DPHARM: Disruptive Innovations

Karen Peterson, Founder and Chief Patient Advocate, Karen's Club

8:40AM - 8:45AM

DPHARM Idol Winner Announced

Cindy Geoghegan, Patient, Advocate

Mark Travers, PhD, MBA, VP, Head of GCTO, Regions and Regional Operations, Merck

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

8:45AM - 9:10AM

Clinical Operations Leadership Insights - Shifting from Necessity to a New Momentum

Siân Ratcliffe, PhD, SVP, Head of Global Clinical Operations, Analytics, Technology & Data Sciences, Biogen

Showing Events in 3 Tracks from 09:10am to 09:45am

Breakout Session A

Track Chair:

John Wilbanks, Former, Head of Data, Biogen Digital Health

Addressing the Clinical Operations Workforce Gap

Shoibal Datta, PhD, Head of Digital Health Sciences, Data Sciences Institute, Takeda

Kimberly Hawkins, Global Head of Clinical Project Operations and Dossier Delivery, Sanofi

Belen Fraile, MD, MSc, VP and Head of Clinical Development Data and Digital, Moderna

Breakout Session B

Track Chair:

Rinol Alaj, Senior Director, Head of Clinical Outcomes Assessment & Patient Innovation, Regeneron

Working Together to Accelerate the Adoption of Digital Biomarkers in Clinical Trials

Michelle Crouthamel, Managing Director, Digital Health Strategy & Implementation, AbbVie

Xuemei Cai, MD, Head of Clinical Research, Digital Sciences & Translational Imaging, Pfizer, Inc

Rinol Alaj, Senior Director, Head of Clinical Outcomes Assessment & Patient Innovation, Regeneron

Matteo Lai, Co-Founder and CEO, Empatica

Breakout Session C

Track Chair:

Cindy Geoghegan, Patient, Advocate

Emily Epstein, LMSW, Clinical Behavioral Health Specialist, Genetics and Personalized Cancer Prevention Program, Weill Cornell Medicine

Patient Disruptors

Patient Disruptors:

Karen Peterson, Founder and Chief Patient Advocate, Karen's Club

Showing Events in 1 Track from 09:45am to 10:20am

Keynote

9:45AM - 10:20AM

KEYNOTE - Leadership Lessons on Driving Operational Efficiencies

General Gustave Perna, Ret. United States Four-Star General, Co-Leader, Operation Warp Speed and Supply Chain Expert, -

Moderated with:

Melanie Ivarsson, OBE, PhD, MBA, Chief Development Officer, Moderna

Showing Events in 1 Track from 10:20am to 11:00am

Keynote

10:20AM - 11:00AM

DPHARM Networking and Breakfast Cafe

Showing Events in 3 Tracks from 11:00am to 11:35am

Breakout Session A

Unconscious Bias Keynote - Navigating the Evolution of Unconscious Bias and Its Impact on Driving Organizational Innovation

Lisa Coleman, PhD, SVP, Global Inclusion and Strategic Innovation and Chief Diversity Officer, New York University

Breakout Session B

Measuring the Value of DCTs and Hybrid Models

Brandon Maggio, Director, Digital & Process Optimization, GSK

Kenneth Getz, MBA, Executive Director and Professor, Tufts Center for the Study of Drug Development

Hassan Kadhim, Business Engagement Lead for Clinical Operations and Development, Vertex Pharmaceuticals

Shayna Lambert, Head, Strategy & Business Transformation, Global Clinical Operations, Johnson & Johnson Innovative Medicine

Anna Yang, PharmD, Clinical Innovation and Technology Leader, Genentech

Breakout Session C

Sustainability in Clinical Research: Ensuring the Benefits of Our Therapies Are Not Offset by the Impacts of Our Operations

Jason Lanier, MS, PMP, Director, Janssen Clinical Innovation, Janssen Research & Development

Showing Events in 1 Track from 11:35am to 12:35am

Today Show at DPHARM

11:35AM - 12:35AM

Today Show at DPHARM

Hosted by:

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

Presenting:

Stuart Cotter, VP, Product Strategy and Innovation, Advarra

Darcy Forman, Chief Delivery Officer, Science 37

Jaydev Thakkar, MBA, Chief Operating Officer, Biofourmis

Lucas Glass, VP, Analytics Center of Excellence, IQVIA

Rosa Coppolecchia, DO, MPH, FACP, FACPM, Global Clinical Lead, Thrombosis and Vascular Diseases, Bayer US, LLC

