The Life Science Rundown (The FDA Group)

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.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group's CEO, Nick Capman, sits down with 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.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group's CEO, Nick Capman 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.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group’s CEO, Nick Capman, 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: www.thefdagroup.com.

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.  

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: www.thefdagroup.com

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 Yuraszeck is a distinguished leader in biopharmaceutical compliance, operations, and quality assurance, specializing in cell therapy manufacturing. Over his extensive career spanning more than two decades, Carlos has significantly impacted the biopharmaceutical industry through his leadership in various pivotal roles. As the Executive Director of GMP Operations at Astellas Pharma US, he led the transformation of research groups into fully operational GMP manufacturing facilities. Earlier, as Senior Vice President of Technical Operations at Talaris Therapeutics, he managed operations focused on groundbreaking organ transplantation therapies. At Celgene, Carlos directed clinical production and supply, where he scaled up manufacturing operations to support the delivery of life-saving CAR T-cell therapies. His tenure in the industry is marked by a commitment to excellence, deep regulatory knowledge, and strategic oversight, which have driven the successful development and commercialization of novel therapies. Carlos's leadership style emphasizes collaboration, transparency, and continuous learning, aiming always to enhance patient outcomes and advance the field of biopharmaceuticals through innovative and efficient manufacturing practices.

The FDA Group's 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.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

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

The agency’s focus on quality metrics began in 2015 and continued with a heavily revised draft guidance on submitting metrics data, including quality-related complaints. The guidance led to two FDA pilot projects in 2018.  

In a new update, FDA stressed that additional quality data can help both the FDA and the supply chain, which needs to have a better understanding of which manufacturers are going above and beyond the status quo.

Current GMP compliance “does not necessarily indicate” whether a manufacturer is investing in improvements and striving for consistent control over its manufacturing performance and quality, FDA said.  

“To provide flexibility to manufacturers, FDA would focus less on standardization of quality metrics and definitions,” the agency said Tuesday. “Instead, FDA would identify practice areas that are critical to ensure sustainable product quality and availability and would permit manufacturers to select a metric(s) from each practice area that are meaningful and enable establishments to identify continual improvement opportunities.”  

Rather than set metric definitions on how establishments calculate particular metrics, the FDA said it will allow reporting establishments (i.e. API and finished dose manufacturers, among others) to select the most appropriate metric(s) from each practice area and inform FDA how the metrics were calculated.  

Based on feedback from the pilot participants, the agency said it identified four general areas as appropriate for its metrics program:  

1. Manufacturing process performance  
2. Pharmaceutical quality system effectiveness  
3. Laboratory performance  
4. Supply chain robustness  

Examples of quality metrics associated with each of these areas include (for area number 1) a metric on the proportion of lots manufactured without the occurrence of a non-conformance, (for area number 2) a measure of the proportion of recurring deviation measures, (for area number 3) a measure that indicates a lab’s ability to accurately perform tests, and (for area number 4) a measure of the extent to which shipments are delivered to their destination containing the correct quantity and according to the order’s schedule.  

As far as questions for industry, the FDA wants to know if stakeholders agree that reporting should be aggregated at an establishment level, and whether reporting at an establishment level would help facilitate the submission of quality metrics data by contract manufacturers.

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: www.thefdagroup.com

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. They discuss: » The critical role of patient advocates and caregivers in conducting successful studies and applications for bringing a rare disease drug to market. » The financial and resource challenges faced in the field of rare diseases and drug development. » The potential for individuals to contribute to the rare disease sector, specifically through the Five Voices program. » Successful and unsuccessful attempts to bring rare disease drugs to market, including the success story of Sarepta in getting the first drug for Duchenne muscular dystrophy approved and the failure of a company to enroll patients for their trial due to poor community relations. » The unique approach required for rare disease drug development, termed as "hyper-targeting," which emphasizes focusing resources on specific rare disease communities and expert centers—and ongoing engagement with the community from the development phase through to commercialization. » The role of rareLife Solutions is providing in guiding to companies interested in the hyper-targeting approach. » The personal aspect of working in the field of rare diseases, including the importance of passion for the work and the need to channel it positively for the benefit of others. Dan is the visionary behind rareLife Solutions and oneVoice, and has spent his career innovating in the medical and pharmaceutical industries. Introduced to the world of rare diseases through his involvement as an investor and Chief Business Officer at Cancer Prevention Pharmaceuticals (CPP), he observed the fragmented nature of rare disease communities, which inspired him to establish oneVoice, a platform for guided communities specific to rare diseases. Earlier in his career, Dan founded Envision Pharma, where he served as President and developed Datavision, a leader in medical publications technology. The company was acquired by United BioSource Corporation (UBC), where he served as Senior Vice President Strategy and Market Development. Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group's CEO Nick Capman, sits down with 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.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group's 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.

