Podcast The Life Science Rundown

The FDA Group's Nick Capman sits down with Stephen Poor, a physician-scientist with over 20 years of experience in the industry, mainly with Novartis — currently serving as Novartis's Global Program Clinical Head (Executive Director). They delve into the psychological and professional impacts of organizational changes, particularly focusing on identity and adaptation during times of transition, such as layoffs or department closures.

Discussion points include:

• Stephen's transition due to organizational shutdown and his journey through change. » Stephen's experiences and thought processes from realizing Novartis's exit from ophthalmology to starting a new job, focusing on identity in times of change.
• The importance of maintaining a positive outlook, using visualization techniques, and combating self-limiting beliefs during periods of professional uncertainty.
• Predictions for 2024 and 2025.
• Nick's upcoming book, "The Passionate Workforce," is based on 15 pillars to create a motivated and high-performing organizational culture.
• Insights into managing layoffs thoughtfully, ensuring those who leave feel respected and valued.
• The FDA Group's strategic plans including potential acquisitions to leverage anticipated economic growth.
• The need for positive thinking, proactive planning, and readiness to capitalize on upcoming opportunities in the life sciences industry.

Stephen Poor is the Global Program Clinical Head at Novartis, bringing over 20 years of experience in ophthalmology biotech-pharma and a strong medical background to his role. He is at the forefront of developing innovative therapies for retinal diseases, focusing on age-related macular degeneration (AMD) and geographic atrophy (GA), the leading causes of blindness in the elderly.

Stephen leads the clinical team for PPY998 (GT005), a Phase 2b subretinal complement factor I gene therapy for GA, a significant acquisition from Gyroscope in 2021. His responsibilities extend beyond PPY998 to overseeing undisclosed gene therapy programs and novel drug delivery devices.

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

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's CEO, Nick Capman sits down with Divya Gowdar, Founder and CEO of NubGenix, to discuss the pitfalls and lessons learned on the frontlines of audit and inspection readiness throughout the FDA-regulated industries.

Discussion points include:

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

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

In the most recent episode of our podcast, The Life Science Rundown, The FDA Group's Nick Capman sat down with Donna Dorozinsky, founder and CEO of Just in Time GCP, to discuss key considerations for Trial Master File (TMF) management and GCP compliance.

Discussion points include:

• The TMF's significance in capturing a study's complete story, including its challenges and achievements and its pivotal role in GCP compliance.

• The evolution of TMF structuring, the development of the TMF Reference Model for standardization, and its benefits for simplifying content integration across different organizations and vendors.

• Donna’s three components of a quality TMF: record quality, timeliness of filing, and completeness, explaining how these factors contribute to maintaining a compliant and effective TMF.

• Considerations for companies that outsource TMF management to CROs.

• The adoption of eTMF systems, especially for smaller companies, and the balance between investment in technology and maintaining compliant TMF practices.

• The challenges and considerations of TMF management during mergers and acquisitions (highlighting the importance of a complete and accessible TMF in these transitions).

• How the TMF is utilized during regulatory inspections, the recent focus of regulatory authorities on TMF compliance, and the importance of a well-managed TMF in demonstrating the quality and integrity of a study.

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

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

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.

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.

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.

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.

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.

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

Discussion points include:

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

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

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

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

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

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

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

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

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

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

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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

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

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

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.

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.