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DAY ONE Thursday, August 8, 2019

7:00

Registration and Continental Breakfast

8:00

Chairman’s Welcome and Opening Remarks

Darren Cowan
Area Head, Americas Global Site & Study Operations,
Clinical Development & Operations, GP
Pfizer Inc

Adoption of a
Direct-to-Patient Trial Model

8:15

Evolution of Siteless Trials — Lessons Learned from REMOTE to TOPAZ

Steve Cummings
Director, SF Coordinating Center Professor of Medicine & Epidemiology
UC San Francisco

8:55

PANEL Virtual or Hybrid Model — Discuss the Feasibility of Adopting a DtP Model

MODERATOR:

Elena Izmailova, PhD
DiMe Co-founder & Co-chair, DiMe Research Committee;
CSO, Koneksa Health

PANELISTS:

Jeff Kingsley
CEO and Founder
IACT Health

Antonieta Sosa
Director, Clinical Innovation
Janssen Research and Development

Ching Tian
GM Digital Accelerator
Novartis

Paul Saratsiotis
Managing Director
Cryologex

9:45

Networking and Refreshment Break

Develop Protocol and
Execute Your Innovative Trial

10:15

INTERACTIVE TABLE TALK Putting the Patient First —
Harness Patient Feedback toDesign Improved Trial Models

Tara Hiley, PhD
Senior Patient Insights/Clinical Scientist Lead
Genentech

T.J. Sharpe
Patient, Speaker, Writer and Advocate
Starfish Harbor LLC

11:15

Enhance the New Model of Clinical Trials by Considering the Importance of Behavior Change

Michelle Shogren
Director of Innovation – Pharma R&D Clinical Operations
Bayer

Nnamdi Ezeanochie
Senior Manager, Behavior Science
Johnson & Johnson

Tiffany McGinnis
US Country Head TA 1
Bayer U.S. LLC Pharmaceuticals

11:55

Networking Luncheon

12:55

Breaking the Traditional Mold to Enable Decentralized Trials

Shelly Barnes
Global Clinical Science and Operations Innovations
UCB Biosciences, Inc

Charles Howerton
Clinical Project Manager
UCB Biosciences, Inc

Amit Patel
Co-Founder
Jiva Science

Embrace Next-Generation Technologies and
Harmonize Data Across Clinical Trial Systems

1:30

Technology Selection and Interoperability —
Choose the Right Technology and Harmonize Different Systems Across Your Trial

Georgia Mitsi
Senior Director, Head of Digital Health Care Initiatives
Sunovion Pharmaceuticals

2:10

Managing a Successful Direct-to-Patient Trial Using IRT

Lisa Killi
Director, Clinical Supplies Management
Bellerophon

Shivanni Sukha
Technical Consultant
Suvoda

2:55

Networking and Refreshment Break

3:25

When Medications Require Temperature Control — Challenges Facing Home-Based Clinical Trials and the Emerging Technologies Offering Solutions

Paul Saratsiotis
Managing Director
Cryologex

Nico Hoeler
Managing Director
Tec4Med

4:10

Moving Beyond Patient Engagement to Human-Centered Design in Digital Health

Greg Silvesti
Head of Digital Health and Innovation
AbbVie

4:50

Effective Strategies to Harness, Maintain and Analyze Clinical Trial Data from Multiple Systems

Kerensa Saljooqi
Associate Director, Clinical Operations
BlackThorn Therapeutics

5:30

Close of Day One

Networking, Wine and
Cheese Reception
immediately following the final session on day one

DAY TWO Friday, August 9, 2019

8:00

Continental Breakfast

8:30

Chairman’s Review of Day One

Darren Cowan
Area Head, Americas Global Site & Study Operations,
Clinical Development & Operations, GP
Pfizer Inc

Ensure Trial Protocol Is Compliant with
Local and Global Regulations

8:45

FDA HIGHLIGHT AND TOWN HALL FDA Perspective —
Clinical Trial Innovation and the Current Regulatory Landscape

