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Agenda

Policy 0070 • Data Anonymization • Lay Summaries • Patient-Level Data Disclosure • International Registries

January 30-31, 2018
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, JANUARY 30, 2018

7:00

Pre-Conference Workshop Registration and Continental Breakfast

8:00

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

A IMPLICATIONS OF TRANSPARENCY ON PUBLICATION REQUIREMENTS — NEW ICMJE AND BMJ POLICIES

With the release of new requirements from both the International Committee of Medical Journal Editors (ICMJE) and the BMJ (formerly the British Medical Journal), it is critical that all individuals with responsibilities in clinical data sharing fully comprehend the scope and detail of these policies to ensure necessary resources and policy compliance. This workshop deep dives into publication requirements to assess impact on transparency, navigates complex examples of data sharing statements and how they should fulfill requirements and addresses valid concerns regarding the feasibility of proposed requirements, risks to trial participants and protection of patient and researcher interests.

I. Assess the Impact of Recent Medical Publications Statements on the Clinical Disclosure and Transparency Landscape

II. Break Down 2016 ICMJE Data Sharing Requirements for Clinical Trials

III. Explore BMJ 2015 Data Sharing Policy and Ensure Compliance

IV. Move the Needle on Ethical Initiatives to Responsibly Share and De-identify Data

Workshop Leaders:

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

Monique Adams
Director, Clinical Trial Transparency and Non-Clinical Research
Bristol-Myers Squibb

B HANDS-ON WORKSHOP FOR MANAGING THE IMPACT OF POLICY 0070 — QUANTIFIED RISK ASSESSMENTS, ANONYMIZATION AND EMA TIMELINE

As we approach the two-year anniversary of EMA’s Policy 0070 release and its mandate to publish summary reports, clinical sponsors are facing increasing pressure from government and industry regulators to safeguard the identities of clinical trial subjects. This workshop shares the experience of several clinical sponsors that have implemented Policy 0070, along with their challenges. Explore multiple scenarios for creating quantified risk assessments which maximize data utility and lay the foundation for sharing individual patient data. Participants gain insight on best practices, lessons learned, implementation tools and strategies for building a path forward aligned with the most current regulatory guidance.

I. Policy 0070 Submission Roundtable

II. Hands-on Policy 0070 Anonymization and Risk Simulation Workshop

Workshop Leaders:

Stephen Baker
Accounting Manager, Life Sciences
d-Wise Technologies

Cathal Gallagher
Life Sciences Consultant
d-Wise Technologies

Chris Connor
Senior Life Sciences Consultant
d-Wise Technologies

Benjamin Rotz, RPh
Advisor, Medical Transparency
Eli Lilly & Co.

*There will be a 30-minute Networking and Refreshment Break at 9:30

11:30

MAIN CONFERENCE | REGISTRATION

12:30

Chairman’s Welcome and Opening Remarks

Benjamin Rotz, RPh
Advisor, Medical Transparency
Eli Lilly & Co.

12:45

KEYNOTE ADDRESS Ethical and Responsible Clinical Data Sharing —
Working towards Better Outcomes for Patients

Richard Moscicki, MD
Former Deputy Director, Science Operations, CDER, FDA;
Chief Medical Officer and Executive Vice President, PhRMA

1:30

NIH KEYNOTE ADDRESS Explore NIH Clinical Trials Reform and Navigate New Requirements for ClinicalTrials.gov

Jodi B. Black, PhD
Deputy Director, Office of Extramural Research
National Institutes of Health

2:15

Navigate FDAAA 801 Final Rule Implementation and Compliance

Colleen Linehan
Director, Team Leader, Clinical Trial Disclosure Group
Pfizer Inc

3:00

Networking and Refreshment Break

3:30

PATIENT EXPERIENCE SPOTLIGHT Improve Communication and Ignite Collaboration to Achieve Meaningful Patient Involvement

