Keith Parent, CEO of Court Square Group, discusses the business aspects of drug development with James Blackwell, Ph.D., MBA, President of Windshire Group. They explore the importance of quality in life science, emphasizing the need for a holistic approach beyond compliance. Blackwell highlights the significance of modality-agnostic strategies, the impact of AI on efficiency, and the necessity of a simple yet effective quality system. He shares insights on managing compliance, the importance of senior leadership, and the potential cost savings from effective quality systems, citing an example where a challenging, but well-executed investigation saved AbbVie ~$8.5 billion by avoiding a delay in the launch of Humira. They also discuss the critical role of consultants in improving quality and operational excellence.

Key Takeaways

• Explore how AI can be leveraged to improve quality and efficiency in GMP operations.
• Assess your organization's quality culture and ensure senior leadership is fully aligned on the importance of quality.
• Review your organization's change control processes to prevent issues like the lead contamination example discussed.
• Evaluate your organization's response to regulatory observations and ensure a systemic approach to addressing root causes, not just a checklist approach.
• Consider bringing in external quality expertise to help assess and improve the organization's quality systems, if needed.