Isaac R. Rodriguez-Chavez, PhD, MHSc, MSc
FDA Officer, Clinical Research Methodology,
Regulatory Compliance and Medical Policy Development
FDA/CDER

9:15

GLOBAL HIGHLIGHT PANEL Gain an Update on Local and Global Regulations Impacting Your Direct-to-Patient Trials

MODERATOR:

Maureen Bennett
Partner
Jones Day

PANELISTS:

Isaac R. Rodriguez-Chavez, PhD, MHSc, MSc
FDA Officer, Clinical Research Methodology,
Regulatory Compliance and Medical Policy Development
FDA/CDER

Bradley Davidsen
Counsel, Clinical R&D
AbbVie

Chris Markus
Partner
King & Spalding

10:15

What Would You Ask An 8 Million Member Patient Advisory Board? - Case Studies of Tech-Enabled Patient Insights at Scale

Shawn Tedman, MBA
Director, Clinical Trials Business
23andMe

10:45

Networking and Refreshment Break

Restructure Supply Chain Logistics and Develop
a Robust Distribution Management Plan

11:15

Manage Supply Logistics and Ensure Adherence Within Chain of Responsibility in DtP Trials

Michael Sparozic
Trial Supplies Operation Manager Leader
Sanofi

12:00

Networking Luncheon

1:00

Leverage PBMs, Retail and Specialty Pharmacies for DtP Trials

Tom Gottschalk
Director, Business Development
TrialCard Inc.

Optimize Network Collaboration and
External Partnerships for Success

1:40

Build a Competent Workforce to Implement Virtual Trials Successfully —
Develop Comprehensive Programs to Ensure Consistency

Jim Kremidas
Executive Director
ACRP

Mark Hanley
CEO
VirTrial

2:20

Partner with Home Healthcare Providers to Enhance Patient Experience for Virtual or Hybrid Trials

Gail Adinamis
Chief Executive Officer
GlobalCare Clinical Trials

3:00

Close of Conference

Want more agenda details? Download the brochure.

DAY ONE Thursday, August 8, 2019

7:00

Registration and Continental Breakfast

8:00

Chairman’s Welcome and Opening Remarks

Darren Cowan
Area Head, Americas Global Site & Study Operations,
Clinical Development & Operations, GP
Pfizer Inc

Adoption of a
Direct-to-Patient Trial Model

8:15

Evolution of Siteless Trials — Lessons Learned from REMOTE to TOPAZ

Steve Cummings
Director, SF Coordinating Center Professor of Medicine & Epidemiology
UC San Francisco

8:55

PANEL Virtual or Hybrid Model — Discuss the Feasibility of Adopting a DtP Model

MODERATOR:

Elena Izmailova, PhD
DiMe Co-founder & Co-chair, DiMe Research Committee;
CSO, Koneksa Health

PANELISTS:

Jeff Kingsley
CEO and Founder
IACT Health

Antonieta Sosa
Director, Clinical Innovation
Janssen Research and Development

Ching Tian
GM Digital Accelerator
Novartis

Paul Saratsiotis
Managing Director
Cryologex

9:45

Networking and Refreshment Break

Develop Protocol and
Execute Your Innovative Trial

10:15

INTERACTIVE TABLE TALK Putting the Patient First —
Harness Patient Feedback toDesign Improved Trial Models

Tara Hiley, PhD
Senior Patient Insights/Clinical Scientist Lead
Genentech

T.J. Sharpe
Patient, Speaker, Writer and Advocate
Starfish Harbor LLC

11:15

Enhance the New Model of Clinical Trials by Considering the Importance of Behavior Change

Michelle Shogren
Director of Innovation – Pharma R&D Clinical Operations
Bayer

Nnamdi Ezeanochie
Senior Manager, Behavior Science
Johnson & Johnson

Tiffany McGinnis
US Country Head TA 1
Bayer U.S. LLC Pharmaceuticals

11:55

Networking Luncheon

12:55

Breaking the Traditional Mold to Enable Decentralized Trials

Shelly Barnes
Global Clinical Science and Operations Innovations
UCB Biosciences, Inc

