3D Tissue Models
REGEN 2013: Clinical Trials & Reimbursement
Charter House
13-15 Carteret Street
London, UK
REGEN 2013: Clinical Trials & Reimbursement
Charter House

Schedule of Presentations:

Tuesday, March 19, 2013
06:00:00 New Presentation
08:00:00 Registration, Coffee & Networking
08:20:00 Chair’s Opening Remarks Lee Buckler
08:30:00 Building the Bridge to Clinical Trials in Regenerative Medicine - How do we Improve Translation
09:00:00 The Cell Therapy Industry Clinical Pipeline and the Story of the Moving Hockey Stick Lee Buckler
09:30:00 Reimbursement Considerations for Medical Devices: A Payor’s Perspective Naomi Aronson
10:00:00 Speed Networking & Morning Refreshments
11:30:00 Cell Therapy Clinical Trials: Effective Trial Design Gregory Bonfiglio
12:00:00 A 20 Year Perspective of Clinical Trial Development for CVD: Lessons and Directions Warren Sherman
12:30:00 Lunch & Networking
13:30:00 Selecting the Most Suitable Biomarkers for your Cell Therapy Development Program
14:00:00 Cost Effectiveness: Critical for Reimbursement and Investment George Emont
14:30:00 Achieving Regulatory Approval and Reimbursement for your Cellular Therapy Across Multiple Markets
15:00:00 Designing Clinical Trials with Economic Endpoints to Achieve Regulatory Approval and Reimbursement Rahul Aras
15:30:00 Afternoon Refreshments & Networking
16:00:00 Overcoming the Challenges of Later Stage Development for Regenerative Medicine Products Gloria Matthews
16:30:00 Quality Control and Biosafety Testing of Clinical Reagents and Patient Cells
17:00:00 Achieving Scaled Manufacturing of Stem Cells in Preparation for Advanced Clinical Investigations
17:30:00 Chair’s Closing Remarks
Wednesday, March 20, 2013
06:00:00 New Presentation
06:00:00 New Presentation
06:00:00 New Presentation
06:00:00 New Presentation
Thursday, March 21, 2013
08:00:00 Registration, Coffee & Networking
09:20:00 Chair’s Opening Remarks Gregory Bonfiglio
09:30:00 Developing and Implementing the Appropriate Business Strategies for Regenerative Medicines
10:00:00 Round Table Discussions
11:00:00 Morning Refreshments & Networking
11:30:00 Understanding the Clinical Trial Strategy for a Cell Therapy for an Acute Neurological Indication Robert Deans
12:00:00 Clinical Trial Design of Placental Derived Adherent Cells in Crohn’s Disease and Multiple Sclerosis
12:30:00 Lunch & Networking
13:30:00 Baxter Phase III Program in Refractory Angina and Chronis Myocardial Ischemia Adel Nada
14:00:00 Are we One Step Closer to a Stem Cell Therapy for Stroke Disability? John Sinden
14:30:00 Afternoon Refreshments & Networking
15:00:00 Clinical Study Evaluation of MultiStem: An Adult Bone Marrow Stem Cell Product in Allogeneic Hematipoietic Stem Cell Transplantation Wouter Van’t Hof
15:30:00 Development of Novel Cellular Therapies Utilizing Patient-Specific Pluripotent Stem Cells Brian Davis
16:00:00 Chair’s Closing Remarks
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