Agenda – 3rd Disclosure and Transparency for Clinical Data Summit

  • Day One
  • Day Two

Day One

 Wednesday, August 14

9:15AM – 10:15AM

Keynote: Examine the Current Regulatory Landscape on a National and Global Scale
Christopher Trudeau, J.D., Associate Professor, UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES (UAMS), CENTER FOR HEALTH LITERACY

10:15AM – 11:00AM

Best Practices in Health Communication and Plain Language As Required by the EU and U.S.
Catina O’Leary, President and CEO, HEALTH LITERACY MEDIA (HLM)
Behtash Bahador, Senior Manager, Quality and Compliance, Communicating Trial Results, CENTER FOR INFORMATION AND STUDY ON CLINICAL RESEARCH PARTICIPATION (CISCRP)

11:00AM – 11:30AM

Networking Break

11:30AM – 12:15PM

Deep Dive Into Barriers to Harmonized Data Disclosure
Do you want to spread the word about your organization’s solutions and services to potential clients attending this event? To learn more about these opportunities, please contact Arthur Butler, Business Development Manager, at abutler@questex.com.

12:15PM – 1:15PM

Luncheon

1:15PM – 2:00PM

Discuss Responsible Clinical Data Sharing for Better Patient Outcomes
Asba Tasneem, Informatics Portfolio Leader, Data Sharing Lead at DCRI, DUKE CLINICAL RESEARCH INSTITUTE

2:00PM – 3:00PM

Digital Innovation While Remaining Non- Promotional: Best Practices for Plain Language Summaries in the Digital Space
Julia Farides-Mitchell, Senior Manager, Quality and Compliance, Communicating Trial Results, CENTER FOR INFORMATION AND STUDY ON CLINICAL RESEARCH PARTICIPATION (CISCRP)

3:00PM – 3:30PM

Networking Break

3:30PM – 4:15PM

The Future of Healthcare: Understanding the Use of AI and Blockchain in Patient-Level Data Sharing
Bob Stewart, Board Member and Chief Technology Officer, THE ALLIANCE FOR CLINICAL RESEARCH EXCELLENCE AND SAFETY (ACRES)

4:15PM –

End Day One


Day Two

 Thursday, August 15

8:00AM – 9:00AM

Continental Breakfast

9:15AM – 10:15AM

Keynote: What Disclosure and Transparency Look Like From the Patients’ View
Deborah Collyar, President, PATIENT ADVOCATES IN RESEARCH (PAIR)

10:15AM – 11:15AM

Using Quality by Design to Simplify Clinical Trial Start-up and Disclosure Compliance
Joyce Hauze, CCRA, ACRP-PM, Associate Director, Clinical Trial Disclosure and Transparency, MALLINCKRODT PHARMACEUTICALS
Mary Brantner, Senior Director, Head of Global Development Operations Process and Systems, MALLINCKRODT PHARMACEUTICALS

11:15AM – 11:45AM

Networking Break

11:45AM – 12:45PM

Planning Clinical Trials With the Disclosure Endpoint in Mind
Jo Anne Blyskal, Head of Global Regulatory Medical Writing and Data Disclosure, TEVA PHARMACETICALS
Kelly DiGian, Ph.D., MBA, Director, Data Transparency and Disclosure, TEVA PHARMACEUTICALS

12:45PM – 1:45PM

Luncheon

1:45PM – 2:45PM

Aligning Clinical Trial Transparency Operations Across Functions to Optimize Compliance
Oladayo Oyelola, Ph.D., Director, Clinical Trial Information Disclosure, DAIICHI SANKYO

2:45PM – 3:45PM

Lessons Learned: Reflecting on Five Years of Responsible Clinical Trial Data Sharing Via the YODA Project
Karla Childers, Senior Director, Strategic Projects, JOHNSON & JOHNSON