Nicholas Capman of The FDA Group welcomes David Festa, Director of Corporate Quality at Thermo Fisher Scientific, to explore whether pharmaceutical and medical device companies are auditing suppliers too frequently and with the right personnel.
With over 25 years of experience in quality management and oversight of tens of thousands of suppliers, David advocates for a more strategic approach that balances quality, compliance, and business needs through "exception-based" auditing.
Rather than rigidly adhering to calendar-based audit schedules, David suggests companies should assess suppliers based on performance metrics, risk factors, and the criticality of materials they provide. He challenges the industry norm that every supplier must be visited at predetermined intervals, arguing that well-performing suppliers with stable processes may not require frequent on-site visits.
David emphasizes the importance of matching auditor expertise with supplier categories. For example, an auditor with deep knowledge of plastics manufacturing will provide far more valuable insights when evaluating a plastics supplier than someone familiar only with general standards. This targeted approach has helped Thermo Fisher predict quality issues and decrease the percentage of poor-performing suppliers.
The conversation explores how post-pandemic practices have evolved, with companies developing more harmonized approaches to global auditing and implementing centralized audit portals. David also introduces the concept of a "supplier pricing index" that quantifies the true cost of poor quality, providing a more accurate picture of supplier value than piece price alone.
While ISO certifications provide a foundation for quality systems, David cautions against over-reliance on certifications or imposing unnecessary standards on suppliers. The most effective approach focuses on whether suppliers can maintain control of their manufacturing processes and consistently deliver quality products, regardless of certification status.
For companies looking to optimize their supplier quality programs, the key is putting the right people in the right places, implementing quantifiable metrics, and taking a holistic view that integrates quality with other business functions.
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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.
Nicholas Capman of The FDA Group welcomes Ashley Preston, SVP of Global Regulatory Affairs & Quality Assurance at BlossomHill Therapeutics, to discuss the critical elements of successful regulatory agency meetings. With over 20 years of experience in regulatory affairs and quality assurance, Ashley shares expertise on preparing for and executing effective interactions with FDA and EMA.
While the FDA and EMA are both considered first-tier regulatory agencies, they handle meetings differently. FDA offers various meeting types with structured timelines, while EMA takes a more committee-based approach through the CHMP.
FDA meetings include several key types, from pre-IND consultations to end-of-phase meetings. The end of phase two meeting, where sponsors agree on pivotal trial designs, and the pre-NDA meeting are considered required interactions. Recent initiatives like Project Optimus have made end-of-phase 1 meetings increasingly critical, particularly in oncology. While FDA meetings are covered by PDUFA fees, EMA scientific advice can cost 70,000-80,000 euros unless the product has orphan designation.
Meeting preparation requires careful strategy and timing. Preston emphasizes the importance of having sufficient data to support proposed development plans, noting that companies sometimes seek meetings too early, leading to delays or unfavorable feedback. Teams must craft focused questions and present just enough data to make persuasive arguments without overwhelming reviewers.
Effective negotiation during meetings requires understanding agency perspectives and finding a middle ground when disagreements arise. Preston advocates for a partnership approach, recognizing that regulators share the ultimate goal of bringing safe, effective medicines to patients. Teams should prepare for various scenarios and be ready to suggest alternative approaches that address agency concerns while maintaining development efficiency.
Documentation has evolved in the post-COVID era, with the FDA often drafting minutes during meetings. This real-time approach allows sponsors to ensure critical decisions and agreements are accurately captured. Follow-up mechanisms, from informal clarifications to formal Type D meetings, provide opportunities to address any remaining questions or challenges that emerge during implementation.
Preston recommends that companies prepare for their first agency meetings by viewing these interactions as opportunities to build relationships and understand agency expectations. While virtual meetings have become common and efficient, maintaining professional, science-based discussions remains crucial regardless of format. Companies working with both the FDA and the EMA should consider how to harmonize feedback, potentially using sequential meetings to incorporate initial FDA input into EMA discussions.