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

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

Discussion points include:

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

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

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

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

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

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

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

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

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

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

For project or resource needs, visit ⁠thefdagroup.com⁠.

The FDA Group's 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.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group's Nick Capman sits down with Stephen Poor, a physician-scientist with over 20 years of experience in the industry, mainly with Novartis — currently serving as Novartis's Global Program Clinical Head (Executive Director).

They delve into the psychological and professional impacts of organizational changes, particularly focusing on identity and adaptation during times of transition, such as layoffs or department closures.

Discussion points include:

» Stephen's transition due to organizational shutdown and his journey through change.

» Stephen's experiences and thought processes from realizing Novartis's exit from ophthalmology to starting a new job, focusing on identity in times of change.

» The importance of maintaining a positive outlook, using visualization techniques, and combating self-limiting beliefs during periods of professional uncertainty.

» Predictions for 2024 and 2025.

» Nick's upcoming book, "The Passionate Workforce," is based on 15 pillars aimed at creating a motivated and high-performing organizational culture.

» Insights into managing layoffs thoughtfully, ensuring those who leave feel respected and valued.The FDA Group's strategic plans include potential acquisitions to leverage anticipated economic growth.

» The need for positive thinking, proactive planning, and readiness to capitalize on upcoming opportunities in the life sciences industry.

Stephen Poor is the Global Program Clinical Head at Novartis, bringing over 20 years of experience in ophthalmology biotech-pharma and a strong medical background to his role. He is at the forefront of developing innovative therapies for retinal diseases, focusing on age-related macular degeneration (AMD) and geographic atrophy (GA), the leading causes of blindness in the elderly. Poor leads the clinical team for PPY998 (GT005), a Phase 2b subretinal complement factor I gene therapy for GA, a significant acquisition from Gyroscope in 2021. His responsibilities extend beyond PPY998 to overseeing undisclosed gene therapy programs and novel drug delivery devices.

In his leadership role, Stephen is pivotal in bridging the gap between Novartis's research, development, and commercial sectors through strategic collaboration and advisory duties. He plays a key role in external strategy, asset and technology review to enhance the department's portfolio, and coordination of scientific support for the portfolio.

The FDA Group's Nicholas Capman welcomes Jen Chew, Vice President of Solutions and Consulting at Bristlecone, to discuss how life sciences companies can effectively implement AI in their supply chain operations. Jen sheds light on a few practical approaches to AI adoption in an industry still adapting to post-COVID realities.

Discussion points include:

• Strategic Implementation Approach: Jen emphasizes the importance of starting with simple, tactical applications before moving to complex strategic implementations. She advocates for a focused departmental approach rather than scattered company-wide experimentation.

• Data Quality and Regulatory Compliance: A major focus is placed on the critical role of data quality, particularly in regulated environments. Jen stresses that life sciences companies must build robust, FDA-validatable datasets before implementing AI solutions.
• Transforming Core Processes: The conversation explores how AI could revolutionize key operations like Sales and Operations Planning (S&OP), potentially reducing multi-day sessions to just hours through pre-run scenarios and more efficient planning.
• Organizational Readiness: Jen discusses how companies can assess their AI readiness and build internal capabilities, warning against the temptation to wait for enterprise vendors like SAP to provide complete solutions.
• Future Outlook: Looking ahead to 2025, Jen predicts massive data projects will be crucial, emphasizing how organizations must combine industry-specific knowledge with their unique data to create competitive advantages in AI implementation.

____

The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations.

For project or resource needs, visit: ⁠⁠⁠⁠⁠thefdagroup.com⁠⁠⁠⁠⁠.

