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.

In this episode of Driving the Business of Science, Stakeholder Engagement: CROs, Vendors, and Sites, Keith Parent, CEO of Court Square Group, discusses the complexities of stakeholder engagement in the life science industry with Kimberly Guedes, VP of Clinical Operations at Intensity Pharmaceuticals. Keith and Kim explore the challenges facing small biotechs when partnering with large CROs, emphasizing the need for fit for purpose, cost-effective solutions like RegDocs365™. Kim discusses the importance of selecting the right CROs and vendors, especially for niche therapeutic areas like CNS. Keith and Kim also discuss the high costs of clinical trials, the necessity of careful planning, and the impact of global regulatory differences. Additionally, Kim shares her involvement with the Alzheimer's Association and the importance of support for caregivers and patients.

Keith Parent, CEO of Court Square Group, hosts Shelley Amster on the "Driving the Business of Science" podcast. Shelley, with over 45 years in women's health, discusses her extensive experience in mentoring startups and connecting them with strategic partners and investors. She highlights the challenges faced by small biotech companies, particularly in women's health, and the importance of mentorship and collaboration. Shelley shares perspectives from her role as an Entrepreneur in Residence, helping Israeli companies establish a presence in the U.S. She emphasizes the need for startups to understand the business aspects of their technology and the value of warm introductions and strategic partnerships.

Keith Parent, CEO of Court Square Group, discusses with Kevin Bittorf, a partner at SCxCMC Solutions, about the role of CMC (Chemistry, Manufacturing, and Controls) in the pharmaceutical industry. Kevin explains that CMC involves the science and business of manufacturing, emphasizing the importance of continuous improvement to reduce costs and enhance quality. SCxCMC, founded two years ago, provides consulting services to small and medium-sized companies, integrating expertise in pharmaceutical development, process chemistry, formulation development, regulatory affairs, quality assurance, supply chain, and packaging. Kevin highlights the significance of AI in predicting manufacturing issues and the benefits of continuous manufacturing over traditional batch processes. He also mentions upcoming conferences on compaction simulation, continuous manufacturing, and advancing drug development.

Discover how artificial intelligence is transforming the life sciences industry in this insightful episode of the Driving the Business Science Podcast. Host Keith Parent, CEO of Court Square Group and RegDocs365, is joined by Bryan Reynolds, CEO of Docxonomy, to discuss practical strategies for developing and implementing AI in organizations of all sizes. Drawing on decades of experience in unstructured data management and AI, Bryan shares actionable insights into overcoming common challenges, such as protecting sensitive corporate data, streamlining processes, and maximizing ROI.
This conversation highlights how AI can revolutionize workflows, accelerate drug development timelines, and reduce manual effort in clinical and regulatory environments—all while keeping humans at the center of critical decision-making. Whether you're leading a startup or a large enterprise, this episode provides a roadmap for integrating AI effectively without getting overwhelmed by technical complexity.
Key Topics:
•How life sciences companies can safely adopt AI solutions.
•Practical steps to develop an AI strategy, starting small and scaling.
•Using AI to automate repetitive tasks like document creation and regulatory submissions.
•Ensuring security and maintaining “human in the loop” for oversight.
•The benefits of partnering with AI experts to drive innovation.
What You'll Learn:
•Strategies to safeguard intellectual property while using AI.
•How to identify and optimize manual processes with AI.
•The role of AI in compressing drug development timelines and enhancing efficiency.
•Tips for navigating the complexities of AI adoption in the life sciences sector.
Tune in to gain a fresh perspective on how AI can unlock new opportunities and help your organization thrive in a rapidly evolving industry!

Keith Parent, CEO of Court Square Group and RegDocs365, discusses the importance of vendor management in life science with Kalyan Obalampalli (KO), CEO of ClinAI. KO shares his experience in managing $100 million in vendor contracts and the challenges of using Excel for RFPs and vendor comparisons. He highlights the benefits of ClinAI's platform, which streamlines vendor selection and management, providing analytics and data-driven decision-making. KO emphasizes the need for fit-for-purpose vendor selection, the importance of clear templates, and the potential of AI in predicting costs and ensuring fair vendor payments.