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DAY ONE Tuesday, September 26, 2017

7:30

Conference Registration and Continental Breakfast

8:30

Chairman’s Welcome and Opening Remarks

David Parrish, PhD
Translational Medicine, Clinical Science and Innovation
Novartis

Examine the Next Steps for
Clinical Trial Disclosure Regulation

8:45

Keep Pace with Regulatory Requirements for Lay Summaries

Barbara Bierer
Professor of Medicine, Harvard Medical School;
Faculty Co-Director & Co-Chair,
MRCT Center of Brigham and Women’s Hospital and Harvard

9:30

Let’s Make Summaries Useful for People

Deborah Collyar
Founder & President, Patient Advocates in Research;
Clinical Trial & Patient Specialist, Health Literacy Media (HLM)

10:15

Networking and Refreshment Break

Understand the Most Effective Techniques
for Implementing Lay Summaries

10:45

Best Practices for Implementing Plain Language Summaries

Jessica Valencia, PhD
Operational Excellence Expert
Novartis Institutes for BioMedical Research

11:30

FIRESIDE CHAT Establish a Standard Practice to Communicate Trial Results to Study Volunteers — Best Practices and Case Studies

MODERATOR:

Jill McNair, MBA
Senior Director, Patient Engagement
Center for Information & Study on Clinical Research Participation (CISCRP)

PANELISTS:

Jaime Houde
Manager, Clinical Trial Transparency
EMD Serono

Poorvi Chablani
Global Clinical Excellence – Clinical Trial Transparency
Biogen

Jeaneen Ahmad
Clinical Trial Disclosure Specialist
Bristol-Myers Squibb

12:30

Networking Luncheon

1:45

CO-PRESENTATION Evaluate Distribution Methods — Print vs. Electronics

Thomas Wicks
Chief Strategy Officer
TrialScope

Jacob Agris, MD, PhD
Head, Regional Medical Support and Medical Information & Grants,
Director, Global Medical and Clinical Affairs
Bayer Healthcare

2:45

CO-PRESENTATION Strategies for “Translating” Endpoints into Lay Summaries

Behtash Bahador
Senior Manager, Quality and Compliance, Communicating Trail Results
Center for Information & Study on Clinical Research Participation (CISCRP)

Jessica Valencia, PhD
Operational Excellence Expert
Novartis Institutes for BioMedical Research

3:30

Networking and Refreshment Break

4:00

DYNAMIC DIALOGUE Innovative Ideas for Lay Summary Implementation

MODERATOR:

Pooja Phogat
Vice President and Global Head, Clinical Trial Disclosure
Kinapse, Inc.

PANELISTS:

Deborah Collyar
Founder & President, Patient Advocates in Research;
Clinical Trial & Patient Specialist, Health Literacy Media (HLM)

Anna Marie Lane
Senior Medical Writing Specialist
Pfizer Inc

Jacob Agris, MD, PhD
Head, Regional Medical Support and Medical Information & Grants,
Director, Global Medical and Clinical Affairs
Bayer Healthcare

5:00

Close of Day One

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

DAY TWO Wednesday, September 27, 2017

8:00

Continental Breakfast

8:30

Chairman’s Review of Day One

Jill McNair, MBA
Senior Director, Patient Engagement
Center for Information & Study on Clinical Research Participation (CISCRP)

IN-CONFERENCE WORKSHOP
Writing an Effective Lay Summary

8:45

Workshop Leader’s Welcome and Opening Remarks

Workshop Objective:

This workshop provides key methods, case studies and best practices for writing lay summaries.

Workshop Outline:

I. Best Practices

II. Case Study

III. Break Away Session

Workshop Leader:

Renee Entzminger, PhD
Senior Director, Clinical Trial Disclosure & Head of Medical Writing
TransPerfect Life Sciences

Deborah Collyar
Founder & President, Patient Advocates in Research;
Clinical Trial & Patient Specialist, Health Literacy Media (HLM)

10:45

Networking and Refreshment Break

Emphasize the Importance of
Being Patient-Centric

11:15

Create a Framework for the Translation Process

Jaime Houde
Manager, Clinical Trial Transparency
EMD Serono

12:00

Close of Conference

Want more agenda details? Download the brochure.

