The Life Science Rundown
The Life Science Rundown is a podcast for professionals in the life sciences, produced by The FDA Group. It covers topics in regulatory affairs, quality assurance, and clinical research. The show discusses industry news, explores trends, and features interviews with expert guests.
Episodes
Is Your Biotech De-Risking or Just Delaying?
What stops a promising platform from becoming an investable company? Kevin Walton, CEO of Baseimmune, has watched this from both sides, first as an investment banker and now running a 23-person biotech through a strategic pivot he led himself.He and Nick Capman get into beachhead decisions, why most preclinical teams run their experiments in the wrong order, how to keep a distributed team aligned
Reg Ops Has Been Kept in a Box. This Is the Way Out.
As the FDA takes its first steps toward receiving clinical data in real time, what happens to regulatory operations professionals? Carla Griffin, CEO of The Sugar Water Operations Team, argues that reg ops has been kept in too small a box for years and that this shift is the opening to change that.Carla and Nick Capman get into why the hardest adjustment is professional rather than technical, how
QA Is Not a Gate — It’s a Technical Partner, with Dr. Andrea Bell
How do biotech companies move QA from late-stage gatekeeper into an early, risk-appropriate technical partner? Dr. Andrea Bell, a VP and Global Head of Quality Assurance, breaks down what phase-appropriate quality looks like across the lifecycle and why the barriers to getting there are cultural rather than procedural.Andrea and Nick get into the real cost of late QA involvement, how risk-based ri
Managing AI Risk Across Global Quality Systems
How do you manage AI risk across global quality systems while the tools change every week? Julio Salwen, SVP and Chief Quality Officer at MiniMed, brings 35 years in pharma, devices, and diagnostics to a conversation about governance, risk tolerance, and what quality leaders need to learn right now.Julio and Nick get into why building for the auditor is the wrong instinct, how to introduce AI wher
The Case for Engaging Regulatory Early
Most companies bring in regulatory expertise when they're ready to file. Leland Keyt, VP of Regulatory Affairs and Quality Assurance at Apreo Health, makes the case that by then you've already absorbed costs you didn't need to, and explains what early regulatory partnership actually looks like in practice.Leland and Nick get into why risk tolerance is the thing that catches scaling com
Why Quality and R&D Default to Conflict (and How to Fix It)
Why do quality and R&D fall into adversarial roles even when both are working toward patient safety? Shawn Fuller, who spent 24 years at Surmodics and rose from regulatory manager to VP of Quality, Regulatory and Clinical Affairs, is candid about how both sides create the problem and what it takes to break the pattern.Shawn and Nick get into the learned behavior behind the roadblock stereotype
Leading Through the AI Shift with ASQ's CEO Sid Bhatnagar
A special one for us: we sat down with Sid Bhatnagar, CEO of ASQ, the American Society for Quality. Sid is an engineer and longtime technology executive who now leads the global body at the center of the quality profession, and he brought a sharp, practical view of how AI is reshaping what leadership requires.Sid and Nick get into why AI pressure now comes from boards and investors rather than the
Why Your CAPA System Isn't Driving Improvement (and How to Fix It)
Why do so many CAPA systems pass their metrics while the same problems keep coming back? Dan Eagles, a medical device quality VP and longtime CAPA mentor, breaks down where these systems quietly fail and how to rebuild them into tools that actually drive improvement.Dan discusses why the problem statement is where most CAPAs go wrong, how teams back-engineer root cause analysis to match a fix they
TerSera's VP of Quality on the Audit Risk Hiding Inside Your Own Procedures
Why do life science companies still scramble when an inspection is coming, even when their quality systems are solid on paper? Yeime Martich, a 25-year quality veteran, makes the case that readiness is a logistics and culture problem, not a documentation problem, and that the procedures you wrote may be creating more audit risk than you realize.Yeime discusses why "minimally compliant" i
What Auditors Are Actually Looking For — and the Psychology Behind How They Find It
Why do audits still trigger panic even at companies with strong quality systems? Sneha Saggurthi — a quality compliance manager and lead auditor in cell therapy — breaks down the gap between being compliant and being audit ready, and shares the psychology, patterns, and logistics that actually determine inspection outcomes.Sneha discusses how auditors think and prioritize, why logistics matter mor
Why Kidney Disease Innovation Is a Tale of Two Cities — and What It Would Take to Change That
Why are there over 400 phase three oncology programs but only one in dialysis? John Butler, who has spent over 30 years in the kidney disease space, breaks down the regulatory and reimbursement dynamics that have created a surge of innovation in rare kidney diseases while leaving dialysis patients behind, and what it would take to change that.John discusses how FDA clarity on endpoints transformed
Syncing Global Regulatory Filings Across FDA, EMA, and PMDA with AJ Acker