The FDA Group's 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.

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.

www.thefdagroup.com

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.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group's Nick Capman sits down with Eric Busenburg, President of Euro-American Worldwide Logistics, where he oversees GMP storage and international shipping solutions for life science manufacturers.

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

Discussion points include:

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

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

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

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

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

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

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

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

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

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

For project or resource needs, visit thefdagroup.com.

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

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

Discussion points include:

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

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

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

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

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

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

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

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

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

For project or resource needs, visit thefdagroup.com.

The FDA Group’s 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. Learn more about our 510(k) consulting services and get in touch with us to access the industry's best regulatory affairs consultants.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more »

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:

• Industry Adoption Patterns: Keith contrasts how large pharma companies are establishing AI centers of excellence for major cost-saving initiatives while smaller companies are experimenting with tools like ChatGPT. He emphasizes the importance of solutions that can scale from large to small organizations.
• Privacy and Compliance: The conversation explores critical considerations around using AI tools within company firewalls, protecting intellectual property, and the evolving attitudes of regulatory groups toward AI-generated documentation.
• Practical Applications: Keith details several real-world use cases, including (1) TMF auto-classification to reduce manual document processing time, (2) automated labeling information compilation from multiple systems, (3) regulatory correspondence analysis for identifying commitments, and (4) historical submission analysis to improve future applications.

• Implementation Strategy: Keith recommends starting with "low-hanging fruit" - manual processes that can be automated - rather than attempting large-scale projects initially. Keith stresses the importance of demonstrating success with smaller projects to build momentum.

• Human Oversight: Keith highlights the importance of maintaining "human-in-the-loop" verification for lower confidence AI decisions while using machine learning to improve system accuracy over time.

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The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. For project or resource needs, visit: thefdagroup.com.

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

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

Nicholas Capman, CEO of The FDA Group, welcomes Harri Järveläinen, an independent consultant specializing in non-clinical and regulatory affairs, to discuss the realities of working with Chinese Contract Research Organizations. With over 20 years in the pharmaceutical industry—including experience with AstraZeneca and in Chinese biotech—Harri shares first-hand insights on selecting and managing Chinese CRO partnerships while addressing common misconceptions.

Chinese CROs have evolved significantly over the past two decades. Initially focused on medicinal chemistry, they have expanded into full-service providers across all areas of preclinical development. Government support in the mid-2010s fueled rapid growth, leading to an industry that today services both domestic and international clients, including many U.S. biotech and pharmaceutical companies. While some remain hesitant about working with Chinese providers, many of these organizations now operate at a level of quality that rivals their Western counterparts.

Regulatory compliance is a key consideration when selecting a CRO. Many of the largest Chinese CROs undergo regular inspections from the U.S. FDA and OECD, ensuring adherence to global standards. For sponsors evaluating potential partners, it is critical to review their inspection history and any recent Form 483 letters to identify potential regulatory risks. Harri emphasizes that working with well-established providers mitigates concerns about compliance and operational transparency.

Many companies are drawn to Chinese CROs due to their cost-effectiveness, faster turnaround times, and unique capabilities. During the pandemic, pricing disparities between U.S. and Chinese CROs were extreme, with some U.S. providers charging up to ten times more. Today, the cost advantage remains significant, particularly for studies involving research primates. Faster lead times also make Chinese CROs attractive, as some studies that take six months in the U.S. can be completed in just two months in China. Certain specialized studies, such as continuous infusion studies in rodents or research involving obese primates, are more commonly performed in China than in the U.S. or Europe.

While concerns about intellectual property remain, Harri argues that they are largely outdated. Past issues, particularly in the early 2000s, created lasting skepticism, but established CROs today have stringent protocols in place to protect client data. Language barriers present a more tangible challenge. English proficiency among younger study directors has declined in recent years, making communication more difficult. Many CROs now assign English-speaking project managers to facilitate interactions and ensure smooth collaboration.

Regulatory uncertainty is another area of concern. The pending Biosecure Act has raised questions about the future of U.S.-China collaborations in life sciences, but Harri clarifies that current discussions primarily focus on manufacturing rather than non-clinical or clinical research. The U.S. FDA continues to evaluate Chinese CROs based on performance and compliance rather than geopolitical factors.