Patricia Furlong
Founding President and CEO
Parent Project Muscular Dystrophy

3:50

Leveraging Lay Summaries as a Meaniningful Approach to Patient Engagement, Not Just a Regulatory Requirement

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

4:10

Speaker Q&A

4:15

MRCT ADDRESS Improve Data Sharing across Stakeholders by Leveraging MRCT’s Interoperable Platform in Clinical Trials

Rebecca Li
Instructor in Medicine and the Center for Bioethics, Harvard Medical School;
Executive Director, Multi-Regional Clinical Trial Center at Harvard (MRCT)

5:00

PREMIER PANEL Protect Patient Privacy and Preserve Regulatory Integrity when Sharing
Patient-Level Data

MODERATOR:

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

PANELISTS:

Robert Janiak
Head, Clinical Trial Transparency
Merck & Co

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

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

6:00

Close of Day One

JOIN US! Networking Cocktail Reception immediately following the final session on day one

DAY TWO WEDNESDAY, JANUARY 31, 2018

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

Benjamin Rotz, RPh
Advisor, Medical Transparency
Eli Lilly & Co.

8:45

EMA TAG GROUP KEYNOTE ADDRESS Explore EMA Technical Anonymization Group (TAG) Activities and the
EMA External Guidance on the Anonymization of Clinical Reports

Monica Dias
Scientific Administrator
European Medicines Agency

9:30

Leverage Artificial Intelligence to Propel Transparency and Disclosure Initiatives

Lora Killian
Director, Disclosure and Transparency
Synchrogenix

10:15

Networking and Refreshment Break

11:00

Choose Between Two Comprehensive Content Streams (I-II)

I DATA DISCLOSURE BOOTCAMP — Practical Applications to Ensure Regulatory Compliance and Promote Clinical Transparency

11:00

Collaborate and Coordinate Across Publication and Results Disclosure Groups

Jan Markind
Director, Publication Operations, North America Medical Affairs
Sanofi

11:45

Elevate Organizational and New Drug ‘Good Pharma Scorecard’ Ratings Through Clinical Transparency Best Practices

Jennifer Miller, PhD
Assistant Professor, NYC Langone Medical Center;
President, Bioethics International

II STRATEGIC EXPERT SUMMIT — Integrating Disclosure into Your Organization’s DNA

11:00

Navigate Varying Regulatory Requirements for Plain Language Summaries

Renee Entzminger, PhD
Global Senior Director, Clinical Trial Disclosure and Medical Writing Head
Transperfect

11:45

Evolving Beyond Compliance — Moving the Needle on Transparency and Disclosure Initiatives

Thomas Wicks
Chief Strategy Officer
TrialScope

1:30

Clinical Data Disclosure and Transparency
Solution Sharing Intensives (1-4) Choose two of the themes that speaks directly to your interests. Topic intensives provide a great environment for participants to share their experiences within a topic aligned directly with their role or gain insight on a new or different aspect of disclosure and transparency. Each Intensive is led by a facilitator helping to drive the discussion surrounding the practical issues behind these topics.

1:30

Navigate Structured Protocol Authoring to Reduce Cost and Ensure Compliance

Jack Yeager
Chief Executive Officer
Sylogent

 

1:30

Enhance Clinical Study Report Transparency Through ICH E3 Guideline Implementation

Jenny Petersen
Director, Clinical Trial Transparency
Xogene Services

     

2:15

Establish a Successful Lay Summary Program within Your Organization

Laura Dodd, MS
Manager,
Global Clinical Trial Data Sharing
PRA Health Sciences

 

2:15

Using Anonymization Standards for Sharing Clinical Trial Data

Khaled El Emam
President
Privacy Analytics

3:00

Closing Discussion and Emerging Topics

During this closing session, attendees explore best practices discussed throughout the past two days and compile key takeaways that can be implemented back in the office. Bring your most pressing questions and receive the answers you need to take your disclosure and transparency processes to the next level.

