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:
Opening Session and Keynotes Welcome & Opening Remarks

10 – 11 a.m.

Welcome and Opening Remarks

Masters of Ceremonies

Jeff James, CEO of Wilmington Health and President of Innovo (Day 1)
Jeremy Edwards, Vice President of Strategic Business Development, SCORR Marketing (Day 2)

Keynote Presentations:
What is the Learning Health Community? What is a Learning Health System? What Would a Well-Functioning LHS Mean to Patients?

Joshua Rubin, Learning Health Community
John Barry, Pharm-Olam

Patient Engagement in Clinical Trials: Challenges and Opportunities

Milena Lolic, FDA Office of Professional Affairs and Stakeholder Engagement

Session Two:
Patient Centricity and Beyond: Including All Stakeholders in the Patient Care Ecosystem

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

Lindsey Wahlstrom-Edwards, Antidote
Anne-Marie Hess, SCORR Marketing

Aligning Direct-to-Patient Trials With Patient Advocacy Groups: Putting Patient-Centricity Into Practice

Michael Keens, Firma Clinical Research

Patients at the Center of Research and Health Care: An Industry Survey

Lisa Henderson, Applied Clinical Trials

Panel Discussion:

Facilitator: Kurt Mussina, Frenova Renal Research
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 take place 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

Kathleen Starr, Syneos Health

Engaging Patients and Caregivers as Partners

Lindsey Wahlstrom-Edwards, Antidote, and Anne-Marie Hess, SCORR Marketing

The Future of the Case Report Form (CRF) Part 1

Shannon Labout, SCDM Board Chair 2018

New Paths for Global Disease-Specific Standards

Rebecca Kush, Elligo Health Research with FDA Representatives

Shifting the Clinical Trials Paradigm From Approving Drugs to Curing Patients

Marty Tenenbaum, Cancer Commons

Knowledge Into Practice: Realizing the Benefit of Learning Health Systems

Megan Klopchin or Graham Millar, Eli Lilly

Data Science: Working With Real-World Data

Michael Ibarra, Elligo Health Research

Preventing ‘Last Mile Privatization’ of Life-Saving Knowledge

Joshua Rubin, Learning Health Community

Using Digital Technologies in Clinical Trials: FDA’s Support for the Use of Digital Technology Tools

Ken Skodacek, FDA/CDRH

Session Three:
International Perspective: Sharing Lessons Learned for Bridging the Gap and Realizing Learning Health Systems

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

Hiroshi Watanabe, Hamamatsu University School of Medicine

The ROAD2Health Initiative and TRANSFoRm Project (Europe, Serbia, China)

Brendan Delaney, Imperial College

Re-Thinking Clinical Research Data from Rare Diseases to Precision Medicine

Alex Sherman, Massachusetts General Hospital, Harvard

Panel Discussion:
Addressing Global Challenges to Bridging the Gap and Realizing Learning Health Systems

Facilitator: Amy Nordo, Pfizer
Hiroshi Watanabe, Hamamatsu University School of Medicine
Brendan Delaney, Imperial College
Alex Sherman, Massachusetts General Hospital, Harvard
Michio Kimura, Hamamatsu University School of Medicine
Eric Gildenhuys, Deep 6 AI

Break
3:30 – 4 p.m.

Session Four:
FDA Standards Strategy

Session Chair: Rebecca Kush

4 – 5 p.m.

Pillar Presentation:
FDA End-to-End Standards Strategy to Bridging Research and Health Care

Ron Fitzmartin, FDA/CBER
Vaishali Popat, FDA/CDER

Session Five:
Reinventing Clinical Research and Cancer Care

Session Chair: Marty Tenenbaum, Cancer Commons

5 – 6 p.m.

Panel Discussion:
Reinventing Clinical Research and Cancer Care

Facilitator: Marty Tenenbaum, Cancer Commons
Brian Alexander, Dana-Farber Cancer Institute
Sean Khozin, FDA Oncology Center of Excellence
William Hoos, xCures
John Eckardt, DAVA Oncology

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:
Day Two Opening Keynotes

John Potthoff, Elligo Health Research

8:20 – 9:20 a.m.

Opening Remarks

Program Co-Chairs and Collaborative Founders

Keynote:
Innovations Toward Collaboratively Bridging Clinical Research and Clinical Care

Badhri Srinivasan, Novartis

Keynote:
Dynamic Assembly: Synthesizing Data for Deeper Patient Behavioral Learnings and Insights

Michelle Keefe, Syneos Health

Session Seven:
Reinventing Research

Session Chair: Brian Burk, Verizon

9:20 – 10:30 a.m.