For companies considering working with a Chinese CRO, Harri advises starting with well-established providers that have a strong track record and regular FDA inspections. Conducting audits before engagement and maintaining oversight throughout the study process is essential. Cultural differences, particularly around work expectations and communication styles, should also be accounted for to ensure smooth collaboration.

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The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. For project or resource needs, visit: thefdagroup.com.

The FDA Group’s 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. They highlight key aspects such as: » The definition and role of 'family offices' in life science investments. » The importance of investors being prepared to lose their investment due to potential risks, highlighting that these investors should be aware of who they're investing alongside. » The mistakes founders often make when raising capital, notably misunderstanding the relationship-driven nature of the business, and the need to build trust before expecting monetary investments. » The significance of startups communicating regularly with potential investors, setting investment deadlines, and offering additional rewards like advisory board positions. » The need to carefully consider going public, as it's not the only exit strategy and can necessitate a change in leadership. » Sal's recently published book "Investing Legacy," aimed at guiding newly wealthy individuals seeking to build a long-term legacy, and the importance of understanding different investment types. » Encouragement for new entrepreneurs to view entrepreneurship as self-development, predicting a resurgence in IPO markets and mergers in the next 12 to 18 months. Salvatore M. Buscemi has made a name for himself through his impressive portfolio of investments and his leadership roles in various investment offices. Currently serving as the CEO and Co-Founding Partner of HRN, LLC, a private multi-family investment office, as well as the CEO for Dandrew Partners Capital Management, Buscemi has demonstrated a keen eye for successful investment strategies. He also serves as the Managing Partner for several other direct investment vehicles, spanning multiple asset classes in commercial real estate and credit, fine art private credit facilities, special situations, and well-performing life sciences investments, among others. Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

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

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group’s CEO, Nick Capman, sits down with Former FDA Investigator, Christopher Smith to dive deep into FDA Pre-Approval Inspections (PAIs). Chris has more than 35 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? Connect with The FDA Group to schedule a mock PAI or discuss other quality and compliance support. Learn more about our GMP Auditing services here.

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: www.thefdagroup.com.

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

Read the full article on FDA.gov 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: www.thefdagroup.com.

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 more in Endpoints News: https://endpts.com/fdas-domestic-biopharma-inspections-return-to-normal-as-agency-faces-backlog-of-8000/

About The FDA Group: The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations.  We help thousands of firms find the resources they need, when and where they need them, through the optimal workforce model. Our resources are located in several dozen countries and have expertise throughout the life sciences. https://www.thefdagroup.com/

The FDA Group's Nick Capman sits down with quality management consultant Kimberly Wallbank to discuss the challenges and best practices of implementing effective quality metrics in the life sciences industry.

Discussion points include:

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

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

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

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

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

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

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

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

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

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

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The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations.

For project or resource needs, visit ⁠thefdagroup.com⁠.

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 (PDF): https://www.deloitte.com/content/dam/assets-shared/legacy/docs/perspectives/2022/gx-lshc-dei-global-life-sciences-outlook-report.pdf

Some key excerpts:

Page 29:

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"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:

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"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:

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"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."

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The FDA Group helps life science companies act on all of these recommendations, enabling RA/QA/Clinical teams to 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 connect with us: https://www.thefdagroup.com/

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. https://metacomet.com/

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group's CEO, Nick Capman sits down with 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.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group’s CEO, Nick Capman, sits down with 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.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group's Nick Capman sits down with Derek Wessman, a consultant based in Japan, to discuss the intricacies of conducting supplier audits in the Japanese life sciences industry. They explore the unique challenges and opportunities presented by Japanese suppliers and the cultural and regulatory nuances that impact auditing processes.

Discussion points include:

Language and Cultural Barriers: Derek explains how the significant language barrier and cultural differences can impact audit efficiency and effectiveness, often doubling the time required for audits.

Strengths of Japanese Suppliers: The conversation highlights the strengths of Japanese suppliers, including their focus on quality, well-organized facilities, and widespread ISO certifications.

FDA Inspections in Japan: Derek provides insights into the frequency and nature of FDA inspections in Japan, emphasizing the time constraints and logistical challenges faced by inspectors.

