Explore every episode of the podcast The Life Science Rundown

Dive into the complete episode list for The Life Science Rundown. Each episode is cataloged with detailed descriptions, making it easy to find and explore specific topics. Keep track of all episodes from your favorite podcast and never miss a moment of insightful content.

	Title	Pub. Date	Duration
	The Adoption Assumptions Hiding in Your Regulatory Strategy	20 oct. 2026	01:03:37
Can the fastest path to FDA approval end up being the slowest path to market adoption? Holley Proctor Miller, Founder and President of Grey Matter Marketing, has spent more than two decades helping medtech companies get new products adopted, starting with the early days of surgical robotics. She and Nick Capman get into the adoption assumptions built into every regulatory pathway decision, why approval evidence and adoption evidence aren’t the same thing, and what regulatory, quality, and commercial leaders should decide together before a pathway is locked in. A few topics they get into: Why clearance gives you the right to enter a market but not a reason for the market to change The questions a substantial equivalence claim raises with buyers Why “for everyone” usually means “for no one” Validating behavior instead of interest in market research Why a narrow initial indication can be the stronger commercial position The “magic triangle” of product design, regulatory design, and adoption design A spinal fusion case where changing one variable transformed a launch About Holley Proctor Miller Holley Proctor Miller is Founder and President of Grey Matter Marketing. She previously worked at Computer Motion (now part of Intuitive Surgical) in corporate communications and product management, led marketing and global brand management roles at Allergan including for the LAP-BAND system, and served as CMO of NewHope Bariatrics. She holds a BA from Washington and Lee University. About 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
	Dr. Robert Califf on What It Will Take for GLP-1s to Become a Public Health Success	05 oct. 2026	00:33:22
We're honored to welcome Dr. Robert Califf, two-time Commissioner of Food and Drugs and founding director of the Duke Clinical Research Institute, to The Life Science Rundown. Dr. Califf joins Nick Capman to talk about how GLP-1 therapies could become a true public health success, and what it will take to get there: affordability, equitable access, trustworthy information, and responsible regulation. He brings the perspective of a cardiologist, clinical trialist, and two-time FDA leader, and he closes on a note of genuine optimism about what this class of drugs may teach us. Some of what he covers: The difference between the goal of individual medical care and the goal of public health Why obesity was long treated as a moral failing, and why earlier drugs fell short What GLP-1 research may reveal about cravings and behavior more broadly Why early access followed resources rather than need How compounding was permitted during the shortage, and why it no longer is for approved drugs His concern about untested peptides sold online Why trust follows trustworthy behavior What success could look like over the next decade Our sincere thanks to Dr. Califf for his time and insight. About Dr. Robert Califf Robert M. Califf, MD, MACC, served as Commissioner of Food and Drugs from 2016 to 2017 and again from 2022 to 2025, and previously as FDA's Deputy Commissioner for Medical Products and Tobacco. Between his terms, he was head of medical strategy and senior advisor at Alphabet for Verily and Google Health. A cardiologist, he spent decades at Duke University, where he was founding director of the Duke Clinical Research Institute, and he is one of the most frequently cited authors in biomedical science. About 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
	Is Your Biotech De-Risking or Just Delaying?	18 sept. 2026	00:34:57
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 when the CEO is an ocean away, and what investors actually weight when science, team, execution, and strategy are all on the table. Some of what comes up: Run the experiment that could kill the program first, before the supporting package exists Accumulating incremental data feels like de-risking and mostly isn't Pick fast and cheap on a CRO and you'll pay for it twice Build culture from where you actually are, not from where you'd like to be Write decisions down, name one owner, and accept that ambiguity compounds faster at distance Hire a scientific advisory board that will argue with you Science gets you the meeting. Team, strategy, and execution decide what happens after About Kevin Walton Kevin Walton is CEO and a board director at Baseimmune, a London biotech developing active immunotherapies for fibrosis with IPF as its lead indication. Before Baseimmune he held corporate development and business development leadership roles at Moderna, StrideBio, Curis, and G1 Therapeutics, following a start in investment banking and consulting. He holds a law degree from Duke University School of Law. About 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
