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DPHARM: Disruptive Innovations

Date: Sep 17, 2024 - Sep 18, 2024

Location: Philadelphia, PA

Day Two: Thursday, September 21, 2023
Showing Events in 1 Track from 08:00am to 10:05am
Day 2 Morning General Session
8:00AM - 8:30AM
Registration and Tea/Coffee
Graciously hosted by:
8:30AM - 8:45AM
Opening Remarks
Speakers:
Jamie Macdonald, CEO, Parexel
8:45AM - 9:10AM
How Eisai Deployed Bayesian Methods that Resulted in an Accelerated Approval in Alzheimer’s Disease
Speakers:
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
Speakers:
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
Speakers:
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 Events in 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
11:30AM - 11:45AM
AI Powered Deep Evidence Generation – A Digitally-Enabled Clinical Trial Platform
Speakers:
Alison Holland, Executive GM, Customer Value, Medable
11:45AM - 11:55AM
Accelerating Clinical Trial Enrollment: Unleashing the Power of EHR Integration and Intelligent Patient Matching
Speakers:
Colleen Hoke, Co-Founder and Chief Executive Officer, ObjectiveHealth
Josh O'Rourke, Chief Technology Officer, ObjectiveHealth
11:55AM - 12:05PM
Challenging the Status Quo in Protocol Design to Drive Speed and Patient Flexibility
Speakers:
Edward Triebell, Executive Director, Product Development of Digital Health, MRN
12:05PM - 12:15PM
By the Patient, for the Patient: Improved Trial Design through Patient-Centered Real-World Evidence
Speakers:
Brian Loew, CEO, Inspire
12:15PM - 12:25PM
The Impact of Patient Activation on Clinical Trial Enrollment
Speakers:
Amanda Rangel, MS, SVP, Business Development, 83Bar
12:25PM - 12:35PM
From Buzzword to Business Strategy — Finding Sustainability in Clinical Trial Communications
Speakers:
Sarah McKeown-Cannon, VP, Growth, Langland
12:35PM - 12:45PM
The Power of Community Research Sites in Engaging Underserved Populations in Clinical Research
Speakers:
Thad Wolfram, President, EmVenio Research
12:45PM - 12:55PM
Infusing Customer Experience and Compliant Consistency into your Clinical Trial Recruitment Approach
Speakers:
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
11:30AM - 11:45AM
Accelerating Patient Recruitment with Cross-Trial Recruitment Methods
Speakers:
Alex Eastman, VP, Products, OneStudyTeam
11:45AM - 11:55AM
Implementing the Right COAs to Support the Patient Experience in Clinical Trials
Speakers:
Elan Josielewski, Senior Principal and head of Operations of Patient Centered Solutions, IQVIA
Anthony Mikulaschek, VP, eCOA, IQVIA
11:55AM - 12:05PM
Accelerating Research Today with AI
Speakers:
Lisa Moneymaker, Chief Technology Officer/Chief Product Officer, Saama
12:05PM - 12:15PM
How LLMs Will Dramatically Accelerate AI Solution Adoption in Clinical Development
Speakers:
Kushal Gohil, SVP, Corporate Strategy & Innovation, Parexel
12:15PM - 12:25PM
Leveraging Risk Data Libraries to Drive Study Efficiencies
Speakers:
Alan Switzer, MBA, Director, IT Client Delivery, Fortrea
12:25PM - 12:35PM
Priming Your Trial Startup with Real-World Data
Speakers:
Joseph Roettgen, PharmD, AVP, Life Sciences, Komodo Health
12:35PM - 12:45PM
A Scalable Blueprint to Solve the Industry’s Need for a Clinical Data Lakehouse
Speakers:
Raj Indupuri, MBA, CEO, eClinical Solutions
12:45PM - 12:50PM
Empowerment through Engagement: Rethinking Patient Involvement in Clinical Trials
Speakers:
Kyle Hogan, President, Datacubed Health
Track C - EHR/RWE/DCT/Mobile Solutions
Track Chair:
Doug Schantz, SVP, Clinical Operations, Asklepios BioPharmaceutical, Inc.
