry Collaboration @DPHARM: Merck Unveils New Strategy for Driving Automation in Clinical Trial Operations

Speaker:

Donald Thampy, Executive Director, Head of Clinical Data Integration, Merck

9:25AM - 9:35AM

Interactive Audience Session

Showing Events in 1 Track from 09:35am to 10:15am

Keynote Fireside

9:35AM - 10:15AM

Staying Ahead of the Geopolitical Landscape on the Future of Clinical Research

Speaker:

Scott Gottlieb, MD, 23rd Commissioner, U.S. Food and Drug Administration

Janelle Sabo, PharmD, SVP, Clinical Research Capabilities, Eli Lilly and Company

Showing Events in 1 Track from 10:15am to 10:55am

Networking Refreshment Break

10:15AM - 10:55AM

Networking Refreshment Break

Showing Events in 1 Track from 11:00am to 12:30pm

4 Track Choices: Innovative Sources & Solutions to Support Patient Enabled Trial Technologies and Services

11:00AM - 12:30PM

Innovative Sources & Solutions to Support Patient Enabled Trial Technologies and Services in 4 Track Choices

Showing Events in 4 Tracks from 11:00am to 12:30pm

Track A. Patient Centric Clinical Trial Services

Track Chair:

Christie Fry, Director, Patient-Centric Trial Design Clinical Acceleration and Performance, AbbVie

Track B. New Frontiers in Digital Tech Solutions

Track Chair:

Doug Schantz, SVP, Clinical Operations, AskBio

Track C. Automating And Accelerating Clinical Trials

Track Chair:

Sean Lynch, Innovative Capabilities Head, Innovative Trial Operations, Novartis

Track D. The Future of Clinical Trials

Track Chair:

Mary Brantner, Senior Director, Clinical Program Optimization and Innovation, Insmed Incorporated

PA Consulting | AI maturity in clinical development: Where are we, and what's next?

Showing Events in 1 Track from 12:40pm to 01:05pm

Leadership Keynote

12:40PM - 1:05PM

Leading with Integrity and Fostering a Culture of Innovation Where All Can Thrive

Speaker:

Ken Frazier, JD, Retired Chairman and CEO, Merck & Co., Inc., Chairman, Health Assurance Initiatives, General Catalyst

Moderated with:

Jennifer Sheller, MPH, SVP, Head of Global Clinical Trial Operations, Global Clinical Development, Merck & Co., Inc.

Showing Events in 1 Track from 01:05pm to 02:05pm

Networking Luncheon and Facilitated Roundtables

1:05PM - 2:05PM

Networking Luncheon and Facilitated Roundtables

Showing Events in 5 Tracks from 01:20pm to 02:00pm

Roundtable A

1:20PM - 2:00PM

Navigating the CRA Role of the Future

Facilitator:

Patrick Floody, MBA, VP and Head of Global Clinical Trial Services, Regeneron Pharmaceuticals Inc

Roundtable B

1:20PM - 2:00PM

Guardrails for Growth: Scaling PI Oversight with Quality at the Core

Facilitator:

Greg Manning, MS, CCRP, Head of Centralized Network Operations, Atlas Clinical Research

Roundtable C

1:20PM - 2:00PM

Informed Consent: Innovating and Collaborating Further to Decrease Patient Burden

Co-facilitators:

Katie Madden, PMP, Director of Digital Enablement, GSK

Jennifer Ribeiro, Director, Patient Recruitment and Retention Strategy, Exelixis

Roundtable D

1:20PM - 2:00PM

Evaluating the Impact of Pharma Sponsors Implementation of Site Centric Approaches

Co-facilitators:

Sylvie Kruyner, Clinical Study Manager, DCT Advisor, Bayer

Andrew Vigario, MA, Senior Clinical Country & Site Lead, Biogen

Roundtable E

1:20PM - 2:00PM

The Collection of SOGI Data in Clinical Research

Facilitator:

Racquel Bruton, Associate Director, Clinical Trial Diversity Portfolio Lead, Biogen

Showing Events in 1 Track from 02:10pm to 03:10pm

Pharma Reporting on Innovation From the Trenches

2:10PM - 3:10PM

Pharma Reporting on Innovation From the Trenches

Showing Events in 4 Tracks from 02:10pm to 03:10pm

Track A. Deploying AI/LLM to Drive Quality, Safety and Cost Reduction

Track Chair:

Vivian Cheng Larsen, Associate Patient Recruitment & Retention Strategy Director, Exelixis

2:10PM - 2:25PM

MINDMED | Using Large Language Models (LLMs) for Greater Oversight in CNS Clinical Trials

Speaker:

Todd Solomon, PhD, Senior Director, Global Clinical Development, CNS and Digital Medicine, MindMed

Moderated with:

Hassan Kadhim, Head of Business Engagement, Clinical Operations and Clinical Development, Vertex Pharmaceuticals

2:25PM - 2:40PM

AMGEN | Amgen’s Custom-Built AI Tool for Advancing Clinical Trial Operations

Speaker:

Angela DeLuca, MBA, PMP, Associate Vice President, Head of Global Study Operations, Amgen

2:40PM - 2:55PM

PFIZER | An Evaluation Framework for Generative AI in Drug Development to Ensure Safety and Quality

Speakers:

Venky Iyer, Director, Clinical Data and Information Services, Pfizer

Sheraz Khan, PhD, Director, Data Science,, Pfizer

2:55PM - 3:10PM

GENMAB | GenSignal: A Solution to Accelerate Safety Surveillance

Speaker:

Azia Tariq, MPH, Senior Manager, Clinical Trial Analytics & Visualization, Genmab

Track B. Protocol Amendment Reductions, AI, GenAi, Predictive Analytics, E2E Forecasting for Trial Acceleration/Monitoring

Track Chair:

Barry Nelson, Patient Advocate, Lived-Experienced Expert

2:10PM - 2:25PM

ROCHE | Optimizing Protocol Change Management

Speaker:

Liz Thompson, Global Development Leader, Senior Clinical Development Scientist, Roche

2:25PM - 2:40PM

VERTEX | Deploying Predictive Analytics and GenAI Solutions across the Clinical Trial Lifecycle to Improve Speed and Predictability

Speaker:

Taylor Uttley, MS, Senior Director, Head of Strategy & Operations, Data Strategy & Solutions, Vertex Pharmaceuticals

2:40PM - 2:55PM

GILEAD | Designing, Planning and Monitoring Performance at Scale for Clinical Trials Using AI

Speakers:

Yi Hong, PhD, Associate Director, Gilead Science

Nicole Sheetz, PharmD, Senior Director, Design & Innovation, Global Development, Gilead

2:55PM - 3:10PM

MODERNA | Accelerating Trial Activation and Study Timelines: Innovative Approaches

Speaker:

Sylvia Marecki, PhD, Senior Director, Head of Portfolio Reporting and Analytics, Moderna

Track C. Next-GEN EDC/CDMS Platforms; EHR Data and Ex-US DCT Adoption for Patient Recruitment

Track Chair:

Sabina Kineen, Patient Advocate, Lived-experience Expert

2:10PM - 2:25PM

PFIZER | Implementing the NextGen EDC/CDMS Platform: Advancing Data Analysis Capabilities

Speaker:

Demetris Zambas, VP, Global Head of Data Monitoring and Management, Pfizer

Moderated with:

Doug Schantz, SVP, Clinical Operations, AskBio

2:25PM - 2:40PM

SANOFI | Leveraging EHR Data at Scale to Accelerate Patient Recruitment

Speaker:

Nadir Ammour, DDS, MBA, Global Lead, Clinical Innovation & External Partnerships, Sanofi

2:40PM - 2:55PM

PFIZER | Scaling DCT Adoption in Ex-US Regions

Speaker:

Jeremy Price, Senior Director Clinical Innovations, Head of Decentralized Clinical Trials, Pfizer

2:55PM - 3:10PM

DAIICHI SANKYO | Metrics, Dashboards, Analytics - Where Do I Start?

Speakers:

Yusuf Ghadiali, Executive Director, Global Clinical Operations & Planning, Daiichi Sankyo

Ashley Williams, Head of Study Optimization, Daiichi Sankyo

Track D. The Power of Patient Insights, Novel Prescreening ID Mechanisms, Change Management, Site Adoption Barriers, and Strategies for Digital Biomarker Adoption

Track Chair:

Patrick Gee Sr, PhD, JLC, Patient Advocate, Founder & Chief Executive Hope Dealer, iAdvocate, Inc

2:10PM - 2:25PM

REGENERON | The Power of Systemic Patient Insights to Inform Trial Design and Address Patient Burden

Speaker:

Tara Gipp, Director Global Trial Optimization, Patient Engagement, Regeneron Pharmaceuticals Inc

2:25PM - 2:40PM

BOEHRINGER INGELHEIM | Addressing Site Innovation Adoption Barriers with Change Management

Speaker:

Wouter Däniels, MSc, Patient & Site Engagement Lead, Boehringer Ingelheim

2:40PM - 2:55PM

BIOGEN | Deploying Novel Prescreening ID Mechanisms to Drive Impactful Patient Recruitment