Exhibitor Access to Set Up/Registration and Continental Breakfast
Welcome to the Bridging Clinical Research & Clinical Health Care Collaborative
Collaborative Keynote Presentation
Bridging Regulatory

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
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)
Networking Break and Exhibits
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
Networking Lunch and Exhibits
Bridging Technology

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
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
Networking and Exhibits
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
Networking Reception, sponsored by: 
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
Welcome to the Collaborative/Introduction to Bridging People and Processes
Bridging People and Processes Keynote Presentation
Patient Keynote Presentation
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
Networking Break and Exhibits
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
Media Roundtable Lunch and Exhibits
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
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
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