3:30

Close of Conference

Agenda

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

DAY ONE TUESDAY, JANUARY 30, 2018

7:00

Pre-Conference Workshop Registration and Continental Breakfast

8:00

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

A IMPLICATIONS OF TRANSPARENCY ON PUBLICATION REQUIREMENTS — NEW ICMJE AND BMJ POLICIES

With the release of new requirements from both the International Committee of Medical Journal Editors (ICMJE) and the BMJ (formerly the British Medical Journal), it is critical that all individuals with responsibilities in clinical data sharing fully comprehend the scope and detail of these policies to ensure necessary resources and policy compliance. This workshop deep dives into publication requirements to assess impact on transparency, navigates complex examples of data sharing statements and how they should fulfill requirements and addresses valid concerns regarding the feasibility of proposed requirements, risks to trial participants and protection of patient and researcher interests.

I. Assess the Impact of Recent Medical Publications Statements on the Clinical Disclosure and Transparency Landscape

II. Break Down 2016 ICMJE Data Sharing Requirements for Clinical Trials

III. Explore BMJ 2015 Data Sharing Policy and Ensure Compliance

IV. Move the Needle on Ethical Initiatives to Responsibly Share and De-identify Data

Workshop Leaders:

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

Monique Adams
Director, Clinical Trial Transparency and Non-Clinical Research
Bristol-Myers Squibb

B HANDS-ON WORKSHOP FOR MANAGING THE IMPACT OF POLICY 0070 — QUANTIFIED RISK ASSESSMENTS, ANONYMIZATION AND EMA TIMELINE

As we approach the two-year anniversary of EMA’s Policy 0070 release and its mandate to publish summary reports, clinical sponsors are facing increasing pressure from government and industry regulators to safeguard the identities of clinical trial subjects. This workshop shares the experience of several clinical sponsors that have implemented Policy 0070, along with their challenges. Explore multiple scenarios for creating quantified risk assessments which maximize data utility and lay the foundation for sharing individual patient data. Participants gain insight on best practices, lessons learned, implementation tools and strategies for building a path forward aligned with the most current regulatory guidance.

I. Policy 0070 Submission Roundtable

II. Hands-on Policy 0070 Anonymization and Risk Simulation Workshop

Workshop Leaders:

Stephen Baker
Accounting Manager, Life Sciences
d-Wise Technologies

Cathal Gallagher
Life Sciences Consultant
d-Wise Technologies

Chris Connor
Senior Life Sciences Consultant
d-Wise Technologies

Benjamin Rotz, RPh
Advisor, Medical Transparency
Eli Lilly & Co.

*There will be a 30-minute Networking and Refreshment Break at 9:30

11:30

MAIN CONFERENCE | REGISTRATION

12:30

Chairman’s Welcome and Opening Remarks

Benjamin Rotz, RPh
Advisor, Medical Transparency
Eli Lilly & Co.

12:45

KEYNOTE ADDRESS Ethical and Responsible Clinical Data Sharing —
Working towards Better Outcomes for Patients

Richard Moscicki, MD
Former Deputy Director, Science Operations, CDER, FDA;
Chief Medical Officer and Executive Vice President, PhRMA

1:30

NIH KEYNOTE ADDRESS Explore NIH Clinical Trials Reform and Navigate New Requirements for ClinicalTrials.gov

Jodi B. Black, PhD
Deputy Director, Office of Extramural Research
National Institutes of Health

2:15

Navigate FDAAA 801 Final Rule Implementation and Compliance

Colleen Linehan
Director, Team Leader, Clinical Trial Disclosure Group
Pfizer Inc

3:00

Networking and Refreshment Break

3:30

PATIENT EXPERIENCE SPOTLIGHT Improve Communication and Ignite Collaboration to Achieve Meaningful Patient Involvement