DAY ONE Tuesday, September 26, 2017

7:30

Conference Registration and Continental Breakfast

8:30

Chairman’s Welcome and Opening Remarks

David Parrish, PhD
Translational Medicine, Clinical Science and Innovation
Novartis

Examine the Next Steps for
Clinical Trial Disclosure Regulation

8:45

Keep Pace with Regulatory Requirements for Lay Summaries

Barbara Bierer
Professor of Medicine, Harvard Medical School;
Faculty Co-Director & Co-Chair,
MRCT Center of Brigham and Women’s Hospital and Harvard

9:30

Let’s Make Summaries Useful for People

Deborah Collyar
Founder & President, Patient Advocates in Research;
Clinical Trial & Patient Specialist, Health Literacy Media (HLM)

10:15

Networking and Refreshment Break

Understand the Most Effective Techniques
for Implementing Lay Summaries

10:45

Best Practices for Implementing Plain Language Summaries

Jessica Valencia, PhD
Operational Excellence Expert
Novartis Institutes for BioMedical Research

11:30

FIRESIDE CHAT Establish a Standard Practice to Communicate Trial Results to Study Volunteers — Best Practices and Case Studies

MODERATOR:

Jill McNair, MBA
Senior Director, Patient Engagement
Center for Information & Study on Clinical Research Participation (CISCRP)

PANELISTS:

Jaime Houde
Manager, Clinical Trial Transparency
EMD Serono

Poorvi Chablani
Global Clinical Excellence – Clinical Trial Transparency
Biogen

Jeaneen Ahmad
Clinical Trial Disclosure Specialist
Bristol-Myers Squibb

12:30

Networking Luncheon

1:45

CO-PRESENTATION Evaluate Distribution Methods — Print vs. Electronics

Thomas Wicks
Chief Strategy Officer
TrialScope

Jacob Agris, MD, PhD
Head, Regional Medical Support and Medical Information & Grants,
Director, Global Medical and Clinical Affairs
Bayer Healthcare

2:45

CO-PRESENTATION Strategies for “Translating” Endpoints into Lay Summaries

Behtash Bahador
Senior Manager, Quality and Compliance, Communicating Trail Results
Center for Information & Study on Clinical Research Participation (CISCRP)

Jessica Valencia, PhD
Operational Excellence Expert
Novartis Institutes for BioMedical Research

3:30

Networking and Refreshment Break

4:00

DYNAMIC DIALOGUE Innovative Ideas for Lay Summary Implementation

MODERATOR:

Pooja Phogat
Vice President and Global Head, Clinical Trial Disclosure
Kinapse, Inc.

PANELISTS:

Deborah Collyar
Founder & President, Patient Advocates in Research;
Clinical Trial & Patient Specialist, Health Literacy Media (HLM)

Anna Marie Lane
Senior Medical Writing Specialist
Pfizer Inc

Jacob Agris, MD, PhD
Head, Regional Medical Support and Medical Information & Grants,
Director, Global Medical and Clinical Affairs
Bayer Healthcare

5:00

Close of Day One

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

DAY TWO Wednesday, September 27, 2017

8:00

Continental Breakfast

8:30

Chairman’s Review of Day One

Jill McNair, MBA
Senior Director, Patient Engagement
Center for Information & Study on Clinical Research Participation (CISCRP)

IN-CONFERENCE WORKSHOP
Writing an Effective Lay Summary

8:45

Workshop Leader’s Welcome and Opening Remarks

Workshop Objective:

This workshop provides key methods, case studies and best practices for writing lay summaries.

Workshop Outline:

I. Best Practices

II. Case Study

III. Break Away Session

Workshop Leader:

Renee Entzminger, PhD
Senior Director, Clinical Trial Disclosure & Head of Medical Writing
TransPerfect Life Sciences

Deborah Collyar
Founder & President, Patient Advocates in Research;
Clinical Trial & Patient Specialist, Health Literacy Media (HLM)

10:45

Networking and Refreshment Break

Emphasize the Importance of
Being Patient-Centric

11:15

Create a Framework for the Translation Process

Jaime Houde
Manager, Clinical Trial Transparency
EMD Serono

12:00

Close of Conference