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DAY ONE Wednesday, September 27, 2017

7:00

Registration and Continental Breakfast

8:00

Chairman’s Welcome and Opening Remarks

Bart Barefoot
Director, VEO & Real World Evidence Policy & Advocacy,
Value Evidence and Outcomes (VEO), Global Medical
GlaxoSmithKline

Setting the Stage — Policy and Context for Understanding the Value of Real-World
Evidence Across Stakeholders

8:15

PANEL
Opportunities for Growth and Development in Real-World Evidence Utilization

MODERATOR:

Bart Barefoot
Director, VEO & Real World Evidence Policy & Advocacy,
Value Evidence and Outcomes (VEO), Global Medical
GlaxoSmithKline

PANELISTS:

Sachin Kamal-Bahl
Vice President and Head, Innovation Center,
Patient and Health Impact
Pfizer Inc

Penny Levin, MS
Director Global Regulatory Intelligence and Policy
Teva

Anita Burrell
Founder & CEO
Anita Burrell Consulting LLC

9:15

Explore Regulatory Developments in RWE

Gregory Daniel, PhD, MPH
Deputy Director
Duke-Robert J. Margolis, MD, Center for Health Policy

10:00

Networking and Refreshment Break

Strategies and Methods for Strong
Evidence Generation and Analysis

10:30

Methodologies for Ensuring Quality and Optimizing Value

Michael Pencina
Director, Biostatistics
Duke Clinical Research Institute

11:15

Develop Standardized Practices for Real-World Evidence Generation and Utilization

Michael Duong
Director, Medical Affairs, Evidence Generation
Hoffmann-La Roche

12:00

The Promises and Pitfalls of RWE Data and Analysis Standardization

Stephanie Reisinger
President and GM Evalytica
Evidera

12:45

Networking Luncheon

1:45

Address Challenges in Working with Medical “Big Data” and Patient Registries

Lisa Wruck, PhD
Director of Center of Predictive Medicine
Duke Clinical Research Institute

Considerations for Value-Based Payment Frameworks

2:30

Identify and Leverage Value Pathways for Commercialization

Tony Hebden
Vice President, Health Economics and Outcomes Research
AbbVie

3:15

Networking and Refreshment Break

3:45

Integrate RWE into Your DecisionMaking Process to Optimize Value

Anita Burrell
Founder & CEO
Anita Burrell Consulting LLC

Explore Applications of Real-World Evidence

4:30

From Big Data to Predictive Analytics —
The Next Generation of Registries and Real-World Evidence

Richard Gliklich, MD
CEO
OM1

5:15

Close of Day One

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

DAY TWO Thursday, September 28, 2017

7:15

Continental Breakfast

7:45

Chairman’s Review of Day One

Bart Barefoot
Director, VEO & Real World Evidence Policy & Advocacy,
Value Evidence and Outcomes (VEO), Global Medical
GlaxoSmithKline

8:00

Applications of Patient Reported Outcomes (PROs) for Greater Insights with RWD

Kyle Brown
Founder & Former CEO
PatientCrossroads

8:45

Evaluate Comparative Effectiveness Through Observational Studies

Janet Espirito, PharmD
Associate Director, Outcomes Research
McKesson Specialty Health

9:30

Using Digital Tools and New Care Models to Tackle Chronic Disease

Deborah Sundal
SVP of Product Architecture, Enterprise Research and Development
UnitedHealth Group

10:00

Networking and Refreshment Break

10:30

Creating the Conditions for a Paradigm Shift

David Miller, ScD SM
Head of RWE Methods, Analytics, Health Economics
UCB

Building the Future for Real-World Evidence

11:15

Making the Most Out of Real World Data

Marc Berger
Chair, Real World Evidence Product Advisory Board
SHYFT

12:00

Putting RWE into Perspective — Past, Present and Future

Jeff Trotter
President
Continuum Clinical

12:45

Networking Luncheon

1:45

CO-PRESENTATION
Develop Strategies for Collaboration Across Stakeholders

Riad Dirani
Vice President, Global Health Economics and Outcomes Research
Teva

Penny Levin, MS
Director, Global Regulatory Intelligence and Policy
Teva

2:30

CASE STUDY
Innovations Throughout The Digital Care Path —
From RWD/RWE to AI to IoT, and Beyond

Robert Boland
Associate Director, Emerging Science & Innovation
Johnson & Johnson

