The FDA Group’s Nick Capman sits down with Dr. Manfred Stapff—physician, author, and founder of Candid Advisory Inc., a consultancy specializing in real-world evidence and clinical development—for a wide-ranging conversation about how real-world data is reshaping drug development, regulatory decisions, and public understanding of evidence.

Dr. Stapff draws on decades of experience across medical affairs, clinical trials, and RWE analytics to explain why real-world evidence isn’t a replacement for randomized controlled trials—but a necessary complement. He outlines how to transform raw data into credible evidence, how the FDA is using RWE today, and why quality, transparency, and context are essential in data-driven science.

He also offers cautionary insight on common pitfalls—from bias in training data and misinterpreted statistics to the challenges of AI integration in healthcare research.

What they cover:

• What real-world evidence is (and isn’t)—and how it differs from clinical trial data

• How RWE is being used by the FDA to support label expansions and safety monitoring

• Key risks around self-reported data, upcoding, and poor data quality

• Why statistical significance isn’t enough—and how to evaluate clinical relevance

• How AI can accelerate pattern recognition and predictive diagnostics

• Why training data matters—and how bias can infiltrate large-scale AI tools

• The role of educated skepticism in interpreting data-driven claims in both science and society

Dr. Manfred Stapff is the founder and principal consultant at a boutique advisory firm focused on real-world evidence strategy, clinical development, and medical data intelligence. He is the author of Real World Evidence Unveiled and a frequent speaker on the role of data integrity, statistical literacy, and AI in advancing medical research. His current work supports life science companies and investors in evaluating drug development strategies, acquisition opportunities, and data-driven innovations.

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 ⁠⁠https://www.thefdagroup.com⁠⁠

The FDA Group's Nick Capman sits down with Dr. Kimberly Garko, Chief Technical Officer and 25-year life science veteran, for a deep dive into one of the most misunderstood concepts in the industry: the cost of quality.

Dr. Garko shares why quality should be viewed not as a cost center but as a strategic investment—and how companies can embed that mindset into their culture, systems, and leadership practices. She outlines the difference between good and poor quality costs, explains how to build ROI-focused metrics, and offers practical ways to foster transparency, psychological safety, and proactive decision-making.

From regulatory intelligence and scorecard design to audit readiness and AI integration, this conversation is packed with insights for quality leaders and executive teams alike.

What they cover:

• How to shift your organization’s mindset from compliance to value creation

• The real financial and operational impact of poor vs. proactive quality

• How to build scorecards, systems, and reporting processes that drive action

• Why culture, transparency, and psychological safety are core to sustainable quality

• Practical approaches to audit readiness, supplier oversight, and training

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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 ⁠⁠https://www.thefdagroup.com/

Nick Capman talks with Marcia Baroni—a microbiologist with 27 years in global pharma-quality leadership—about reframing quality from a controllable expense to a strategic asset.

Baroni contrasts “bad-quality” costs (scrap, recalls, deviations) with “good-quality” investments (testing, preventive controls, oversight) and explains why the latter pay for themselves in resilience and brand value. She illustrates the stakes with a $600 million nationwide OTC-drug recall caused by chemically treated pallets—an error frontline staff flagged but a weak quality culture ignored.

The conversation dives into building psychological safety and metrics that drive the right behaviors, not under-reporting, shifting quality from “policing” to cross-functional partnership, and practical first steps executives can take to gauge their current maturity and start investing for future yield.

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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 ⁠⁠https://www.thefdagroup.com/

Nicholas Capman of The FDA Group welcomes David Marlin, Co-Founder and CEO of Metacomet Systems, to explore the often-overlooked complexities of royalty management in life sciences.

Drawing from his experience helping over 200 companies automate royalty payouts, David explains how biotech, pharma, and medical device firms struggle to manage licensing agreements as they scale. What starts as a simple once-a-year payment can quickly evolve into a tangled web of tiered rates, stacked IP, country-specific rules, and audit requirements.

David breaks down where companies most often go wrong—managing rules in Excel, underestimating the operational burden, and lacking traceability across contracts, SKUs, and sales data. He discusses how automation not only reduces risk and effort but also preserves trust with licensors by ensuring accuracy and transparency.

The conversation also covers how organizations can recognize when it's time to move beyond spreadsheets, what a successful royalty system implementation looks like, and why experience matters in such a niche space.

Whether you're paying or receiving royalties, this episode offers valuable insight into a critical but often misunderstood area of life sciences operations.

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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 ⁠https://www.thefdagroup.com/

Nick Capman talks with Jesse Gillikan, President of cGMP Validation, about the challenges compounding pharmacies face with GMP compliance in 2025. After helping over 100 pharmacies navigate FDA regulations since the 2013 Drug Quality and Security Act, Jesse shares candid insights about this industry transformation.The conversation reveals how compounders have moved from resistance to acceptance of GMP requirements, though major hurdles persist. For 503B facilities, the primary challenge isn't knowledge but cost, particularly testing expenses that might be manageable for pharmaceutical giants making millions of units but become prohibitive for compounders producing just thousands.Jesse highlights practical space constraints, with many facilities not designed for GMP manufacturing. He recommends dedicating one-third of facility space to clean operations and another third to compliant warehousing, which targets many smaller operations that struggle to achieve.Jesse also sheds light on validation has shifted from qualifying individual technicians to validating entire processes, requiring completely new approaches to media fills and documentation. Despite these challenges, Jesse notes the industry's impressive information sharing and collaborative spirit.When discussing FDA inspections, Jesse emphasizes the importance of thorough deviation management — a common citation area. He also addresses the FDA shortage list volatility, sharing how clients invested in automated filling lines for GLP-1 products only to have those drugs removed from the list, creating significant business disruption.Jesse maintains that while compliance is non-negotiable, the FDA genuinely wants compounders to succeed. His practical advice focuses on risk-based prioritization, industry collaboration, and maintaining open communication with regulators._____The FDA Group connects compounding pharmacies with specialized consultants who understand the unique challenges of 503B compliance. Our experts provide practical solutions that balance regulatory requirements with business viability – from GMP implementation and environmental monitoring to documentation systems and FDA inspection support. Visit https://www.thefdagroup.com/ for more information.

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.

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.