Recent FDA Hearing Highlights ALS Drug Development Concerns

On February 25, 2013 the FDA held the first ever public hearing on ALS. The hearing included testimony from clinicians, scientists, various ALS organizations, industry representatives, as well as patients and families. Prize4Life Scientific Advisory Board Member and ALS Association Chief Scientist Dr. Lucie Bruijn discussed the need to work collaboratively to accelerate treatments and a cure for ALS. “It is absolutely critical that the FDA and the ALS community come together to not only identify the obstacles and challenges of ALS drug development but also to find the solutions,” said Dr. Bruijn. Dr. Jonathan Glass, director of the Emory ALS Center and site investigator on the recently completed Neuralstem Phase I clinical trial, echoed Dr. Bruijnā€™s comments and offered some potential solutions. Dr. Glass suggested “In order to move faster toward effective therapeutics, it may be necessary to develop short, less-expensive trials to determine if a drug can hit a therapeutic target in order to test therapeutic hypotheses, prior to the initiation of efficacy trials. This will give a quicker answer to whether a potential therapeutic has any chance of success in treating ALS.”

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