	Reg Ops Has Been Kept in a Box. This Is the Way Out.	14 sept. 2026	00:24:00
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 to vet technology vendors who don't understand your regulations, and the three things reg ops professionals should do in the next twelve months. A few of Carla's key takeaways: Reg ops specialists are problem solvers who've been siloed into links, bookmarks, and document construction The instinct that makes reg ops strong, wanting everything systematic, is what will make this shift hardest Getting reg ops and IT into decisions earlier isn't optional if the goal is getting data to FDA faster When evaluating technology, look for options rather than solutions, then eliminate risk to make an option viable Ask vendors whether they understand the regulations you're held to. If they can't answer, move on Put on your FDA hat: where do the data integrity questions come from, and can you show a human was in the loop? Old technology isn't the enemy. It's just at a disadvantage now Note that this was recorded in September 2026. The FDA's real-time clinical trials work has been developing quickly, and Carla's forward-looking comments are her own assessment rather than announced agency policy. New developments may supersede the information provided here. About Carla Griffin Carla Griffin, M.A., M.S., is CEO and Principal Operations Consultant at The Sugar Water Operations Team (SWOT), supporting emerging biotech and pharmaceutical companies across regulatory operations, submissions management, and quality systems. She has close to two decades of experience, including eight years at Esperion leading development and regulatory operations, with earlier roles at Sarah Cannon Research Institute, LIQUENT (a PAREXEL company), and Human Genome Sciences. She holds a master's in regulatory science from Johns Hopkins. About 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
	QA Is Not a Gate — It’s a Technical Partner, with Dr. Andrea Bell	01 sept. 2026	00:28:11
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 rigor differs from uniform rigor, what makes a quality management review actually function, and how QA earns credibility with technical teams. A few of Andrea's key takeaways: Late QA involvement costs money and removes the option to remediate cheaply Most of the cost of poor quality sits below the waterline in scrap, cycle time, investigations, and reputation Early means early in the decision forums, not just early in the lifecycle Risk-based rigor isn't looser rigor. Uniform checklists are a weaker position and agencies will challenge them The barriers to embedding QA earlier are quality culture and reporting structure, not procedure Data only makes QA proactive if people are empowered to act on it QA earns credibility by co-authoring the argument you'll make to the regulator, not by signing off at the end About Andrea Bell Andrea Bell is a Vice President and Global Head of Quality Assurance with more than 25 years in biotechnology building quality and CMC organizations across RNA, biologics, and small molecule programs. She holds a doctorate in global public health, a master's in quality assurance and regulatory affairs, an MBA in international business, and a bachelor's in biology. About 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
	Managing AI Risk Across Global Quality Systems	17 août 2026	00:32:07
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 where the risk is genuinely low, why one overreaction makes an organization risk-averse, and what regulators will expect from AI governance. A few of Julio's key takeaways: Regulatory confidence means decisions you can explain, not just documentation you can produce Stop asking what the auditor will think. Control the real risk and compliance follows as a byproduct You can't ChatGPT compliance. Turning people loose on AI without defined intended use is a serious unintentional risk Start AI where risk is low, research and drafting, and build confidence from there. Decisions stay with qualified professionals Drop the control tower. Hybrid governance needs standards, decision rights, and escalation, not central control of everything Automating a broken process just gives you a faster broken process Quality leaders need risk management depth plus enough technical literacy to ask hard questions Inventory your AI use cases and classify them by risk. That's the practical starting point About Julio Salwen Julio Salwen is SVP and Chief Quality Officer at MiniMed, the diabetes company recently spun off from Medtronic. An engineer by training with over 35 years in pharma, medical devices, and IVD, he previously served as VP of Quality for Medtronic's Diabetes Operating Unit, Divisional VP of Quality for Abbott Point of Care, and Global Head of Quality for Abbott Molecular, following more than two decades at Baxter Healthcare across Puerto Rico, Europe, and the US. About 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
