Skip navigation
Agenda

Global Disclosure Mandates • Data Sharing • Patient Privacy • Lay Summaries • Data and Document Anonymization

January 29-30, 2019
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, JANUARY 29, 2019

7:30

Conference Registration and Continental Breakfast

8:30

CHOOSE BETWEEN TWO IN-CONFERENCE WORKSHOPS (A-B)

A ONBOARDING — DISCLOSURE AND TRANSPARENCY BOOTCAMP

Are you new to the disclosure and transparency arena? Do you want a refresher on all of the policies, platforms, methods and intricacies that are required of someone in your position? Join us to become skilled in clinical data disclosure and transparency.

I. NIH Final Rule for FDAAA

II. Explore ClinicalTrials.Gov and EudraCT Platforms

III. Summary of Local Registries

IV. Overview and Evolution of Policy 0070

V. EU Clinical Trials Regulation

VI. Lay Summaries

VII. ICMJE Requirements

VIII. Introduction to Data Sharing

Workshop Leaders:

Linda Ubelacker
Senior CT Transparency Specialist
Xogene Services LLC

Kelly Coulbourne
Associate Director,
Clinical Trial Data Registries
Allergan

B EXPLORE HOW RISK ASSESSMENT AND ANONYMIZATION ARE KEY TOOLS FOR SUCCESSFUL CLINICAL INFORMATION SHARING

As clinical trial transparency regulations continue to evolve, anonymization has ascended the agenda. Dive into the techniques and approaches needed for success. Explore the end to end anonymization process for balancing data utility and personal risk as part of clinical data and documents sharing. This workshop will better prepare companies to deliver to new and emerging policies and needs such as Health Canada’s new document disclosure policy, EMA Policy 0070 and external data sharing.

I. Define Key Principles and Concepts

II. Work through Anonymization Lifecycle

III. Panel Discussion on Anonymization Experience

Workshop Leaders:

Stephen Baker
Director of Client Management
d-Wise

Cathal Gallaher
Senior Life Science Consultant
d-Wise

Julie Holtzople
Clinical Trial Transparency and Operations Director
AstraZeneca

10:30

Networking and Refreshment Break

11:00

Chairperson’s Welcome and Opening Remarks

Jo Anne-Marie Blyskal
Senior Director, Head of Global Regulatory Medical Writing and Clinical Data Disclosure
Teva Pharmaceuticals

11:15

KEYNOTE ADDRESS Achieve Data and Document Anonymization Globally —
Overview, Opportunities and Challenges

Julie Holtzople
Clinical Trial Transparency and Operations Director
AstraZeneca

12:00

The Big Picture —
How EU Regulations Impact Small to Mid-Sized Life Science Companies

Thomas Wicks
Chief Strategy Officer
TrialScope

12:45

Networking Luncheon

1:45

Best Practices Regarding the NIH Final Rule for FDAAA

Jodi Black, PhD
Deputy Director, Office of Extramural Research
National Institutes of Health (NIH)

2:30

Exploration of the September 2018 FDA Draft Guidance and Its Impact on the Future of Disclosure and Transparency

Mahnu Davar
Partner
Arnold & Porter

3:15

Networking and Refreshment Break

3:45

Prepare Your Organization for the Implementation of Health Canada’s Public Release of Clinical Information in Drug Submissions and Medical Device Applications

Speaker TBA

4:30

Assess and Navigate the Impact that GDPR has on Collection and Sharing of Clinical Trial Data

Michael A. DiMaio
Associate
Ropes & Gray, LLP

5:00

Utilize Real-World Evidence to Advance the Use of Clinical Data

Iwona Bucior
Director, Medical Communications
Portola Pharmaceuticals, Inc.

5:30

Close of Day One

NETWORKING, WINE AND CHEESE RECEPTION immediately following the final session on day one

DAY TWO WEDNESDAY, JANUARY 30, 2019

7:30

Continental Breakfast

8:00

Chairperson’s Review of Day One

Jo Anne-Marie Blyskal
Senior Director, Head of Global Regulatory Medical Writing and Clinical Data Disclosure
Teva Pharmaceuticals

8:15

STAKEHOLDER DISCUSSION Gain Insight from Different Perspectives on How Each Utilize Clinical Data and View Data Sharing

MODERATOR:

Benjamin Rotz, RPh
Senior Advisor, Global Medical Strategy and Operations
Eli Lilly & Co.