What does it actually take to navigate global regulatory filings across the FDA, EMA, and PMDA, and why do so many programs stumble despite technically harmonized dossiers? AJ Acker draws on about 30 years of rare disease regulatory experience to break down the real differences between regions and the strategies that drive successful multi-regional approvals.AJ discusses why ICH compliance doesn&#
Navigating Regulatory Leadership Across Large and Small Life Science with Tammy Sarnelli
What actually changes for regulatory leaders when they move between large pharma and small biotech, and what stays the same? Tammy Sarnelli draws on over 35 years of experience across organizations of every size to break down the real differences in workload, risk tolerance, resource access, and culture.Tammy discusses how organizational silos create friction in large companies, why limited resour
Getting Data Governance for Regulatory Submissions Right Before AI Gets it Wrong with Cary Smithson
How should life science companies govern their data to meet increasingly structured regulatory submission requirements and actually get value from AI? Cary Smithson shares lessons from decades of helping organizations modernize their regulatory, quality, and R&D operations.Cary discusses why data governance has become urgent across three fronts — structured submissions, cross-functional intero
Building Resilient Biotech Teams in Cell and Gene Therapy with Nelly Viseux
How do you build an organization that can absorb change, learn from failure, and keep patients at the center—even when the science is uncertain? Nelly Viseux shares lessons from over 20 years in biotech and a decade leading cell and gene therapy development.Nelly discusses how she structured a 100-person CMC organization at Regeneron to balance innovation with operational execution, why documentin
Building Phase-Appropriate Quality from Preclinical to Commercial with Jackie Klecker
Scaling a product from preclinical development to commercial manufacturing is one of the most complex transitions life science teams face—and one of the easiest places to lose time and momentum.In this episode of The Life Science Rundown, host Nick Capman speaks with Jackie Klecker, Executive Vice President of Quality and Development Services at Lifecore Biomedical, about how sponsors and CDMOs ca
Preparing the Workforce That Will Shape Pharma’s Future with ISPE President & CEO Mike Martin
The FDA Group's Nick Capman sits down with Mike Martin, President and CEO of ISPE, for a conversation on how the pharmaceutical industry must rethink workforce development amid rapid technological and cultural change.Drawing on nearly four decades of global experience in pharmaceutical engineering, operations, and manufacturing leadership, Mike shares his perspective on why the industry is enterin
How to Build (and Sustain) a Quality-Centric Culture with Chris Masterson
The FDA Group’s Nick Capman sits down with Chris Masterson, Senior Vice President of Quality and Chief Quality Officer at Tolmar, for a wide-ranging conversation about how to create and sustain a quality-centric culture that drives compliance, operational excellence, and long-term resilience in the biopharmaceutical industry. A microbiologist by training with more than 35 years of BioPharma leader
From Molecule to Market: A Commercial-Readiness Playbook for Biotechs with Carlos Carrillo
The FDA Group’s Nick Capman sits down with Carlos Carrillo, PhD, MSc, Senior Vice President of Regulatory Affairs & Quality Assurance at SAB Biotherapeutics. With nearly 30 years of experience across Operations, R&D, Regulatory Affairs, Quality Assurance, and Project Management, Carlos has led global regulatory strategy for small- and large-molecule programs from Phase 1 through launch. He
How Regulators Are Bringing AI Into Review (Without Losing Trust) with Maria Vassileva
The FDA Group’s Nick Capman sits down with Maria Vassileva, PhD—Chief Science & Regulatory Officer at the Drug Information Association (DIA)—for a grounded, forward-looking discussion on how regulators are actually using AI today, where the technology is going, and what life science organizations should be preparing for now.Maria draws on two decades of leadership across nonprofit, government-
A Playbook for FDA Inspections and Remediation with Jeff Hines
Coruna Medical’s Vice President of Quality, Jeff Hines, joins host Nick Capman to share a leadership-driven playbook for navigating FDA remediation—without overwhelming teams or losing focus on long-term improvement.Drawing from nearly four decades in pharmaceutical quality, including more than 30 years at Eli Lilly, Jeff offers practical guidance for building calm, effective inspection environmen
Leading Cross-Functional Teams from Concept to Commercialization with Marwan Fathallah
The FDA Group’s Nick Capman speaks with Marwan Fathallah, President and CEO of DIA Global, for a wide-ranging discussion on what it takes to lead effectively across the life science product development cycle—from concept to commercialization.With nearly 30 years of leadership experience spanning pharmaceuticals, medical devices, and diagnostics, Marwan has held senior roles in R&D, regulatory,
Breaking Down FDA’s E21 Draft Guidance: Including Pregnant and Breastfeeding Women in Clinical Trials with Regina Atim