11:30AM - 11:45AM
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
11:45AM - 11:55AM
Expediting Clinical Research Through Point-of-Care Data Acquisition
Speakers:
Mariel Boyd, Senior Product Manager, Flatiron Health
11:55AM - 12:05PM
Pragmatic Trials, Real-time Registries, and Automated Comparator Arms: New Frontiers in EHR-to-EDC
Speakers:
Ardy Arianpour, CEO & Co-Founder, SEQSTER
Scott Morris, VP and GM, Clinical Trial Solutions, Optum Life Sciences
12:05PM - 12:15PM
Leveraging Data-Driven and Patient-Informed Solutions to Improve Diversity in Your Clinical Trials
Speakers:
Kelly McKee, VP, DCTs and Patient Registries, Medidata
12:15PM - 12:25PM
The Evolutionary Impact of Mobile Devices on eCOA/ePRO
12:25PM - 12:35PM
Transforming Clinical Trials: Expanding Data Collaboration and AI-Driven Innovations
Speakers:
Michael Ibara, PharmD, Chief Data Officer, Elligo
12:35PM - 12:45PM
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?
Speakers:
Jessica Mays, VP, Life Sciences, 20/20 Onsite
12:50PM - 12:55PM
Streamlining Digital Health Data Acquisition
Speakers:
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.
11:30AM - 11:45AM
The Impact of Simulation on a Complex Global Phase 3 Study
Speakers:
David Hadden, Founder and President, Pro-ficiency
11:45AM - 11:55AM
How to Future-Proof Your Technology Ecosystem with Sites in Mind
Speakers:
Stuart Cotter, VP, Product Strategy and Innovation, Advarra
11:55AM - 12:05PM
Unlocking the Full Value Potential of Digital Protocols
Speakers:
Marigrace Ambrosia, Director, PwC
Eddie Valaitis, PhD, Director, PwC
12:05PM - 12:15PM
Revolutionizing Biopharma Research: Driving Efficiencies through Site Enablement Technologies
Speakers:
David Hine, Senior Director, Sales Engineering, Greenphire
12:15PM - 12:25PM
Flexibility That Scales
12:25PM - 12:35PM
AI with Impact: Real-world Approaches to Making AI Work in Clinical Trials
Speakers:
Shae Wilkins, CEO, TRYAL
12:35PM - 12:45PM
Deploying AI Across the Clinical Trial Life Cycle to Deliver Efficient, Safe and Impactful Clinical Research
Speakers:
Paul Mancinelli, Chief Technology Officer, WCG
12:45PM - 12:55PM
Marketplaces: The Key to Unlocking Access in Clinical Trials
Speakers:
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
12:55PM - 2:00PM
Networking Luncheon and Facilitated Roundtables
Showing Events in 6 Tracks from 12:55pm to 02:00pm
Table A
12:55PM - 2:00PM
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
12:55PM - 2:00PM
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
12:55PM - 2:00PM
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
12:55PM - 2:00PM
Harmonization of Digital Endpoints
Roundtable Facilitators:
Bert Hartog, PhD, Senior Director, Janssen Clinical Innovation, Janssen R&D Global Development, Janssen Pharmaceuticals
Table E
12:55PM - 2:00PM
Strategies for Implementing Complex Clinical Trials
Roundtable Facilitator:
Mindy Gruba, MPH, Senior Manager, Patient Centricity, Moderna
Table F
12:55PM - 2:00PM
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 Events in 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
2:05PM - 2:20PM
Amgen's Approach to Using the critical Path to Accelerate Startup
Speakers:
Taras Carpiac, Executive Director, Innovation - Global Development Operations, Amgen
2:20PM - 2:35PM
How AbbVie Scaled 40+ Patient Apps in a Calendar Year and Its impact on Efficiencies and Costs
Speakers:
Sanjay Bhardwaj, Global Head of Clinical Data Strategy & Operations, AbbVie
Kapil Gombar, Director, Clinical Technologies and Innovation, AbbVie
2:35PM - 2:50PM
Implementing a Data Products Approach to Drive Digital Clinical Operations Excellence
Speakers:
Eric Hoberman, RN, MBA, Head, Digital Clinical Operations Excellence, Biogen Digital Health
2:50PM - 3:05PM
Sanofi's Approach to Scaling EHRs as eSource in Clinical Trials
Speakers:
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, -
2:05PM - 2:20PM
How to Increase Value and Impact of Data Science Solutions for Clinical Operations
Speakers:
Taylor Uttley, MBA, Senior Director, Head of Strategy & Operations, Data Strategy & Solutions, Vertex
2:20PM - 2:35PM
The Impacts of Decentralized Trial Methods in a Hybrid, Phase 1 Drug Trial
Speakers:
Jane Myles, Chairperson, Strategic Advisory Board and Program Director, Curebase and DTRA
Rajesh Patel, Associate Director, Technology & Innovation, Global Development Operations, Gilead Sciences, Inc.
