The Life Science Rundown

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, 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/

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 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 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 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. They highlight key aspects such as:

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 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 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/