PANELISTS:

Yolanda Davis
Quality Assurance Manager, Clinical Trial Disclosure
University of Miami

Deborah Collyar
President
Patient Advocates in Research

Luba Smolensky
Director, Research Partnerships (Data Science and Analytics)
The Michael J. Fox Foundation for Parkinsons Research

9:00

Optimizing Outcomes for Patients — Policy Considerations

Olivia Shopshear
Senior Director, Science and Regulatory Advocacy
PhRMA

9:45

Networking and Refreshment Break

10:30

TRAILBLAZER EXCHANGE Voluntary Data Sharing Methods Intensive —
Navigate the Different Platforms Available (Vivli, CSDR, Yoda, SOAR)

MODERATOR:

Pooja Phogat
Head of Development Operations
Kinapse

PANELISTS:

Karla Childers
Director, Strategic Projects
Johnson & Johnson

Rebecca Li
Executive Director
Vivli

Scott Martin
Chair of Steering Committee
ClinicalStudyDataRequest.com

Asba Tasneem, PhD
Informatics Project Leader II
Duke Clinical Research Institute

11:30

Disclosures and Data Sharing — Develop Documents with the End in Mind

Nate Root
Associate Director, Clinical Data Disclosure and Transparency
Ionis Pharma

Annadoir Staveley
Associate Director, Clinical Trial Disclosure and Transparency, Ethics and Compliance
Otsuka Pharmaceuticals

12:15

ICMJE Requirement Updates and Publication Overview

Sonia Schweers
Global Publications Practices Monitor, Associate Director, Medical Capabilities
Bristol-Myers Squibb

12:45

Networking Luncheon

1:45

CHOOSE FROM THREE MINI MASTER CLASSES (1-3)

1 Medical Writing to Meet Global Disclosure and Transparency Regulations

Iwona Bucior
Director, Medical Communications
Portola Pharmaceuticals, Inc.

2Transparency and Best Practices in Publication Planning

Sonia Schweers
Global Publications, Practice Monitor, Associate Director, Medical Capabilities
Bristol-Myers Squibb

Alan Hempel
Medical Communications, Associate Director
Bristol-Myers Squibb

3 Lay Summaries — Leverage and Understand the Importance of Lay Summaries from Regulatory Requirements and Patient Engagement

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

2:45

CHOOSE FROM THREE WORKING GROUPS (I-III)

I Utilize Genomic Databases for Clinical Data
II Publication Planning to Achieve Industry Collaboration and Understanding
III Device Regulations in the Era of Disclosure

FACILITATOR:

Scott Feiner
Clinical Data Disclosure Specialist
Allergan

3:15

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, JANUARY 29, 2019

7:30

Conference Registration and Continental Breakfast

8:30

CHOOSE BETWEEN TWO IN-CONFERENCE WORKSHOPS (A-B)

A ONBOARDING — DISCLOSURE AND TRANSPARENCY BOOTCAMP

Are you new to the disclosure and transparency arena? Do you want a refresher on all of the policies, platforms, methods and intricacies that are required of someone in your position? Join us to become skilled in clinical data disclosure and transparency.

I. NIH Final Rule for FDAAA

II. Explore ClinicalTrials.Gov and EudraCT Platforms

III. Summary of Local Registries

IV. Overview and Evolution of Policy 0070

V. EU Clinical Trials Regulation

VI. Lay Summaries

VII. ICMJE Requirements

VIII. Introduction to Data Sharing

Workshop Leaders:

Linda Ubelacker
Senior CT Transparency Specialist
Xogene Services LLC

Kelly Coulbourne
Associate Director,
Clinical Trial Data Registries
Allergan

B EXPLORE HOW RISK ASSESSMENT AND ANONYMIZATION ARE KEY TOOLS FOR SUCCESSFUL CLINICAL INFORMATION SHARING

As clinical trial transparency regulations continue to evolve, anonymization has ascended the agenda. Dive into the techniques and approaches needed for success. Explore the end to end anonymization process for balancing data utility and personal risk as part of clinical data and documents sharing. This workshop will better prepare companies to deliver to new and emerging policies and needs such as Health Canada’s new document disclosure policy, EMA Policy 0070 and external data sharing.

