Evidence Generation
The Development Alignment Gap
Why Clinical Development Programs Fail Before FDA Ever Reviews the Data A Strategic Perspective on Evidence Generation, Regulatory Alignment, and Development Success Denis Katz, MD
Why Clinical Development Programs Fail Before FDA Ever Reviews the Data A Strategic Perspective on Evidence Generation, Regulatory Alignment, and Development Success Denis Katz, MD
Denis Katz, M.D. Founder & Medical Director, Salience Clinical LLC Introduction The optimism surrounding psilocybin is not unfounded. Early clinical findings have been striking enough
Executive Summary In today’s highly competitive pharmaceutical landscape, Medical Affairs leadership plays a pivotal role in determining whether innovative therapies achieve rapid adoption or underperform.
By Denis Katz, MD, MHAFounder, Salience Clinical, LLC For decades, psychiatry has framed major depressive disorder (MDD) as a disorder of chemistry, an imbalance of
From Syndromes to Signatures: The Strategic Rewiring of CNS Drug Development Executive Summary For decades, neurology has been governed by syndromes—clusters of symptoms standing in
By Denis Katz, MD Strategic Frameworks for Clinical, Regulatory, and Commercial Success Founder, Salience Clinical, LLC Executive Summary Musculoskeletal regenerative medicine programs with rigorous biomarker