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...

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...

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...

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...

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 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...

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...

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...

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....

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...

The FDA Group’s CEO, Nick Capman, sits down with William V. Williams, MD, FACP, President and CEO of BriaCell Therapeutics Corporation, a company at the forefront of developing personalized cell therapies and immunotherapies for cancer. Dr. Williams reveals the current landscape and future potential of cancer treatments, focusing on the role of immunotherapies and cell therapies in revolutionizing patient care. Discussion points include: » Dr. Williams's extensive background in drug...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...