The rate of discovery and approval of new medicines is declining despite substantially increased investment. Safety and efficacy failures are caused by:
• Highly novel targets, for which there is limited knowledge of the biology and role in human disease
• Diseases that are poorly understood in terms of pathophysiologic mechanisms, such as chronic obstructive pulmonary disease, osteoarthritis, and Alzheimer's disease
• Limitations in the animal models of human disease
• Limited biomarkers to optimize treatment
The pharmaceutical industry is preeminent in moving compounds from discovery through the development phases. Its scientific and technological expertise is phenomenal - from molecular modeling to protein engineering to metabolic pathways for compounds/biologics - all are industry proficiencies.
With such obvious strength and leadership from industry, why are we in the current crisis? Simply put, despite the huge investment and technological successes, organizational and process weaknesses prevent the effective translation of...