Charles Howerton
Clinical Project Manager
UCB Biosciences, Inc

Amit Patel
Co-Founder
Jiva Science

Embrace Next-Generation Technologies and
Harmonize Data Across Clinical Trial Systems

1:30

Technology Selection and Interoperability —
Choose the Right Technology and Harmonize Different Systems Across Your Trial

Georgia Mitsi
Senior Director, Head of Digital Health Care Initiatives
Sunovion Pharmaceuticals

2:10

Managing a Successful Direct-to-Patient Trial Using IRT

Lisa Killi
Director, Clinical Supplies Management
Bellerophon

Shivanni Sukha
Technical Consultant
Suvoda

2:55

Networking and Refreshment Break

3:25

When Medications Require Temperature Control — Challenges Facing Home-Based Clinical Trials and the Emerging Technologies Offering Solutions

Paul Saratsiotis
Managing Director
Cryologex

Nico Hoeler
Managing Director
Tec4Med

4:10

Moving Beyond Patient Engagement to Human-Centered Design in Digital Health

Greg Silvesti
Head of Digital Health and Innovation
AbbVie

4:50

Effective Strategies to Harness, Maintain and Analyze Clinical Trial Data from Multiple Systems

Kerensa Saljooqi
Associate Director, Clinical Operations
BlackThorn Therapeutics

5:30

Close of Day One

Networking, Wine and
Cheese Reception
immediately following the final session on day one

DAY TWO Friday, August 9, 2019

8:00

Continental Breakfast

8:30

Chairman’s Review of Day One

Darren Cowan
Area Head, Americas Global Site & Study Operations,
Clinical Development & Operations, GP
Pfizer Inc

Ensure Trial Protocol Is Compliant with
Local and Global Regulations

8:45

FDA HIGHLIGHT AND TOWN HALL FDA Perspective —
Clinical Trial Innovation and the Current Regulatory Landscape

Isaac R. Rodriguez-Chavez, PhD, MHSc, MSc
FDA Officer, Clinical Research Methodology,
Regulatory Compliance and Medical Policy Development
FDA/CDER

9:15

GLOBAL HIGHLIGHT PANEL Gain an Update on Local and Global Regulations Impacting Your Direct-to-Patient Trials

MODERATOR:

Maureen Bennett
Partner
Jones Day

PANELISTS:

Isaac R. Rodriguez-Chavez, PhD, MHSc, MSc
FDA Officer, Clinical Research Methodology,
Regulatory Compliance and Medical Policy Development
FDA/CDER

Bradley Davidsen
Counsel, Clinical R&D
AbbVie

Chris Markus
Partner
King & Spalding

10:15

What Would You Ask An 8 Million Member Patient Advisory Board? - Case Studies of Tech-Enabled Patient Insights at Scale

Shawn Tedman, MBA
Director, Clinical Trials Business
23andMe

10:45

Networking and Refreshment Break

Restructure Supply Chain Logistics and Develop
a Robust Distribution Management Plan

11:15

Manage Supply Logistics and Ensure Adherence Within Chain of Responsibility in DtP Trials

Michael Sparozic
Trial Supplies Operation Manager Leader
Sanofi

12:00

Networking Luncheon

1:00

Leverage PBMs, Retail and Specialty Pharmacies for DtP Trials

Tom Gottschalk
Director, Business Development
TrialCard Inc.

Optimize Network Collaboration and
External Partnerships for Success

1:40

Build a Competent Workforce to Implement Virtual Trials Successfully —
Develop Comprehensive Programs to Ensure Consistency

Jim Kremidas
Executive Director
ACRP

Mark Hanley
CEO
VirTrial

2:20

Partner with Home Healthcare Providers to Enhance Patient Experience for Virtual or Hybrid Trials

Gail Adinamis
Chief Executive Officer
GlobalCare Clinical Trials

3:00

Close of Conference