Podcast The Life Science Rundown

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Episode #039 Navigating FDA Regulations for SaMD AI and Machine Learning with Adam Foresman

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:

» The Regulatory Landscape for AI in Dental Diagnostics: Adam shares his insights on how AI and ML are becoming integral in dental diagnostics, aiding in identifying previously missed detections, enhancing patient education, and streamlining administrative tasks. He highlights that early adopters in healthcare and dental organizations are reporting significant benefits from AI, encouraging broader adoption.

» FDA Clearance for Pediatric AI Applications: Adam sheds light on VideaHealth's recent 510(k) clearance for a dental AI application for pediatric patients. he offers pointers for successful software as a medical device (SaMD) submissions, emphasizing the importance of Q-submissions, thorough software documentation, and specific considerations for pediatric applications.

» Predetermined Change Control Plans (PCCPs): Adam explains the concept of PCCPs, allowing manufacturers to include future design changes in pre-market submissions, potentially avoiding re-submissions. While he sees broader applications outside of AI, he notes the challenges AI manufacturers face in predicting future design changes accurately.

» Comparative Regulatory Approaches — US vs. EU: Adam compares regulatory frameworks between the US and the EU, noting that while both aim to ensure clinical benefits outweigh risks, their methodologies differ. He praises the EU’s focus on post-market surveillance and risk management processes, suggesting the FDA could benefit from similar approaches.

» AI Transparency and Bias Considerations: With growing concerns about AI transparency and bias, Adman discusses the FDA's recent emphasis on these issues. He advocates for clear communication of AI test results by subgroups and suggests that the FDA might develop more detailed transparency guidelines in the future.

» Role of Regulatory Affairs Professionals: Adam encourages regulatory professionals to promote AI understandability and transparency within design teams, ensuring that patient and clinician perspectives are considered in AI development.

» Future Trends and Recommendations: Adam predicts an increase in AI submissions that bundle multiple models, urging adherence to FDA guidelines for such complex submissions. He also emphasizes the importance of engaging with regulatory bodies early in the design process and maintaining robust QMS processes.

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.

Episode #038 Crafting Quality Systems for Each Phase of Drug Development with Carlos Yuraszeck

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:

» Defining Phase-Appropriate Quality Systems: Carlos detailed these systems as strategic frameworks designed to adapt to the requirements of different stages of drug development, emphasizing their critical role in accelerating the development process.

» Regulatory Framework and Impact: Insights into how FDA guidelines are tailored to expedite the transition from laboratory research to market, highlighting the regulatory nuances that allow for such flexibility.Handling

» Variability in Drug Development: Strategies for managing the inherent variability in early development phases were discussed. Carlos emphasized the necessity of flexible, responsive quality systems that facilitate quick adaptations.

» Analytical Testing and Development Oversight: Carlos explored the significant role of analytical testing in early phases, focusing on controlling and understanding variability to improve assay development continuously.

» Challenges in Preclinical to Clinical Transition: He underscored the importance of maintaining consistency in the quality of preclinical materials to ensure seamless progression into clinical trials.

» Importance of Effective Change Control Systems: The conversation covered how early-stage quality systems should anticipate and manage frequent changes to support rapid learning and adaptation.

» Strategic Approach to Quality System Design: Carlos discussed designing quality systems that reflect the company's risk tolerance and the urgency of patient needs, effectively balancing speed, cost, and compliance.

» Future Trends in the Life Sciences Sector: Carlos provided predictions on the evolution of quality systems to meet the dynamic needs of ongoing and future drug development projects.

Carlos 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.

Episode #037 Leading Through Transition: Strategic Insights from Novartis's Front Lines


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 to create 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 including 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.

Stephen 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.

Episode #036 Real Talk on Remote Leadership with Nick Klingensmith


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's journey from sales in the telecom and logistics industries to becoming a motivational speaker and coach, emphasizing resilience and overcoming obstacles.
  • The fundamental disconnect in remote work environments, where leaders fail to engage effectively with their teams, leading to feelings of isolation and disconnection among employees.
  • The perception gap between managers and employees regarding communication and engagement, with many employees feeling overlooked unless there's a problem.
  • The need for leaders to adapt to remote work by overcommunicating, setting clear expectations, and fostering genuine connections with their teams.
  • Klingensmith’s critique of the lack of training for managers on how to lead remote teams effectively, emphasizing the need for mentorship, accountability, and proactive communication.
  • The importance of understanding the distinction between micromanagement and accountability, and the role of empathy and vulnerability in leadership.

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.

Episode #035 Audit and FDA Inspection Readiness Best Practices with Divya Gowdar

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:

  • The need for a formalized inspection readiness program, especially highlighted by challenges in accessing critical documents like quality manuals or SOPs in a timely manner.
  • The complexities and confusion surrounding QMS integration post-merger or acquisition, emphasizing the importance of clear SOP adherence and SME identification.
  • The strategic development of an inspection readiness playbook outlining detailed procedural actions for audits, including preparation of SMEs and document management.
  • Common gaps in the QMS, such as inadequate design controls and insufficient risk management, and the critical area of supplier management, where many organizations struggle to maintain quality audits and qualification programs.
  • The distinction between R&D and commercial suppliers, underscoring the need for early and comprehensive qualification processes to mitigate commercialization risks.

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 the quality management system, product development lifecycle, risk management, quality compliance, quality management review, inspection management, training, change controls, supplier management, complaint management, and technical operations.

Episode #034 Mastering the TMF: Ensuring GCP Compliance and Inspection Readiness with Donna Dorozinsky

In the most recent episode of our podcast, The Life Science Rundown, The FDA Group's Nick Capman sat 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:

  • The TMF's significance in capturing a study's complete story, including its challenges and achievements and its pivotal role in GCP compliance.
  • The evolution of TMF structuring, the development of the TMF Reference Model for standardization, and its benefits for simplifying content integration across different organizations and vendors.
  • Donna’s three components of a quality TMF: record quality, timeliness of filing, and completeness, explaining how these factors contribute to maintaining a compliant and effective TMF.
  • Considerations for companies that outsource TMF management to CROs.
  • The adoption of eTMF systems, especially for smaller companies, and the balance between investment in technology and maintaining compliant TMF practices.
  • The challenges and considerations of TMF management during mergers and acquisitions (highlighting the importance of a complete and accessible TMF in these transitions).
  • How the TMF is utilized during regulatory inspections, the recent focus of regulatory authorities on TMF compliance, and the importance of a well-managed TMF in demonstrating the quality and integrity of a study.