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The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our regulatory affairs expertise spans the entire drug development cycle, from pre-IND strategy through approval. For project or resource needs, visit thefdagroup.com.
Nicholas Capman, CEO of The FDA Group, welcomes Harri Järveläinen, an independent consultant specializing in non-clinical and regulatory affairs, to discuss the realities of working with Chinese Contract Research Organizations. With over 20 years in the pharmaceutical industry—including experience with AstraZeneca and in Chinese biotech—Harri shares first-hand insights on selecting and managing Chinese CRO partnerships while addressing common misconceptions.
Chinese CROs have evolved significantly over the past two decades. Initially focused on medicinal chemistry, they have expanded into full-service providers across all areas of preclinical development. Government support in the mid-2010s fueled rapid growth, leading to an industry that today services both domestic and international clients, including many U.S. biotech and pharmaceutical companies. While some remain hesitant about working with Chinese providers, many of these organizations now operate at a level of quality that rivals their Western counterparts.
Regulatory compliance is a key consideration when selecting a CRO. Many of the largest Chinese CROs undergo regular inspections from the U.S. FDA and OECD, ensuring adherence to global standards. For sponsors evaluating potential partners, it is critical to review their inspection history and any recent Form 483 letters to identify potential regulatory risks. Harri emphasizes that working with well-established providers mitigates concerns about compliance and operational transparency.
Many companies are drawn to Chinese CROs due to their cost-effectiveness, faster turnaround times, and unique capabilities. During the pandemic, pricing disparities between U.S. and Chinese CROs were extreme, with some U.S. providers charging up to ten times more. Today, the cost advantage remains significant, particularly for studies involving research primates. Faster lead times also make Chinese CROs attractive, as some studies that take six months in the U.S. can be completed in just two months in China. Certain specialized studies, such as continuous infusion studies in rodents or research involving obese primates, are more commonly performed in China than in the U.S. or Europe.
While concerns about intellectual property remain, Harri argues that they are largely outdated. Past issues, particularly in the early 2000s, created lasting skepticism, but established CROs today have stringent protocols in place to protect client data. Language barriers present a more tangible challenge. English proficiency among younger study directors has declined in recent years, making communication more difficult. Many CROs now assign English-speaking project managers to facilitate interactions and ensure smooth collaboration.
Regulatory uncertainty is another area of concern. The pending Biosecure Act has raised questions about the future of U.S.-China collaborations in life sciences, but Harri clarifies that current discussions primarily focus on manufacturing rather than non-clinical or clinical research. The U.S. FDA continues to evaluate Chinese CROs based on performance and compliance rather than geopolitical factors.
For companies considering working with a Chinese CRO, Harri advises starting with well-established providers that have a strong track record and regular FDA inspections. Conducting audits before engagement and maintaining oversight throughout the study process is essential. Cultural differences, particularly around work expectations and communication styles, should also be accounted for to ensure smooth collaboration.
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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 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. For project or resource needs, visit: thefdagroup.com.
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:
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.
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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.
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.
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.
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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.
The FDA Group's Nick Capman sits down with Adam Foresman, Head of Quality & Regulatory Affairs at VideaHealth, to explore the intersection of AI, machine learning, and diagnostics within the FDA's regulatory environment. Adam brings over 15 years of experience in medical device design, quality management systems, and regulatory affairs, with a recent focus on AI in the dental diagnostic market.
Discussion points include:
Adam Foresman is the Head of Quality & Regulatory Affairs at VideaHealth. with over 15 years of experience in the medical device industry, Adam excels in product quality, quality systems, and regulatory compliance. His expertise encompasses design controls, statistical analysis, internal and external auditing, CAPA management, product performance, metrology program management, cGMP practices, and ISO 13485 & 21 CFR 820 quality management activities.
