Does process excellence handcuff drug development?

Area of Science:

• Pharmaceutical industry
• Research and Development (R&D)
• Process Improvement

Background:

• Increasing R&D expenditures in pharmaceuticals contrast with stagnating new drug development.
• The industry faces pressure from patent expirations and payer pricing demands, necessitating greater efficiency.
• Current R&D models require optimization to enhance effectiveness and innovation.

Purpose of the Study:

• To identify key areas for process improvement within the pharmaceutical R&D value stream.
• To explore how enhanced process governance and management can drive efficiency and innovation.
• To highlight the potential of methodologies like quality by design (QbD) in manufacturing.

Main Methods:

• Analysis of R&D expenditure trends versus new drug approvals.
• Identification of primary targets for process optimization in early-stage research, service platforms, administration, and supplier interactions.
• Evaluation of advanced manufacturing concepts like Quality by Design (QbD).

Main Results:

• Process improvements in early research phases (service platforms, administration, supplier interactions) are critical.
• Quality by Design (QbD) offers potential for manufacturing flexibility.
• Increased process understanding and control are prerequisites for QbD implementation.

Conclusions:

• Optimizing processes across the R&D lifecycle is essential for pharmaceutical industry efficiency.
• Strategic focus on early-stage R&D processes and advanced manufacturing techniques like QbD can improve drug development.
• Mature process governance and management are fundamental to achieving greater R&D effectiveness and innovation.