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
Introduction Orthopedic clinical trials—characterized by complex surgical interventions, device-specific variables, and extended rehabilitation follow-ups—are prime candidates for Risk-Based Quality Management (RBQM). RBQM is an adaptive,
Alzheimer’s disease (AD) drug development is the ultimate high-stakes gamble in biopharma. For decades, it was known as the “graveyard” of promising molecules, defined by