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.

Episode #033 The Startup's Guide to Setting Up Cell Therapy Manufacturing: Navigating Regulations, Resources and Timelines


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.

Episode #032 A Blueprint for Quality Culture with Vincent Cafiso


The FDA Group's CEO Nick Capman, sits down with Vincent Cafiso for a deep dive into the nuances of quality culture within the life sciences sector. Vincent is a former FDA Investigator and industry expert who now helps firms with inspection readiness, compliance, quality assurance, and quality systems consulting expertise.

Discussion points include:

» The essence of quality culture being more than just adherence to procedures. It encompasses the actions, mindsets, and execution methods of employees—areas that are pivotal for inspection readiness and regulatory compliance.

» The integral components of quality culture, including an emphasis on resolving issues constructively rather than avoiding them, the crucial role of trust, a shared commitment to quality, and holding each other accountable for outcomes.

» How leadership should exemplify and consistently reinforce quality values, impacting trust and openness within the organization.

» The challenges in sustaining a quality culture, which underscore the need for ongoing employee engagement and assimilating new staff into the existing culture.

» The fact that quality culture isn't static and must evolve with changing internal and external business environments.

Vincent is a distinguished expert in quality assurance and regulatory compliance with over 30 years of extensive experience in the life sciences industry. As the Founder and Managing Consultant of Practical Compliance Results, LLC, he specializes in inspection readiness, compliance, and quality systems, focusing particularly on medical devices and in vitro diagnostics (IVD).

His expertise includes the development, management, and auditing of quality systems to ensure adherence to both domestic and international regulatory standards. Vincent is known for his skill in building and leading effective quality and regulatory compliance teams, ensuring their operational excellence and sustained inspection preparedness.

With a background as an internal and supplier auditor, Vincent brings practical insights into FDA inspection techniques and a comprehensive understanding of quality system standards such as ISO 13485 and ISO 9001. His experience is extensive in the European and Global regulatory landscape, including the EU Medical Device Regulations. He also offers valuable expertise in collaborating with contract design and manufacturing organizations (CDMOs), ensuring products are designed and manufactured in compliance with global quality system requirements. His proficiency covers a wide range of areas, including FDA Regulations, Quality Assurance, Regulatory Compliance, Change Control, and FDA Readiness and Remediation.

Episode #031 An FDA Inspection Survival Guide with Jonathan Wacks

The FDA Group's CEO, Nick Capman, sits down with Jonathan Wacks to discuss ways to minimize the stress associated with FDA inspections.

Jonathan is an experienced healthcare industry executive with a proven track record in startups and Fortune 500 companies. He has a strong background in international QA/RA, engineering, and project management, specifically with medical devices, electronic assemblies, and supply chain management.

Discussion points include:

» The importance of a robust QMS and the role of third-party audits in ensuring unbiased compliance assessments, and preemptively identifying compliance issues, underlining the need for thorough and honest internal evaluations.

» The need for leadership teams to understand audit findings in depth and use them to enhance internal processes.

» The importance of having well-calibrated and maintained test equipment, alongside well-crafted SOPs and trained personnel.

» The need for independent reviews of batch records, focusing on the clarity of lot status and data integrity.

» The need for regular reviews and updates of QMS processes, especially validation and verification procedures.

» The importance of re-evaluating product and process validation, including considerations for stability data, human factors, and the impact of significant changes.

» The critical role of software validation in the QMS.

» How to effectively handle questions from FDA investigators and the importance of clear, honest communication during audits.

Jonathan is a medical device and pharmaceutical Consultant specializing in QA/RA and Product/Process Control. His services include M&A due diligence support, conducting site quality and regulatory compliance audits, and leading employee training programs focused on FDA QSR/cGMP and validation.

He also works in project management and operations improvement, particularly in research use diagnostics and API manufacturing. He's a regular and highly-valued contributor to our Insider Newsletter.

Episode #030 Clinical Data Standards in Focus: SDTM Compliance with Sunil Gupta

The FDA Group's CEO Nick Capman, sits down with Sunil Gupta, a seasoned expert in pharmaceutical data, to shed light on the nuances of SDTM (Study Data Tabulation Model) compliance and its pivotal role in clinical trial processes.

Sunil brings a wealth of experience from his three decades in the pharmaceutical industry, focusing on areas like SAS programming, submissions, and leveraging new technologies for clinical trials.

Discussion points include:

» The transition from manual processes to technology-enhanced procedures in clinical trials — specifically the shift towards automation and standardization.

» An in-depth look at SDTM compliance, its critical importance in FDA submissions, and the need for uniform data standardization.

» The many challenges associated with ensuring compliance in clinical data management, including those related to documentation, security, and proactive monitoring.

» Navigating the common pitfalls in SDTM compliance, such as misinterpretations in compliance reports and the importance of granular data verification.

» Sunil’s recommended resources for mastering compliance, including websites like cdisc.org and phuse.global, and the value of attending relevant webinars and workshops.

» Predictions for the future of clinical data tools and applications, and the growing integration of compliance tools in the SDTM generation process.

» The crucial role of collaboration and resource utilization in achieving effective SDTM compliance. Sunil shares his involvement in mentoring and open-source initiatives.

» The importance of automation, technology, and standardization in enhancing the quality and efficacy of clinical trial data.

Sunil Gupta is an expert in CDISC and SAS programming, offering specialized teaching and mentoring services. He emphasizes real-world examples and utilizes a CDISC reference file to ensure compliance with CDISC and FDA guidelines.

Sunil is also the founder of SASSavvy.com, a pioneering SAS® Blog membership subscription service. This platform simplifies the search and application process for SAS® programming challenges.