At VideaHealth, Adam has co-developed and executed business strategies, globalization, and the clinical roadmap. He leads efforts in product quality, quality systems, pre-market approvals, and regulatory compliance for cutting-edge artificial intelligence and machine learning diagnostics. Adam is also a champion of cybersecurity and HIPAA activities, ensuring robust protection and privacy for sensitive health data.
The FDA Group's Nick Capman sits down with Carlos Yuraszeck, an accomplished leader in biopharmaceutical compliance, operations, and quality assurance, with a specialized focus on driving innovation and efficiency in cell therapy manufacturing.
With over two decades of dedicated service in the biopharmaceutical industry, most recently serving as the Head of GMP Manufacturing at the Astellas Institute of Regenerative Medicine, Carlos provided profound insights into the pivotal role of phase-appropriate quality systems in managing drug development from research to commercialization. Our discussion focused on how these systems facilitate the rapid delivery of treatments to patients in urgent need.
Discussion points include:
Carlos Yuraszeck is a distinguished leader in biopharmaceutical compliance, operations, and quality assurance, specializing in cell therapy manufacturing. Over his extensive career spanning more than two decades, Carlos has significantly impacted the biopharmaceutical industry through his leadership in various pivotal roles. As the Executive Director of GMP Operations at Astellas Pharma US, he led the transformation of research groups into fully operational GMP manufacturing facilities. Earlier, as Senior Vice President of Technical Operations at Talaris Therapeutics, he managed operations focused on groundbreaking organ transplantation therapies. At Celgene, Carlos directed clinical production and supply, where he scaled up manufacturing operations to support the delivery of life-saving CAR T-cell therapies. His tenure in the industry is marked by a commitment to excellence, deep regulatory knowledge, and strategic oversight, which have driven the successful development and commercialization of novel therapies. Carlos's leadership style emphasizes collaboration, transparency, and continuous learning, aiming always to enhance patient outcomes and advance the field of biopharmaceuticals through innovative and efficient manufacturing practices.
The FDA Group's Nick Capman sits down with Stephen Poor, a physician-scientist with over 20 years of experience in the industry, mainly with Novartis — currently serving as Novartis's Global Program Clinical Head (Executive Director).
They delve into the psychological and professional impacts of organizational changes, particularly focusing on identity and adaptation during times of transition, such as layoffs or department closures.
Discussion points include:
» Stephen's transition due to organizational shutdown and his journey through change.
» Stephen's experiences and thought processes from realizing Novartis's exit from ophthalmology to starting a new job, focusing on identity in times of change.
» The importance of maintaining a positive outlook, using visualization techniques, and combating self-limiting beliefs during periods of professional uncertainty.
» Predictions for 2024 and 2025.
» Nick's upcoming book, "The Passionate Workforce," is based on 15 pillars aimed at creating a motivated and high-performing organizational culture.
» Insights into managing layoffs thoughtfully, ensuring those who leave feel respected and valued.The FDA Group's strategic plans include potential acquisitions to leverage anticipated economic growth.
» The need for positive thinking, proactive planning, and readiness to capitalize on upcoming opportunities in the life sciences industry.
Stephen Poor is the Global Program Clinical Head at Novartis, bringing over 20 years of experience in ophthalmology biotech-pharma and a strong medical background to his role. He is at the forefront of developing innovative therapies for retinal diseases, focusing on age-related macular degeneration (AMD) and geographic atrophy (GA), the leading causes of blindness in the elderly. Poor leads the clinical team for PPY998 (GT005), a Phase 2b subretinal complement factor I gene therapy for GA, a significant acquisition from Gyroscope in 2021. His responsibilities extend beyond PPY998 to overseeing undisclosed gene therapy programs and novel drug delivery devices.
In his leadership role, Stephen is pivotal in bridging the gap between Novartis's research, development, and commercial sectors through strategic collaboration and advisory duties. He plays a key role in external strategy, asset and technology review to enhance the department's portfolio, and coordination of scientific support for the portfolio.
