DPHARM: Disruptive Innovations Agenda 2024 Page 2

Jamie Macdonald, CEO, Parexel

8:45AM - 9:10AM

How Eisai Deployed Bayesian Methods that Resulted in an Accelerated Approval in Alzheimer’s Disease

Shobha Dhadda, PhD, SVP, Global Head, Biostatistics & Project Operations, ADBH, Eisai Pharmaceuticals

Lynn D Kramer, MD, FAAN, Chief Clinical Officer ADBH and Corporate Officer, Eisai Co., Ltd.

9:10AM - 9:35AM

ZEITGEIST SPEAKER - Zeitgeist Talk on the Current and Future State of Health Data Interoperability

Micky Tripathi, PhD, MPP, National Coordinator Health IT, U.S. Department of Health & Human Services

Moderated with:

Amy Cramer, MMCi, BSN, CPHQ, Global Product Development Strategic Partnerships, Pfizer

9:35AM - 10:05AM

LEADERSHIP PANEL - Navigating and Adopting Innovation in a Post-Pandemic World

Moderator:

Lynn D Kramer, MD, FAAN, Chief Clinical Officer ADBH and Corporate Officer, Eisai Co., Ltd.

Panelists:

Janice Chang, CEO, TransCelerate BioPharma Inc

Kenneth Getz, MBA, Executive Director and Professor, Tufts CSDD

Bari Kowal, SVP, Head Development Operations & Portfolio Management, Regeneron

Andy Lee, SVP, Head of Global Clinical Trial Operations, Merck

Showing Events in 1 Track from 10:05am to 10:45am

Change Management Keynote

10:05AM - 10:45AM

KEYNOTE - Change Management

Rita McGrath, PhD, Best-selling Author and Professor, Columbia Business School

Showing Events in 1 Track from 10:45am to 11:30am

DPHARM Networking and Breakfast Cafe, Graciously hosted by PRAXIS

10:45AM - 11:30AM

DPHARM Networking and Breakfast Cafe

Graciously Hosted By:

Showing 3 of 4 Tracks

from 11:30am to 12:55pm

Track A - Patient-Centric Clinical Trial Services

Track Chair:

Victoria L. Chiou, MD, Head, Clinical Excellence and Innovation, AstraZeneca

AI Powered Deep Evidence Generation – A Digitally-Enabled Clinical Trial Platform

Alison Holland, Executive GM, Customer Value, Medable

Accelerating Clinical Trial Enrollment: Unleashing the Power of EHR Integration and Intelligent Patient Matching

Colleen Hoke, Co-Founder and Chief Executive Officer, ObjectiveHealth

Josh O'Rourke, Chief Technology Officer, ObjectiveHealth

Challenging the Status Quo in Protocol Design to Drive Speed and Patient Flexibility

Edward Triebell, Executive Director, Product Development of Digital Health, MRN

By the Patient, for the Patient: Improved Trial Design through Patient-Centered Real-World Evidence

Brian Loew, CEO, Inspire

The Impact of Patient Activation on Clinical Trial Enrollment

Amanda Rangel, MS, SVP, Business Development, 83Bar

From Buzzword to Business Strategy — Finding Sustainability in Clinical Trial Communications

Sarah McKeown-Cannon, VP, Growth, Langland

The Power of Community Research Sites in Engaging Underserved Populations in Clinical Research

Thad Wolfram, President, EmVenio Research

12:45PM - 12:55PM

Infusing Customer Experience and Compliant Consistency into your Clinical Trial Recruitment Approach

Jean McCoy, EVP, Partnerships, Reverba

Track B - New Frontiers in Digital Technology Solutions

Track Chair:

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

Accelerating Patient Recruitment with Cross-Trial Recruitment Methods

Alex Eastman, VP, Products, OneStudyTeam

Implementing the Right COAs to Support the Patient Experience in Clinical Trials

Elan Josielewski, Senior Principal and head of Operations of Patient Centered Solutions, IQVIA

Anthony Mikulaschek, VP, eCOA, IQVIA

Accelerating Research Today with AI

Lisa Moneymaker, Chief Technology Officer/Chief Product Officer, Saama

How LLMs Will Dramatically Accelerate AI Solution Adoption in Clinical Development