Sunil's extensive experience in the pharmaceutical and medical device industries has proven his skills as a hands-on CDISC/SAS programmer and project lead. His unique methods have resulted in substantial time and cost savings, demonstrating his exceptional ability to innovate in the field of CDISC and SAS programming.

Episode #029 The Link Between Quality Culture and QA Communication Pathways with David Marks

The FDA Group's CEO Nick Capman, sits down with David Marks to discuss the intricacies of Quality culture and QA communication pathways in the life sciences. David is a strategic advisor and experienced executive with a proven track record in establishing global Quality, Operational, Corporate Stewardship, Change Management, and Integration programs across biopharma and CROs.

Discussion points include:

» The crucial role of a Quality culture, especially in biopharma and clinical settings. David discusses how a strong Quality culture leads to proactive organizations, reducing the frequency of audits and audit findings.

» The separation of Quality from Operations to prevent conflicts of interest, and the importance of a partnership between these departments for effective decision-making and communication.

» The responsibility of leaders in cultivating a culture of Quality, and how leaders should actively demonstrate and reinforce Quality values within the organization to build trust and openness.

» The business case for Quality culture, and how it's more efficient and cost-effective to do things right the first time. David advises Operations to approach Quality issues without fear or ego, fostering open discussions.

» How investing in Quality as a crucial preventive measure saves money and avoids future issues, particularly vital in life sciences.

» Encouraging informal, trust-building discussions between QA and Operations. He stresses the importance of QA being approachable and open to discussions, which leads to significant organizational improvements.

» A shift towards more open communication in modern Quality cultures. He highlights the importance of mechanisms for employees to ask questions anonymously in environments where fear or ego might be present.

» The often-overlooked human element in Quality culture, underscoring the need for personal relationships, understanding, and cooperation between Quality and Operations teams.

» The tangible benefits of a strong quality culture, such as improved efficiency, reduced costs, and enhanced organizational maturity.

David is a distinguished executive in the bio-pharma and CRO industries, known for his strategic expertise in global Quality, Operational, Corporate Stewardship, Change Management, and Integration programs. His career spans leading and supporting Cross-Functional Strategic Partnerships, GxP Quality Assurance/Management Operations, and Sustainability/ESG initiatives.

He has a proven track record of hands-on leadership and program oversight across North America, Latin America, Europe, and Asia-Pacific, demonstrating his ability to navigate complex international environments. He is adept at managing high-level strategic initiatives and C-suite special assignments across multiple corporate divisions, showcasing his versatile leadership skills.

Additionally, as an Emeritus Registered Quality Assurance Professional in Good Clinical Practice (RQAP-GCP) from the Society of Quality Assurance (SQA), he brings a deep commitment to quality assurance and extensive knowledge in Good Clinical Practice. His contributions have significantly influenced organizational success and set benchmarks in quality and operational excellence in the bio-pharma and CRO sectors.

Episode #028 Mastering Medical Device Supplier Management with Paul Hakamaki


The FDA Group’s CEO, Nick Capman, sits down with Paul Hakamaki, Vice President of Quality at Anteris Technologies, to explore the nuances of medical device supplier management in the medical device industry.

Discussion points include:

» Paul's journey from a supplier quality engineer to Vice President of Quality and his experience across various company sizes in the medical device sector.

» The critical importance of supplier management in the medical device industry, highlighting the necessity for clear expectations, risk management, and fostering partnerships beyond mere transactional relationships.

» A spectrum of supplier relationships, ranging from transactional for standard components to deeply involved partnerships for custom components, necessitating rigorous expectations and qualifications.

» The pivotal roles in supplier management, including purchasing professionals who handle business aspects and supplier quality engineers who manage the technical relationship, ensuring suppliers meet the company's stringent expectations.

» The extensive role of supplier quality engineers beyond conducting audits, emphasizing their importance in relationship building and technical liaison with suppliers.

» The Global Harmonization Task Force (GHTF) guidance document from 2008, which provides a six-stage process for supplier management, underscoring the significance of continuous improvement and proactive management in mature supplier relationships.

» The human element in supplier relationships, often overlooked in guidance documents, which is essential for building strong partnerships that involve personal relationships, understanding, and cooperation.

» The tangible benefits of strong supplier relationships, such as consistent quality, timely delivery, and reduced production issues, which underscore the importance of the human element in forming cooperative relationships.

Paul is a seasoned Quality Leader renowned for driving significant quality improvements through data-driven projects and the daily application of Six Sigma fundamentals. With a robust track record of achieving challenging results across various business units, Paul's approach to quality leadership is rooted in collaborative problem-solving and the innovative application of Six Sigma principles. His expertise has been pivotal in overseeing complex projects such as post-market product design changes, reorganizations, facility moves, and Quality System software implementations.

Before assuming his current role as Vice President of Quality at Anteris Technologies, Paul Hakamaki honed his leadership and quality management skills in several significant roles within the healthcare and medical device industry. As the VP of Quality at Colder Products Company, he led all Quality and Quality System functions, ensuring compliance with ISO standards and overseeing the Six Sigma program across three sites in Minnesota. His strategic vision was further exemplified during his tenure as Director of Global Supplier Quality at 3M's Health Care Business Group, where he developed and implemented a comprehensive supplier quality methodology compliant with FDA and ISO 13485 standards. Prior to 3M, at Medtronic, he led a team of 125 professionals in supplier controls, managing a broad range of quality assurance processes and upholding stringent regulatory requirements. His expertise also extended to American Medical Systems, where he spearheaded supplier quality functions and internal audits, successfully closing FDA-identified compliance gaps and re-engineering the CAPA process through Lean Six Sigma methodologies.

Episode #027 Recent FDA Enforcement Trends with George Toscano

The FDA Group’s CEO, Nick Capman, sits down with George Toscano, President & CEO of Toscano Consulting Group, to explore recent FDA enforcement trends and the nuances of the FDA inspection process, especially in light of the COVID-19 pandemic's impact on the industry.

Discussion points include:

» George's extensive background in the pharmaceutical, biologics, and medical device industries, highlighting his transition from an analytical development chemist to a consultant specializing in quality and regulatory work.