2:35PM - 2:50PM
GPT: The Catalyst for Disruptive Innovation in Clinical Development
Speakers:
Prasanna Rao, Senior Director, Global Head of AI/ML, Clinical Data Sciences, GPD, Pfizer
2:50PM - 3:05PM
Genmab’s Journey to Drive Rapid Adoption of AI in Clinical Operations
Speakers:
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, -
2:05PM - 2:20PM
How Gilead’s Preferred Sites Network Drives Patient Access
Speakers:
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.
2:20PM - 2:35PM
How Lilly Sources Validated Alternatives to Gold Standard Measures to Alleviate Patient & Site Burden
Speakers:
Meri Kay Scott, PhD, AVP, Digital Health R&D, Eli Lilly and Company
2:35PM - 2:50PM
Innovate for Impact: Harnessing the Value of Clinical Trials Innovations
Speakers:
Kimberly Barnholt, PhD, MS, Sr Director, Evidence Generation Leader, Genentech
2:50PM - 3:05PM
Biogen’s Approach to Address Sites Resource Constraints
Speakers:
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
2:05PM - 2:20PM
Prioritizing a “Patient First” Approach: Automating the RBQM Revolution
Speakers:
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
2:20PM - 2:35PM
Developing “Direct to Patient” Cohorts to Drive More Inclusive Enrollment Strategies
Speakers:
Jake Harrell, Head of R&D Data and Data Convergence, AbbVie
Moderated with:
Jane Perlmutter, PhD, MBA, Founder and President, Gemini Group
2:35PM - 2:50PM
Bayer’s Approach to Drive Operational Implementation of DCTs
Speakers:
Sylvie Kruyner, Director, DCT Operations, Bayer
2:50PM - 3:05PM
Sanofi’s Implementation of a Data Driven Indication Level Strategy to Optimize Portfolio Success
Speakers:
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
Speakers:
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
Speakers:
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
Speakers:
Jennifer Bittinger, President, Narrativa
Scott Chetham, PhD, CEO and Co-Founder, Faro Health
Chris Economos, VP, Life Science, Eko Health
Gen Li, PhD, MBA, President and Founder, Phesi, Inc.
Matt Michelson, PhD, Co-Founder and CEO, Readout AI
Maria Perkinson, SVP, Process & Technology Optimization, Nurocor
DPharm Idol Disrupt Judges 2023::
Jennifer Levin Carter, MD, MPH, MBA, Venture Partner, Sandbox Industry
Esther Dyson, Founder, Wellville
Cindy Geoghegan, Patient Advocate, -
Yusuf Ghadiali, Executive Director, Global Clinical Operations & Planning, Daiichi Sankyo
Bert Hartog, PhD, Senior Director, Janssen Clinical Innovation, Janssen R&D Global Development, Janssen Pharmaceuticals
Andrea Jackson, MBA, Partner, Northpond Ventures
Hassan Kadim, Director, Head of Clinical Trial Business Capabilities, Global Development Operations, BMS
Sarah Krüg, Executive Director / CEO, Cancer101 / Health Collaboratory
Nuwan Kurukulasuriya, MS, PhD, Global Vice President and Therapeutic Area Head, Medical Affairs, Alexion, AstraZeneca Rare Disease
Matt W. Maddox, AVP, Eli Lilly and Company
Siân Ratcliffe, PhD, SVP, Head of Global Clinical Operations, Analytics, Technology & Data Sciences, Biogen
Doug Schantz, SVP, Clinical Operations, Asklepios BioPharmaceutical, Inc.
