George Vradenburg is the co-founder and chairman of USAgainstAlzheimer's, a patient advocacy organization founded in 2010, which has successfully worked to increase funding for Alzheimer’s and dementia research. Along with his philanthropic activities, George Vradenburg is also a very successful corporate lawyer and has been the Executive Vice President of AOL Time Warner and the Fox Broadcasting Company.

The podcast discusses the current state of Alzheimer's research and the potential impact of CMS guidance requiring confirming clinical trials for new treatments targeting Amyloid plaques in its prevention. We also highlight a growing consensus of concern surrounding CMS' current guidance as unintended consequences will likely be detrimental to future therapy developments in high unmet medical need areas.  The FDA's accelerated approval pathway itself is now also at risk as therapies developed for high unmet medical needs have historically utilized this FDA-approved pathway.

The views expressed in the podcast are purely those of Vital Transformation LLC and our guest, George Vradenburg.  While Biogen commissioned and funded Vital Transformation’s recent report on CMS’ impact on Draft National Coverage Determination on R&D investments, Biogen did not participate in the content creation.