» The emergence of new companies in the pharmaceutical space during the COVID-19 pandemic, particularly those producing hand sanitizers, and the challenges they faced with Good Manufacturing Practices (GMP).

» The FDA's increased scrutiny on the presence of diethylene glycol and ethylene glycol in components, reflecting on historical issues and the importance of stringent testing for these contaminants.

» The problem of inadequate authority within quality units, especially in Over-The-Counter (OTC) manufacturers, leading to compliance issues and insufficient testing for harmful impurities.

» A shift in the FDA's focus towards ophthalmic products due to recent contamination issues, and the anticipation of this becoming a new wave of enforcement.

» The significant reduction in on-site FDA inspections during the pandemic, the transition to remote evaluations and document requests, and the gradual return to on-site inspections with continued use of remote tools.

» The concept of FDA "waves" of focus, with a recent pre-COVID wave on OTC manufacturers, and the potential for new waves targeting different areas such as ophthalmic products.

» The perennial issues cited by the FDA, such as the failure to conduct adequate investigations and the lack of or failure to follow written procedures, which are expected to continue being focal points in FDA observations.

Episode #026 Growing Your Career in RA/QA with Jessica Smith Beaver, PhD

The FDA Group’s CEO, Nick Capman, sits down with Jessica Smith Beaver, PhD, President & CEO of Verinetics, to explore various career trajectories within the quality and regulatory space in the life science industry, the advantages and challenges of different paths, and the crucial role of personal reflection in career development.

Discussion points include:

» Dr. Beaver's journey from a pharmacist to a contributing scientist in the pharmaceutical industry, and her eventual transition into regulatory affairs and quality space.

» The dilemmas faced by professionals in RA/QA roles, such as the decision to specialize or generalize, and the choice between working for large pharmaceutical companies or startups.

» The pros and cons of being a specialist versus a generalist in the industry, highlighting the importance of adaptability and broad experiences.

» The benefits and risks associated with working in large pharma companies compared to startups, including the opportunities for learning, career growth, and the potential for instability.

» The choice between focusing on small molecules, large molecules, pharmaceuticals, biotech, or medical devices, and how this decision ties into the broader specialist versus generalist debate.

» The transition from being an individual contributor to taking on a managerial role, emphasizing the different skill sets required and the significance of leadership in team development.

Dr. Beaver is a skilled pharmaceutical industry executive with experience at all stages of R&D for product candidates in discovery, early and late-stage development, and marketed products. Drug candidates/marketed products have included both small and large (biologic) molecules. Beginning as a product team scientist in the industry, her roles have evolved to include functional area experience in regulatory affairs, healthcare compliance, quality assurance, risk management, corporate investigations, and other business operational functions required for the distribution, marketing, sale, and promotion of pharmaceutical products.

Episode #025 Drug Delivery System Innovation and Leadership with Steve Knowles



The FDA Group’s CEO, Nick Capman, sits down with Steve Knowles, MB.BS, M.R.C.P., M.F.P.M., Chief Medical Officer at Halozyme, a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies.

They discuss advancements in drug delivery technology and the role of leadership in fostering innovation and addressing challenges in this field.

Discussion points include:

» Dr. Knowles's transition from a physician in the UK to Chief Medical Officer at Halozyme in San Diego.

» The evolution in drug delivery systems, such as the shift from hospital-based treatments to self-administration of drugs at home and the introduction of auto-injectors and on-body devices for efficient, patient-friendly drug administration.

» Addressing human factors and compliance to ensure products are user-friendly—and the importance of human factor studies in product development.

» The advantages of subcutaneous drug delivery, including reduced side effects, improved pharmacokinetic profiles, and patient convenience.

» How Halozyme’s one-team approach fosters a culture of curiosity, flexibility, and feedback.

» Aligning individual and organizational goals to drive innovation.

Dr. Knowles has deep pharmacovigilance and medical affairs experience gained over a career spanning almost 20 years. Dr. Knowles joined Halozyme in January 2018 as Vice President, Drug Safety & Pharmacovigilance. He is responsible for the Medical, Regulatory and Drug Safety organizations.

Prior to Halozyme, Dr. Knowles served as Senior Medical Director, Global Patient Safety and Benefit Risk Management at Eli Lilly & Co. where he led the global safety physician/scientist group responsible for overseeing the safety profiles and benefit risk management of medicines across all therapeutic areas and phases of development and supported numerous BLA and MAA submissions. During his 16 years at Lilly, he held positions in Medical Affairs and from 2005 to 2017 he held roles of increasing responsibility within Global Patient Safety. Prior to these roles, Dr. Knowles spent more than 17 years in clinical practice in the UK in both hospital-based and general practice roles.

Dr. Knowles received his Bachelor of Medicine and Surgery degrees (MB.BS) from the University of Newcastle Upon Tyne and is a Member of the Royal College of Physicians (MRCP) and a Member of the Faculty of Pharmaceutical Medicine (MFPM).

Episode #024 Motivating Technical Teams in the Life Sciences: A Conversation with Rick Beatty

The FDA Group’s CEO, Nick Capman, sits down with Rick Beatty, Chief Science Officer and Senior VP of Quality and Regulatory at Robinson Pharma, the largest industry contract manufacturer in the U.S.

They discuss:

» Leadership philosophy, particularly the importance of focusing on employees’ success as a pathway to organizational achievement.

» Rick's shift in leadership approach after training with Marshall Goldsmith, moving from a self-centered to a people-centered approach.

» The generational gap in leadership styles, with older generations often struggling to understand the mindset of younger employees.

» How scientific and technical teams, often introverted, face challenges in communication and emotional intelligence (EQ)—and the importance of acknowledging and respecting different perceptions and realities to foster effective communication.

» How Rick’s international experience highlights the need for leaders to adapt their communication styles to different cultures and individual preferences.

» Why reflective listening and using various communication styles are essential to ensure messages are effectively received and understood.

Rick currently leads and manages multi-site manufacturing processes and systems for DSHEA, foods, and cosmetics. He manages employees, teams, and technology to pursue corporate goals in R&D, formulation, QC, Laboratory, QA, Regulatory, Audits, Compliance, and Customer Service engagement with National and FMD customers.