Kushal Gohil, SVP, Corporate Strategy & Innovation, Parexel

Leveraging Risk Data Libraries to Drive Study Efficiencies

Alan Switzer, MBA, Director, IT Client Delivery, Fortrea

Priming Your Trial Startup with Real-World Data

Joseph Roettgen, PharmD, AVP, Life Sciences, Komodo Health

A Scalable Blueprint to Solve the Industry’s Need for a Clinical Data Lakehouse

Raj Indupuri, MBA, CEO, eClinical Solutions

12:45PM - 12:50PM

Empowerment through Engagement: Rethinking Patient Involvement in Clinical Trials

Kyle Hogan, President, Datacubed Health

Track C - EHR/RWE/DCT/Mobile Solutions

Track Chair:

Doug Schantz, SVP, Clinical Operations, Asklepios BioPharmaceutical, Inc.

A Live, Head-to-Head Showdown Between a Paper Protocol and Digital Automation to Eliminate Deviations and Reduce Site Burden

Chaired By:

Joseph Kim, MBA, Chief Strategy Officer, ProofPilot

Bernadette Tosti, Chief Product Officer, ProofPilot

Expediting Clinical Research Through Point-of-Care Data Acquisition

Mariel Boyd, Senior Product Manager, Flatiron Health

Pragmatic Trials, Real-time Registries, and Automated Comparator Arms: New Frontiers in EHR-to-EDC

Ardy Arianpour, CEO & Co-Founder, SEQSTER

Scott Morris, VP and GM, Clinical Trial Solutions, Optum Life Sciences

Leveraging Data-Driven and Patient-Informed Solutions to Improve Diversity in Your Clinical Trials

Kelly McKee, VP, DCTs and Patient Registries, Medidata

The Evolutionary Impact of Mobile Devices on eCOA/ePRO

Transforming Clinical Trials: Expanding Data Collaboration and AI-Driven Innovations

Michael Ibara, PharmD, Chief Data Officer, Elligo

How Unique Patient Characteristics and AI/ML-based Solutions Can Predict Patient Behaviors (Placebo Response, Drop Out Risk and More)

12:45PM - 12:50PM

The Blind Spot: Are Eye Exams Holding Back Your Non-Ophthalmic Clinical Trial?

Jessica Mays, VP, Life Sciences, 20/20 Onsite

12:50PM - 12:55PM

Streamlining Digital Health Data Acquisition

Geoffrey Gill, Founder and CEO, Verisense Health, Inc.

Track D - The Future of Clinical Trials

Track Chair:

Tracy Vanderslice, MSc, VP and Head, Clinical Operations Oncology, Gilead Sciences, Inc.

The Impact of Simulation on a Complex Global Phase 3 Study

David Hadden, Founder and President, Pro-ficiency

How to Future-Proof Your Technology Ecosystem with Sites in Mind

Stuart Cotter, VP, Product Strategy and Innovation, Advarra

Unlocking the Full Value Potential of Digital Protocols

Marigrace Ambrosia, Director, PwC

Eddie Valaitis, PhD, Director, PwC

Revolutionizing Biopharma Research: Driving Efficiencies through Site Enablement Technologies

David Hine, Senior Director, Sales Engineering, Greenphire

Flexibility That Scales

AI with Impact: Real-world Approaches to Making AI Work in Clinical Trials

Shae Wilkins, CEO, TRYAL

Deploying AI Across the Clinical Trial Life Cycle to Deliver Efficient, Safe and Impactful Clinical Research

Paul Mancinelli, Chief Technology Officer, WCG

12:45PM - 12:55PM

Marketplaces: The Key to Unlocking Access in Clinical Trials

Liz Beatty, Chief Strategy Officer and Co-Founder, Inato

Showing Events in 1 Track from 12:55pm to 02:00pm

Networking Luncheon and Facilitated Roundtables

Networking Luncheon and Facilitated Roundtables

Showing 3 of 6 Tracks

from 12:55pm to 02:00pm

Table A

Benchmarking Clinical Operations Digital Maturity and How it Impacts Priorities and Focus

Roundtable Facilitators:

Leslie Addy, Director, Development Operations Innovation and Decentralized Clinical Trials, Amgen