Mark Travers, PhD, MBA, VP, Head of GCTO, Regions and Regional Operations, Merck
Donna Usiskin, Chief Strategy Officer, New Enterprise Ventures
Taylor Uttley, MBA, Senior Director, Head of Strategy & Operations, Data Strategy & Solutions, Vertex
Presenting Companies:
Showing Events in 1 Track from 06:00pm to 07:00pm
Backyard BBQ and Cocktail Reception, Graciously hosted by MRN
6:00PM - 7:00PM
Backyard BBQ and Cocktail Reception
Graciously Hosted By:
Showing Events in 1 Track from 08:00am to 10:05am
Day 2 Morning General Session
8:00AM - 8:30AM
Registration and Tea/Coffee
Graciously hosted by:
8:30AM - 8:45AM
Opening Remarks
Speakers:
Jamie Macdonald, CEO, Parexel
8:45AM - 9:10AM
How Eisai Deployed Bayesian Methods that Resulted in an Accelerated Approval in Alzheimer’s Disease
Speakers:
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
Speakers:
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
Speakers:
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 Events in 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
11:30AM - 11:45AM
AI Powered Deep Evidence Generation – A Digitally-Enabled Clinical Trial Platform
Speakers:
Alison Holland, Executive GM, Customer Value, Medable
11:45AM - 11:55AM
Accelerating Clinical Trial Enrollment: Unleashing the Power of EHR Integration and Intelligent Patient Matching
Speakers:
Colleen Hoke, Co-Founder and Chief Executive Officer, ObjectiveHealth
Josh O'Rourke, Chief Technology Officer, ObjectiveHealth
11:55AM - 12:05PM
Challenging the Status Quo in Protocol Design to Drive Speed and Patient Flexibility
Speakers:
Edward Triebell, Executive Director, Product Development of Digital Health, MRN
12:05PM - 12:15PM
By the Patient, for the Patient: Improved Trial Design through Patient-Centered Real-World Evidence
Speakers:
Brian Loew, CEO, Inspire
12:15PM - 12:25PM
The Impact of Patient Activation on Clinical Trial Enrollment
Speakers:
Amanda Rangel, MS, SVP, Business Development, 83Bar
12:25PM - 12:35PM
From Buzzword to Business Strategy — Finding Sustainability in Clinical Trial Communications
Speakers:
Sarah McKeown-Cannon, VP, Growth, Langland
12:35PM - 12:45PM
The Power of Community Research Sites in Engaging Underserved Populations in Clinical Research
Speakers:
Thad Wolfram, President, EmVenio Research
12:45PM - 12:55PM
Infusing Customer Experience and Compliant Consistency into your Clinical Trial Recruitment Approach
Speakers:
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
11:30AM - 11:45AM
Accelerating Patient Recruitment with Cross-Trial Recruitment Methods
Speakers:
Alex Eastman, VP, Products, OneStudyTeam
11:45AM - 11:55AM
Implementing the Right COAs to Support the Patient Experience in Clinical Trials
Speakers:
Elan Josielewski, Senior Principal and head of Operations of Patient Centered Solutions, IQVIA
Anthony Mikulaschek, VP, eCOA, IQVIA
11:55AM - 12:05PM
Accelerating Research Today with AI
Speakers:
Lisa Moneymaker, Chief Technology Officer/Chief Product Officer, Saama
12:05PM - 12:15PM
How LLMs Will Dramatically Accelerate AI Solution Adoption in Clinical Development
Speakers:
Kushal Gohil, SVP, Corporate Strategy & Innovation, Parexel
12:15PM - 12:25PM
Leveraging Risk Data Libraries to Drive Study Efficiencies
Speakers:
Alan Switzer, MBA, Director, IT Client Delivery, Fortrea
12:25PM - 12:35PM
Priming Your Trial Startup with Real-World Data
Speakers:
Joseph Roettgen, PharmD, AVP, Life Sciences, Komodo Health
12:35PM - 12:45PM
A Scalable Blueprint to Solve the Industry’s Need for a Clinical Data Lakehouse
Speakers:
Raj Indupuri, MBA, CEO, eClinical Solutions
12:45PM - 12:50PM
Empowerment through Engagement: Rethinking Patient Involvement in Clinical Trials
Speakers:
Kyle Hogan, President, Datacubed Health
Track C - EHR/RWE/DCT/Mobile Solutions
Track Chair:
Doug Schantz, SVP, Clinical Operations, Asklepios BioPharmaceutical, Inc.