2023 Presenting Companies:

Showing Events in 1 Track from 12:35pm to 01:35pm

Networking Luncheon and Facilitated Roundtables

12:35PM - 1:35PM

Networking Luncheon and Facilitated Roundtables

Showing Events in 6 Tracks from 12:35pm to 02:00pm

Roundtable A

Continuous Learning from Patients Participating in our Trials

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

Jason Lanier, MS, PMP, Director, Janssen Clinical Innovation, Janssen Research & Development

Roundtable B.

Strategies for Implementing Complex Clinical Trials

Jordan Brayanov, PhD, Senior Director, Digital Strategy, Takeda

Roundtable C

Managing the Unparalleled Amount of Data and Emerging Technologies with the Decentralization of Clinical Research

Roundtable Facilitators::

Matt W. Maddox, AVP, Eli Lilly and Company

John Wilbanks, Former, Head of Data, Biogen Digital Health

Roundtable D.

DCT Launch: Designing Optimal Preparation Plan for Sites, Study Teams and Patients

Christie Fry, Director, Strategic Technology Innovation, AbbVie

Roundtable E.

Rethinking Clinical Trials Technology Strategy: Pros & Cons of Buy vs Build

Bill Illis, Head, Technology and Collaboration, Novartis

Roundtable F

Digital Protocols: The Vision from Clinical Development Plan to Study Report

Steve Walker, Senior Director, Operational Excellence and Clinical Compliance, CSL

Showing Events in 3 Tracks from 01:35pm to 04:30pm

Track A: Innovative Approaches to Reduce Patient & Sites Burden

Track Chair:

Mark Travers, PhD, MBA, VP, Head of GCTO, Regions and Regional Operations, Merck

Sites Views: Delineating Critical Challenges and How/Where Trial Sponsors Can Assist:

Mark Travers, PhD, MBA, VP, Head of GCTO, Regions and Regional Operations, Merck

Cheryl Kechichian, RN, Research Coordinator, Butler Hospital

Cameron Sze, RN, Clinical Trials Nurse, Dana Farber Cancer Institute

Mark Scullion, CEO, Atlas Clinical Research

New Tools for Clinical Development: Hype vs What’s Really Working Today?

Melissa Easy, VP and GM, Clinical Technologies, IQVIA

How Digital Health Can Revolutionize Community Health

Ash Rishi, Founder & Chair of the Board of Trustees, Demand Diversity, a part of COUCH Health

Developing the CRA Model of the Future

Patrick Floody, MBA, Executive Director, Global Clinical Trials Services, Regeneron Pharmaceuticals Inc

Alison Holland, Executive GM, Customer Value, Medable

Maureen Silverman, Director, Global Monitoring Strategy & Oversight, Regeneron

Jennifer Sozio, SVP, Clinical Operations, FSP 360, Syneos Health

Merck’s Approach to Building Collaborative Sites/Sponsor Partnerships

Jane Hiatt, Executive Director, U.S. Site Management and Monitoring, Early Stage Development, Merck

Sean Jensen, MBA, Director, Site Relationship Management, Merck

Adam Kinsey, Associate VP, Clinical Operations, Regional Head North America, Merck

Track B: Leveraging AI/ML & Digital Tech to Drive Excellence in the Patient Clinical Trials Experience

Track Chair:

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

Delivering Exceptional Clinical Trial Experiences for Patients

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

Karen Peterson, Founder and Chief Patient Advocate, Karen's Club

Jenn Curry, Head of Patient Engagement Capabilities, Biogen

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

Sarah Small, Associate Director, Patient Centricity, Moderna

Improving Randomization Rates with Machine Learning and AI

Ivor Clarke, Chief Innovation Officer, SubjectWell

Transforming Clinical Trial Biospecimen Processing by Digitizing Lab Manuals

Hope Meely, Chief Clinical Officer, Slope

Effective Approaches to Drive Hybrid and DCT Model Deployment

Anthony K. Taylor, DHSc, MSPharm, Director, Clinical Study Patient Platform and Decentralized Clinical Trials, AbbVie