Pillar Presentations:
New Ways to Do Clinical Trials: Opportunities to Solve Big Hairy Problems

Brian Burk, Verizon

New Clinical Research Models Addressing the Industry’s Core Challenges

Michael Gibertini, Elligo Health Research

Panel Discussion:
Reinventing Research – Thoughts From Various Stakeholders

Facilitators: Brian Burk, Verizon and Michael Gibertini, Elligo Health Research
Badhri Srinivasen, Novartis
Nancy Nurthen, Digital Infuzion
Kimberly Finn, Marken
Mary Tobin, ACRES
Solomon Babani, PRA Health Sciences
Blake Adams, Florence Healthcare
Joe Dustin, Medidata Solutions
Jodi Akin, Hawthorne Effect

Break
10:30 – 11 a.m.

Session Eight:
Designing Real-World Data and Evidence Research From the Beginning with the End in Mind – Informing Quality Decision-making with Timely Credible Evidence

Session Chair: Lucinda Orsini, ISPOR

11 a.m. – 12:30 p.m.

Pillar Presentations:
Quality Real-World Data for Regulatory Use – From Raw Data to Fit-For-Purpose

Paul Bleicher, Optum Labs

Delivering Timely and Credible Real-World Evidence; Overcoming Regulatory, Legal, and Logistical Challenges for the Benefit of Patients

Brande Ellis, Eli Lilly

Panel Discussion:

Facilitator: Lucinda Orsini, ISPOR
Michio Kimura, Hamamatsu University School of Medicine
Paul Bleicher, Optum Labs
Brande Ellis, Eli Lilly
Lauren Becnel, Pfizer
David Thompson, Syneos Health
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

Michio Kimura, Hamamatsu University School of Medicine, and Hugh Levaux, Protocol First

NIH/NCATS Center for Data 2 Health (CD2H)

Melissa Haendel, OHSU, and Sam Volchenboum, University of Chicago Clinical Research Informatics

The Future of eSource Technology

Amy Nordo, Pfizer and Michael Buckley, Memorial Sloan Ketterig Cancer Center

The Future of the Case Report Forum Part 2

Shannon Labout, SCDM Board Chair 2018

Integrated Research Organizations and Site Perspectives of Research

Chad Moore, Elligo Health Research

The Future of the Learning Health Community: Taking the Consensus Action Plan Forward to Realize Learning Health Systems

Jonathan Silverstein, University of Pittsburgh and LHC Board Chair

Collaborative Models for Data Sharing

Adam Pertman, Stewards of Change

Fighting for the Soul of the Future of Health and Healthcare

Joshua Rubin, Learning Health Community

Developing Clinical Evidence to Support Innovative Medical Devices: Looking Beyond Regulatory Hurdles

Ken Skocadek, FDA/CDRH

Session Nine:
Unlocking Real-World Value for EHRs: Harmonization of Common Data Models for Real-World Evidence with Oncology Use Case

Session Chair: Michael Ibara, Elligo Health Research

2 – 3 p.m.

Panel Discussion:

Facilitators: Ken Gersing, NIH/NCATS, and Scott Gordon, FDA
Mitra Rocca, FDA
David Vulcano, Hospital Corporation of America
Sam Volchenboum, University of Chicago Clinical Research Informatics
Shrujal Baxi, Flatiron Health
Christian Reich, IQVIA
Michael Ibarra, Elligo Health Research

Session Ten:
Learning Health Systems and Partnerships

Session Chair: Joshua Rubin, Learning Health Community and Bridging Advisory Board Member

3 – 4:20 p.m.

Pillar Presentations:
Creating Learning Health Systems Through Structured, Digitized Care Plan Information from EHRs

Hidehisa Soejima, Saiseikai Kumamoto Hospital

Bridging Partnership Between the Department of Veteran Affairs and Industry for High-Quality Clinical Trials

Rick Starrs, NAVREF
Grant D. Huang, Department of Veterans Affairs

Panel Discussion:
Next Steps to Bridge the Chasm

Facilitators: Rebecca Kush, Elligo Health Research, and Joshua Rubin, Learning Health Community
Rick Starrs, NAVREF
Grant Huang, Department of Veterans Affairs
Hidehisa Soejima, Saiseikai Kumamoto Hospital
Blake Adams, Florence Healthcare
Kathleen Starr, Syneos Health

Closing Remarks:
4:20 – 4:30 p.m.
Master of Ceremonies
Jeremy Edwards, SCORR Marketing