Episode #023 Cross-Cultural Pharma: Mike Martin's Experiences from Puerto Rico to China


The FDA Group’s CEO, Nick Capman, sits down with CAI's CEO, Mike Martin, BSME, MBA, PE, whose roles have spanned from designing facilities and systems to CEO, including experiences in device manufacturing, global project management, and regulatory insights.

They discuss:

  • Mike's personal journey from growing up in Southern Indiana with a passion for math and science to leading major pharmaceutical projects around the world.
  • The importance of servant leadership in the pharmaceutical sector, emphasizing the success of team members over personal achievements.
  • The challenges and intricacies of navigating the regulatory landscape in the life sciences industry, especially in device manufacturing.
  • Advocacy for thorough preparation for regulatory inspections, emphasizing the need to start years in advance.
  • The role of mentorship in shaping one's career, with Mike crediting his mentors for providing guidance and feedback throughout his journey.
  • The cultural experiences and challenges Mike faced while working in diverse environments like Puerto Rico, China, and Ireland.
  • The belief that with the right guidance, mentorship, and leadership, it's possible to navigate the complex world of pharmaceuticals and make a significant impact.

Episode #022 Courageous Leadership to Reinvent Our Healthcare System


The FDA Group's CEO, Nick Capman speaks with Cheryl Blasie, Ph.D., a healthcare consultant and advocate whose roles have spanned from entry-level Ph.D. Research Scientist to Vice President and Head of Quality at biotech and biopharma companies, including Program Management, Business Operations, and Patient Advocacy.

They discuss:

  • Cheryl's personal journey from being a biotech industry veteran to becoming a healthcare advocate, driven by her own health challenges.
  • The need for courageous leadership in the healthcare sector to challenge the status quo and explore alternative treatment options beyond traditional allopathic medicine.
  • The issues affecting the current healthcare system—particularly its one-size-fits-all approach and the lack of individualized solutions.
  • Advocacy for a healthcare system that considers each person as a holistic organism and provides a range of treatment options, including vitamins, supplements, herbals, essential oils, chiropractic, massage, and acupuncture.
  • The role of local offices or advocates in educating patients about these alternative therapies and connecting them with vetted practitioners whose personalities and treatment approaches align with patients' needs.
  • The challenges in integrating these alternative therapies into the current healthcare system, particularly in terms of regulation and insurance coverage.
  • The belief that with courageous leadership, it's possible to create a healthcare system that embraces all treatment options and assists patients in finding the best alternatives for them on an individual level.

Episode #021 The Critical Role of 'Hyper-Targeting' in Rare Disease Drug Development with Dan Donovan


The FDA Group’s CEO Nick Capman sits down with Dan Donovan, an expert in rare disease drug development, to explore the unique challenges and new opportunities presented in the rare disease space.

Episode #020 A Journey into Life Sciences Investment: Strategies, Challenges, and Opportunities with Sal Buscemi


The FDA Group’s CEO Nick Capman sits down with seasoned investor Salvatore Buscemi to delve into the intricacies of investment in early-stage life science and device companies.

Episode #019 Navigating Risk Management in Medical Devices with Brian Dense


The FDA Group's CEO, Nick Capman sits down with Brian Dense, a medical device consultant with over 30 years of experience across several parts of the industry, to discuss risk management for medical devices, emphasizing key points such as:

  • The importance of risk management in the medical device industry as it forms the basis of regulations and ensures safe and cost-effective products.
  • Different markets, including the European Union, Canada, and the United States, and their specific regulatory requirements.
  • The primary standard for risk management, ISO 14971, with the 2019 version designed to align with the EU MDR regulation.
  • The significance of addressing the EU's 15 General Safety and Performance Requirements (GSPRs) and including usability in risk management.
  • Risk acceptability determination, using ISO 14971's standard ranking system and evaluating products based on safety rather than cost.
  • The importance of usability in risk management, even for lower-class devices, and its integration with design history and risk management files.
  • The role of FMEA in assessing risk by identifying potential failure modes, their effects, and their probability of occurrence.
  • The value of involving a diverse team with backgrounds in engineering, manufacturing, quality, and marketing when conducting FMEA.
  • The use of process FMEA to evaluate each step in the manufacturing process and identify potential failures impacting the device's performance or safety.
  • The importance of reading and understanding ISO 14971 and ISO/TR 24971, as well as the EU MDR regulation and its GSPRs for those entering the European market.

Brian's medical device experience covers a diverse range of products from dental instruments and diagnostic equipment to orthopedics, spine, contact lenses, and urological products. His extensive background spans various company sizes, including working with two startups and three large conglomerate corporations.

Over the course of his career, Brian has developed expertise in several areas of the medical device sector, such as orthopedics and spine, as well as other specialized fields. In the past 13 years, he has transitioned to consulting, where he has been connected with The FDA group for seven years.

Episode #018 The DEA, FDA & Controlled Substances: An Insider's Perspective with Former DEA Agent Dennis Wichern

The FDA Group's CEO, Nick Capman sits down with former DEA agent Dennis Wichern to discuss the vital role of compliance for pharmaceutical companies dealing with controlled substances and the significance of adhering to DEA regulations. Key discussion points include:

  • The importance of strong compliance programs, record-keeping, and suspicious order monitoring systems, especially in light of the nationwide opioid lawsuits.
  • Common issues faced by DEA registrants, such as poor record-keeping and security, and the need for adequate security measures and compliant record-keeping systems.
  • The process of determining a buyer's legitimacy and the reasonability of their controlled substance purchases, with suggestions for due diligence, background checks, and evaluating the balance between controlled and non-controlled substances.
  • The focus of DEA inspections on large manufacturers and distributors, and Dennis's work with pain providers, pharmacies, hospitals, and small distributors when problems or fears of DEA intervention arise.
  • Mock inspections and tips for interacting with the DEA to help clients prepare for real inspections.
  • Dennis's experience as an expert witness in opioid lawsuits and the interactions between DEA and FDA, highlighting the different authorities of the two agencies and their collaborative efforts in determining drug schedules.

