IBC's Inaugural Cell Therapy Clinical Development Conference
10th September 2012 — 11th September 2012
Overcoming Regulatory and Reimbursement Hurdles to Translate Promising Cell-based Assets into Clinical Commercial Success
Cell Therapy has come of age.
Today there are over 200 companies involved in cell-based therapeutics including cell/stem cell therapy, tissue engineering and gene therapy, with approximately 30% of the companies said to be in commercial product stage, and another 30% in clinical trial stage, indicating a fast growing industry with a robust pipeline.
With the fast growth and huge potential naturally comes a host of challenges, roadblocks and pitfalls. This conference will bring the most pertinent topics including regulations, reimbursement, ethics, preclinical translation and clinical trials to the forefront, and showcase case studies, first-hand accounts and strategies that will help companies put these obstacles in perspective.
Join 30 industry leading CEOs, CSOs, Senior VPs and Directors from companies in US, UK, Germany and Israel to review what failed, what worked, and what's ahead in this highly promising yet challenging industry!
Featuring 13 Cell Therapy Clinical Trial Updates and Commercialization Strategies!
- Janssen outlines their strategies on navigating the different regulatory approaches of US and Europe toward cell therapies
- Advanced BioHealing presents lessons learned from Dermagraft's numerous coding, coverage and reimbursement challenges over the last 12 years
- CIGNA, Sanofi Biosurgery, Oregon Health & Science University relay strategies to gain coverage and reimbursement for innovative cell-based therapies
- Stanford University, Roslin Cells UK and Humacyte explore challenges in translating a novel technology into preclinical and clinical success
- Aldagen, Athersys, BioHeart, Cardio3, Cellerant, Immunovative Therapies, Intercytex, Medipost, NovaRx, ReNeuron, San Bio, University Children's Hospital and VIRxSYS share their clinical development and commercialization strategies..
Why Cell Therapy Trials Fail
Founder & Managing Partner
Proteus Venture Partners
Do Greater Regulations lead to Higher Ethics?
Kenneth K. Kleinhenz
Vice President, Regulatory Affairs and Quality Assurance
Cytori Therapeutics Inc.
Strategies to Gain Coverage and Reimbursement - What Are The Options and Challenges?
Special Introductory Remarks and Moderator:
Michael Werner, J.D., Partner, Holland & Knight, LLP and Executive Director, Alliance for Regenerative Medicine
Managing High Risk Stem Cell Tourism and Upholding Patient Safety
Kenneth K. Kleinhenz, Vice President, Regulatory Affairs and Quality Assurance, Cytori Therapeutics
Expected Number of Attendees
View Conference Website: IBC's Inaugural Cell Therapy Clinical Development Conference
Price of Attendance
DoubleTree by Hilton Hotel