I. Define Key Principles and Concepts

II. Work through Anonymization Lifecycle

III. Panel Discussion on Anonymization Experience

Workshop Leaders:

Stephen Baker
Director of Client Management
d-Wise

Cathal Gallaher
Senior Life Science Consultant
d-Wise

Julie Holtzople
Clinical Trial Transparency and Operations Director
AstraZeneca

10:30

Networking and Refreshment Break

11:00

Chairperson’s Welcome and Opening Remarks

Jo Anne-Marie Blyskal
Senior Director, Head of Global Regulatory Medical Writing and Clinical Data Disclosure
Teva Pharmaceuticals

11:15

KEYNOTE ADDRESS Achieve Data and Document Anonymization Globally —
Overview, Opportunities and Challenges

Julie Holtzople
Clinical Trial Transparency and Operations Director
AstraZeneca

12:00

The Big Picture —
How EU Regulations Impact Small to Mid-Sized Life Science Companies

Thomas Wicks
Chief Strategy Officer
TrialScope

12:45

Networking Luncheon

1:45

Best Practices Regarding the NIH Final Rule for FDAAA

Jodi Black, PhD
Deputy Director, Office of Extramural Research
National Institutes of Health (NIH)

2:30

Exploration of the September 2018 FDA Draft Guidance and Its Impact on the Future of Disclosure and Transparency

Mahnu Davar
Partner
Arnold & Porter

3:15

Networking and Refreshment Break

3:45

Prepare Your Organization for the Implementation of Health Canada’s Public Release of Clinical Information in Drug Submissions and Medical Device Applications

Speaker TBA

4:30

Assess and Navigate the Impact that GDPR has on Collection and Sharing of Clinical Trial Data

Michael A. DiMaio
Associate
Ropes & Gray, LLP

5:00

Utilize Real-World Evidence to Advance the Use of Clinical Data

Iwona Bucior
Director, Medical Communications
Portola Pharmaceuticals, Inc.

5:30

Close of Day One

NETWORKING, WINE AND CHEESE RECEPTION immediately following the final session on day one

DAY TWO WEDNESDAY, JANUARY 30, 2019

7:30

Continental Breakfast

8:00

Chairperson’s Review of Day One

Jo Anne-Marie Blyskal
Senior Director, Head of Global Regulatory Medical Writing and Clinical Data Disclosure
Teva Pharmaceuticals

8:15

STAKEHOLDER DISCUSSION Gain Insight from Different Perspectives on How Each Utilize Clinical Data and View Data Sharing

MODERATOR:

Benjamin Rotz, RPh
Senior Advisor, Global Medical Strategy and Operations
Eli Lilly & Co.

PANELISTS:

Yolanda Davis
Quality Assurance Manager, Clinical Trial Disclosure
University of Miami

Deborah Collyar
President
Patient Advocates in Research

Luba Smolensky
Director, Research Partnerships (Data Science and Analytics)
The Michael J. Fox Foundation for Parkinsons Research

9:00

Optimizing Outcomes for Patients — Policy Considerations

Olivia Shopshear
Senior Director, Science and Regulatory Advocacy
PhRMA

9:45

Networking and Refreshment Break

10:30

TRAILBLAZER EXCHANGE Voluntary Data Sharing Methods Intensive —
Navigate the Different Platforms Available (Vivli, CSDR, Yoda, SOAR)

MODERATOR:

Pooja Phogat
Head of Development Operations
Kinapse

PANELISTS:

Karla Childers
Director, Strategic Projects
Johnson & Johnson

Rebecca Li
Executive Director
Vivli

Scott Martin
Chair of Steering Committee
ClinicalStudyDataRequest.com

Asba Tasneem, PhD
Informatics Project Leader II
Duke Clinical Research Institute

11:30

Disclosures and Data Sharing — Develop Documents with the End in Mind

Nate Root
Associate Director, Clinical Data Disclosure and Transparency
Ionis Pharma

Annadoir Staveley
Associate Director, Clinical Trial Disclosure and Transparency, Ethics and Compliance
Otsuka Pharmaceuticals

12:15

ICMJE Requirement Updates and Publication Overview

Sonia Schweers
Global Publications Practices Monitor, Associate Director, Medical Capabilities
Bristol-Myers Squibb

12:45

Networking Luncheon

1:45

CHOOSE FROM THREE MINI MASTER CLASSES (1-3)

1 Medical Writing to Meet Global Disclosure and Transparency Regulations

Iwona Bucior
Director, Medical Communications
Portola Pharmaceuticals, Inc.

2Transparency and Best Practices in Publication Planning

Sonia Schweers
Global Publications, Practice Monitor, Associate Director, Medical Capabilities
Bristol-Myers Squibb

Alan Hempel
Medical Communications, Associate Director
Bristol-Myers Squibb

3 Lay Summaries — Leverage and Understand the Importance of Lay Summaries from Regulatory Requirements and Patient Engagement

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

2:45

CHOOSE FROM THREE WORKING GROUPS (I-III)

I Utilize Genomic Databases for Clinical Data
II Publication Planning to Achieve Industry Collaboration and Understanding
III Device Regulations in the Era of Disclosure

FACILITATOR:

Scott Feiner
Clinical Data Disclosure Specialist
Allergan

3:15

Close of Conference