	The Case for Engaging Regulatory Early	13 août 2026	00:22:15
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 companies, the hidden costs of rework beyond timeline, how regulatory input changes product decisions across geographies, and what regulators are scrutinizing more closely now. A few of Leland's key takeaways: Early means concept phase, not pre-submission. Even your IP narrative can matter years later in a submission Companies often run more testing than they need. Efficiency means answering the right questions with the least data Risk tolerance is what gets companies in trouble. What's acceptable in development isn't acceptable at PMA Post-market obligations happen underneath the water, and they're a resourcing problem more than a regulatory one Rework isn't just timeline, it's product cost and a supply chain issue Biocompatibility interpretation varies by geography and can change what you develop and when AI, usability, and management review are all getting closer regulatory attention Build a scalable QMS. It's the bedrock, and it isn't an afterthought About Leland Keyt Leland Keyt is VP of Regulatory Affairs and Quality Assurance at Apreo Health, which is running a US pivotal study for an implantable airway scaffold for severe emphysema. She has over 20 years in medical devices across startups, mid-size companies, and multinationals, previously serving as Chief Product Officer at Biorithm and Senior Director of RA/QA at Pulmonx, where she navigated FDA's Breakthrough Device Program to a 178-day PMA approval. About 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
	Why Quality and R&D Default to Conflict (and How to Fix It)	06 août 2026	00:30:29
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, why quality's timeline never gets extended, the memo-to-file versus special 510(k) trade-off, and the difference between a compliance gatekeeper and a strategic risk advisor. A few of Shawn's key takeaways: The quality roadblock and the R&D cowboy are learned behaviors, and each one justifies the other A regulatory conclusion delivered without the risk logic or alternatives behind it guarantees a defensive response If quality is afraid of FDA, R&D takes the cue. Don't ask the agency what to do, but you can share what you plan to do Quality gets the last timeline and it rarely gets extended, which builds the speed-versus-quality conflict into the schedule Quality plans are prescriptive, which cuts both ways. Consider folding quality into the project plan instead Trust is built outside the meeting, over time, and you can't assume it when you walk in the door Don't blindly defend your own team. A leader who lets their group go down the wrong road to protect the quality seat loses trust fastest About Shawn Fuller Shawn Fuller spent more than 24 years at Surmodics, joining as a regulatory manager and rising to Vice President of Quality, Regulatory and Clinical Affairs. She built the quality and regulatory infrastructure supporting Class I, II, and III devices and served as program director for a Class III device from concept through commercialization. She previously held regulatory roles at Protein Design Labs and conducted transplant research at the University of Minnesota. She is now semi-retired. About 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
	Leading Through the AI Shift with ASQ's CEO Sid Bhatnagar	03 juil. 2026	00:49:13
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 ground up, how to keep human judgment on both ends of the process, what executives owe their people through the change, and how to think about ROI when the technology won't sit still. A few of the takeaways: AI made the executive a steward of adoption and culture, not just a decision-maker, and the pressure is coming top down Keep humans on both ends: ideation from people, work from the tool, validation back to people Lean toward critical decision-making, not tasks. Pilots and anesthesiologists get paid for what they know when things go wrong Hire for innovation, change management, and system thinking. Lead by pulling people along, not pushing Executives owe their teams upskilling; employees owe the effort. When there's no seat left, be transparent and generous You can't retrofit ethics, and data isn't power, good data is Think about return on time, not just return on investment. Operations and customer service pay off fastest; talent is the long play About Sid Bhatnagar Sid Bhatnagar is CEO of ASQ, the American Society for Quality, a global organization with members in more than 130 countries. An engineer by training and a longtime technology executive and CIO across manufacturing and financial services, he joined ASQ in 2020 as CIO, became COO and Chief of Staff, and has led as CEO since 2023. About 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
