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Agenda

Develop Technology-Driven Partnerships that Revolutionize Patient Engagement and Data Management and Ensure Effective Clinical Trials

December 13-14, 2017
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE Wednesday, December 13, 2017

7:15

Main Conference Registration

8:15

Co-Chairs’ Welcome and Opening Remarks

Joseph C. Cappelleri
Executive Director, Biostatistics
Pfizer Inc

Jonathan Helfgott
Faculty Coordinator,
Regulatory Science & Food Safety Programs
Johns Hopkins University

8:30

Opening Address An Update on eCOA and ePRO —
Innovative New Technologies and Strategies for Implementation

Joseph Cappelleri
Senior Director, Biostatics
Pfizer Inc

Examine New Regulations and Drive Adoption
of More Efficient eCOA/ePRO Operations

9:15

Explore New FDA Guidelines For New Clinical Outcome Assessment Qualification Programs

Jonathan Helfgott
Faculty Coordinator,
Regulatory Science & Food Safety Programs
Johns Hopkins University

10:00

Networking and Refreshment Break

10:30

Navigate Your eCOA Audit Trail — Preparedness for Regulatory Scrutiny

Colin Cleary, MPH
Vice President, Strategic Solutions
YPrime

11:15

Overcome Barriers to Implementation of Electronic Collection of
COA-based Endpoint Data

Aaron McCormick
Lead, IRT & ePRO Operations
Shire

12:00

Networking Luncheon

1:15

Roundtable Discussions

Challenges and Innovations in
Data Streamsfor eCOA/ ePRO —
Leveraging Wearables, Biosensors, and IoT

2:15

Examine eCOA/ePRO Growth with an Eye Towards mHealth with Biosensors and Mobile Solutions

Kenneth Grice
eCOA Strategist, Data Acquisition Services
Bayer

3:00

Networking and Refreshment Break

3:30

Bring Your Own Solution — Is BYOD the Best Approach Towards eCOA?

Chris Dell
Sr. Manager, Patient Technologies
Pfizer Inc

4:15

Future Focus — A Unified Model for eCOA

Donna M. Mongiello, RN, BSN
Vice President, Strategic Solutions
YPrime

Speaker TBD
Mapi Group

5:00

Close of Day One

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

DAY TWO Thursday, December 14, 2017

7:45

Continental Breakfast

8:15

Co-Chairs’ Review of Day One

Joseph C. Cappelleri
Executive Director, Biostatistics
Pfizer Inc

Jonathan Helfgott
Faculty Coordinator,
Regulatory Science & Food Safety Programs
Johns Hopkins University

8:30

PANEL DISCUSSION What is Slowing Down the Digital Revolution?
What is the Digital Future of eCOA/ePRO in 2020?

MODERATOR:

Donna M. Mongiello, RN, BSN
Vice President, Strategic Solutions
YPrime

PANELISTS:

Aaron McCormick
Lead IRT & ePRO Operations
Shire

Ari Gnanasakthy
Principal Scientist, Patient Centered Outcomes Assessment
RTI Health Solutions

Liz Quinlan
Manager – eCOA, eClinical Technology
CSL Behring

Develop Best Practices to Ensure Data Quality
and Data Management for eCOA/ePRO

9:30

Overcome Challenges in the Assessment of PRO in Cancer Studies

Ari Gnanasakthy
Principal Scientist, Patient Centered Outcomes Assessment
RTI Health Solutions

10:15

Prepare for Quality Reviews of eCOA Data

Kenneth Grice
eCOA Strategist, Data Acquisition Services
Bayer

Kristina Agbayani
Senior eCOA Project Manager
InVentiv on behalf of Bayer

11:00

Networking and Refreshment Break

11:30

Streamline eCOA/ePRO Data Monitoring Processes

Liz Quinlan
Manager – eCOA, eClinical Technology
CSL Behring

Sachin Walawalkar
Clinical Programmer
CSL Behring

12:00

Close of Conference

Agenda

Want more agenda details? Download the brochure.
Want more agenda details? Download the brochure.