Data Integrity Challenges: The discussion covers common data integrity issues in Japanese companies, including shared logins and the use of unvalidated Excel files for critical calculations.

Cultural Impact on Quality Systems: Derek shares how Japanese business culture, including long-term employment and collective mindset, can influence quality management systems and CAPA processes.

Strategies for Effective Audits: The conversation provides practical advice for companies looking to audit Japanese suppliers, emphasizing the importance of local resources and cultural understanding.

Derek has been based in Japan since 2004 and has run his own consultancy since 2009. He specializes in helping Japanese companies navigate regulatory hurdles, FDA inspections, and compliance issues in the pharmaceutical, medical device, and combination product sectors. Derek's expertise bridges the gap between Japanese suppliers and global life science companies, offering unique insights into conducting effective audits in Japan.

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The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations.

For project or resource needs, visit ⁠⁠⁠thefdagroup.com⁠⁠⁠.

The FDA Group's Nick Capman sits down with pharmaceutical scientist and consultant Gary Ritchie to discuss the intricacies of statistical sampling in biopharmaceuticals.

They explore the limitations of the square root of n plus one sampling method, particularly for small lot sizes, and the advantages of more rigorous statistical approaches.

Discussion points include:

Limitations of Square Root of n + 1: Gary explains why this commonly used method is inadequate for small biopharmaceutical lot sizes, leading to potential risks in sample representativity and patient safety.

Importance of Proper Sampling: Gary highlights the need for statistically valid sampling plans considering lot size, inspection levels, and acceptance quality levels (AQLs) to ensure representative sampling and compliance with regulatory requirements.

Cost and Risk Management: The discussion emphasizes how improper sampling can increase business costs and risk to patients, while proper sampling can offer significant cost savings and better risk management.

Adoption of ANSI Standards: Gary encourages the industry to adopt ANSI standards for sampling, demystifying the complexity of statistical methods and emphasizing their importance for compliance and efficiency.

Practical Implementation: Gary shares insights from his experience, recommending resources and literature for better understanding and applying statistical sampling in the pharmaceutical industry, including Dan O'Leary's paper "Attributes Acceptance Sampling: Understanding How It Works" and Ron Snee's "Solving Statistical Mysteries: What Does the FDA Want?"

Gary Ritchie is a veteran pharmaceutical scientist with nearly 30 years of experience in the life sciences industry. He specializes in statistical sampling, analytical chemistry, and pharmaceutical waters. Gary's expertise spans various areas, including process analytics, quality control, and regulatory affairs. Gary’s held key positions at the United States Pharmacopeia, where he served for five years on expert committees for waters, statistics, and general chapters. His experience as a liaison allowed him to work closely with the FDA, industry leaders, and academia.

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The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations.

For project or resource needs, visit ⁠⁠thefdagroup.com⁠⁠.

The FDA Group’s 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.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group’s CEO, Nick Capman, 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.

Links and Resources:

• Blog Post: 7 Key Takeaways from FDA's Pandemic Inspections FAQ Guidance
• Blog Post: Key Takeaways from FDA's Guidance for Resuming Drug and Biologic Manufacturing Operations during COVID-19
• Guidance for Industry: Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers
• Guidance for Industry: Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency

The FDA Group's CEO, Nick Capman, sits down with Donna Dorozinsky, founder and CEO of Just in Time GCP, to discuss key considerations for Trial Master File (TMF) management and GCP compliance.

Discussion points include:

• 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's top 5 takeaways:

1. Adopt the TMF Reference Model to standardize the structuring of TMFs across organizations. This makes integrating content from different vendors easier and simplifies regulatory inspections by providing a uniform structure that regulators have come to expect.
2. Focus on the record quality, timeliness, and completeness of the TMF. High-quality records without missing or draft pages, timely filing of documents to reflect an up-to-date story of the study, and ensuring that the TMF is complete with all necessary documents are crucial for a compliant TMF.
3. Maintain tight sponsor oversight on CRO-managed TMFs. Even if a Contract CRO manages the TMF, the sponsor retains ultimate responsibility for its completeness and quality. Sponsors should perform regular oversight activities, such as routine completeness checks and applying a risk-based approach to ensure the CRO's TMF meets regulatory standards.
4. Organizations, especially smaller ones, need to weigh the decision to adopt an eTMF system carefully. It's essential to align the investment in eTMF technology with the company's long-term goals and ensure it is supported by appropriate business processes and quality oversight.
5. When involved in mergers or acquisitions, ensure thorough due diligence on the TMF to fully understand the study's story. For regulatory inspections, having a complete, well-organized, and accessible TMF can significantly influence the outcome. A well-managed TMF supports compliance and serves as a critical tool in demonstrating the quality and integrity of clinical research to regulatory authorities.