The FDA Group’s Nick Capman speaks with Regina Atim, PharmD, pharmacist, maternal and perinatal health advocate, and founder of Clinicians Touch Healthcare Solutions. Regina brings deep expertise at the intersection of clinical practice, regulatory strategy, and maternal health innovation—including work on technologies to detect pregnancy-acquired cardiovascular disease.Their conversation explores
Staying Ready for the FDA (When Inspections Are Less Predictable)
The FDA Group’s Nick Capman speaks with Jeff Brenneman, Vice President of Global Operations Quality at Alora Pharmaceuticals. With more than 25 years of pharmaceutical manufacturing experience spanning branded, generic, and OTC products, Jeff brings a deep perspective on sustaining inspection readiness across multiple sites while leading global quality teams.Jeff shares why inspections feel less p
Building the Next-Gen Lab: AI in a GLP Environment with Catherine Lunardi
The FDA Group's Nick Capman speaks with Catherine Lunardi, Founder and CEO of GenAIz. With nearly a decade leading GenAIz and prior leadership roles at GSK, CGI, and Héma-Québec, Catherine brings a seasoned perspective on how life science organizations can practically and compliantly deploy AI to build the next generation of labs.Catherine explains the biggest challenges labs face today—like f
How to Build High-Performing Quality Teams with Marcus Gesner
The FDA Group's Nick Capman speaks with Marcus Gesner, Vice President of Global Quality at embecta. With more than two decades of leadership experience at companies including Boston Scientific, Olympus, Covidien, JUUL Labs, and others, Marcus brings a unique perspective to what makes a quality organization truly high-performing.Marcus shares why compliance is only the baseline “entry fee” for
The 4 Cs of MedTech Leadership with Sean Gallimore
The FDA Group's Nick Capman sits down with executive consultant Sean Gallimore to break down what makes medtech leaders and teams truly effective. Drawing from decades of experience across medical devices, diagnostics, CROs, and industrial technology, Sean shares his practical framework for leadership—the 4 Cs: Strategic Clarity, Capabilities, Compliance, and Connectedness—and how each one dir
The Power (and Pitfalls) of Real-World Evidence with Dr. Manfred Stapff
The FDA Group’s Nick Capman sits down with Dr. Manfred Stapff—physician, author, and founder of Candid Advisory Inc., a consultancy specializing in real-world evidence and clinical development—for a wide-ranging conversation about how real-world data is reshaping drug development, regulatory decisions, and public understanding of evidence.Dr. Stapff draws on decades of experience across medical af
Quality Is Not a Cost Center—It’s a Culture (with Dr. Kimberly Garko)
The FDA Group's Nick Capman sits down with Dr. Kimberly Garko, Chief Technical Officer and 25-year life science veteran, for a deep dive into one of the most misunderstood concepts in the industry: the cost of quality.Dr. Garko shares why quality should be viewed not as a cost center but as a strategic investment—and how companies can embed that mindset into their culture, systems, and leaders
From Cost Center to Value Driver: Rethinking Quality in the Life Sciences with Marcia Baroni
Nick Capman talks with Marcia Baroni—a microbiologist with 27 years in global pharma-quality leadership—about reframing quality from a controllable expense to a strategic asset. Baroni contrasts “bad-quality” costs (scrap, recalls, deviations) with “good-quality” investments (testing, preventive controls, oversight) and explains why the latter pay for themselves in resilience and brand value. She
Managing Royalties in Biotech, Pharma, and Medtech with David Marlin
Nicholas Capman of The FDA Group welcomes David Marlin, Co-Founder and CEO of Metacomet Systems, to explore the often-overlooked complexities of royalty management in life sciences.Drawing from his experience helping over 200 companies automate royalty payouts, David explains how biotech, pharma, and medical device firms struggle to manage licensing agreements as they scale. What starts as a simpl
GMP Compliance in 503B Compounding Pharmacies with Jesse Gillikan
Nick Capman talks with Jesse Gillikan, President of cGMP Validation, about the challenges compounding pharmacies face with GMP compliance in 2025. After helping over 100 pharmacies navigate FDA regulations since the 2013 Drug Quality and Security Act, Jesse shares candid insights about this industry transformation.The conversation reveals how compounders have moved from resistance to acceptance of
A Smarter Approach to Supplier Quality Audits with Thermo Fisher's David Festa
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 b
Mastering FDA and EMA Regulatory Meetings with Ashley Preston
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 th
Working with Chinese CROs: Benefits, Risks, and Best Practices with Harri Järveläinen
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 Ch
The Smart Way to Adopt AI in Clinical Trials and Regulatory Affairs with Keith Parent
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:
Demystifying AI in Life Sciences Supply Chain with Jennifer Chew
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 emph
Streamlining Promotional Reviews in the Life Sciences with Annalise Ludtke
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 regulato
Navigating Supplier Audits in Japan with Derek Wessman
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:
Small Lots, Big Risks: Rethinking Statistical Sampling in Biopharma
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 Roo