The FDA Group's Nick Capman sits down with Nick Klingensmith, a four-time cancer survivor, motivational speaker, and mindset coach. They discuss the challenges of remote work, especially the disconnect between leadership, management, and frontline employees, and how it affects company culture and employee engagement.
Key points discussed include:
Klingensmith provides actionable advice for building a resilient remote workforce, such as staying present, focusing on what can be controlled, and being authentic and vulnerable as a leader. He also highlights his upcoming book, "Selling Inspired," aimed at sales professionals, and shares where he can be found online for speaking engagements.
Nick helps remote sales teams and leaders develop a warrior mindset and overcome self-sabotage, fears, and excuses to achieve success. With 20 years of sales experience and 10 years of executive leadership, he's passionate about driving revenue growth and developing people. He collaborates cross-functionally to identify opportunities, author unique value propositions, and analyze gaps to drive stronger performance.
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 CEO, Nick Capman sits down with Divya Gowdar, Founder and CEO of NubGenix to discuss the pitfalls and lessons learned on the frontlines of audit and inspection readiness throughout the FDA-regulated industries.
Discussion points include:
Divya's top 5 takeaways:
Divya is a performance-driven and hands-on Quality leader and professional with extensive experience in the medical device and combination product industry. She has contributed significantly to quality management systems, product development lifecycle, risk management, quality compliance, quality management review, inspection management, training, change controls, supplier management, complaint management, and technical operations.
Who is The FDA Group? 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. https://www.thefdagroup.com/
The FDA Group's CEO, Nick Capman, sits down with Donna Dorozinsky, founder and CEO of Just in Time GCP, to discuss key considerations for Trial Master File (TMF) management and GCP compliance.
Discussion points include:
Donna's top 5 takeaways:
Donna is a Registered Nurse and business consultant who has spent over 30 years in drug development with extensive experience in study operations, including clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management.
Donna is a TMF Reference Model Steering Committee member and is a member of the Association of Women Entrepreneurs. She’s a founding member of the Society of Nurse Scientists, Innovators, Entrepreneurs, & Leaders. She serves on the Board of Trustees at Gwynedd Mercy University, where she received her BSN, and also has an MSN from Widener University.
Who is The FDA Group? 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. https://www.thefdagroup.com/
The FDA Group's CEO Nick Capman sits down with Mukesh Kumar, PhD, RAC, for a deep dive into the challenges of setting up GMP facilities for cell therapy startups.
Discussion points include:
» Common questions startups have around engaging with the FDA and determining costs and timelines for GMP facility setup and clinical trials.
» Recommendations for engaging regulatory experts early and doing first-in-human manufacturing in-house rather than through a CMO to reduce costs and time.
» The importance of educating oneself on regulations before meetings with experts or the FDA to get the most benefit from those interactions.
» Best practices for GMP facility setup and clinical trials in a cost-effective manner to advance cell therapies to patients.
Dr. Mukesh Kumar is CEO and Founder of FDAMap, a Washington DC-based firm helping manufacturers and developers of FDA-regulated products in regulatory affairs, quality assurance, clinical trials, and smart development strategies. His key expertise is in global regulatory project management, regulatory submissions, compliance inspections, operational management, supply management, clinical operations, and multi-national project management for medicinal and diagnostic products. He has led the clinical development of over 100 products over the last 20 years.
He has been a leader in more than 150 clinical trials in about 34 countries, including countries in the EU, Taiwan, Korea, Japan, China, Canada, countries in South America, Australia, and India. He has led more than 100 GCP, GLP, GMP, and GACP audits in the US and several countries in Europe, North and South Americas, and Asia in the last 15 years. He has conducted numerous training workshops on FDA compliance-related issues and has authored numerous articles in peer-reviewed journals.
His weekly blog, FDA Puran, is subscribed by over 80,000 readers globally. He is also the Professor (Adjunct), Regulatory Sciences, at the School of Medicine, George Washington University, Washington DC. Dr. Kumar is a PhD in Biochemistry and a certified regulatory professional by the Regulatory Affairs Professionals Society, USA.
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