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

Krista Russell, MSHI, Head, Digital Health Solutions, Takeda

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

Enabling Precision Medicine Development with Digital Intelligenc

Shameer Khader, PhD, MPH, Executive Director, Sanofi

Track C: End-to-End Digital Transformation in Early Research Workshop

Track Chair:

Adama Ibrahim, MBA, VP, Digital Strategy and Change Management, Novo Nordisk

Isaac R Rodriguez-Chavez, PhD, MHS, MS, Principal Independent Consultant & Co-chair, 4Biosolutions Consulting/IEEE-SA-DCT/DHT Program

1:35PM - 1:45PM

Welcome and Introduction

Adama Ibrahim, MBA, VP, Digital Strategy and Change Management, Novo Nordisk

Isaac R Rodriguez-Chavez, PhD, MHS, MS, Principal Independent Consultant & Co-chair, 4Biosolutions Consulting/IEEE-SA-DCT/DHT Program

1:45PM - 2:15PM

Overview of the Changing Digital Landscape Supporting Clinical Trial Planning and Execution

Kenneth Getz, MBA, Executive Director & Professor, Tufts Center for the Study of Drug Development

2:15PM - 3:00PM

Workshop Theme 1: Desired outcomes for digitalization across the lifecycle of the medical product development value chain that we should aspire to

Shameer Khader, PhD, MPH, Executive Director, Sanofi

Nuwan Kurukulasuriya, MS, PhD, Global Vice President and Therapeutic Area Head, Medical Affairs, Alexion, AstraZeneca Rare Disease

3:00PM - 3:45PM

Workshop Theme 2: Pathways that enable or hinder digital transformation

Angela Radcliffe, Former R&ED IT Digital Performance Improvement & Innovation Lead, Bristol Myers Squibb

Michael S. Sherman, MD, MBA, MS, EVP, CMO, Point32Health

3:45PM - 4:30PM

Workshop Theme 3: How to measure success with metrics and industry benchmarks

Disa Lee Choun, Head of Integrated Clinical and Operational Analytics, The Janssen Pharmaceutical Companies of Johnson & Johnson

Patrick Schorderet, PhD, MBA, Head of Strategy, Data Science and Innovation, Novo Nordisk

Showing Events in 1 Track from 08:00am to 09:10am

Day 3 Morning General Session

8:00AM - 8:30AM

Morning Coffee/Tea

8:30AM - 8:40AM

Day Three Morning Welcome

Karen Peterson, Founder and Chief Patient Advocate, Karen's Club

8:40AM - 8:45AM

DPHARM Idol Winner Announced

Cindy Geoghegan, Patient, Advocate

Mark Travers, PhD, MBA, VP, Head of GCTO, Regions and Regional Operations, Merck

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

8:45AM - 9:10AM

Clinical Operations Leadership Insights - Shifting from Necessity to a New Momentum

Siân Ratcliffe, PhD, SVP, Head of Global Clinical Operations, Analytics, Technology & Data Sciences, Biogen

Showing Events in 3 Tracks from 09:10am to 09:45am

Breakout Session A

Track Chair:

John Wilbanks, Former, Head of Data, Biogen Digital Health

Addressing the Clinical Operations Workforce Gap

Shoibal Datta, PhD, Head of Digital Health Sciences, Data Sciences Institute, Takeda

Kimberly Hawkins, Global Head of Clinical Project Operations and Dossier Delivery, Sanofi

Belen Fraile, MD, MSc, VP and Head of Clinical Development Data and Digital, Moderna

Breakout Session B

Track Chair:

Rinol Alaj, Senior Director, Head of Clinical Outcomes Assessment & Patient Innovation, Regeneron

Working Together to Accelerate the Adoption of Digital Biomarkers in Clinical Trials

Michelle Crouthamel, Managing Director, Digital Health Strategy & Implementation, AbbVie

Xuemei Cai, MD, Head of Clinical Research, Digital Sciences & Translational Imaging, Pfizer, Inc

Rinol Alaj, Senior Director, Head of Clinical Outcomes Assessment & Patient Innovation, Regeneron

Matteo Lai, Co-Founder and CEO, Empatica

Breakout Session C

Track Chair:

Cindy Geoghegan, Patient, Advocate

Emily Epstein, LMSW, Clinical Behavioral Health Specialist, Genetics and Personalized Cancer Prevention Program, Weill Cornell Medicine

