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Wednesday, April 4
7:00-7:45 am
Exhibitor Access to Set Up/Registration and Continental Breakfast
7:45-8:15 am
Welcome to the Bridging Clinical Research & Clinical Health Care Collaborative
8:15-8:45 am
Collaborative Keynote Presentation
Bridging Regulatory
Sponsored by: 
8:45-9:45 am
Bridging Regulations to Real-World Health Care
Session Moderator: Jeff Wendel, President, Advarra
Regulatory Guidance on the Use of Electronic Health Records for Clinical Research
- Leonard Sacks, MD, Acting Deputy Director, Office of Medical Policy, CDER, FDA
New Laws and Regulations Affecting Expanded Access, Research, Consent and IRB Oversight
- David Vulcano, LCSW, MBA, CIP, RAC, Assistant Vice President and Responsible Executive for Clinical Research, HCA Healthcare
Using eConsent to Improve Patient Understanding and Regulatory Compliance
- Michele Russell-Einhorn, JD, Chief Compliance Officer and Institutional Official, Advarra
9:45-10:30 am
Harmonization of Common Data Models to Facilitate the Generation of Real-World Evidence
Session Moderator: Mitra Rocca, Associate Director, Medical Informatics, FDA
Harmonization of Various Common Data Models and Open Standards for Evidence Generation
- Mitra Rocca, Associate Director, Medical Informatics, FDA
Oncology Use Case for the PCORTF Model Harmonization Project
- Sean Khozin, MD, MPH, Associate Director (Acting), Oncology Center of Excellence, FDA
Panel Discussion
- Michael Ibara, PharmD, Owner, Michael Ibara LLC
- Panelists invited from NIH, ONC, PCORI, ODHSI and Harvard (Sentinel, PCORI and i2b2)
10:30-11:00 am
Networking Break and Exhibits
11:00 am-12:00 pm
Regulatory Implications and Opportunities With New Technology in Clinical Research
Case Study: Use of Wearables and Sensors in Clinical Trials by University of Chicago and Litmus Health
- Sam Volchenboum, MD, PhD, Director, Center for Research Informatics, The University of Chicago
Case Study: Biometric Monitoring Devices for Assessing Endpoints in Clinical Trials: Developing an Ecosystem
- Stephen Arneric, PhD, Executive Director, Coalition Against Major Diseases, and Professor of Research, University of Arizona College of Medicine
Case Study: FDA/CDER Regulations and Guidance for the Use of Devices in Clinical Research
- Ken Skodacek, MS, Policy Analyst, Clinical Trials Program, Center for Devices and Radiological Health, FDA
12:00-1:00 pm
Networking Lunch and Exhibits
Bridging Technology
Sponsored by: 
1:00-2:00 pm
Creating Synergies Between Health Care and Clinical Trial Data Through Technology
Session Moderator: Karim Damji, Senior Vice President, Product Management and Marketing, Saama
- Karim Damji, Senior Vice President, Product Management and Marketing, Saama with Pharma Company Representative
How AI is Transforming Patient Recruitment for Clinical Trials
- Eric Gildenhuys, Vice President of Business Development, Deep 6 AI
2:00-3:00 pm
Role of Electronic Health Records in Bridging Research With Health Care
Session Moderator: Rebecca Kush, PhD, Scientific Innovation Officer, Elligo Health Research
Current Uses of Electronic Health Records for Clinical Research, Moving Toward a Learning Health System
- Rebecca Kush, PhD, Scientific Innovation Officer, Elligo Health Research
Panel Discussion:
- Jose Galvez, MD, NIH Clinical Center
- Lauren Becnel, PhD, Vice President of Strategy and Innovation, CDISC
- Hugh Levaux, PhD, Founder and CEO, Protocol First
- Era Prakash, MHSA, Director, Product Management, Allscripts
- Prasanna Rao, Offering Leader, IBM Watson Health
- Komathi Stem, MSE, Founder and CEO, monARC Bionetworks
3:00-3:30 pm
Networking and Exhibits
3:30-5:00 pm
Bridging Clinical Research and Clinical Care in Precision Oncology
Oncology Keynote Speaker: Laura Esserman, MD, MBA, Director, UCSF Carol Franc Buck Breast Care Center
How to Build Knowledge Networks and Expert Physician Networks
- George Lundberg, MD, Chief Medical Officer, Self Care Catalysts
Additional Presentations By:
- B.J. Rimel, MD, OB/GYN, Gynecologic Oncologist, Cedars-Sinai Medical Center
- Marty Tenenbaum, PhD, Founder and Chairman, Cancer Commons
- Laura Esserman, MD, MBA, Director, UCSF Carol Franc Buck Breast Care Center
5:30-7:00 pm
Networking Reception, sponsored by: 
Thursday, April 5
7:00-8:00 am
Patient Advocacy Matching Breakfast
Opportunity for attendees to meet with various patient advocacy groups.