	Why Your CAPA System Isn't Driving Improvement (and How to Fix It)	15 juin 2026	00:27:51
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've already chosen, and why "retrain the operator" is usually the wrong answer. A few of Dan's key takeaways: A closed CAPA that fails again for the same reason was never successful, repeat offenders are the clearest sign of a broken-but-compliant system Most CAPA trouble starts with a poorly worded problem statement, train your owners to write good ones and you get value across NCRs too Humans back-engineer root cause analysis to justify the fix they already wanted, the J&J forklift story shows how that goes wrong Trade retrospective "wait three months and see" verification for process validation that proves capability with objective evidence Know the difference between a correction (fixes the immediate problem) and a corrective action (prevents recurrence) Without leadership buy-in across functional groups, CAPA becomes a hot potato, but a recall costs far more time and money Track whether your VOEs are effective, not just whether CAPAs closed on time About Dan Eagles Dan Eagles is Vice President of Quality Assurance at NeuraSignal, a company developing robotic transcranial Doppler ultrasound technology for stroke detection. He has over 20 years in the medical device and pharmaceutical industries, with 23 years in quality assurance and prior roles at NuVasive, Dendreon, Endologix, and Edwards Lifesciences. He is a CAPA and NCR mentor and is listed on 21 ophthalmic device patents. About 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
	TerSera's VP of Quality on the Audit Risk Hiding Inside Your Own Procedures	18 mai 2026	00:30:38
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" is a discipline rather than a shortcut, how leadership shapes quality culture through what they ask about, fund, and tolerate, and why the strongest signal of a healthy quality system is when people come to quality voluntarily to report problems. A few of Yeime's key takeaways: Inspection readiness is the natural output of a healthy quality system, not something you build in the weeks before an audit "Minimally compliant" means meeting the regulatory intent without overcommitting in your procedures to things your team can't actually follow Quality should come to the table with options, not just a no — release to warehouse on risk while the investigation closes, for example Leadership shapes culture through what they ask about, what they fund, and what they tolerate The strongest quality culture signal: people voluntarily surfacing problems without fear of blame AI is useful for data analysis and review, but accountability for quality decisions sits with people — "AI didn't tell us" showed up in a recent FDA warning letter Design your QMS around flexibility — rigid procedures that block product release unnecessarily are self-imposed constraints the regulation never required About Yeime MartichYeime Martich is Vice President of Quality Assurance at TerSera Therapeutics with 25 years of experience in pharmaceutical and medical device quality systems. Before TerSera, she spent over 11 years at Hospira in global compliance roles overseeing internal audit programs across international manufacturing sites, and held quality systems leadership positions at Melinta Therapeutics and Abbott. About The FDA GroupThe 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
	What Auditors Are Actually Looking For — and the Psychology Behind How They Find It	28 avr. 2026	00:19:30
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 more than most companies realize, and the specific psychological techniques auditors are trained to use — including how to handle them. A few of Sneha's key takeaways: Being compliant and being audit ready are not the same thing — compliance is your documentation; readiness is your logistics, your plan, and your ability to defend your approach Auditors think in terms of SISPQ (safety, identity, strength, purity, quality) — everything rolls up to whether the product has those attributes Logistics are the make or break — fast document retrieval, defined roles, and coordinated teams create more auditor confidence than perfect systems with slow access Batch records are the most common rabbit hole — have a storyboard ready for anything you put in front of an auditor Train your floor staff to be comfortable with auditors, not to hide from them — use internal audits as practice Auditors use strategic silence, open-ended questions, and deliberate friendliness to get people talking — train your team to give concise answers and redirect to documentation The daily question that changes everything: "If someone reads this two years from now, will they know what happened?" About Sneha SaggurthiSneha Saggurthi is Quality Compliance Manager at Cartesian Therapeutics, a cell therapy company, where she manages inspection readiness, supplier quality, and the audit program. She holds an ASQ Certified Quality Auditor (CQA) credential and a Lean Six Sigma Green Belt, with prior quality and training roles at Catalent, Precision For Medicine, and Charles River Laboratories. She is an adjunct instructor at Frederick Community College and serves as Vice Chair of Young Women In Bio. About The FDA GroupThe 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
