Perestroika in pharma: evolution or revolution in drug development?

Area of Science:

• Biomedical Science
• Drug Discovery and Development
• Regulatory Science

Background:

• New drug approvals have plateaued since 1950.
• The cost of drug development has significantly increased.
• The current model faces challenges in delivering novel therapeutics efficiently.

Purpose of the Study:

• To propose a more modular and collaborative approach to drug discovery and development.
• To identify key areas for reform to incentivize innovation.
• To address the critical need for enhanced human capital and data infrastructure.

Main Methods:

• Analysis of trends in drug approvals and development costs.
• Identification of necessary components for a reformed drug development ecosystem.
• Emphasis on collaboration between academia, industry, and regulatory bodies.

Main Results:

• A projected evolution towards a modular drug discovery and development model.
• The necessity of addressing human capital deficits in translational medicine, therapeutics, and regulatory science.
• The importance of regulatory reform to foster innovation and precompetitive space expansion.

Conclusions:

• A robust informatics infrastructure for secure, compliant data sharing is essential.
• Linked initiatives involving academia, industry, NIH, FDA, and venture capital are required.
• Failure to adapt threatens the US leadership in biomedical science and therapeutic innovation.