Moderator: John Lewis, MA, Consultant, Intersect Strategies
Participants:
- Sarah Berk, MPH, Associate Director, Research Partnerships, The Michael J. Fox Foundation for Parkinson’s Research
- Keith Fargo, PhD, Director of Scientific Programs and Outreach, Alzheimer’s Association
- Hrant Jamgochian, JD, LLM, Chief Executive Officer, Dialysis Patient Citizens
- Amy Miller, PhD, President and CEO, Society for Women’s Health Research
- Andrew Spiegel, JD, Executive Director, Global Colon Cancer Association and Global Pneumonia Prevention Coalition
Bridging People and Processes
8:00-8:15 am
Welcome to the Collaborative/Introduction to Bridging People and Processes
8:15-8:45 am
Bridging People and Processes Keynote Presentation
8:45-9:15 am
Patient Keynote Presentation
9:15-10:15 am
Patient Perspective on Research and Health Care
Session Moderator: Josh Rubin, JD, MBA, Program Officer for Learning Health System Initiatives, University of Michigan Learning Health Sciences
Patient Empowerment and the Learning Health System
- Josh Rubin, JD, MBA, Program Officer for Learning Health System Initiatives, University of Michigan Learning Health Sciences
Additional Presentation By:
- Andrew Spiegel, JD, Executive Director, Global Colon Cancer Association
Enhancing Clinical Trial Design Through the Patient Journey
- Sarah Berk, MPH, Associate Director, Research Partnerships, The Michael J. Fox Foundation for Parkinson’s Research
10:15-10:30 am
Networking Break and Exhibits
10:30-11:45 am
CRO Perspective: Bridging Clinical Trial Processes to Real-World Health Care
Session Moderator: David Windley, MBA, Managing Director, Jefferies LLC
The Use of Real-World Diagnostic Data to Inform Clinical Trial Design Optimization
- Bill Hanlon, PhD, Chief Development Officer, Regulatory Affairs, Strategic Product Development, Market Access Solutions, Covance
Additional Presentations By:
- David Windley, MBA, Managing Director, Jefferies LLC
- Clare Grace, PhD, Vice President, Site and Patient Access, Syneos Health
- Kent Thoelke, Chief Scientific Officer, PRA Health Sciences
11:45 am-12:45 pm
Media Roundtable Lunch and Exhibits
12:45-1:45 pm
Established Bridges: Health Care Integrations With Clinical Research
Session Moderator: Kurt Mussina, MBA, General Manager, Frenova Renal Research
- Kurt Mussina, MBA, General Manager, Frenova Renal Research
- Dee Anna Smith, Chief Executive Officer, Sarah Cannon
- Jennifer Weis, Business Analyst, Mayo Clinic
1:45-2:30 pm
New and Returning Investigators: Why Clinicians Choose to Add Clinical Trials to Their Practice (Or Not)
Session Moderator: Deirdre BeVard, Chief Operating Officer, Elligo Health Research
- Ken Getz, MBA, Director of Sponsored Research, Associate Professor, Center for the Study of Drug Development, Tufts University School of Medicine
Panel Discussion:
- Peter Glass, MD, ChB, FFA, Chief Medical Officer, Advantia Health
- Christian Burns, President of Clinical Operations and Marketing, ClinEdge
- Raymond Nomizu, JD, Co-Founder, Clinical Researh IO
2:30-4:00 pm
Pharma’s Role in Bridging Clinical Research and Health Care
Session Moderator: Joseph Kim, Senior Advisor, Clinical Innovation, Eli Lilly and Company, TransCelerate
- Ken Getz, MBA, Director of Sponsored Programs, Research Associate Professor, Center for the Study of Drug Development, Tufts University School of Medicine
TransCelerate’s Clinical Research Awareness Initiative
- Joseph Kim, Senior Advisor, Clinical Innovation, Eli Lilly and Company, TransCelerate
- Craig Lipset, Head of Clinical Innovation, Pfizer
4:00-4:15 pm