The Life Science Rundown

The FDA Group's Nicholas Capman welcomes Keith Parent, CEO of Court Square Group and RegDocs365, to discuss practical approaches to implementing AI in clinical trials and regulatory operations. With 30 years of experience managing infrastructure for life science companies, Keith offers insights on how organizations can effectively adopt AI while maintaining compliance.

Discussion points include:

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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.

Court Square Group is a managed service firm specializing in infrastructure management for life science companies, working with both large pharmaceutical companies and small biotech firms for about 30 years. Visit: courtsquaregroup.com

RegDocs365 is a specialized provider of regulatory solutions for the life sciences industry. Visit: regdocs365.com

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:

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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:

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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.

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.

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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.

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.

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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 quality management consultant Kimberly Wallbank to discuss the challenges and best practices of implementing effective quality metrics in the life sciences industry.

Discussion points include:

Quality vs. Quantity in Metrics: Kimberly emphasizes the importance of focusing on meaningful metrics rather than simply tracking throughput.

Aligning Metrics with Business Goals: Kimberly discusses how to connect quality metrics to financial impacts and overall business objectives.

Optimal Number of Metrics: Kimberly advises on starting with a few key metrics and gradually expanding, while regularly reassessing their relevance.

Frequency of Metric Reviews: Kimberly recommends monthly reviews at minimum, with the possibility of more frequent checks for critical metrics.

Balancing Value and Effort in Data Collection: Kimberly explains the importance of weighing the potential insights against the resources required to collect and analyze data.

Essential Quality Metrics: Kimberly outlines key categories of metrics that should always be included in a quality scorecard.

Adding and Removing Metrics: Kimberly provides guidance on how to determine when to update the metrics on a scorecard.

Common Implementation Challenges: Kimberly addresses issues such as stakeholder understanding, data structure, and involving the right people in metric discussions.

Continuous Improvement: Kimberly stresses the importance of viewing the quality scorecard as a living document that evolves with the business.

Practical Application: Kimberly shares real-world examples from her experience to illustrate effective metric implementation and use.

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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 Matt Lowe, Chief Strategy Officer at MasterControl, to discuss the opportunities and challenges of implementing AI in the life sciences industry.

Discussion points include:

AI Applications in Life Sciences: Matt outlines the broad spectrum of AI applications, from early-stage drug discovery to post-market analysis of customer feedback and adverse events.

Risk-Based Approach to AI: Matt emphasizes the importance of applying a risk-based approach to AI implementation, similar to other processes in the life sciences industry.

Low-Risk, High-Value Use Cases: Matt provides examples of low-risk, high-value AI applications, such as automated exam generation for employee training and document change summarization.

Human Oversight in AI Systems: Matt stresses the critical role of human oversight in AI implementations to catch errors, ensure regulatory compliance, and maintain control over critical processes.

The "3% Problem" and AI Hallucinations: Matt explains the challenges of AI errors and "hallucinations," emphasizing the need for strategies to detect and manage these issues.

High-Risk AI Applications: Matt discusses the potential risks of using AI for critical processes like manufacturing recommendations, highlighting the need for thorough understanding and validation.

Gradual AI Implementation: Matt advises on starting with simpler AI applications and gradually progressing to more complex use cases as organizations gain experience.

AI as a Competitive Tool: Matt explores how AI implementation might affect a company's competitive position in the market, balancing potential benefits against adoption risks.

Regulatory Considerations: Matt addresses the importance of aligning AI implementations with regulatory requirements in the life sciences industry.

Future of AI in Life Sciences: Matt shares his perspective on the evolving role of AI in the life sciences industry and the importance of continuous learning and adaptation.

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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 Eric Busenburg, President of Euro-American Worldwide Logistics, where he oversees GMP storage and international shipping solutions for life science manufacturers.

They discuss the critical challenges and solutions for storage in the life sciences industry, particularly for manufacturers experiencing rapid growth.

Discussion points include:

Understanding Storage Challenges: Eric explains the common storage issues that arise as life science manufacturers grow, including unexpected large orders and fluctuating production demands.

Evaluating Storage Options: Eric outlines the pros and cons of building additional infrastructure versus outsourcing to third-party providers, including considerations of control, cost, and time.

Quality Considerations: Eric emphasizes the importance of maintaining high-quality standards when outsourcing, and how third-party providers can align closely with manufacturers' in-house processes.

Time and Cost Implications: Eric discusses the extended timelines for building new infrastructure post-pandemic and how outsourcing can provide more immediate solutions.

Selecting the Right Provider: Eric provides key factors to consider when choosing a third-party storage provider, including proximity, size, expertise, and flexibility.

The Importance of Location: Eric explains the strategic advantage of providers located within a one-hour radius of manufacturing facilities, particularly in biotech hubs like Massachusetts.

Long-term Cost Analysis: Eric shares insights on the long-term cost comparison between building and outsourcing, including the typical 10+ year crossover point.

Flexibility and Risk Management: Eric discusses how outsourcing can provide more flexibility to adapt to market changes and mitigate risks associated with long-term investments.

Leveraging Outsourced Expertise: Eric explains how manufacturers can benefit from the immediate access to expertise that outsourcing provides without the need to hire and train new staff.