	Why Kidney Disease Innovation Is a Tale of Two Cities — and What It Would Take to Change That	10 avr. 2026	00:35:12
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 the rare kidney disease investment landscape, why the dialysis bundle makes innovation functionally impossible for providers, and how the Kidney Care Access Protection Act could be the first meaningful step toward a sustainable path for new dialysis therapies. A few of John's key takeaways: Regulatory clarity is the single biggest driver of rare kidney disease investment — FDA's work with industry to define approvable endpoints changed the entire landscape The dialysis bundle is structurally hostile to innovation — at $280 per session for all services, supplies, and drugs, there's no room for new therapies The Corsuva story is a cautionary tale — a good product at a reasonable price failed because the payment mechanism didn't work K-CAPA could change the calculus by extending the TDAPA window to three years and shifting to pay-per-use reimbursement Investors are willing to take clinical risk, but they need a clear path to both approval and payment FDA and CMS are generally better when they don't try to coordinate — FDA should focus on science and benefit-risk, not system cost The science is moving upstream — SGLT-2s, GLP-1s, porcine kidney transplants, and wearable kidneys all point toward a future with fewer patients on dialysis About John ButlerJohn Butler is President and CEO of Akebia Therapeutics, where he has led the company for over 12 years. He has worked in kidney disease since 1991, with roles at Amgen and 13 years at Genzyme leading the renal and rare disease businesses. John chaired the American Kidney Fund and Kidney Care Partners, and recently testified before the House Ways & Means health subcommittee on dialysis innovation and reimbursement reform. He holds an MBA from Baruch College's Zicklin School of Business and a BA in Chemistry from Manhattan University. About The FDA GroupThe 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
	Syncing Global Regulatory Filings Across FDA, EMA, and PMDA with AJ Acker	30 mars 2026	00:28:53
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't equal regulatory alignment, how Japan's evolving regulatory landscape creates both opportunity and complexity, and why the preparation that starts early in development (not at submission) is what determines whether a program achieves tight global approval timelines. A few of AJ's key takeaways: FDA, EMA, and PMDA share the same goal but ask fundamentally different questions — sponsors need to understand each lens, not just the shared science ICH harmonization provides a common foundation, but technical alignment is not regulatory alignment — region-specific engagement is essential Start planning for all three regions early, especially Japan — PMDA will ask why they weren't included in early development Expect different regulators to want different endpoints from the same data — early conversations prevent study design misalignment Local regulatory experts and ex-regulators are most valuable as strategic advisors and early warning systems, not just document producers Simultaneous filings are becoming the norm, but resource planning for parallel review cycles is critical AI is emerging as a tool for sharpening submission strategy — not replacing expertise, but catching gaps human reviewers might miss About AJ AckerAJ Acker is Senior Vice President of Regulatory, Quality & Clinical Safety at Annexon Biosciences. He has about 30 years of pharmaceutical industry experience with a focus on rare diseases and global regulatory approvals across the FDA, EMA, and PMDA. Prior to Annexon, AJ led global regulatory affairs at Zogenix (including serving as President of Zogenix Japan K.K.) and held regulatory leadership roles at Bioskin, Santen, and BioMarin. He is an Oregon State University alumnus. About The FDA GroupThe 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
	Navigating Regulatory Leadership Across Large and Small Life Science with Tammy Sarnelli	19 mars 2026	00:32:46