Patient Disruptors

Patient Disruptors:

Karen Peterson, Founder and Chief Patient Advocate, Karen's Club

Showing Events in 1 Track from 09:45am to 10:20am

Keynote

9:45AM - 10:20AM

KEYNOTE - Leadership Lessons on Driving Operational Efficiencies

General Gustave Perna, Ret. United States Four-Star General, Co-Leader, Operation Warp Speed and Supply Chain Expert, -

Moderated with:

Melanie Ivarsson, OBE, PhD, MBA, Chief Development Officer, Moderna

Showing Events in 1 Track from 10:20am to 11:00am

Keynote

10:20AM - 11:00AM

DPHARM Networking and Breakfast Cafe

Showing Events in 3 Tracks from 11:00am to 11:35am

Breakout Session A

Unconscious Bias Keynote - Navigating the Evolution of Unconscious Bias and Its Impact on Driving Organizational Innovation

Lisa Coleman, PhD, SVP, Global Inclusion and Strategic Innovation and Chief Diversity Officer, New York University

Breakout Session B

Measuring the Value of DCTs and Hybrid Models

Brandon Maggio, Director, Digital & Process Optimization, GSK

Kenneth Getz, MBA, Executive Director and Professor, Tufts Center for the Study of Drug Development

Hassan Kadhim, Business Engagement Lead for Clinical Operations and Development, Vertex Pharmaceuticals

Shayna Lambert, Head, Strategy & Business Transformation, Global Clinical Operations, Johnson & Johnson Innovative Medicine

Anna Yang, PharmD, Clinical Innovation and Technology Leader, Genentech

Breakout Session C

Sustainability in Clinical Research: Ensuring the Benefits of Our Therapies Are Not Offset by the Impacts of Our Operations

Jason Lanier, MS, PMP, Director, Janssen Clinical Innovation, Janssen Research & Development

Showing Events in 1 Track from 11:35am to 12:35am

Today Show at DPHARM

11:35AM - 12:35AM

Today Show at DPHARM

Hosted by:

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

Presenting:

Stuart Cotter, VP, Product Strategy and Innovation, Advarra

Darcy Forman, Chief Delivery Officer, Science 37

Jaydev Thakkar, MBA, Chief Operating Officer, Biofourmis

Lucas Glass, VP, Analytics Center of Excellence, IQVIA

Rosa Coppolecchia, DO, MPH, FACP, FACPM, Global Clinical Lead, Thrombosis and Vascular Diseases, Bayer US, LLC

2023 Presenting Companies:

Showing Events in 1 Track from 12:35pm to 01:35pm

Networking Luncheon and Facilitated Roundtables

12:35PM - 1:35PM

Networking Luncheon and Facilitated Roundtables

Showing Events in 6 Tracks from 12:35pm to 02:00pm

Roundtable A

Continuous Learning from Patients Participating in our Trials

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

Jason Lanier, MS, PMP, Director, Janssen Clinical Innovation, Janssen Research & Development

Roundtable B.

Strategies for Implementing Complex Clinical Trials

Jordan Brayanov, PhD, Senior Director, Digital Strategy, Takeda

Roundtable C

Managing the Unparalleled Amount of Data and Emerging Technologies with the Decentralization of Clinical Research

Roundtable Facilitators::

Matt W. Maddox, AVP, Eli Lilly and Company

John Wilbanks, Former, Head of Data, Biogen Digital Health

Roundtable D.

DCT Launch: Designing Optimal Preparation Plan for Sites, Study Teams and Patients

Christie Fry, Director, Strategic Technology Innovation, AbbVie

Roundtable E.

Rethinking Clinical Trials Technology Strategy: Pros & Cons of Buy vs Build

Bill Illis, Head, Technology and Collaboration, Novartis

Roundtable F

Digital Protocols: The Vision from Clinical Development Plan to Study Report

Steve Walker, Senior Director, Operational Excellence and Clinical Compliance, CSL

Showing Events in 3 Tracks from 01:35pm to 04:30pm

Track A: Innovative Approaches to Reduce Patient & Sites Burden

Track Chair:

Mark Travers, PhD, MBA, VP, Head of GCTO, Regions and Regional Operations, Merck

Sites Views: Delineating Critical Challenges and How/Where Trial Sponsors Can Assist:

Mark Travers, PhD, MBA, VP, Head of GCTO, Regions and Regional Operations, Merck

Cheryl Kechichian, RN, Research Coordinator, Butler Hospital

Cameron Sze, RN, Clinical Trials Nurse, Dana Farber Cancer Institute

Mark Scullion, CEO, Atlas Clinical Research

New Tools for Clinical Development: Hype vs What’s Really Working Today?

