The Life Science Rundown

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 impo...

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 industr...

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 ph...

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 addressin...

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...

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 pharm...

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...

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...

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, highlighti...

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. » Diff...

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 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...

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 fo...

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...

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 a...

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 function...

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 l...

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,...

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 inspe...

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 re...

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-benchmark...

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...

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 clinica...

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 bes...

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...