Webinar: Focus on the Eye

Return to CIRM Meetings and Events

Webinar: Focus on the Eye

Presentations from FDA and Leading Experts

May 2, 2012

The Webinar was held on May 2, 2012

• Click here to watch and listen to a recording of the webinar.
   

Slides for each presenter are also available by clicking on the links below.

Moderator: Ellen Feigal, MD, Senior Vice President of Research and Development, CIRM

Speakers:

• Samuel Barone, MD, [download slides] Medical Officer, Office of Cellular, Tissue and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA)
• Gary Rabin, Chairman and CEO, Matthew Vincent, Ph.D., [download slides] Director of Business Development, and Edmund Mickunas, Vice President of Regulatory Affairs, Advanced Cell Technology (ACT)
• Mark Humayun, MD, Ph.D., [download slides] Professor of Ophthalmology, Biomedical Engineering and Cell and Neurobiology at the Keck School of Medicine of the University of Southern California (USC) as well as the associate director of research at the Doheny Retina Institute at USC
   

Topics to be covered:

• Presentation by FDA – overview of FDA regulations for Cellular and Gene Therapies for Retinal Disorders including combination products
• Examples of issues and challenges of taking an ophthalmic product through to an Investigational New Drug (IND) application
• Points to consider in clinical trial design for retinal disorders – immune monitoring and selecting appropriate endpoints
• Questions and Answers A written set of the questions and answers is posted here [pdf]

Background material:

• CIRM Macular Degeneration Fact Sheet
• List of awarded CIRM grants related to vision loss
• Funding opportunities
  • CIRM: Strategic Partnership I Awards – RFA 12-05 Applications due June 26, 2012
  • Department of Health and Human Resources, National Institute of Health, National Eye Institute: Stem Cell Approaches for Developing New Therapies for Ocular Diseases (R01) – RFA-EY-12-001 Applications Due July 2, 2012
• Research conferences and meetings related to vision loss
  • Louis J. Fox Center for Vision Restoration, 2012 Conference: Regenerative Medicine in Ophthalmology, May 11, 2012, University of Pittsburgh, Pennsylvania [Click here for more information]
  • 6th Sayer Vision Research lecture and NEI Symposium on Stem Cells, April 16, 2012. The intramural science program of the National Eye Institute, in collaboration with the NIH Center for Regenerative Medicine, is organizing its second symposium on Stem Cells, to be held on the NIH Campus in Bethesda on Monday, April 16, 2012. The symposium will focus on advances in stem cells research as they relate to ocular physiology and disease analysis. [Click here for more information]
  • FDA’s Cellular, Tissue and Gene Therapies Advisory Committee Meeting Presentation: Cellular and Gene Therapies for Retinal Disorders, June 29, 2011 [Click here for more information]
• Stem cell therapeutic applications in opthamology
  
• Stem cell companies active in opthamology
  
• Ongoing & Completed Clinical Trial Details for Stem Cell/ Cell Therapy in Ophthalmology
  
• charts supplied by Irv Arons and are current as of June 2013

 

---