London Cardiovascular Device Innovation SummitAugust 28th, 2015

Presented byYale University School of Medicine

University College London Queen Mary University

The National Institute for Health Research Biomedical Research Unit and Centre at Barts and University College London NHS Trust

Program ChairsMark Caulfield – Alexandra Lansky – Anthony Mathur

Program Co-ChairsAndreas Baumbach – Mark De Belder

Charles Knight – Andrew Taylor

London Cardiovascular Device Innovation SummitFriday August 28th, 2015

The Derek Willoughby Lecture Theatre,The National Institute for Health Research Biomedical Research Unit at Barts Heart Centre and

The William Harvey Research Institute, Queen Mary University of London, Charterhouse Square London EC1M 6BQ.

8:00 am Check-In and Breakfast

8:50 am Welcome and IntroductionMark CaulfieldCo-Director, William Harvey Research Institute Alexandra LanskyDirector, Yale Heart and Vascular Clinical Research Program

SESSION I CARDIOVASCULAR INNOVATION TRENDS AND COMMISSIONING Moderator: Anthony Mathur

Session Goals: To discuss trends in CV device innovation To discuss how UK and European reimbursement can be streamlined in early

device evaluation To discuss the roles and interface of academia and the private sector in

innovation

9:00 am Device Innovation Trends in Interventional Cardiovascular Therapeutics Alexandra LanskyDirector, Yale Heart and Cardiovascular Clinical Research

9:15 am The Interface of Industry and Academia in Innovation: The Unique Perspective of a Clinician in IndustryMartin RothmanChief Medical Officer, Medtronic

9:30 am Streamlining the Commissioning Process: Aiming for an Early and Efficient Integrated Clinical, Regulatory and Reimbursement PathwayMark De Belder

9:45 am Discussion: Integrating Value Based Healthcare into Innovation and the Role of Academia

Moderator: Anthony Mathur Panel: Mark De Belder, John Martin, Martin Rothman, Alexandra Lansky, Krishna Sudhir

10:15 am Coffee Break- The Norfolk Cloister of the Charterhouse

SESSION II DIGITAL HEALTH CARE AND BIG DATA IN CARDIOVASCULAR INNOVATION AND HEALTH CARE DELIVERY Session Goals:

To discuss the goals of digital health to increase access, improve quality and compliance and reduce cost

To discuss the status and impact of digital monitoring on health care To explore the full potential of national databases in the innovation cycle To discuss the impact of health informatics and big data on population health

and innovation

Moderator: Mark Caulfield and Andrew TaylorPanel: Bart Segers, Peter Ludman, Adam Timmis, Mark De Belder, Semih Oktay, Adi Livneh, John Deanfield

10:45 am NICOR in the UK Cardiovascular Innovation Life Cycle: Role of National Databases for Cardiovascular Interventions in Streamlining Device Evaluation and Outcomes AssessmentPeter Ludman

11:00 am Population Genomics and Opportunities for Innovation in Cardiovascular DiseasesMark Caulfield

11:15 am Non invasive Hemodynamic Monitoring: Bringing Value to HealthCareAdi Livneh

11:30 am 3D Printing in Entrepreneurship and Cardiovascular Device Innovation Andrew Taylor

11:45 am Computational Modeling in Device Development: Case ExamplesSilvia Schievano

12:00 pm Hilbert Paradox: A Unique Way of Worldwide Capturing and Correlating Digital Health DataBart Segers

12:15 pm Discussion: Integrating Information Technology into Health Care: Ready for Prime Time?Moderator: Mark Caulfield and Andrew TaylorPanel: Peter Ludman, Semih Oktay, Gunnar Brandrup-Wognsen, Adi Livneh, John Deanfield, Bart Segers, Krishna Sudhir

12:30 pm Lunch- The Charterhouse and Gardens

SESSION III CORONARY INTERVENTIONS, STENTS AND SCAFFOLDS: THE NEXT GENERATION Session Goals:

To discuss remaining challenges in coronary intervention To discuss limitations of current stent technology To explore stents and scaffolds as delivery vehicles for biologics To discuss regulatory considerations and challenges in delivery of biologics

Moderator: Andreas Baumbach Panel: Anthony Mathur, Todd Brinton, Semih Oktay, Martin Rothman, Albert Sinusas, Krishna Sudhir, Gunnar Brandrup-Wognsen, Alvaro Mata

1:30 pm Unmet Clinical Need in Coronary Interventions, Stenting and ScaffoldsAndreas Baumbach

1:45 pm Lithoplasty for Calcified Vessels and Degenerative Valve Disease: In Situ Vascular RemodelingTodd BrintonCMO, Shockwave Medical

2:00 pm Smart Stents and Scaffolds: Targeted Delivery VehiclesAnthony Mathur

2:15 pm Advanced Imaging Techniques in Device Design and Targeted Biologic Therapies: The Role of Imaging in the Balance of Injury, Inflammation and HealingAlbert Sinusas

2:30 pm A Practical US Regulatory Roadmap for Combination Products: How to Get There?Semih Oktay

3:00 pm Discussion: The Bright Future of Percutaneous Vascular Intervention-Next FrontiersModerator: Andreas Baumbach Panel: Anthony Mathur, Todd Brinton, Semih Oktay, Martin Rothman, Albert Sinusas, Krishna Sudhir, Gunnar Brandrup-Wognsen, Alvaro Mata

3:30 pm Tea in the Norfolk Cloister of the Charterhouse

SESSION VI ADVANCES IN REGENERATIVE MEDICINE FOR THE HEART Session Goals:

To review current status of Stem Cell and pluripotent cell therapy in AMI To discuss novel tissue engineering applications To discuss different applications of gene therapy To discuss the role of nanotechnology and nanomaterial in regenerative

medicine

Moderator: John MartinPanel: Anthony Mathur, Alvaro Mata, Ken Suzuki, Semih Oktay, Alexander Seifalian, Martin Rothman

4:00 pm Autologous Stem Cell Therapy in Acute Myocardial Infarction: Lessons learnedAnthony Mathur

4:15 pm Nanocomposite Polymeric Percutaneous Aortic Valve: Design and Durability Features Alexander Seifalian

4:30 pm Biomaterial-Mediated Epicardial Placement of Stem Cells for Cardiac RepairKen Suzuki

4:45 pm Local Intrauterine Delivery of Gene Therapy in Growth RetardationJohn Martin

5:00 pm Smart Nanomaterials for Regenerative MedicineAlvaro MataDirector, Institute of Bioengineering

5:15 pm DiscussionModerator: John MartinPanel: Anthony Mathur, Alvaro Mata, Ken Suzuki, Semih Oktay, Alexander Seifalian, Martin Rothman

5:45 pm Closing remarks: Charles Knight

6:00 pm Reception in the Great Chamber of the Masters Court of the Charterhouse