Agenda – Disclosure and Transparency for Clinical Data Summit

  • Day One
  • Day Two

Day One

 Monday, August 7, 2017

8:45AM – 9:00AM

Chairperson’s Opening Remarks
Liz Roberts, Senior Director, Global Lead Transparency and Data Sharing, UCB

9:00AM – 10:00AM

Open Patient Data Access and Sharing: Where Are We on the Journey and Is the Destination Worth the Cost of the Trip?
Frank Rockhold, Ph.D., Professor of Biostatistics and Bioinformatics, Duke Clinical Research Institute, DUKE UNIVERSITY MEDICAL CENTER

10:00AM – 10:45AM

Best Practices for Anonymizing Structured Clinical Trial Data for Disclosure
Khaled El Emam, Ph.D., President, PRIVACY ANALYTICS, INC.

10:45AM – 11:15AM

Networking Break

11:15AM – 12:00PM

EMA Policy 0070 Lessons Learned and Best Practices Gained From Three Case Studies
Trevor Standish, Business Analyst, SYNCHROGENIX

12:00PM – 12:45PM

Strategic and Practical Disclosure Considerations Regarding the EMA Policy 0070 Update
René Allard, Public Disclosure Lead, GRÜNENTHAL GMBH

12:45PM – 1:45PM

Luncheon

1:45PM – 2:30PM

A Holistic Approach to the Evolving Transparency Landscape
Liz Roberts, Senior Director, Global Lead Transparency and Data Sharing, UCB

2:30PM – 3:15PM

The Global Transparency Challenge
Thomas Wicks, Chief Strategy Officer, TRIALSCOPE INC.

3:15PM – 3:45PM

Align Timelines, Communication Resources and Data Across Functions to Optimize Transparency and Disclosure
Oladayo Oyelola, Ph.D., Director, Clinical Trial Information Disclosure, DAIICHI SANKYO

3:45PM – 4:15PM

Networking Break

4:15PM – 5:00PM

Standardize Manual Processes to Accomplish Data Disclosure and Clinical Trial Registry
Laura Troast, M.S., Associate Director, Clinical Data Disclosure and Transparency, MERCK

5:00PM – 5:45PM

Case Study: Johnson & Johnson’s Yale Open Data Access (YODA) Project
Karla Childers, Senior Director, Strategic Projects, JOHNSON & JOHNSON

5:45PM – 6:30PM

Implement and Manage a Clinical Disclosure Group or Process for Your Organization
Frantz Derilus, Associate Director, Clinical Trial Transparency, SHIRE


Day Two

 Tuesday, August 8, 2017

8:00AM – 8:45AM

Continental Breakfast

8:45AM – 9:00AM

Chairperson’s Recap of Day One
Liz Roberts, Senior Director, Global Lead Transparency and Data Sharing, UCB

9:00AM – 9:45AM

Enable Next Generation Smart Processes Through Federated Informatics Technology
Greg Koski, M.D., Ph.D., President and CEO, ALLIANCE FOR CLINICAL RESEARCH EXCELLENCE AND SAFETY (ACRES); Associate Professor, MASSACHUSETTS GENERAL HOSPITAL, HARVARD MEDICAL SCHOOL; Senior Scientist, MONGAN INSTITUTE FOR HEALTH POLICY

9:45AM – 10:30AM

Compliance by Design - Can Compliance Become Culture?
Jack Yeager, CEO, SYLOGENT

10:30AM – 11:00AM

SHRINE (Shared Health Research Information Network): Enable Patient Cohort Identification for Accrual to Clinical Trials
Bhanu Bahl, Ph.D., Director, Clinical and Translational Science Center, HARVARD MEDICAL SCHOOL

11:00AM – 11:30AM

Networking Break

11:30AM – 12:15PM

Best Practices for Balancing Your Organization’s Commercial Value and Data Sharing
Pranab Mitra, Ph.D., Assoc. Principal Scientist (Biostatistician), MERCK

12:15PM – 1:00PM

The Challenges of Medical Writing in Clinical Trial Disclosure
Sulochanda Gawande, Ph.D., Director, Oncology Medical Writing and Publications, EISAI

1:00PM – 2:00PM

Luncheon

2:00PM – 2:45PM

Implement Disclosure Infrastructure to Facilitate Rapid Changes to Preexisting Data
Nathaniel Root, Global Clinical Trial Registration and Results Disclosure Lead, TAKEDA

2:45PM – 3:15PM

Lay Language Summaries As Tools for Patient Engagement: Driving Patient Engagement Through Sharing Overall Trial Results
Julia Farides-Mitchell, M.A., Senior Project Manager, CENTER FOR INFORMATION & STUDY ON CLINICAL RESEARCH PARTICIPATION (CISCRP)

3:15PM – 3:45PM

Networking Break

3:45PM – 4:30PM

Strategies and Resources for Sharing Clinical Research Data in Academia
Kristen Bolt, Former Program Manager, Data Sharing and Transparency, MULTI-REGIONAL CLINICAL TRIALS CENTER OF BRIGHAM AND WOMEN’S HOSPITAL AND HARVARD

4:30PM – 5:15PM

Examine Data Disclosure Methods to Achieve Full Transparency and to Ensure Credibility
Debra Mayo, Vice President, Global Scientific Communications, TEVA

5:5:15PM – 5:30PM

Chairperson’s Closing Remarks
Liz Roberts, Senior Director, Global Lead Transparency and Data Sharing, UCB