3:15

Close of Conference

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DAY ONE Wednesday, September 27, 2017

7:00

Registration and Continental Breakfast

8:00

Chairman’s Welcome and Opening Remarks

Bart Barefoot
Director, VEO & Real World Evidence Policy & Advocacy,
Value Evidence and Outcomes (VEO), Global Medical
GlaxoSmithKline

Setting the Stage — Policy and Context for Understanding the Value of Real-World
Evidence Across Stakeholders

8:15

PANEL
Opportunities for Growth and Development in Real-World Evidence Utilization

MODERATOR:

Bart Barefoot
Director, VEO & Real World Evidence Policy & Advocacy,
Value Evidence and Outcomes (VEO), Global Medical
GlaxoSmithKline

PANELISTS:

Sachin Kamal-Bahl
Vice President and Head, Innovation Center,
Patient and Health Impact
Pfizer Inc

Penny Levin, MS
Director Global Regulatory Intelligence and Policy
Teva

Anita Burrell
Founder & CEO
Anita Burrell Consulting LLC

9:15

Explore Regulatory Developments in RWE

Gregory Daniel, PhD, MPH
Deputy Director
Duke-Robert J. Margolis, MD, Center for Health Policy

10:00

Networking and Refreshment Break

Strategies and Methods for Strong
Evidence Generation and Analysis

10:30

Methodologies for Ensuring Quality and Optimizing Value

Michael Pencina
Director, Biostatistics
Duke Clinical Research Institute

11:15

Develop Standardized Practices for Real-World Evidence Generation and Utilization

Michael Duong
Director, Medical Affairs, Evidence Generation
Hoffmann-La Roche

12:00

The Promises and Pitfalls of RWE Data and Analysis Standardization

Stephanie Reisinger
President and GM Evalytica
Evidera

12:45

Networking Luncheon

1:45

Address Challenges in Working with Medical “Big Data” and Patient Registries

Lisa Wruck, PhD
Director of Center of Predictive Medicine
Duke Clinical Research Institute

Considerations for Value-Based Payment Frameworks

2:30

Identify and Leverage Value Pathways for Commercialization

Tony Hebden
Vice President, Health Economics and Outcomes Research
AbbVie

3:15

Networking and Refreshment Break

3:45

Integrate RWE into Your DecisionMaking Process to Optimize Value

Anita Burrell
Founder & CEO
Anita Burrell Consulting LLC

Explore Applications of Real-World Evidence

4:30

From Big Data to Predictive Analytics —
The Next Generation of Registries and Real-World Evidence

Richard Gliklich, MD
CEO
OM1

5:15

Close of Day One

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

DAY TWO Thursday, September 28, 2017

7:15

Continental Breakfast

7:45

Chairman’s Review of Day One

Bart Barefoot
Director, VEO & Real World Evidence Policy & Advocacy,
Value Evidence and Outcomes (VEO), Global Medical
GlaxoSmithKline

8:00

Applications of Patient Reported Outcomes (PROs) for Greater Insights with RWD

Kyle Brown
Founder & Former CEO
PatientCrossroads

8:45

Evaluate Comparative Effectiveness Through Observational Studies

Janet Espirito, PharmD
Associate Director, Outcomes Research
McKesson Specialty Health

9:30

Using Digital Tools and New Care Models to Tackle Chronic Disease

Deborah Sundal
SVP of Product Architecture, Enterprise Research and Development
UnitedHealth Group

10:00

Networking and Refreshment Break

10:30

Creating the Conditions for a Paradigm Shift

David Miller, ScD SM
Head of RWE Methods, Analytics, Health Economics
UCB

Building the Future for Real-World Evidence

11:15

Making the Most Out of Real World Data

Marc Berger
Chair, Real World Evidence Product Advisory Board
SHYFT

12:00

Putting RWE into Perspective — Past, Present and Future

Jeff Trotter
President
Continuum Clinical

12:45

Networking Luncheon

1:45

CO-PRESENTATION
Develop Strategies for Collaboration Across Stakeholders

Riad Dirani
Vice President, Global Health Economics and Outcomes Research
Teva

Penny Levin, MS
Director, Global Regulatory Intelligence and Policy
Teva

2:30

CASE STUDY
Innovations Throughout The Digital Care Path —
From RWD/RWE to AI to IoT, and Beyond

Robert Boland
Associate Director, Emerging Science & Innovation
Johnson & Johnson

3:15

Close of Conference