8:00 – 10:00 AM      

Session 3: Option Two, Heart Track: Rise of the Machines - Regulatory Considerations in MCS Therapy*

Moderators: Liviu Klein, MD                                                  

Rondalyn Ford-McLean, MD

8:00 AM    LVADs as Destination Therapy- When Best Practice Criteria Meets the Real World

                   Farooq Sheikh, MD

8:15 AM    The Total Artificial Heart – What Metrics Should be Met for Standard Use? For Future Technology

                    Francisco Arabia, MD

8:30 AM    ECMO and Short Term Support -Utilization Guidelines and Impact of the New Heart Allocation Sytem

                   Jeffrey Teuteberg, MD 

8:45 AM    MCS Complications-Understanding Risks and Rewards in the Context of Appropriate Use Benchmarks

                    Liviu Klein, MD

9:00 AM    DEBATE:

                    Innovation in MCS Technology is Helped by Regulation

                     Palak Shah, MD

                     Innovation in MCS Technology is Hindered by Regulation

                      O.H. Frazier, MD

9:30 AM    The Cost of Success vs the Cost of Failure – Financial Considerations in Advancing Innovation

                     Simon Maltais, MD

8:00 – 10:00 AM      

Session 3: Option Three, Lung Track: The Evolution of Lung Support Devices - Regulatory Considerations in Lung Transplantation*

Moderators: Sangeeta Bhorade, MD                        

Christopher Wigfield, MD

8:00 AM    DEBATE: ECMO as a Bridge to Transplant Should be Exempt from 1 Year Mortality Outcomes in Lung Transplant

- Con

Charles Hoopes, MD

– Pro

Duane Davis, MD           

8:40 AM    DEBATE: Ex Vivo Lung Perfusion is an Essential Tool for Donor Optimization

 – Pro

Shaf Keshavjee, MD

– Con

Thomas Egan, MD, MSc

9:20 AM    The Regulatory Imperative – Impact on the Practice of Lung Transplant

                    Christopher Wigfield, MD

9:35 AM    Regulatory Realities – Redefining Benefit of Lung Transplant in the Current Era

                   Gundeep Dhillon, MD, MS

Break

10:15 – 12:15 PM     Session 5: Option One, Program-Specific Reports: Past, Present and Future. Where do we go from here?*

Moderators: Jesse Schold, PhD, M. Stat, M. Ed                          

John Gill, MD, MS

10:15 AM      The Past

                     Bertram Kasiske, MD 

10:45 AM      The Present

                     Jon Snyder, PhD

Shelley Hall, MD

10:15 AM      DCD Heart Donation – Understanding the Regulatory and Ethical Issues

                    Val Jeevanandum, MD

10:35 AM      Xenotransplantation – Promise and Pragmatism

                    Robin Pierson, MD

10:55 AM      Whole Organ Engineering – Science and Sensibility

                    Doris Taylor, MD 

11:15 AM      Stem Cell Therapy – Engineering Process

                    Lawrence Czer, MD 

11:35 AM      Ex Vivo Heart Perfusion – Removing Time and Distance Barriers

                    Abbas Ardehali, MD

10:15 – 12:15 PM        

Session 5: Option Three, Lung Track: Trials, Tribulations and Triumphs in Lung Transplant Innovations

Moderators: Martin Zamora, MD                                           

Duane Davis, MD

10:15 AM      Cell Free DNA and Other Immune Monitoring Techniques in Lung Transplantation – Are We There Yet?

                    David Neujhar, MD

10:35 AM      Controlled Donation After Determination of Circulatory Death (cDCDD) – Improving Yield

                    Michael Smith, MD 

10:55 AM      Xeno Lung Transplantation – The Path Forward

                    Agnes Azimzadeh, PhD 

11:15 AM      Extracorporeal Lung Support – A Bridge Too Far?

                   Jonathan D’Cunha, MD

11:35 AM      The Artificial Lung – Can it be Realized?

                    Williams Federspiel, PhD

12:15 – 1:00 PM Congressional Keynote Speaker

The Honorable Congresswoman Jaime Herrera Beutler (R-WA)
U.S. House of Representatives

8:30 – 10:00 AM       

Session 6: Option One, Clinical Therapeutics to Improve Patient Outcomes - The Tribulations of Trials in Transplantation*

Moderator: Roy Bloom, MD            

Roslyn Mannon, MD

8:30 AM      Tracking Transplant Treatment Trials - Where Are We and What are the Barriers

                    Roy Bloom, MD 

9:00 AM      Victims of Success- Do We Still Need Clinical Trials and If So, What are Our Needs

                   Robert Gaston, MD 

9:30 AM      Can We Get There? Re-Thinking Clinical Trial Design

                   Jesse Schold, PhD 

9:45 AM      Panel Discussion with:

                   Renata Albrecht, MD

                   Peter Maag, PhD

                   Kevin Campbell 

8:30 – 10:00 AM       

Session 6: Option Two, Case Studies in Thoracic Transplantation - Integrating Innovation

Moderators: Jon Kobashigawa, MD            

Nicholas Braus, MD

8:30 AM      Extended Criteria Heart vs Destination LVAD

                    Liviu Klein, MD and Mahwash Kassi, MD

8:45 AM      Hep-C Heart and Lung Transplantation

                    Shelley Hall, MD and Luke Cunningham, MD 

9:00 AM      Ex Vivo Lung

                    Jonathan D’Cunha, MD and Lara Schaheen, MD 

9:15 AM      Ex Vivo Heart

                   Jason Smith, MD and Tori Lennox, MD 

9:30 AM      DCD Lung

                    Martin Zamora and Nicholas Braus, MD 

Session 8: Out of Synch - How Can Factors That Drive OPO and Transplant Center Practice be Aligned to Increase the Number of Patients Who Receive a Transplant*

Moderators: John Gill, MD, MS                    

Dave Foley, MD, FACS

1:30 PM      Critique of the Current OPO Performance Metrics and Proposed Improvement

                    Characteristics of an Optimal OPO Metric

                     David Goldberg, MD, MSCE

                     My Pick for A New OPO Metric

                     Elling Eidbo, MBA

1:45 PM      Regulatory and Financial Considerations That Impact OPO Performance – What Changes Would Increase Transplantation?

                    Kevin O’Connor, MS, PA

2:00 PM      Regulatory and Financial Considerations That Impact Transplant Center Practice – What Changes Would Increase Transplantation?

                    Matthew Cooper, MD

2:15 PM      Reaction to the Proposed Solutions

                    Brian Shepard, MBA

2:30 PM      Panel Discussion with:

                     Jon Snyder, PhD