Dennis is the former Special Agent-in-Charge of the Chicago, Illinois regional office of the U.S. Drug Enforcement Administration (DEA). He offers clients over three decades of federal law enforcement experience as well as a keen understanding federal agencies and working relationships with all major federal agencies, the U.S. Sentencing Commission, Assistant U.S. Attorneys, U.S. Attorneys, and other Department of Justice officials.

EPISODE #017 A Deep Dive into Medical Device Regulatory Strategy with Regulatory Attorney Christine P. Bump

The FDA Group's CEO, Nick Capman, sits down with Regulatory Attorney Christine P. Bump to discuss the current regulatory landscape for medical devices and the importance of developing a thoughtful regulatory strategy. Discussion points include:

  • The three classifications of medical devices and the various regulatory submission types — each with different risk levels, required data, costs, and approval timelines.
  • The costs associated with FDA approval.
  • Why it's important to craft a regulatory strategy early, even at the product concept stage, to determine device functionality and anticipate FDA requirements.
  • The challenges that the rapidly evolving nature of software, algorithms, and AI present for the FDA's traditional device paradigm.
  • The benefits of pre-submission meetings with the FDA, which provide valuable feedback and insights to streamline the submission process.
  • The differences between regulatory attorneys and consultants.
  • The common pitfalls for companies navigating the FDA approval process, such as insufficient budgeting and lack of in-house expertise.
  • The importance of planning well in advance and adjusting operational goals to align with regulatory requirements.
  • The importance of understanding product claims to avoid regulatory complications.

Christine is a regulatory attorney with more than 15 years of experience developing and implementing FDA strategies for cutting-edge technologies. As the founder of Penn Avenue Law & Policy, she focuses on devices, software as a medical device, digital health, diagnostics, wellness, genetics and genomics, and advertising and promotion. She advises CEOs, scientists, and teams of all levels regarding regulatory pathways, clinical investigations, premarket submissions, pre- and postmarket compliance, and promotional issues. She counsels a variety of clients, including start-ups, national and multi-national corporations, venture capital groups, and portfolio companies on navigating the FDA process.

Episode #016 Lessons from a Medtech Entrepreneur: Ram Konduru on Fostering Teamwork and Personal Growth in Leadership

The FDA Group's CEO, Nick Capman sits down with Ram Konduru, CEO of PrimeSoft Inc (North America & Europe) and Co-Founder of Coherence Health. Ram discusses his experience in leadership and management, highlighting the importance of having a common purpose and goal for a team. Ram and Nick also discuss the need for leaders to create strong bonds within their teams, provide opportunities for team members to bond, and be humble and relatable.

Other discussion points include:

  • Ram’s personal growth journey as a leader, the impact of his mentors on his development, and the importance of self-reflection, practice, and having a genuine belief in the company's mission. 
  • The idea that money is a byproduct of value creation.
  • The challenges of being a modern leader and manager—and the importance of staying curious and maintaining a learning attitude.
  • Life-impacting questions.
  • The importance of personal relationships and reflecting on one’s actions.
  • A few book recommendations.

EPISODE #015 Unlocking Effective Leadership: A Conversation with MetaComet Systems President, David Marlin


The FDA Group's CEO, Nick Capman sits down with David Marlin, President of MetaComet Systems, a company specializing in royalty automation software. David shares his background, thoughts on leadership and management, and the importance of working towards a common goal. He emphasizes the value of joining peer groups, vulnerability, trust, and using the Entrepreneurial Operating System (EOS). He credits the concept of "letting go of the vine" for reducing stress and improving overall business performance.

David also discusses:

  • His transformation from a charismatic leader to a better listener and the pride he takes in his company's software.
  • Various books on leadership and management.
  • Self-awareness, empathy, and creating positive environments as key aspects of effective leadership and management.

MetaComet was founded in 1999 to revolutionize royalties through automation. More than two decades on, it remains steered by founder and President, technologist and publishing expert David Marlin, and continues to strive for the highest levels of efficiency. MetaComet serves many different industries, and more than 140 companies of all sizes and types trust it to make royalties effortless. 

EPISODE #014 Leadership, Management, and Enhancing Quality of Life: A Conversation with Dan Barker, CEO of Wikimotive


The FDA Group's CEO, Nick Capman sits down with David Marlin, President of MetaComet Systems, a company specializing in royalty automation software. David shares his background, thoughts on leadership and management, and the importance of working towards a common goal. He emphasizes the value of joining peer groups, vulnerability, trust, and using the Entrepreneurial Operating System (EOS). He credits the concept of "letting go of the vine" for reducing stress and improving overall business performance.

David also discusses:

  • His transformation from a charismatic leader to a better listener and the pride he takes in his company's software.
  • Various books on leadership and management.
  • Self-awareness, empathy, and creating positive environments as key aspects of effective leadership and management.

MetaComet was founded in 1999 to revolutionize royalties through automation. More than two decades on, it remains steered by founder and President, technologist and publishing expert David Marlin, and continues to strive for the highest levels of efficiency. MetaComet serves many different industries, and more than 140 companies of all sizes and types trust it to make royalties effortless.

EPISODE #013 Navigating the 510(k) Process: A Q&A with Regulatory Consultant Trey Thorsen, MS, RAC

The FDA Group’s CEO, Nick Capman, sits down with Regulatory Consultant Trey Thorsen, MS, RAC, to answer some of the most frequently asked questions about navigating the 510(k) premarket notification process.

Trey brings experience in Class I, II, and III devices, such as active implantables with MRI functionality, external therapeutic devices indicated for pain, devices that have software functionality, transvaginal catheter systems that evaluate fallopian tube patency, sterile and non-sterile wound care devices, compression devices, surgical booms, surgical lights and devices indicated for incontinence. He also has experience with 513(g)s, Pre-Subs and CFGs, UDI/GUDID implementation, as well as EU MDR technical file development and remediation.