Craig Lipset, Advisor and Founder, Clinical Innovation Partners

Nicole Sheetz, PharmD, Senior Director, Clinical Development Technology and Innovation, Gilead

Table B

Discussing Better Ways to Design Trials to Optimize for Safety, to Show Efficacy and Keep Patient Burden Low

Roundtable Facilitator:

Rodrigo Crispim, PharmD, MBA, Clinical Trials Portfolio head for Latin America and Canada, Novartis

Antoniu Fantana, PhD, Lead, Emerging Technology Strategy, Clinical Design, Delivery & Analytics, Eli Lilly and Company

Table C

Asking the Tough Questions: Garnering Patient Feedback to Drive Protocol Design in Sensitive Therapeutic Areas

Roundtable Facilitators::

Pirinka Georgiev, Associate Director, Clinician, Digital Sciences, Early Clinical Development, Pfizer

Bert Hartog, PhD, Senior Director, Janssen Clinical Innovation, Janssen R&D Global Development, Janssen Pharmaceuticals

Table D

Harmonization of Digital Endpoints

Roundtable Facilitators:

Bert Hartog, PhD, Senior Director, Janssen Clinical Innovation, Janssen R&D Global Development, Janssen Pharmaceuticals

Table E

Strategies for Implementing Complex Clinical Trials

Roundtable Facilitator:

Mindy Gruba, MPH, Senior Manager, Patient Centricity, Moderna

Table F

Call to Action: Providing Input on Duke University’s CTTI Metrics Framework to Assess Progress in Achieving Initiative Goals by 2030

Roundtable Facilitator:

Summer Starling, DrPH, MPH, Project Manager, Clinical Trials Transformation Initiative

Showing 3 of 4 Tracks

from 02:05pm to 03:05pm

Track A - Accelerating and Scaling Efficiencies in Trial Startup, App Development and Data Output

Track Chair:

Emily Epstein, Patient Advocate, Behavioral Health Specialist, Weill Cornell Medicine

Amgen's Approach to Using the critical Path to Accelerate Startup

Taras Carpiac, Executive Director, Innovation - Global Development Operations, Amgen

How AbbVie Scaled 40+ Patient Apps in a Calendar Year and Its impact on Efficiencies and Costs

Sanjay Bhardwaj, Global Head of Clinical Data Strategy & Operations, AbbVie

Kapil Gombar, Director, Clinical Technologies and Innovation, AbbVie

Implementing a Data Products Approach to Drive Digital Clinical Operations Excellence

Eric Hoberman, RN, MBA, Head, Digital Clinical Operations Excellence, Biogen Digital Health

Sanofi's Approach to Scaling EHRs as eSource in Clinical Trials

Paul Bassett, BSN, RN, Project Lead, Early Development Oncology Operations, Sanofi

Track B - Optimizing Study Designs with Data Science, DCT Methods, and AI

Track Chair:

Cindy Geoghegan, Patient Advocate, -

How to Increase Value and Impact of Data Science Solutions for Clinical Operations

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

The Impacts of Decentralized Trial Methods in a Hybrid, Phase 1 Drug Trial

Jane Myles, Chairperson, Strategic Advisory Board and Program Director, Curebase and DTRA

Rajesh Patel, Associate Director, Technology & Innovation, Global Development Operations, Gilead Sciences, Inc.

GPT: The Catalyst for Disruptive Innovation in Clinical Development

Prasanna Rao, Senior Director, Global Head of AI/ML, Clinical Data Sciences, GPD, Pfizer

Genmab’s Journey to Drive Rapid Adoption of AI in Clinical Operations

Elmutaz Shaikho, BPharm, Rph, MBA, PhD, Associate Director, Data Engineering and Platform, Genmab

Track C: Innovating to Address Patient Access and Alleviate Site Burden

Track Chair:

Barry Nelson, Patient Advocate, -

How Gilead’s Preferred Sites Network Drives Patient Access

Hila Barak, PhD, RAC, Head of Clinical Science and Chief of Staff, Oncology, Gilead Sciences

Tracy Vanderslice, MSc, VP and Head, Clinical Operations Oncology, Gilead Sciences, Inc.

