Summary
In this episode of Driving the Business of Science, The Importance of Quality, 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.
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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.
Introduction to Court Square Group and Podcast Goals
- Keith introduces himself as the CEO of Court Square Group and explains the podcast’s focus on the business aspect of drug development and bringing new products to market.
- Court Square Group has been around for 30 years, managing IT infrastructure for life science companies, including clinical trials and safety systems.
- RegDocs365™ is introduced as a content repository hosting both clinical and regulatory content. It has AI tools built in to unlock content from documents.
- Keith introduces James Blackwell, President of Windshire Group, and invites him to provide background on himself and his company.
James Blackwell’s Background and Windshire Group’s Focus
- James Blackwell thanks Keith for the invitation and praises his visionary approach to the industry, particularly in the areas of cloud and AI.
- James formed Windshire Group after working at various companies, including Repligen, Genzyme, and Abbvie, where he was involved in the launch of HUMIRA.
- Windshire Group consults on CMC (quality, manufacturing, and process development) at all stages of the product life cycle, from virtual companies to multinationals, covering various therapy modalities.
- The company consults for product companies, and their investors and service providers.
Understanding Modalities and Quality in Life Science
- Keith asks James to elaborate on the different modalities in life science, including biologics, cell and gene therapy, vaccines, antibodies, peptides, and small molecules.
- James explains the diverse field of personalized medicines, including antibody drug conjugates (ADCs) and the importance of staying updated on new modalities.
- Keith and James discuss the importance of quality in various aspects of life science, including SOPs, computer systems, and lab quality.
- James emphasizes the need for a holistic view of quality, not just focused on compliance, to ensure patient safety and operational excellence.
Compliance and Quality: Balancing Efficiency and Effectiveness
- James explains the importance of compliance in ensuring patient safety and delivering efficacious products, but notes that compliance alone does not guarantee quality.
- He shares an example of a graduate school friend who became head of quality for Amgen, emphasizing the need to “walk the line” between compliance and efficiency.
- Keith discusses the challenge of balancing compliance with business operations, stressing the importance of documenting everything to show compliance to the FDA.
- James and Keith agree on the need for a simple yet effective quality system, starting with paper or electronic equivalents and transitioning to more advanced systems as needed.
Challenges and Best Practices in Quality Management
- James highlights the challenge of getting the entire organization on the quality train, starting with senior leadership and ensuring quality is not seen as an expense.
- He discusses the importance of proper impact assessments and change control, using an example of a client who experienced a lead contamination issue due to lack of change control.
- Keith shares his experience of working with companies where quality is overboard, leading to unnecessary work and inefficiency.
- James emphasizes the importance of understanding the systemic reasons behind compliance issues and bringing in external expertise when needed.
Impact of Warning Letters and Form 483 Observations
- James explains the seriousness of warning letters and Form 483 observations, noting that they can lead to consent decrees and significant remediation costs.
- He advises against treating Form 483 observations as a checklist and stresses the need to address systemic issues behind the observations.
- James shares a personal story of successfully investigating a contamination issue that had high potential to delay HUMIRA approval, resulting in significant revenue for AbbVie by avoiding an approval delay.
- Keith and James discussed the FDA’s power to shut down facilities and the importance of taking compliance issues seriously.
Best Practices for Quality Management and Organizational Culture
- James emphasizes the importance of having a quality system that is fit for purpose and not overly complex.
- He shares an example of a client in during a visit to India that effectively managed risk and impact assessments, demonstrating a well-embedded risk management culture.
- James advises elevating the authority of the quality unit and ensuring they have the resources and support they need.
- He highlights the importance of effective investigation and cost-saving systems, using Amgen’s example of tracking cost savings from their investigation and cost management system.
Final Thoughts and Closing Remarks
- Keith and James discuss the importance of building quality into everything the organization does, making it a natural component of the workflow.
- Keith thanks James for his insights and contributions to the podcast, emphasizing the value of the discussion for their audience.
- James reiterates the importance of quality, compliance, and operational excellence, and the benefits of having an effective quality system.
- The podcast concludes with Keith thanking the audience and expressing his appreciation for the opportunity to discuss these important topics.