Patricia Furlong
Founding President and CEO
Parent Project Muscular Dystrophy

3:50

Leveraging Lay Summaries as a Meaniningful Approach to Patient Engagement, Not Just a Regulatory Requirement

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

4:10

Speaker Q&A

4:15

MRCT ADDRESS Improve Data Sharing across Stakeholders by Leveraging MRCT’s Interoperable Platform in Clinical Trials

Rebecca Li
Instructor in Medicine and the Center for Bioethics, Harvard Medical School;
Executive Director, Multi-Regional Clinical Trial Center at Harvard (MRCT)

5:00

PREMIER PANEL Protect Patient Privacy and Preserve Regulatory Integrity when Sharing
Patient-Level Data

MODERATOR:

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

PANELISTS:

Robert Janiak
Head, Clinical Trial Transparency
Merck & Co

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

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

6:00

Close of Day One

JOIN US! Networking Cocktail Reception immediately following the final session on day one

DAY TWO WEDNESDAY, JANUARY 31, 2018

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

Benjamin Rotz, RPh
Advisor, Medical Transparency
Eli Lilly & Co.

8:45

EMA TAG GROUP KEYNOTE ADDRESS Explore EMA Technical Anonymization Group (TAG) Activities and the
EMA External Guidance on the Anonymization of Clinical Reports

Monica Dias
Scientific Administrator
European Medicines Agency

9:30

Leverage Artificial Intelligence to Propel Transparency and Disclosure Initiatives

Lora Killian
Director, Disclosure and Transparency
Synchrogenix

10:15

Networking and Refreshment Break

11:00

Choose Between Two Comprehensive Content Streams (I-II)

I DATA DISCLOSURE BOOTCAMP — Practical Applications to Ensure Regulatory Compliance and Promote Clinical Transparency

11:00

Collaborate and Coordinate Across Publication and Results Disclosure Groups

Jan Markind
Director, Publication Operations, North America Medical Affairs
Sanofi

11:45

Elevate Organizational and New Drug ‘Good Pharma Scorecard’ Ratings Through Clinical Transparency Best Practices

Jennifer Miller, PhD
Assistant Professor, NYC Langone Medical Center;
President, Bioethics International

II STRATEGIC EXPERT SUMMIT — Integrating Disclosure into Your Organization’s DNA

11:00

Navigate Varying Regulatory Requirements for Plain Language Summaries

Renee Entzminger, PhD
Global Senior Director, Clinical Trial Disclosure and Medical Writing Head
Transperfect

11:45

Evolving Beyond Compliance — Moving the Needle on Transparency and Disclosure Initiatives

Thomas Wicks
Chief Strategy Officer
TrialScope

1:30

Clinical Data Disclosure and Transparency
Solution Sharing Intensives (1-4) Choose two of the themes that speaks directly to your interests. Topic intensives provide a great environment for participants to share their experiences within a topic aligned directly with their role or gain insight on a new or different aspect of disclosure and transparency. Each Intensive is led by a facilitator helping to drive the discussion surrounding the practical issues behind these topics.

1:30

Navigate Structured Protocol Authoring to Reduce Cost and Ensure Compliance

Jack Yeager
Chief Executive Officer
Sylogent

 

1:30

Enhance Clinical Study Report Transparency Through ICH E3 Guideline Implementation

Jenny Petersen
Director, Clinical Trial Transparency
Xogene Services

     

2:15

Establish a Successful Lay Summary Program within Your Organization

Laura Dodd, MS
Manager,
Global Clinical Trial Data Sharing
PRA Health Sciences

 

2:15

Using Anonymization Standards for Sharing Clinical Trial Data

Khaled El Emam
President
Privacy Analytics

3:00

Closing Discussion and Emerging Topics

During this closing session, attendees explore best practices discussed throughout the past two days and compile key takeaways that can be implemented back in the office. Bring your most pressing questions and receive the answers you need to take your disclosure and transparency processes to the next level.

3:30

Close of Conference