Donna is a Registered Nurse and business consultant who has spent over 30 years in drug development with extensive experience in study operations, including clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management.

Donna is a TMF Reference Model Steering Committee member and is a member of the Association of Women Entrepreneurs. She’s a founding member of the Society of Nurse Scientists, Innovators, Entrepreneurs, & Leaders. She serves on the Board of Trustees at Gwynedd Mercy University, where she received her BSN, and also has an MSN from Widener University.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group’s CEO, Nick Capman, sits down with 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 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-specific reports:

• Laboratory Safety: FDA Should Strengthen Efforts to Provide Effective Oversight: https://www.gao.gov/products/gao-20-594
  
• Drug Safety: FDA's Future Inspection Plans Need to Address Issues Presented by COVID-19 Backlog: https://www.gao.gov/products/gao-21-409t
  

Need expert help preparing for a potential increase in FDA inspection and enforcement activity? 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: www.thefdagroup.com.

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.

Mr. Toscano is an experienced consultant with over 25 years in the industry, specializing in international compliance, Data Integrity, and quality systems. He has successfully managed projects addressing FDA enforcement actions, such as 483 responses, Warning Letters, and Consent Decrees. His expertise extends to laboratory and manufacturing investigations, CAPA, change control, and stability programs. He has also led analytical R&D labs, overseeing product development and regulatory submissions, including ANDA, NDA, and 505(b)2 applications. Recently, he spearheaded a multi-year expansion and remediation for a biologics manufacturer under a consent decree. His comprehensive knowledge in quality assurance, data integrity, validation, and cGMP training has been pivotal in helping clients develop and fix quality systems to meet FDA standards.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group's CEO Nick Capman sits down with Mukesh Kumar, PhD, RAC, for a deep dive into the challenges of setting up GMP facilities for cell therapy startups.

Discussion points include:

» Common questions startups have around engaging with the FDA and determining costs and timelines for GMP facility setup and clinical trials.

» Recommendations for engaging regulatory experts early and doing first-in-human manufacturing in-house rather than through a CMO to reduce costs and time.

» The importance of educating oneself on regulations before meetings with experts or the FDA to get the most benefit from those interactions.

» Best practices for GMP facility setup and clinical trials in a cost-effective manner to advance cell therapies to patients.

Dr. Mukesh Kumar is CEO and Founder of FDAMap, a Washington DC-based firm helping manufacturers and developers of FDA-regulated products in regulatory affairs, quality assurance, clinical trials, and smart development strategies. His key expertise is in global regulatory project management, regulatory submissions, compliance inspections, operational management, supply management, clinical operations, and multi-national project management for medicinal and diagnostic products. He has led the clinical development of over 100 products over the last 20 years.

He has been a leader in more than 150 clinical trials in about 34 countries, including countries in the EU, Taiwan, Korea, Japan, China, Canada, countries in South America, Australia, and India. He has led more than 100 GCP, GLP, GMP, and GACP audits in the US and several countries in Europe, North and South Americas, and Asia in the last 15 years. He has conducted numerous training workshops on FDA compliance-related issues and has authored numerous articles in peer-reviewed journals.

His weekly blog, FDA Puran, is subscribed by over 80,000 readers globally. He is also the Professor (Adjunct), Regulatory Sciences, at the School of Medicine, George Washington University, Washington DC. Dr. Kumar is a PhD in Biochemistry and a certified regulatory professional by the Regulatory Affairs Professionals Society, USA.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group's Nick Capman sits down with Matt Lowe, Chief Strategy Officer at MasterControl, to discuss the opportunities and challenges of implementing AI in the life sciences industry.

Discussion points include:

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

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

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

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

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

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

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

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

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

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

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The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations.