Some of the questions Trey tackles include:

  • "I would like to distribute a manufacturer's product under my own company name. Do I need to submit a 510(k)?"
  • "Can foreign companies submit a 510(k)?
  • "Besides the fees for paying a consultant to help me put this together, are there any other fees I should be aware of?
  • "How much does a U.S. Agent typically cost?"
  • "Do I need to register my facility before I submit a 510(k)?"
  • "Do I need to provide documentation that my facility complies with the quality system in my 510(k)?"
  • "Do I need to have my facility inspected to the Quality System Regulations before I submit a 510(k)?"

Need expert 510(k) assistance? At The FDA Group, we help you move through the 510(k) submission process quickly and efficiently. Our regulatory affairs consultants, many of whom are former FDA personnel, have years of experience working with and within the agency.

EPISODE #012 The Future of Life Science Talent Acquisition: Securing In-Demand Skills in a Competitive Market

Earlier this year, Deloitte released its Global Life Sciences Outlook report, featuring a section devoted to "transforming the talent experience."

The FDA Group's CEO, Nick Capman, sat down with Larry Stevens, RAC, to unpack some of Deloitte's findings and what they might mean for life science teams looking to innovate their workforce strategies and navigate a hyper-competitive specialized labor market.

Read Deloitte's full report here (PDF).

Some key excerpts:

Page 29:

"Life sciences companies are still optimizing virtual ways of working, and other issues of concern for life science leaders in 2022 include:

  • What is our talent acquisition strategy? How do we secure in-demand skills and capabilities in a competitive market?
  • What are the “Great Resignation” effects on our company? How can we create a more meaningful talent experience?
  • How can we become a more agile and adaptable organization?"

"Life sciences companies that want to succeed in the future of work will need to be flexible in how work is done and how talent is sourced, trained, and managed. Human resources is also undergoing a massive transformation. Instead of trying to predict the future, leaders might consider how they can develop an open culture of experimentation, learning, and iteration."

Page 30:

"Throughout the next year, many life sciences companies will continue to grapple with how to solve these issues, and each will land in a different place on the spectrum. The 'Great Resignation' is calling for a 'Great Re-imagination', and a winning strategy includes creating value for workers as whole human beings and key stakeholders—including internal and external workers."

"Successful companies are no longer concentrating on just hiring the smartest people, but rather on having access to the smartest people. New workforce ecosystems include in-house employees combined with a diverse mix of external contributors—e.g., contractors, app developers, other gig workers, external partners and suppliers, and even software bots. According to recent research from MIT Sloan Management Review and Deloitte, only 28% of global managers feel they are sufficiently preparing to manage a workforce that will rely more on external participants."

"One agile strategy is to shift from a hierarchical structure to a more team- and networked-based approach that may combine internal and external workers into specialized or cross-functional teams."

Page 35:

"According to a recent Fortune/Deloitte CEO Survey, attracting and retaining talent in a tight labor market has ascended to the top of CEOs’ list of strategic priorities. Companies should reimagine work as a landscape of tasks and skills that dynamically evolves with business priorities."

EPISODE #011 FDA Revives Its Proposed Quality Metrics Program for Pharma

The FDA Group's Nick Capman discusses the recent news that the FDA is once again returning to its quality metrics program for pharma manufacturers.

EPISODE #010 Inspection Alternatives Are Driving More FDA Enforcement Actions: What It Means for Industry


Product sampling and remote records requests accounted for most import alerts and drug GMP warning letters over FDA's fiscal year 2021. They may play a key role post-pandemic.  
As remote records reviews conducted during the pandemic accounted for a growing share of warning letters, experts have advised the industry to prepare for remote FDA oversight to continue even after routine site inspections resume and the pandemic recedes.  
The FDA, which historically relied solely on on-site inspections as a basis for drug adulteration warning letters, only based 28% of warning letters issued in the first 11 months of fiscal year 2021 on-site inspections, with 62% based on sample testing and 10% on remote records reviews.  
In this episode, we sit down with former FDA professional, Larry Stevens, RAC, to talk about how inspection alternatives may become a permanent facet of FDA's oversight program and what companies may want to consider doing to prepare accordingly.  
FDA official: Growing number of enforcement actions stem from inspection alternatives: https://www.raps.org/news-and-articles/news-articles/2021/11/fda-official-says-increasing-number-of-enforcement (RAPS)   
About Larry Stevens, RAC:
Larry has held almost every field position within FDA during his 21-year career with the Agency. He has over 18 years of experience in the medical device industry, rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers. He specializes in planning, creating, and auditing quality systems as well as creating clinical plans, including protocol development, case report form development, and implementing and managing clinical trials. He also assists in design control to meet FDA requirements. Larry is a professional speaker who regularly trains on all aspects of FDA requirements while offering practical, successful solutions to FDA problems.  

EPISODE #009 FDA's Domestic Biopharma Inspections Return to Normal


From Endpoints News:

For the first time since March 2020, the FDA’s inspections of US-based biopharma sites have returned to normal, according to FDA acting commissioner Janet Woodcock.

“I’m pleased to say that as of this month, we’ve begun transitioning back to standard operations for domestic inspections while continuing to prioritize mission-critical work for foreign inspections,” Woodcock said. The return to normalcy will be welcomed by industry, which has grappled with a growing backlog of mostly surveillance inspections, although some of those delayed inspections have also delayed the approval of new drugs.

According to a report from FDA in May, an estimated 68 applications (including 48 for human drugs) have been delayed due to FDA’s inability to conduct pre-approval, pre-market, or pre-license inspections as of March. The agency said it postponed nearly 8,000 non-mission-critical surveillance inspections in 2020 due to the pandemic.

Surveillance inspections are routine inspections that monitor conformance to FDA requirements to identify quality problems and adverse trends, but unlike others, they’re planned in advance by applying established risk factors and statutory inspection frequency mandates.

Read the full article here.

EPISODE #008 Quality Management Review: Benchmarking Quantitatively!


The FDA Group’s CEO, Nick Capman, sits down with Tobias Kuners of Koenders, Managing Consultant at Tob Management, to discuss his integrated approach to implementing and interpreting qualitative and quantitative metrics in the GMP and non-GMP sides of a life science business.