Future Outlook: Eric shares his perspective on the future of storage needs in the life science industry, including the role of government initiatives and the importance of support services.

For project or resource needs, visit thefdagroup.com.

The FDA Group's ⁠Nick Capman⁠ sits down with ⁠Aaron Snyder⁠, the Vice President of Quality Assurance at Allotex, where he oversees the development and implementation of quality systems for medical devices and pharmaceuticals.

They discuss the critical elements of building and leading a successful QA team in the life sciences industry.

Discussion points include:

Recognizing the Need for Change: Aaron explains how to identify early signs of strain in the quality system and the importance of transitioning from a small to a larger, more structured QA team to support business growth.

The Interview Process: Aaron emphasizes the importance of vetting potential employers by asking direct questions about management styles, conflict resolution, and organizational support.

First 90 Days in a New Role: Aaron outlines the initial steps for understanding team dynamics, identifying stakeholders, and learning the organization's goals to set a solid foundation for improvements.

Creating a Strategic Plan: Developing a strategic plan with tools like Gantt charts and accountability charts, and engaging team members for feedback to ensure alignment and progress.

Effective Communication and Meeting Cadence: Aaron stresses the need for a structured meeting schedule, including daily stand-ups and weekly reviews, to maintain momentum and accountability.

Building the Right Team: Assessing team members' roles and reallocating based on strengths, while supporting career development to ensure high performance and job satisfaction.

Making the Business Case for Team Expansion: Preparing a comprehensive business case for hiring additional staff, using metrics and workload analysis to justify the need for expansion.

Utilizing Contractors: Leveraging contractors to manage immediate workload increases while recruiting full-time staff, and using their insights to refine job descriptions and onboarding processes.

Continuous Improvement and Adaptability: Implementing continuous improvement initiatives, regularly updating processes, and engaging in feedback sessions to keep the quality system effective and relevant.

Leveraging Experience and Young Talent: Combining experienced leadership with young talent to foster innovation and create a dynamic team environment.

For project or resource needs, visit ⁠thefdagroup.com⁠.

The FDA Group's Nick Capman sits down with Tagg McGurrin, who most recently served as the President and Chief Business Officer (COO/CFO) at Neumentum, Inc., where he led corporate strategy, capital markets, corporate financing, accounting, legal, investor relations, and business development.

They discuss the critical elements of planning, governance, and capital access necessary to build a strong foundation for a pharmaceutical startup in today’s economic environment.

Discussion points include:

Access to Capital: Tagg emphasizes the crucial role of securing capital in starting a pharmaceutical company. He shares strategies for identifying and cultivating relationships with high net worth investors and specialized investment groups. Tagg highlights the importance of prioritizing "smart money" – investors who understand the long-term nature of pharmaceutical investments.

Board and Leadership Structure: Tagg discusses the need for a committed board with proper governance and checks and balances. He recommends separating the roles of CEO and executive chairman to ensure accountability and effective oversight. Additionally, Tagg underscores the necessity of having a dedicated full-time team with a long-term vision, avoiding reliance on part-time or fractional roles for key positions.

Clear Mission and Objectives: Establishing clear, dynamic annual goals and objectives aligned with value inflection points is vital. Tagg highlights the importance of setting specific, measurable, attainable, relevant, and timely (SMART) goals and revisiting them regularly to ensure alignment with the company's progress. He also advocates for a structured meeting schedule with weekly, annual, and substantive quarterly meetings to maintain focus and accountability.

Effective Investor Pitching: When pitching to investors, Tagg advises highlighting the executive team, commercial opportunity, and technical aspects of the asset. He emphasizes the importance of transparency and objectivity to build and maintain trust with investors. Tagg also suggests including a detailed business model in the pitch, outlining expected outcomes and the company's strategy for achieving them.

Due Diligence and Investor Relationships: Tagg stresses the importance of conducting thorough due diligence to avoid nefarious individuals posing as well-connected investors. He recommends asking detailed questions to understand potential investors' past performance and seeking references from other companies they have supported. Transparency and regular communication with investors are key to maintaining trust and support.

Leadership Synergy and Conflict Management: Tagg underscores the importance of a management team that is committed to the company's mission and strategy. He advises proactively addressing potential conflicts of interest to maintain the integrity and performance of the company. Ensuring independence in both fact and appearance is crucial to prevent personal motives from hijacking investor value.

Growth and Communication Strategies: Maintaining efficient communication and growth is essential. Tagg highlights the importance of keeping investors informed with regular updates, even during slow periods, to sustain trust and support. He also emphasizes the need to stay nimble and efficient, avoiding bureaucratic complexities.

Incentivizing Key Players: Tagg advocates for using innovative incentive structures, such as reverse vesting, to retain top talent and ensure their long-term commitment to the company's success. This approach helps align the interests of key players with those of the company and its investors.

Combining Experience with Young Talent: Tagg emphasizes the value of combining experienced leadership with young talent to drive innovation and success. This synergy blends the wisdom of experience with the energy and creativity of younger team members, fostering a dynamic startup environment.

For project or resource needs, visit thefdagroup.com.