DAY ONE Wednesday, December 13, 2017

7:15

Main Conference Registration

8:15

Co-Chairs’ Welcome and Opening Remarks

Joseph C. Cappelleri
Executive Director, Biostatistics
Pfizer Inc

Jonathan Helfgott
Faculty Coordinator,
Regulatory Science & Food Safety Programs
Johns Hopkins University

8:30

Opening Address An Update on eCOA and ePRO —
Innovative New Technologies and Strategies for Implementation

Joseph Cappelleri
Senior Director, Biostatics
Pfizer Inc

Examine New Regulations and Drive Adoption
of More Efficient eCOA/ePRO Operations

9:15

Explore New FDA Guidelines For New Clinical Outcome Assessment Qualification Programs

Jonathan Helfgott
Faculty Coordinator,
Regulatory Science & Food Safety Programs
Johns Hopkins University

10:00

Networking and Refreshment Break

10:30

Navigate Your eCOA Audit Trail — Preparedness for Regulatory Scrutiny

Colin Cleary, MPH
Vice President, Strategic Solutions
YPrime

11:15

Overcome Barriers to Implementation of Electronic Collection of
COA-based Endpoint Data

Aaron McCormick
Lead, IRT & ePRO Operations
Shire

12:00

Networking Luncheon

1:15

Roundtable Discussions

Challenges and Innovations in
Data Streamsfor eCOA/ ePRO —
Leveraging Wearables, Biosensors, and IoT

2:15

Examine eCOA/ePRO Growth with an Eye Towards mHealth with Biosensors and Mobile Solutions

Kenneth Grice
eCOA Strategist, Data Acquisition Services
Bayer

3:00

Networking and Refreshment Break

3:30

Bring Your Own Solution — Is BYOD the Best Approach Towards eCOA?

Chris Dell
Sr. Manager, Patient Technologies
Pfizer Inc

4:15

Future Focus — A Unified Model for eCOA

Donna M. Mongiello, RN, BSN
Vice President, Strategic Solutions
YPrime

Speaker TBD
Mapi Group

5:00

Close of Day One

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

DAY TWO Thursday, December 14, 2017

7:45

Continental Breakfast

8:15

Co-Chairs’ Review of Day One

Joseph C. Cappelleri
Executive Director, Biostatistics
Pfizer Inc

Jonathan Helfgott
Faculty Coordinator,
Regulatory Science & Food Safety Programs
Johns Hopkins University

8:30

PANEL DISCUSSION What is Slowing Down the Digital Revolution?
What is the Digital Future of eCOA/ePRO in 2020?

MODERATOR:

Donna M. Mongiello, RN, BSN
Vice President, Strategic Solutions
YPrime

PANELISTS:

Aaron McCormick
Lead IRT & ePRO Operations
Shire

Ari Gnanasakthy
Principal Scientist, Patient Centered Outcomes Assessment
RTI Health Solutions

Liz Quinlan
Manager – eCOA, eClinical Technology
CSL Behring

Develop Best Practices to Ensure Data Quality
and Data Management for eCOA/ePRO

9:30

Overcome Challenges in the Assessment of PRO in Cancer Studies

Ari Gnanasakthy
Principal Scientist, Patient Centered Outcomes Assessment
RTI Health Solutions

10:15

Prepare for Quality Reviews of eCOA Data

Kenneth Grice
eCOA Strategist, Data Acquisition Services
Bayer

Kristina Agbayani
Senior eCOA Project Manager
InVentiv on behalf of Bayer

11:00

Networking and Refreshment Break

11:30

Streamline eCOA/ePRO Data Monitoring Processes

Liz Quinlan
Manager – eCOA, eClinical Technology
CSL Behring

Sachin Walawalkar
Clinical Programmer
CSL Behring

12:00

Close of Conference