11:30AM - 11:45AM
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
11:45AM - 11:55AM
Expediting Clinical Research Through Point-of-Care Data Acquisition
Speakers:
Mariel Boyd, Senior Product Manager, Flatiron Health
11:55AM - 12:05PM
Pragmatic Trials, Real-time Registries, and Automated Comparator Arms: New Frontiers in EHR-to-EDC
Speakers:
Ardy Arianpour, CEO & Co-Founder, SEQSTER
Scott Morris, VP and GM, Clinical Trial Solutions, Optum Life Sciences
12:05PM - 12:15PM
Leveraging Data-Driven and Patient-Informed Solutions to Improve Diversity in Your Clinical Trials
Speakers:
Kelly McKee, VP, DCTs and Patient Registries, Medidata
12:15PM - 12:25PM
The Evolutionary Impact of Mobile Devices on eCOA/ePRO
12:25PM - 12:35PM
Transforming Clinical Trials: Expanding Data Collaboration and AI-Driven Innovations
Speakers:
Michael Ibara, PharmD, Chief Data Officer, Elligo
12:35PM - 12:45PM
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?
Speakers:
Jessica Mays, VP, Life Sciences, 20/20 Onsite
12:50PM - 12:55PM
Streamlining Digital Health Data Acquisition
Speakers:
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.
11:30AM - 11:45AM
The Impact of Simulation on a Complex Global Phase 3 Study
Speakers:
David Hadden, Founder and President, Pro-ficiency
11:45AM - 11:55AM
How to Future-Proof Your Technology Ecosystem with Sites in Mind
Speakers:
Stuart Cotter, VP, Product Strategy and Innovation, Advarra
11:55AM - 12:05PM
Unlocking the Full Value Potential of Digital Protocols
Speakers:
Marigrace Ambrosia, Director, PwC
Eddie Valaitis, PhD, Director, PwC
12:05PM - 12:15PM
Revolutionizing Biopharma Research: Driving Efficiencies through Site Enablement Technologies
Speakers:
David Hine, Senior Director, Sales Engineering, Greenphire
12:15PM - 12:25PM
Flexibility That Scales
12:25PM - 12:35PM
AI with Impact: Real-world Approaches to Making AI Work in Clinical Trials
Speakers:
Shae Wilkins, CEO, TRYAL
12:35PM - 12:45PM
Deploying AI Across the Clinical Trial Life Cycle to Deliver Efficient, Safe and Impactful Clinical Research
Speakers:
Paul Mancinelli, Chief Technology Officer, WCG
12:45PM - 12:55PM
Marketplaces: The Key to Unlocking Access in Clinical Trials
Speakers:
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
12:55PM - 2:00PM
Networking Luncheon and Facilitated Roundtables
Showing Events in 6 Tracks from 12:55pm to 02:00pm
Table A
12:55PM - 2:00PM
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
12:55PM - 2:00PM
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
12:55PM - 2:00PM
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
12:55PM - 2:00PM
Harmonization of Digital Endpoints
Roundtable Facilitators:
Bert Hartog, PhD, Senior Director, Janssen Clinical Innovation, Janssen R&D Global Development, Janssen Pharmaceuticals
Table E
12:55PM - 2:00PM
Strategies for Implementing Complex Clinical Trials
Roundtable Facilitator:
Mindy Gruba, MPH, Senior Manager, Patient Centricity, Moderna
Table F
12:55PM - 2:00PM
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 Events in 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
2:05PM - 2:20PM
Amgen's Approach to Using the critical Path to Accelerate Startup
Speakers:
Taras Carpiac, Executive Director, Innovation - Global Development Operations, Amgen
2:20PM - 2:35PM
How AbbVie Scaled 40+ Patient Apps in a Calendar Year and Its impact on Efficiencies and Costs
Speakers:
Sanjay Bhardwaj, Global Head of Clinical Data Strategy & Operations, AbbVie
Kapil Gombar, Director, Clinical Technologies and Innovation, AbbVie
2:35PM - 2:50PM
Implementing a Data Products Approach to Drive Digital Clinical Operations Excellence
Speakers:
Eric Hoberman, RN, MBA, Head, Digital Clinical Operations Excellence, Biogen Digital Health
2:50PM - 3:05PM
Sanofi's Approach to Scaling EHRs as eSource in Clinical Trials
Speakers:
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, -
2:05PM - 2:20PM
How to Increase Value and Impact of Data Science Solutions for Clinical Operations
Speakers:
Taylor Uttley, MBA, Senior Director, Head of Strategy & Operations, Data Strategy & Solutions, Vertex
2:20PM - 2:35PM
The Impacts of Decentralized Trial Methods in a Hybrid, Phase 1 Drug Trial
Speakers:
Jane Myles, Chairperson, Strategic Advisory Board and Program Director, Curebase and DTRA
Rajesh Patel, Associate Director, Technology & Innovation, Global Development Operations, Gilead Sciences, Inc.
