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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 increasing transparency and disclosure of clinical trial data and the release of new requirements from the International Committee of Medical Journal Editors (ICMJE) 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 the cross-section of publication and transparency requirements and highlights areas of collaboration.

I. Overview of Clinical Trial Transparency and Medical

II. Areas of Collaboration of Clinical Trial Transparency and Medical Publications

III. International Committee of Medical Journal Editors (ICMJE) Requirements

IV. Commitment to Publish

V. Data Sharing

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
Senior Client Engagement Manager
d-Wise

Chris Connor
Senior Life Sciences Consultant
d-Wise

Cathal Gallagher
Life Sciences Consultant
d-Wise

Phil Loucks
Sales Analyst
d-Wise

Chris Decker
Vice President, Life Sciences Practices
d-Wise

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

Debra Mayo
former Vice President, Global Scientific Communications
Teva Pharmaceuticals

Robert Janiak
Head, Clinical Trial Transparency
EMD Serono

Julie Holtzople
Clinical Trial Transparency Operations Director
AstraZeneca

Teresa Armstrong, ELS
Advisor, Clinical Document Transparency
Eli Lilly and Company

*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
Senior Advisor Global Medical Strategy and Operations
Eli Lilly & Co.

12:45

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

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

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

Francine Lane
Director, Product Management
TrialScope

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 Meaningful 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

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

Rebecca Li
Executive Director, Vivli;
Instructor in Medicine and the Center for Bioethics, Harvard Medical School

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
EMD Serono

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
Senior Advisor Global Medical Strategy and Operations
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

Kelley Kendle
President
Synchrogenix

10:15

Navigate Structured Protocol Authoring to Reduce Cost and Ensure Compliance

Jack Yeager
Chief Executive Officer
Sylogent

11:00

Networking and Refreshment Break

11:30

PANEL Navigate Varying Regulatory Requirements for Plain Language Summaries

MODERATOR:

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

PANELISTS:

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

Sarah Larson
Director, Global Clinical Operations
Biogen

Jessica Johns
Director, Translations Business Development
TransPerfect

Thomas Wicks
Chief Strategy Officer
TrialScope

12:15

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

Thomas Wicks
Chief Strategy Officer
TrialScope

1:00

Networking Luncheon

2:00

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.

2:00

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

 

2:00

Enhance Clinical Study Report Transparency Through ICH E3 Guideline Implementation

Jenny Petersen
Director, Clinical Trial Transparency
Xogene Services

Julie Holtzople
Clinical Trial Transparency Operations Director
AstraZeneca

     

2:45

Establish a Successful Lay Summary Program within Your Organization

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

 

2:45

Using Anonymization Standards for Sharing Clinical Trial Data

Andrew Baker
Principal Scientist
Privacy Analytics

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 increasing transparency and disclosure of clinical trial data and the release of new requirements from the International Committee of Medical Journal Editors (ICMJE) 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 the cross-section of publication and transparency requirements and highlights areas of collaboration.

I. Overview of Clinical Trial Transparency and Medical

II. Areas of Collaboration of Clinical Trial Transparency and Medical Publications

III. International Committee of Medical Journal Editors (ICMJE) Requirements

IV. Commitment to Publish

V. Data Sharing

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
Senior Client Engagement Manager
d-Wise

Chris Connor
Senior Life Sciences Consultant
d-Wise

Cathal Gallagher
Life Sciences Consultant
d-Wise

Phil Loucks
Sales Analyst
d-Wise

Chris Decker
Vice President, Life Sciences Practices
d-Wise

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

Debra Mayo
former Vice President, Global Scientific Communications
Teva Pharmaceuticals

Robert Janiak
Head, Clinical Trial Transparency
EMD Serono

Julie Holtzople
Clinical Trial Transparency Operations Director
AstraZeneca

Teresa Armstrong, ELS
Advisor, Clinical Document Transparency
Eli Lilly and Company

*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
Senior Advisor Global Medical Strategy and Operations
Eli Lilly & Co.

12:45

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

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

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

Francine Lane
Director, Product Management
TrialScope

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 Meaningful 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

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

Rebecca Li
Executive Director, Vivli;
Instructor in Medicine and the Center for Bioethics, Harvard Medical School

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
EMD Serono

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
Senior Advisor Global Medical Strategy and Operations
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

Kelley Kendle
President
Synchrogenix

10:15

Navigate Structured Protocol Authoring to Reduce Cost and Ensure Compliance

Jack Yeager
Chief Executive Officer
Sylogent

11:00

Networking and Refreshment Break

11:30

PANEL Navigate Varying Regulatory Requirements for Plain Language Summaries

MODERATOR:

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

PANELISTS:

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

Sarah Larson
Director, Global Clinical Operations
Biogen

Jessica Johns
Director, Translations Business Development
TransPerfect

Thomas Wicks
Chief Strategy Officer
TrialScope

12:15

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

Thomas Wicks
Chief Strategy Officer
TrialScope

1:00

Networking Luncheon

2:00

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.

2:00

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

 

2:00

Enhance Clinical Study Report Transparency Through ICH E3 Guideline Implementation

Jenny Petersen
Director, Clinical Trial Transparency
Xogene Services

Julie Holtzople
Clinical Trial Transparency Operations Director
AstraZeneca

     

2:45

Establish a Successful Lay Summary Program within Your Organization

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

 

2:45

Using Anonymization Standards for Sharing Clinical Trial Data

Andrew Baker
Principal Scientist
Privacy Analytics

3:30

Close of Conference