The following 2019 Bridging Collaborative agenda will focus on providing collaborative opportunities with panel discussions stimulated through keynote and pillar presentations. In addition, there will be roundtable luncheon discussions on a variety of topics. You will receive an opportunity in February to sign up for your preferred luncheon discussion groups.
Please ensure you are registered in advance so you are on the National Academy of Sciences attendee roster. License ID will be required upon registration check in for security purposes.
Monday, March 4 (Day One)
Registration and Breakfast
9 – 10 a.m.
Session One
10 – 11 a.m.
Welcome and Opening Remarks
Keynote:
What is the Learning Health Community? What is an Learning Health System? What Would a Well-Functioning LHS Mean to Patients?
John Barry, Pharm-Olam
Session Two
Session Chair: Kurt Mussina, Frenova
11 a.m. – 12:30 p.m.
Pillar Presentations:
Perceptions and Attitudes of Patients as Partners in Research: A Survey
Anne-Marie Hess, SCORR Marketing
Aligning Direct-to Patient Trials With Patient Advocacy Groups: Putting Patient-Centricity Into Practice
Patients at the Center of Research and Health Care: An Industry Survey
Panel Discussion:
The Bridging Collaborative and Learning Health Systems: What Could These Mean for Patients?
Anne-Marie Hess, SCORR Marketing
Lisa Henderson, Applied Clinical Trials
Michael Keens, Firma Clinical Research
Lindsey Wahlstrom-Edwards, Antidote
Ivor Clarke, SubjectWell
Derek Ansel, PRA Health Sciences
Stephen Chick, Veradigm Health
Joanne Stone Wyman, Patient
Lunch
12:30 – 2 p.m.
Ten roundtable discussion groups with 10 different topics led by 10 experts (10 participants per table) will meet during this time for those who are interested in participating.
Day One Luncheon Discussion Group Topics and Leaders
Using Behavioral Science to Motivate Patients and Stakeholders
Engaging Patients and Caregivers as Partners
The Future of the Case Report Form (CRF) Part 1
New Paths for global Disease-Specific Standards
Shifting the Clinical Trials Paradigm from Approving Drugs to Curing Patients
Knowledge into Practice: Realizing the Benefit of Learning Health Systems
Data Science: Working with Real World Data
Preventing ‘Last Mile Privatization’ of Life-Saving Knowledge
Session Three
Session Chair: Amy Nordo, Pfizer
3 – 3:30 p.m.
Pillar Presentations:
Development of a New Seamless Data Stream from EMR to EDC System using SS-MIX2 Standards Applied for Observational Research in Diabetes Mellitus
The ROAD2Health Initiative and TRANSFoRm Project (Europe, Serbia, China)
Re-Thinking Clinical Research Data from Rare Diseases to Precision Medicine
Panel Discussion:
Addressing Global Challenges to Bridging the Gap and Realizing Learning Health Systems
Professor Hiroshi Watanabe, Hamamatsu University School of Medicine
Professor Brendan Delaney, Imperial Collage
Alex Sherman, Massachusetts General Hospital
Dr. Kimura, Hamamatsu University School of Medicine
Eric Gildenhuys, Deep 6 A
Break
3:30 – 4 p.m.
Session Four
4 – 5 p.m.
Pillar Presentation:
FDA End-to-End Standards Strategy to Bridging Research and Health Care
One additional FDA representative
Session Five
5 – 6 p.m.
Panel Discussion:
Reinventing Clinical Research and Cancer Care
Dr. Brian Alexander, Dana Farber Cancer Institute
Dr. Sean Khozin, FDA Cancer Center of Excellence
Networking Reception
6 – 7 p.m.
National Academy of Sciences Atrium
Tuesday, March 5 (Day Two)
Breakfast & Registration
7:30 – 8:20 a.m.
Session Six
8:20 – 9:20 a.m.
Opening Remarks
Keynote:
Innovations Towards Collaboratively Bridging Clinical Research and Clinical Care
Keynote:
Dynamic Assembly: Synthesizing Data for Deeper Patient Behavioral Learnings and Insights
Session Seven
9:20 – 10:30 a.m.
Pillar Presentations:
New Ways to do Clinical Trials: Opportunities to Solve Big Hairy Problems
New Clinical Research Models Addressing the Industry’s Core Challenges
Panel Discussion:
Reinventing Research – Thoughts from Various Stakeholders
Dr.Nancy Nurthen, Digital Infuzion
Kimberly Finn, Marken
Dr. Mary Tobin, ACRES
Solomon Babani, PRA Health Sciences
Blake Adams, Florence Healthcare
Joe Dustin, Medidata Solutions
Break
10:30 – 11 a.m.
Session Eight
11 a.m. – 12:30 p.m.
Pillar Presentations:
Quality Real-World Data for Regulatory Use – From Raw Data to Fit-for-Purpose
Delivering Timely and Credible Real-World Evidence; Overcoming Regulatory, Legal and Logistical Challenges for the Benefit of Patients
Panel Discussion:
Designing Quality and Real-World Evidence into Research Studies and Learning Health Systems from the Beginning
Dr. Michio Kimura, Hamamatsu Hospital
Dr. Bleicher, Optum Labs
Brande Ellis Yaist, Eli Lilly
Dr. Lauren Becnel, Pfizer
David Thompson, Syneos Health
Dr. Hugh Levaux, Protocol First
Lunch
12:30 – 2 p.m.
Ten roundtable discussion groups with 10 different topics led by 10 experts (10 participants per table) will meet during this time for those who are interested in participating.
Day Two Luncheon Discussion Group Topics and Leaders
Solving the Interoperability Challenge
NIH/NCATS Center for Data 2 Health (CD2H)
The Future of eSource Technology
The Future of the Case Report Forum Part 2
Integrated Research Organizations and Site Perspectives of Research
The Future of the Learning Health Community: Taking the Consensus Action Plan Forward to Realize Learning Health Systems
Collaborative Models for Data Sharing
Session Nine
2 – 3 p.m.
Panel Discussion:
Unlocking Real-World Value for EHRs: Harmonization of Common Data Models for Real-World Evidence with Oncology Use Case
Mitra Rocca, FDA
David Vulcano, Hospital Corporation of America
Dr. Sam Volchenboum, University of Chicago Clinical Research Informatics
Dr. Shrujal Baxi, Flatiron
Christian Reich, OMOP/IQVIA
Dr. Michael Ibara, Elligo Health Research
Session Ten
3 – 4:20 p.m.
Pillar Presentations:
Creating Learning Health Systems Through Structured, Digitized Care Plan Information from EHRs
Bridging Partnership Between the Department of Veteran Affairs and Industry for High-Quality Clinical Trials
Dr. Grant D. Huang, Veteran Association
Panel Discussion:
Next Steps to Bridge the Chasm
Dr. Rick Starrs, NAVREF
Dr. Grant Huang, Veterans Association
Dr. Hidehise Soejima, Saiseikai Kumamoto Hospital
Blake Adams, Florence Healthcare
Dr. Kathleen Starr, Syneos Health