Skip navigation
Agenda

Advanced Methods for Medical Writing, Lay Summary Implementation and Improving Communication with Patients

September 24-25, 2018
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE Monday, September 24, 2018

7:30

Conference Registration and Continental Breakfast

8:30

Chairman’s Welcome and Opening Remarks

Julie Holtzople
Clinical Trial Transparency Operations Director
AstraZeneca

Review Industry Progress with
Clinical Trial Disclosure

8:45

The Evolution of Lay Summaries — Where Do We Stand Today?

Jaime Houde
Manager, Clinical Trial Transparency
EMD Serono

9:30

What’s New with Lay Summaries and the EU Clinical Trial Regulation?

Virginia Acha
Executive Director, Global Regulatory Policy (ex-Americas)
MSD R&D Innovation Centre

10:15

Networking and Refreshment Break

Understand the Most Effective Techniques
for Implementing Lay Summaries

10:45

PANEL DISCUSSIONGain In-Depth Insights from Lay Summary Implementation Case Studies

MODERATOR:

Debra Guerreiro
Associate Director, Plain Language Summary Lead
Janssen

PANELISTS:

Brittany Jordan
PharmD, Manager, Neurology, External Scientific Communications
Allergan

Anna Mendlin, PhD
Associate Director, Regulatory Medical Writing
Johnson & Johnson

Julie Holtzople
Clinical Trial Transparency Operations Director
AstraZeneca

Annadoir Staveley
Associate Director
Otsuka America Pharmaceutical

11:45

Plain Language Summaries and Beyond – Data Sharing and Patient Engagement

Thomas Wicks
Chief Strategy Officer
TrialScope

12:15

Networking Luncheon

1:30

Creating Meaningful Phase 1 PK Lay Summaries

Pooja Phogat
Head of Development Operations
Kinapse

Vidhi Vashisht
Senior Manager, Clinical Trial Disclosure
Kinapse

2:15

Writing Lay Summaries Internally — Lessons Learned From the Inside

Susan Patrick, PhD
Senior Medical Writer
UCB Biosciences, Inc.

3:00

Networking and Refreshment Break

3:30

Explore Patient Engagement Beyond Lay Summaries

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

Combatting the Downstream Challenges of Lay Summaries

4:15

PANEL DISCUSSIONBig Pharma vs. Small Pharma — Overcoming Unique and Universal Challenges

MODERATOR:

David Parrish
Head of Patient Engagement and Advocacy, Translational Medicine
Novartis Institutes for BioMedical Research

PANELISTS:

Jeaneen Ahmad
Clinical Trial Disclosure Specialist
Bristol-Myers Squibb

Brittany Jordan
PharmD, Manager, Neurology, External Scientific Communications
Allergan

Oladayo Oyelola, PhD, SC (ASCP)
Director, Clinical Trial Information Disclosure
Daiichi Sankyo, Inc.

5:15

Close of Day One

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

DAY TWO Tuesday, September 25, 2018

7:30

Continental Breakfast

8:00

Chairman’s Review of Day One

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

8:15

Lessons Learned Implementing a Communication Plan for Clinical Trial Participants

Jessica Valencia, PhD
Operational Excellence Expert
Novartis Pharmaceuticals

9:00

Return of Individual Results to Participants — From Theory to Practice

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

9:45

Ensuring Successful Lay Language Summaries —
A Project Management Perspective

Francesca Lauritano, PSM
CT Transparency Analyst
Xogene Services

10:30

Networking and Refreshment Break

11:00

Key Challenges and Predictors of Success in Lay Summary Development

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

11:45

CO-PRESENTATION Uncover the Recipe for a Successful Translation Process

Julie Holtzople
Clinical Trial Transparency Operations Director
AstraZeneca

Poorvi Chablani
Global Clinical Operations, Global Clinical Excellence –
Clinical Trial Transparency
Biogen

12:30

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE Monday, September 24, 2018

7:30

Conference Registration and Continental Breakfast

8:30

Chairman’s Welcome and Opening Remarks

Julie Holtzople
Clinical Trial Transparency Operations Director
AstraZeneca

Review Industry Progress with
Clinical Trial Disclosure

8:45

The Evolution of Lay Summaries — Where Do We Stand Today?

Jaime Houde
Manager, Clinical Trial Transparency
EMD Serono

9:30

What’s New with Lay Summaries and the EU Clinical Trial Regulation?

Virginia Acha
Executive Director, Global Regulatory Policy (ex-Americas)
MSD R&D Innovation Centre

10:15

Networking and Refreshment Break

Understand the Most Effective Techniques
for Implementing Lay Summaries

10:45

PANEL DISCUSSIONGain In-Depth Insights from Lay Summary Implementation Case Studies

MODERATOR:

Debra Guerreiro
Associate Director, Plain Language Summary Lead
Janssen

PANELISTS:

Brittany Jordan
PharmD, Manager, Neurology, External Scientific Communications
Allergan

Anna Mendlin, PhD
Associate Director, Regulatory Medical Writing
Johnson & Johnson

Julie Holtzople
Clinical Trial Transparency Operations Director
AstraZeneca

Annadoir Staveley
Associate Director
Otsuka America Pharmaceutical

11:45

Plain Language Summaries and Beyond – Data Sharing and Patient Engagement

Thomas Wicks
Chief Strategy Officer
TrialScope

12:15

Networking Luncheon

1:30

Creating Meaningful Phase 1 PK Lay Summaries

Pooja Phogat
Head of Development Operations
Kinapse

Vidhi Vashisht
Senior Manager, Clinical Trial Disclosure
Kinapse

2:15

Writing Lay Summaries Internally — Lessons Learned From the Inside

Susan Patrick, PhD
Senior Medical Writer
UCB Biosciences, Inc.

3:00

Networking and Refreshment Break

3:30

Explore Patient Engagement Beyond Lay Summaries

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

Combatting the Downstream Challenges of Lay Summaries

4:15

PANEL DISCUSSIONBig Pharma vs. Small Pharma — Overcoming Unique and Universal Challenges

MODERATOR:

David Parrish
Head of Patient Engagement and Advocacy, Translational Medicine
Novartis Institutes for BioMedical Research

PANELISTS:

Jeaneen Ahmad
Clinical Trial Disclosure Specialist
Bristol-Myers Squibb

Brittany Jordan
PharmD, Manager, Neurology, External Scientific Communications
Allergan

Oladayo Oyelola, PhD, SC (ASCP)
Director, Clinical Trial Information Disclosure
Daiichi Sankyo, Inc.

5:15

Close of Day One

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

DAY TWO Tuesday, September 25, 2018

7:30

Continental Breakfast

8:00

Chairman’s Review of Day One

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

8:15

Lessons Learned Implementing a Communication Plan for Clinical Trial Participants

Jessica Valencia, PhD
Operational Excellence Expert
Novartis Pharmaceuticals

9:00

Return of Individual Results to Participants — From Theory to Practice

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

9:45

Ensuring Successful Lay Language Summaries —
A Project Management Perspective

Francesca Lauritano, PSM
CT Transparency Analyst
Xogene Services

10:30

Networking and Refreshment Break

11:00

Key Challenges and Predictors of Success in Lay Summary Development

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

11:45

CO-PRESENTATION Uncover the Recipe for a Successful Translation Process

Julie Holtzople
Clinical Trial Transparency Operations Director
AstraZeneca

Poorvi Chablani
Global Clinical Operations, Global Clinical Excellence –
Clinical Trial Transparency
Biogen

12:30

Close of Conference