Alternative Regulatory Pathways for Rare Disease: Breaking the ICE

April 25, 2016 Tim Franson, MD



There is a heightened sense of urgency by all stakeholders to accelerate development of therapies for rare disease.  The FDA shares this urgency, but it also must protect the public safety and follow the well-defined laws and regulations governing the process.

The challenge (or opportunity) is to develop creative approaches, which accelerate access and stay within the regulatory boundaries – or find ways to shape the boundaries.  Intermediate Clinical Endpoints, or ICE, could represent one such approach. 

I sat down with Dr. Joe Lamendola on April 7th to discuss this approach, and you can listen/watch the full converation below. 

You can download the slides for your reference, and leave a comment below if you have questions. I hope you enjoy. 


  watch the recording - alternative regulatory pathways - franson and lamendola


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