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Recent progress in the clinical translation of stem cell-derived beta cells has generated tremendous excitement. However, there is still a long road ahead to the development of successful products. Stem cell-based therapies continue to face challenging and time-consuming regulatory requirements and require new approaches by academia, industry and healthcare systems. Regulations and standards must be put in place to ensure the ethical integrity while removing unnecessary barriers slowing implementation of stem cell-based therapies. The standardization of cell culture protocols and the execution of good manufacturing practices for the manipulation of these cells are crucial. Finally, the rapid progression of biologic medicinal products toward the clinic brings challenges of scaling-up and deployment that will require new extended supply chains and innovative treatment modalities necessitating partnership between healthcare providers and industry. This Q&A session will bring together basic and clinical scientists, ethicists and regulators to discuss these and other challenges that lie ahead for the development of stem cell-based treatments for diabetes.
Prof. Bruce S. Schneider, United States
Panelist on Regulatory landscape for stem cell based therapies
Dr. Gary Meininger, United States
Panelist on Regulatory landscape for stem cell based therapies
Christopher Bravery, United Kingdom
Panelist on Regulatory landscape for stem cell based therapies
Dr. A.M. James Shapiro, Canada
Panelist on Clinical field of cell based therapies for diabetes
Dr. David M. Thompson, Canada
Panelist on Clinical field of cell based therapies for diabetes
Dr. Daniel Pipeleers, Belgium
Panelist on Clinical field of cell based therapies for diabetes
Rosario Isasi, United States
Panelist on Ethical/ social/ legal aspects of stem cell based therapies
Tania Bubela, Canada
Panelist on Ethical/ social/ legal aspects of stem cell based therapies
