Thursday 21st March 2013
9.00 Registration, Coffee & Networking
9.20 Chair’s Opening Remarks
9.30 Developing and Implementing the Appropriate Business Strategies for Regenerative Medicines
Clinical Trial Execution: Learning From Industry Case Studies
10.00 Clinical Trial Design of Placental Derived Adherent Cells in Crohn’s Disease and Multiple Sclerosis
10.30 Morning Refreshments & Networking
Clinical Trial Execution: Learning From Industry Case Studies
11.00 Baxter Phase III Program in Refractory Angina and Chronis Myocardial Ischemia
11.30 Round Table Discussions
- How can we optimize clinical trial design for regenerative medicine products?
- Achieving regulatory approval and reimbursement for your cellular therapy
- Preparation of INDs and planning/conducting Pre-IND and Pre-BLA meetings
Our round table discussions are designed for you to access the perspectives of multiple stakeholders across the industry. Take away multiple new ideas for your clinical strategies and gain diverse perspectives and solutions to the problems you’re facing.
Round Table Leaders
Gregory Bonfiglio, Founder & Managing Partner, Proteus Venture Partners
Patrick Ginty, Regulatory Affairs Manager, Cell Therapy Catapult Limited
Kate Giovino, Vice President of Clinical Operations, Organogenesis
12.15 Lunch & Networking
1.15 Are we One Step Closer to a Stem Cell Therapy for Stroke Disability?
1.45 Clinical Study Evaluation of MultiStem: An Adult Bone Marrow Stem Cell Product in Allogeneic Hematipoietic Stem Cell Transplantation
Emerging Approaches in Cell Therapy: Will iPS Cell Therapies Face Similar Challenges in The Clinic?
2.15 Development of Novel Cellular Therapies Utilizing Patient-Specific Pluripotent Stem Cells
2.45 Chair’s Closing Remarks