How Lilly Sources Validated Alternatives to Gold Standard Measures to Alleviate Patient & Site Burden

Meri Kay Scott, PhD, AVP, Digital Health R&D, Eli Lilly and Company

Innovate for Impact: Harnessing the Value of Clinical Trials Innovations

Kimberly Barnholt, PhD, MS, Sr Director, Evidence Generation Leader, Genentech

Biogen’s Approach to Address Sites Resource Constraints

Jenn Curry, Head of Patient Engagement Capabilities, Biogen

Track D: Driving Patient Inclusivity and Operationalizing DCTs

Track Chair:

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

Prioritizing a “Patient First” Approach: Automating the RBQM Revolution

Katherine Taylor, MBA, Head, Risk Evaluation and Adaptive Integrated Monitoring (REAIM), Global Clinical Trial Operations (GCTO), Merck

Althea Wilson, Director, Risk Evaluation and Adaptive Integrated Monitoring, Merck

Developing “Direct to Patient” Cohorts to Drive More Inclusive Enrollment Strategies

Jake Harrell, Head of R&D Data and Data Convergence, AbbVie

Moderated with:

Jane Perlmutter, PhD, MBA, Founder and President, Gemini Group

Bayer’s Approach to Drive Operational Implementation of DCTs

Sylvie Kruyner, Director, DCT Operations, Bayer

Sanofi’s Implementation of a Data Driven Indication Level Strategy to Optimize Portfolio Success

Sourav Das, Associate Principal, ZS

Mara Kramer, Feasibility Transversal Project Lead, Early Operational Strategy, Sanofi

Chirag Trivedi, Global Head, Clinical Study Units, Early Operational Strategy, Sanofi

Showing Events in 1 Track from 03:10pm to 03:40pm

Afternoon Ice Cream and Networking Break, Graciously hosted by Fortrea

3:10PM - 3:40PM

Afternoon Ice Cream and Networking Break

Graciously Hosted By:

Showing Events in 2 Tracks from 03:40pm to 04:40pm

Breakout Session A

3:40PM - 4:05PM

Earning Patient Trust and Goodwill by Innovating the Clinical Trial Experience

Judy Sewards, VP, Head of Clinical Trial Experience and Participant Recruitment, Pfizer, Inc.

4:05PM - 4:40PM

Getting to Next-Gen Collaborative Platform Trials to Enable Efficient, Patient-Centric Clinical Trials

Moderator:

Daniel Millar, MBA, Senior Director, Strategic Business Transformation, Janssen Research & Development, LLC

Panelists:

Abbey Gohl, Director, Global Program Leader, Janssen Research & Development, LLC

Wendy Komocscar, Principal Clinical Research Scientist, Eli Lilly and Company

Gregory Levin, PhD, Associate Director for Statistical Science and Policy, FDA/CDER/OTS/OB

Jane Perlmutter, PhD, MBA, Founder and President, Gemini Group

Martin Roessner, MS, Corporate VP, Biostatistics, Parexel

Breakout Session B

3:40PM - 4:05PM

Fireside Leadership Lessons: Clinical Operations Strategies Ripe for Disruption

Angela DeLuca, MBA, PMP, VP, Head of Oncology & Cell Therapies Clinical Operations, Global Development Office, R&D, Takeda

Moderated with:

Barry Nelson, Patient Advocate, -

4:05PM - 4:40PM

Evolving the U.S Clinical Trials Infrastructure for Emergency Response to Outbreaks/Biological Incidents

Moderated by:

Amy Cramer, MMCi, BSN, CPHQ, Global Product Development Strategic Partnerships, Pfizer

Panelists:

Brian Anderson, MD, Chief Digital Health Physician, MITRE

Jennifer Roberts, PhD, Director, Resilient Systems Office (RSO), Advanced Research Projects Agency for Health (ARPA-H)

Grail Sipes, JD, Assistant Director for Biomedical Regulatory Policy, Health Outcomes Division, Office of Science and Technology Policy, Executive Office of the President

Showing Events in 1 Track from 04:40pm to 06:00pm

DPHARM Idol Disrupt 2023

4:40PM - 6:00PM

DPHARM Idol Disrupt 2023

DPHARM Idol 2022 Winner:

Del Smith, PhD, CEO and Co-Founder, Acclinate