For project or resource needs, visit thefdagroup.com.

The FDA Group's 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 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. https://www.pennavenuelaw.com/

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group’s CEO, Nick Capman, sits down with 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: www.thefdagroup.com.

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).

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

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 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.

The FDA Group's CEO, Nick Capman sits down with Dan Barker, CEO of Wikimotive, to explore perspectives on management and leadership. Dan shares his unique professional journey and dives into the importance of vulnerability and constant learning in leadership and management, as well as discussing other topics, including:

• How management can be the 'easy' side of the equation, with leadership being about ensuring management systems are built and executed effectively.
• Dan's non-typical career path, from cabinet maker to marketer and eventually CEO.
• The importance of leadership and management in enhancing people's quality of life.
• How good leaders and managers appreciate significant moments in their employees' lives.
• How enthusiasm and constant learning are important qualities for leaders.

In 2023, Dan Barker was named as successor to [owner and founder] Tim Martell, accepting the role of Wikimotive’s Chief Executive Officer. Since joining the company in 2018, Dan’s extensive background in both personnel and project management, combined with his insatiable pursuit of knowledge, fueled his trajectory through nearly every role that Wikimotive had to offer. Inspiring optimizations and efficiencies along the way, the impact of Dan’s expansive knowledge, sound decision-making, and measured management style can be felt in every facet of Wikimotive’s daily operations. https://wikimotive.com/

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group’s CEO, Nick Capman, sits down with 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.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group’s CEO, Nick Capman, sits down with 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. Read his full column in Pharmaceutical Online: https://www.pharmaceuticalonline.com/doc/quality-management-review-benchmarking-quantitatively-0001

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. You can contact him at tobias.kunersofkoenders@tobmanagement.nl.

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: www.thefdagroup.com.

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's top 5 takeaways:

1. Implement an Inspection Readiness Playbook: Develop a comprehensive playbook that details all aspects of audit preparation, from SME preparation to document retrieval, to streamline the inspection process.
2. Address Post-Merger QMS Integration: Carefully plan and execute the integration of disparate QMSs following mergers or acquisitions to ensure clarity in SOP adherence and effective SME role allocation.
3. Conduct Mock Inspections Regularly: Utilize mock inspections to test the effectiveness of the inspection readiness playbook, identifying and rectifying any gaps in readiness.
4. Focus on Supplier Management: Establish rigorous qualification and ongoing monitoring programs for suppliers, differentiating between R&D and commercial suppliers to ensure quality and compliance.
5. Adopt the PDCA Cycle for Continuous Improvement: Implement the Plan-Do-Check-Act methodology to manage QMS elements, ensuring robust inspection readiness and fostering a culture of continuous improvement.

Divya is a performance-driven and hands-on Quality leader and professional with extensive experience in the medical device and combination product industry. She has contributed significantly to quality management systems, product development lifecycle, risk management, quality compliance, quality management review, inspection management, training, change controls, supplier management, complaint management, and technical operations.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group's Nicholas Capman welcomes Annalise Ludtke, Senior Manager of Marketing and Communications at Vodori. They explore the essential steps and challenges involved in bringing compliant marketing content to market in a regulated industry.

Discussion points include:

• Bottlenecks and Feedback Challenges: Annalise details how differing team goals, particularly between marketing and regulatory, often lead to bottlenecks, making it essential to streamline feedback and improve claim management.

• Role of Claims Matrices and Version Control: Effective claims matrices and version control processes are critical for pre-approved content to ensure accuracy, avoid compliance delays, and maintain consistency.

• Managing Team Size and Risk Tolerance: Annalise explains the varied team sizes and the different levels of review needed based on content type, from high-stakes conference presentations to quick social media posts.

• Efficiency Best Practices: Annalise shares actionable tips, including the use of concept reviews to create shared ownership, digital asset management systems to centralize content, and strategies to address recurring review delays.

• Future Role of AI in Compliance: While cautious about AI’s application in compliance, Annalise discusses its potential for handling pre-checks, such as spelling and logo verification, allowing human reviewers to focus on more complex compliance tasks.

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The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations.

For project or resource needs, visit: ⁠⁠⁠⁠thefdagroup.com⁠⁠⁠⁠.

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