London Cardiovascular Device Innovation Summit August 28th, 2015 Presented by Yale 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 Chairs Mark Caulfield – Alexandra Lansky – Anthony Mathur Program Co-Chairs Andreas Baumbach – Mark De Belder Charles Knight – Andrew Taylor London Cardiovascular Device Innovation Summit Friday 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 Introduction Mark Caulfield Co-Director, William Harvey Research Institute Alexandra Lansky Director, 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 Lansky Director, Yale Heart and Cardiovascular Clinical Research 9:15 am The Interface of Industry and Academia in Innovation: The Unique Perspective of a Clinician in Industry Martin Rothman Chief Medical Officer, Medtronic 9:30 am Streamlining the Commissioning Process: Aiming for an Early and Efficient Integrated Clinical, Regulatory and Reimbursement Pathway Mark 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 Taylor Panel: 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 Assessment Peter Ludman 11:00 am Population Genomics and Opportunities for Innovation in Cardiovascular Diseases Mark Caulfield 11:15 am Non invasive Hemodynamic Monitoring: Bringing Value to HealthCare Adi Livneh 11:30 am 3D Printing in Entrepreneurship and Cardiovascular Device Innovation Andrew Taylor 11:45 am Computational Modeling in Device Development: Case Examples Silvia Schievano 12:00 pm Hilbert Paradox: A Unique Way of Worldwide Capturing and Correlating Digital Health Data Bart Segers 12:15 pm Discussion: Integrating Information Technology into Health Care: Ready for Prime Time? Moderator: Mark Caulfield and Andrew Taylor Panel: 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 Scaffolds Andreas Baumbach 1:45 pm Lithoplasty for Calcified Vessels and Degenerative Valve Disease: In Situ Vascular Remodeling Todd Brinton CMO, Shockwave Medical 2:00 pm Smart Stents and Scaffolds: Targeted Delivery Vehicles Anthony 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 Healing Albert 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 Frontiers Moderator: 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 Martin Panel: Anthony Mathur, Alvaro Mata, Ken Suzuki, Semih Oktay, Alexander Seifalian, Martin Rothman 4:00 pm Autologous Stem Cell Therapy in Acute Myocardial Infarction: Lessons learned Anthony 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 Repair Ken Suzuki 4:45 pm Local Intrauterine Delivery of Gene Therapy in Growth Retardation John Martin 5:00 pm Smart Nanomaterials for Regenerative Medicine Alvaro Mata Director, Institute of Bioengineering 5:15 pm Discussion Moderator: John Martin Panel: 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