Melissa Easy, VP and GM, Clinical Technologies, IQVIA

How Digital Health Can Revolutionize Community Health

Ash Rishi, Founder & Chair of the Board of Trustees, Demand Diversity, a part of COUCH Health

Developing the CRA Model of the Future

Patrick Floody, MBA, Executive Director, Global Clinical Trials Services, Regeneron Pharmaceuticals Inc

Alison Holland, Executive GM, Customer Value, Medable

Maureen Silverman, Director, Global Monitoring Strategy & Oversight, Regeneron

Jennifer Sozio, SVP, Clinical Operations, FSP 360, Syneos Health

Merck’s Approach to Building Collaborative Sites/Sponsor Partnerships

Jane Hiatt, Executive Director, U.S. Site Management and Monitoring, Early Stage Development, Merck

Sean Jensen, MBA, Director, Site Relationship Management, Merck

Adam Kinsey, Associate VP, Clinical Operations, Regional Head North America, Merck

Track B: Leveraging AI/ML & Digital Tech to Drive Excellence in the Patient Clinical Trials Experience

Track Chair:

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

Delivering Exceptional Clinical Trial Experiences for Patients

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

Karen Peterson, Founder and Chief Patient Advocate, Karen's Club

Jenn Curry, Head of Patient Engagement Capabilities, Biogen

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

Sarah Small, Associate Director, Patient Centricity, Moderna

Improving Randomization Rates with Machine Learning and AI

Ivor Clarke, Chief Innovation Officer, SubjectWell

Transforming Clinical Trial Biospecimen Processing by Digitizing Lab Manuals

Hope Meely, Chief Clinical Officer, Slope

Effective Approaches to Drive Hybrid and DCT Model Deployment

Anthony K. Taylor, DHSc, MSPharm, Director, Clinical Study Patient Platform and Decentralized Clinical Trials, AbbVie

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

Krista Russell, MSHI, Head, Digital Health Solutions, Takeda

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

Enabling Precision Medicine Development with Digital Intelligenc

Shameer Khader, PhD, MPH, Executive Director, Sanofi

Track C: End-to-End Digital Transformation in Early Research Workshop

Track Chair:

Adama Ibrahim, MBA, VP, Digital Strategy and Change Management, Novo Nordisk

Isaac R Rodriguez-Chavez, PhD, MHS, MS, Principal Independent Consultant & Co-chair, 4Biosolutions Consulting/IEEE-SA-DCT/DHT Program

1:35PM - 1:45PM

Welcome and Introduction

Adama Ibrahim, MBA, VP, Digital Strategy and Change Management, Novo Nordisk

Isaac R Rodriguez-Chavez, PhD, MHS, MS, Principal Independent Consultant & Co-chair, 4Biosolutions Consulting/IEEE-SA-DCT/DHT Program

1:45PM - 2:15PM

Overview of the Changing Digital Landscape Supporting Clinical Trial Planning and Execution

Kenneth Getz, MBA, Executive Director & Professor, Tufts Center for the Study of Drug Development

2:15PM - 3:00PM

Workshop Theme 1: Desired outcomes for digitalization across the lifecycle of the medical product development value chain that we should aspire to

Shameer Khader, PhD, MPH, Executive Director, Sanofi

Nuwan Kurukulasuriya, MS, PhD, Global Vice President and Therapeutic Area Head, Medical Affairs, Alexion, AstraZeneca Rare Disease

3:00PM - 3:45PM

Workshop Theme 2: Pathways that enable or hinder digital transformation

Angela Radcliffe, Former R&ED IT Digital Performance Improvement & Innovation Lead, Bristol Myers Squibb

Michael S. Sherman, MD, MBA, MS, EVP, CMO, Point32Health

3:45PM - 4:30PM

Workshop Theme 3: How to measure success with metrics and industry benchmarks