2:35PM - 2:50PM
GPT: The Catalyst for Disruptive Innovation in Clinical Development
Speakers:
Prasanna Rao, Senior Director, Global Head of AI/ML, Clinical Data Sciences, GPD, Pfizer
2:50PM - 3:05PM
Genmab’s Journey to Drive Rapid Adoption of AI in Clinical Operations
Speakers:
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, -
2:05PM - 2:20PM
How Gilead’s Preferred Sites Network Drives Patient Access
Speakers:
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.
2:20PM - 2:35PM
How Lilly Sources Validated Alternatives to Gold Standard Measures to Alleviate Patient & Site Burden
Speakers:
Meri Kay Scott, PhD, AVP, Digital Health R&D, Eli Lilly and Company
2:35PM - 2:50PM
Innovate for Impact: Harnessing the Value of Clinical Trials Innovations
Speakers:
Kimberly Barnholt, PhD, MS, Sr Director, Evidence Generation Leader, Genentech
2:50PM - 3:05PM
Biogen’s Approach to Address Sites Resource Constraints
Speakers:
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
2:05PM - 2:20PM
Prioritizing a “Patient First” Approach: Automating the RBQM Revolution
Speakers:
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
2:20PM - 2:35PM
Developing “Direct to Patient” Cohorts to Drive More Inclusive Enrollment Strategies
Speakers:
Jake Harrell, Head of R&D Data and Data Convergence, AbbVie
Moderated with:
Jane Perlmutter, PhD, MBA, Founder and President, Gemini Group
2:35PM - 2:50PM
Bayer’s Approach to Drive Operational Implementation of DCTs
Speakers:
Sylvie Kruyner, Director, DCT Operations, Bayer
2:50PM - 3:05PM
Sanofi’s Implementation of a Data Driven Indication Level Strategy to Optimize Portfolio Success
Speakers:
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
Speakers:
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
Speakers:
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
Speakers:
Jennifer Bittinger, President, Narrativa
Scott Chetham, PhD, CEO and Co-Founder, Faro Health
Chris Economos, VP, Life Science, Eko Health
Gen Li, PhD, MBA, President and Founder, Phesi, Inc.
Matt Michelson, PhD, Co-Founder and CEO, Readout AI
Maria Perkinson, SVP, Process & Technology Optimization, Nurocor
DPharm Idol Disrupt Judges 2023::
Jennifer Levin Carter, MD, MPH, MBA, Venture Partner, Sandbox Industry
Esther Dyson, Founder, Wellville
Cindy Geoghegan, Patient Advocate, -
Yusuf Ghadiali, Executive Director, Global Clinical Operations & Planning, Daiichi Sankyo
Bert Hartog, PhD, Senior Director, Janssen Clinical Innovation, Janssen R&D Global Development, Janssen Pharmaceuticals
Andrea Jackson, MBA, Partner, Northpond Ventures
Hassan Kadim, Director, Head of Clinical Trial Business Capabilities, Global Development Operations, BMS
Sarah Krüg, Executive Director / CEO, Cancer101 / Health Collaboratory
Nuwan Kurukulasuriya, MS, PhD, Global Vice President and Therapeutic Area Head, Medical Affairs, Alexion, AstraZeneca Rare Disease
Matt W. Maddox, AVP, Eli Lilly and Company
Siân Ratcliffe, PhD, SVP, Head of Global Clinical Operations, Analytics, Technology & Data Sciences, Biogen
Doug Schantz, SVP, Clinical Operations, Asklepios BioPharmaceutical, Inc.
Mark Travers, PhD, MBA, VP, Head of GCTO, Regions and Regional Operations, Merck
Donna Usiskin, Chief Strategy Officer, New Enterprise Ventures
Taylor Uttley, MBA, Senior Director, Head of Strategy & Operations, Data Strategy & Solutions, Vertex
Presenting Companies:
Showing Events in 1 Track from 06:00pm to 07:00pm
Backyard BBQ and Cocktail Reception, Graciously hosted by MRN
6:00PM - 7:00PM
Backyard BBQ and Cocktail Reception
Graciously Hosted By:

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