Courtesy of The Healthcare Channel, Dr. Janet Woodcock, the Director of the FDA’s drug division, CDER, discusses the newly created “Breakthrough” pathway for new drug applications. Distinct from Fast-track, a drug will receive a “Breakthrough” designation if, during early clinical trials, the drug shows significant efficacy for serious and life-threatening diseases. The new pathway could be a paradigm change for drugs in development to treat Alzheimer’s, ALS, and many other diseases.
August 29, 2010
Since the ICAD meeting in July, the topic of surrogate markers to diagnose Alzheimer’s in younger patients decades before noticeable onset of dementia has received considerable mainstream press. We interviewed Alzheimer specialist Richard Isaacson of Miami about how these new markers will change current therapy or speed drug development.
Lon Schneider, MD, Director of USC’s Alzheimer’s Center, discusses the new lexicon to discuss prodromal Alzheimer’s and the new biomarkers to diagnose AD decades sooner than current methods. These new methods promise to expedite clinical trials and drug development, but pose challenges for the current day clinician.
Dr. Walter Bradley, Chairman Emeritus, Department of Neurology, The University of Miami School of Medicine, discusses the new theory on the etiology of Amyotrophic Lateral Sclerosis (ALS, Lou Gehrig’s Disease) and some new drugs in development that might prolong survival.
In Part 1, Dr. Bradley discusses the new theories from Boston that ALS is caused by brain trauma.
In Part 2, he discusses new drugs in the pipeline.
Alzheimer's Disease, FDA, Neurology, Policy | apples49 | 
March 30, 2013 8:00 am | 
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