Quality Metrics that Matter with Kimberly Wallbank
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 w
Applying AI in the Life Sciences with MasterControl's Matt Lowe
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 even
Navigating Challenges in Raw Material and Finished Product Storage with Eric Busenburg
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:
Understandi
Building and Leading Effective Quality Assurance Teams with Aaron Snyder
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:
The Pharma Startup Playbook: Advice from the Field with Taggart McGurrin
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 st
Navigating FDA Regulations for SaMD AI and Machine Learning with Adam Foresman
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 diagnosti
Crafting Quality Systems for Each Phase of Drug Development with Carlos Yuraszeck
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 I
Leading Through Transition: Strategic Insights from Novartis's Front Lines
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 trans
Real Talk on Remote Leadership with Nick Klingensmith
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
Audit and FDA Inspection Readiness Best Practices with Divya Gowdar
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 ma
Mastering the TMF: Ensuring GCP Compliance and Inspection Readiness with Donna Dorozinsky
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 TM
The Startup's Guide to Setting Up Cell Therapy Manufacturing: Navigating Regulations, Resources and Timelines
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 doi
A Blueprint for Quality Culture with Vincent Cafiso
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
An FDA Inspection Survival Guide with Jonathan Wacks
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 ass
Clinical Data Standards in Focus: SDTM Compliance with Sunil Gupta
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 t
The Link Between Quality Culture and QA Communication Pathways with David Marks
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
Mastering Medical Device Supplier Management with Paul Hakamaki
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
Recent FDA Enforcement Trends with George Toscano
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
Growing Your Career in RA/QA with Jessica Smith Beaver, PhD
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
Drug Delivery System Innovation and Leadership with Steve Knowles
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
Motivating Technical Teams in the Life Sciences: A Conversation with Rick Beatty
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 trainin
Cross-Cultural Pharma: Mike Martin's Experiences from Puerto Rico to China
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
Courageous Leadership to Reinvent Our Healthcare System
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 v
The Critical Role of 'Hyper-Targeting' in Rare Disease Drug Development
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 challen
A Journey into Life Sciences Investment: Strategies, Challenges, and Opportunities with Sal Buscemi
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, highligh
Navigating Risk Management in Medical Devices with Brian Dense
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 DEA, FDA & Controlled Substances: An Insider's Perspective with Former DEA Agent Dennis Wichern
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
A Deep Dive into Medical Device Regulatory Strategy with Regulatory Attorney Christine P. Bump
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, an
Lessons from a Medtech Entrepreneur: Ram Konduru on Fostering Teamwork and Personal Growth in Leadership
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
Unlocking Effective Leadership: A Conversation with MetaComet Systems President, David Marlin
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
Leadership, Management, and Enhancing Quality of Life: A Conversation with Dan Barker, CEO of Wikimotive
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
Navigating the 510(k) Process: A Q&A with Regulatory Consultant, Trey Thorsen, MS, RAC
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
The Future of Life Science Talent Acquisition: Securing In-Demand Skills in a Competitive Market
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
FDA Revives Its Proposed Quality Metrics Program for Pharma
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,
Inspection Alternatives Are Driving More FDA Enforcement Actions: What It Means for Industry
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
FDA's Domestic Biopharma Inspections Return to Normal
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
Quality Management Review: Benchmarking Quantitatively!
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
Addressing FDA's Inspection Backlog with Mary Denigan-Macauley, GAO's Director of Health Care
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
FDA's Fraudulent Products Task Force and Operation Quack Hack Battle COVID Vaccine Scams
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
What to Expect for the FDA's Regulation of Medical Devices & Digital Health Under the Biden Administration
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
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English with Olivia | Slow Conversations & Vocabulary
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