Tobias has worked with Biogen, Ipsen, Thermo Fisher, Kite Pharma, and Danone, among other companies, gaining hands-on experience in engineering services, equipment qualification, maintenance, supply chain, warehousing, and distribution. He has led the design, engineering, and construction of multiple facilities to meet cGMP requirements. He performs audits, identifies gaps, and develops remediation plans, working within organizations to assist with deviation investigations and CAPA implementation and to develop scientific, risk-based solutions. 

EPISODE #007 Addressing FDA's Inspection Backlog with Mary Denigan-Macauley, Director of Health Care, GAO

The FDA Group’s CEO, Nick Capman, sits down with Mary Denigan-Macauley, Director of Health Care in the Government Accountability Office (GAO) to understand the situation the FDA finds itself in with respect to a formidable pandemic-induced inspection backlog, and what measures the agency may take to address it.

Mary joined GAO in 2001, managing a diverse portfolio related to science and animal health for GAO’s Natural Resource and Environment team. This work covered cross-cutting topics such as foreign animal diseases, antibiotic resistance, food safety, and emergency preparedness. Prior to joining GAO, Mary taught various courses in public policy and public affairs at Sam Houston State University, Troy University, and the Georgian Institute of Public Affairs.

Over the past year, Mary and her team at the GAO have published two FDA-focused reports:

EPISODE #006 FDA's Fraudulent Products Task Force and Operation Quack Hack Battle COVID Vaccine Scams


The FDA Group’s CEO, Nick Capman, discusses the federal effort to thwart COVID-19 vaccine scams.

From FDA.gov:

"The FDA’s dedicated COVID-19 Fraudulent Products Task Force continues to monitor the market, including online, for fraudulent COVID-19 products, and the Operation Quack Hack initiative continues to leverage agency expertise and advanced analytics, resulting in the removal of hundreds of unlawful products from the marketplace. To date, the agency has uncovered nearly 1,300 fraudulent products, sent more than 160 warning letters, issued more than 270 abuse complaints to domain registrars, and sent more than 290 requests to various marketplaces to remove listings for fraudulent COVID-19 products.

The FDA will continue working with its state and federal partners to take appropriate action against bad actors who prey upon people seeking a COVID-19 vaccine in the midst of this global pandemic. The agency has gone to great lengths to ensure that the authorized vaccines available to the public are safe and effective."

Read the full article here.

EPISODE #005 What to Expect for the FDA's Regulation of Medical Devices & Digital Health Under the Biden Administration

The FDA Group’s CEO, Nick Capman, breaks down the key points in a recent Morgan Lewis article laying out what to expect for the FDA's regulation of medical devices and digital health under the Biden administration.
Read the full Morgan Lewis piece here.
Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of 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. Learn more and get the conversation started.

EPISODE #004 Clinical Outsourcing & Insourcing: Selecting the Right Model or Mix


The FDA Group’s CEO, Nick Capman, sits down with Mark Shapiro, a Partner with biopharmaceutical consulting firm Pharma Initiatives, to discuss outsourcing and insourcing models in the current clinical R&D environment, and what to consider when selecting the right model or mix of models for a project.

Download the corresponding white paper and put these insights into practice: A Modern Guide to Clinical Operations Resourcing.

Mark is widely recognized as an expert on the business of clinical research and is frequently quoted in the press, including Outsourcing Pharma, PharmaVoice, and CenterWatch. His comments have also been featured in the New York Times and Raleigh News & Observer on topics pertaining to the business of drug development. His focus at Pharma Initiatives is growth and innovation strategies in clinical research, development, and medical affairs. He has led strategic planning, growth, and change management initiatives at many pharmaceutical, biotech, and clinical research organizations. 

Prior to joining Pharma Initiatives, Mark was SVP, Operations at a global CRO, where he was responsible for an operations team of about 500 drug development professionals in more than 30 countries, and a portfolio of more than 100 active clinical trials. He was previously a management consultant at Campbell Alliance in the Clinical Development and Medical Affairs Practice, where he worked with many global CROs and biopharma companies on R&D innovation strategy. Mark is a pharmacologist, holds an MBA from Duke University’s Fuqua School of Business, and has received numerous certifications in clinical research, regulatory affairs, and healthcare management.

Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of 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. Learn more and get the conversation started.

Episode #003 What RA/QA/Clinical Leaders Should Expect From the FDA in 2021


The FDA Group’s CEO, Nick Capman, sits down with Ben Locwin, Senior Consultant for Public Health Outreach at the CDC, and Executive Advisor for Valeocon Management Consulting, to discuss what life science leaders should expect from the FDA in 2021 as it pertains to quality system management, regulatory approvals, GxP compliance, and more.

Ben has extensive experience working with the FDA and international regulatory officials. His project work includes Pre-IND, NDA, Ph1-3, and marketed/post-market drug products, as well as PMA and 510(k) medical devices. Ben has trained FDA inspectors within their headquarters and has participated in the design of the FDA's Global Quality Metrics Initiative.

Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of 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. Learn more and get the conversation started.

EPISODE #002 Inside FDA Pre-Approval Inspections with Former FDA Investigator, Christopher Smith


The FDA Group’s CEO, Nick Capman, sits down with Former FDA Investigator, Christopher Smith to dive deep into FDA Pre-Approval Inspections (PAIs). Chris has more than 40 years of experience having held senior positions at the FDA, large and small pharmaceutical companies, and contract research organizations. 

Learn how PAIs are planned and conducted, how to prepare for them, and where to go to find helpful resources your team can utilize.

Need expert help with PAI preparation? Contact us to schedule a mock PAI or discuss other quality and compliance support. Learn more about our GMP Auditing services here.


EPISODE #001 A Look at FDA's Pandemic Inspections Q&A Guidance


The FDA Group’s CEO, Nick Capman, breaks down the FDA’s Q&A guidance on drug and biologic inspections during the pandemic, pointing out the important takeaways manufacturers should consider and prepare for. Read our blog post for a written breakdown of the key takeaways. We've also written on FDA's more recent guidance outlining its expectations for resuming normal manufacturing operations during the pandemic. Read that post here. Need expert quality system remediation assistance? Learn more and get in touch.


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