The Life Science Rundown

The FDA Group's Nicholas Capman welcomes Jen Chew, Vice President of Solutions and Consulting at Bristlecone, to discuss how life sciences companies can effectively implement AI in their supply chain operations. Jen sheds light on a few practical approaches to AI adoption in an industry still adapting to post-COVID realities. Discussion points include: Strategic Implementation Approach: Jen emphasizes the importance of starting with simple, tactical applications before moving to complex strategic implementations. She advocates for a focused departmental approach rather than scattered company-wide experimentation. Data Quality and Regulatory Compliance: A major focus is placed on the critical role of data quality, particularly in regulated environments. Jen stresses that life sciences companies must build robust, FDA-validatable datasets before implementing AI solutions. Transforming Core Processes: The conversation explores how AI could revolutionize key operations like Sales and Operations Planning (S&OP), potentially reducing multi-day sessions to just hours through pre-run scenarios and more efficient planning. Organizational Readiness: Jen discusses how companies can assess their AI readiness and build internal capabilities, warning against the temptation to wait for enterprise vendors like SAP to provide complete solutions. Future Outlook: Looking ahead to 2025, Jen predicts massive data projects will be crucial, emphasizing how organizations must combine industry-specific knowledge with their unique data to create competitive advantages in AI implementation. ____ The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. For project or resource needs, visit: ⁠⁠⁠⁠⁠thefdagroup.com⁠⁠⁠⁠⁠.

The FDA Group's Nicholas Capman welcomes Annalise Ludtke, Senior Manager of Marketing and Communications at Vodori. They explore the essential steps and challenges involved in bringing compliant marketing content to market in a regulated industry. Discussion points include: Bottlenecks and Feedback Challenges: Annalise details how differing team goals, particularly between marketing and regulatory, often lead to bottlenecks, making it essential to streamline feedback and improve claim management. Role of Claims Matrices and Version Control: Effective claims matrices and version control processes are critical for pre-approved content to ensure accuracy, avoid compliance delays, and maintain consistency. Managing Team Size and Risk Tolerance: Annalise explains the varied team sizes and the different levels of review needed based on content type, from high-stakes conference presentations to quick social media posts. Efficiency Best Practices: Annalise shares actionable tips, including the use of concept reviews to create shared ownership, digital asset management systems to centralize content, and strategies to address recurring review delays. Future Role of AI in Compliance: While cautious about AI’s application in compliance, Annalise discusses its potential for handling pre-checks, such as spelling and logo verification, allowing human reviewers to focus on more complex compliance tasks. ____ The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. For project or resource needs, visit: ⁠⁠⁠⁠thefdagroup.com⁠⁠⁠⁠. Check out Vidori's Amend & Progress podcast: https://www.vodori.com/amend-and-progress.

The FDA Group's Nick Capman sits down with Derek Wessman, a consultant based in Japan, to discuss the intricacies of conducting supplier audits in the Japanese life sciences industry. They explore the unique challenges and opportunities presented by Japanese suppliers and the cultural and regulatory nuances that impact auditing processes. Discussion points include: Language and Cultural Barriers: Derek explains how the significant language barrier and cultural differences can impact audit efficiency and effectiveness, often doubling the time required for audits. Strengths of Japanese Suppliers: The conversation highlights the strengths of Japanese suppliers, including their focus on quality, well-organized facilities, and widespread ISO certifications. FDA Inspections in Japan: Derek provides insights into the frequency and nature of FDA inspections in Japan, emphasizing the time constraints and logistical challenges faced by inspectors. Data Integrity Challenges: The discussion covers common data integrity issues in Japanese companies, including shared logins and the use of unvalidated Excel files for critical calculations. Cultural Impact on Quality Systems: Derek shares how Japanese business culture, including long-term employment and collective mindset, can influence quality management systems and CAPA processes. Strategies for Effective Audits: The conversation provides practical advice for companies looking to audit Japanese suppliers, emphasizing the importance of local resources and cultural understanding. Derek has been based in Japan since 2004 and has run his own consultancy since 2009. He specializes in helping Japanese companies navigate regulatory hurdles, FDA inspections, and compliance issues in the pharmaceutical, medical device, and combination product sectors. Derek's expertise bridges the gap between Japanese suppliers and global life science companies, offering unique insights into conducting effective audits in Japan. ____ The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. For project or resource needs, visit ⁠⁠⁠thefdagroup.com⁠⁠⁠.

The FDA Group's Nick Capman sits down with pharmaceutical scientist and consultant Gary Ritchie to discuss the intricacies of statistical sampling in biopharmaceuticals. They explore the limitations of the square root of n plus one sampling method, particularly for small lot sizes, and the advantages of more rigorous statistical approaches. Discussion points include: Limitations of Square Root of n + 1: Gary explains why this commonly used method is inadequate for small biopharmaceutical lot sizes, leading to potential risks in sample representativity and patient safety. Importance of Proper Sampling: Gary highlights the need for statistically valid sampling plans considering lot size, inspection levels, and acceptance quality levels (AQLs) to ensure representative sampling and compliance with regulatory requirements. Cost and Risk Management: The discussion emphasizes how improper sampling can increase business costs and risk to patients, while proper sampling can offer significant cost savings and better risk management. Adoption of ANSI Standards: Gary encourages the industry to adopt ANSI standards for sampling, demystifying the complexity of statistical methods and emphasizing their importance for compliance and efficiency. Practical Implementation: Gary shares insights from his experience, recommending resources and literature for better understanding and applying statistical sampling in the pharmaceutical industry, including Dan O'Leary's paper "Attributes Acceptance Sampling: Understanding How It Works" and Ron Snee's "Solving Statistical Mysteries: What Does the FDA Want?" Gary Ritchie is a veteran pharmaceutical scientist with nearly 30 years of experience in the life sciences industry. He specializes in statistical sampling, analytical chemistry, and pharmaceutical waters. Gary's expertise spans various areas, including process analytics, quality control, and regulatory affairs. Gary’s held key positions at the United States Pharmacopeia, where he served for five years on expert committees for waters, statistics, and general chapters. His experience as a liaison allowed him to work closely with the FDA, industry leaders, and academia. — The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. For project or resource needs, visit ⁠⁠thefdagroup.com⁠⁠.