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 resources at small companies can actually accelerate decision-making, and how risk tolerance shapes not just strategy but the speed at which products move forward, especially in rare disease. A few of Tammy's key takeaways: Regulatory expectations are the same regardless of company size — it's the day-to-day experience and workload distribution that differ Silos in large organizations restrict collaboration and can fragment how a company approaches health authority interactions Small companies benefit from "all-in thinking" — fewer programs mean faster alignment, but leaders must fill multiple roles simultaneously Risk tolerance is cultural, not organizational — when people aren't punished for good-faith decisions, they move faster Regulatory "failure" can mean not taking a chance when you had one, especially in rare disease where patients can't wait AI is shifting medical writing from structured formatting toward strategy and interpretation — but adoption speed depends on resources About Tammy SarnelliTammy Sarnelli is Senior Vice President and Global Head of Regulatory Affairs and Clinical Quality at Amylyx Pharmaceuticals. She has over 35 years of regulatory experience spanning Biogen (27 years), Bioverativ, EMD Serono (Merck KGaA), and Amylyx, working across therapeutic areas and organization sizes with a sustained focus on rare disease. She holds a Master's degree in Public Administration from Suffolk University and a Bachelor's degree in Biology from Saint Anselm College. About The FDA GroupThe 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
	Getting Data Governance for Regulatory Submissions Right Before AI Gets it Wrong with Cary Smithson	05 mars 2026	00:28:05
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 interoperability, and AI reliability — and walks through the foundational steps companies should take, the organizational challenges they'll hit, and what measurable results look like when governance is done right. A few of Cary's key takeaways: Regulatory submissions are no longer just documents — they're structured data that demands consistent master data, controlled vocabularies, and traceable lineage Start with scope and pain points, not a boil-the-ocean exercise — pilot governance in one or two high-value use cases, then scale Data ownership belongs in the business, not IT — IT facilitates, but stewards and business owners should be accountable for their data Tools support governance but don't replace it — get the people and process foundation right before selecting platforms AI reliability depends on governed data — without standardized inputs and clear provenance, models produce unreliable or unexplainable outputs Tie governance to business outcomes people are already measured on — submission cycle time, audit readiness, right-first-time metrics — or compliance won't stick About Cary SmithsonCary Smithson is Managing Partner and Owner of LeapAhead Solutions, Inc., where she leads a consulting practice focused on IT strategy, data governance, and business process consulting for life sciences. She leads the DIA RIM Working Group and the DIA RIM Intelligent Automation Team and co-authored the DIA RIM eBook. With experience spanning large consulting firms (Grant Thornton, PharmaLex), enterprise technology organizations (OpenText), and her own practice, Cary has served clients including Regeneron, Bristol-Myers Squibb, Johnson & Johnson, Daiichi Sankyo, Bayer, and BeiGene. She is a recognized thought leader who regularly presents at industry conferences on regulatory information management, intelligent automation, and AI adoption in life sciences. About The FDA GroupThe 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
	Building Resilient Biotech Teams in Cell and Gene Therapy with Nelly Viseux	09 févr. 2026	00:37:59
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 documenting your assumptions is critical to managing risk, and what it really takes to maintain resilience when you're literally holding patient lives in your hands. A few of Nelly's key takeaways: Resilience is adaptability—build organizations that absorb and anticipate change rather than resist it Separate innovation from execution with intentional gates for when new approaches are ready to implement Document your assumptions so you can revisit decisions effectively when circumstances change Failure is a process problem, not a personal one—root cause analysis should improve systems, not assign blame Data is the common language that aligns scientists, regulators, and stakeholders Everyone is a leader in cell therapy—manufacturing and QC teams hold patient lives in their hands About Nelly Viseux Nelly Viseux is Vice President of Cell Therapies Development, Manufacturing, Supply & Quality at Regeneron, leading a 100-person organization supporting autologous cell therapy programs. She has over 20 years of biotechnology experience spanning large pharma (Shire, Biogen, Baxter) and startups, working across cell and gene therapies, biologics, and nanoparticles. Her accomplishments include building a Phase 1 cell therapy manufacturing facility that achieved 100% cGMP success and first IND submission within two years. She holds a Ph.D. in Biochemistry and Molecular Biology from University of Lille and is a member of the Society for Immunotherapy of Cancer and the American Society of Gene & Cell Therapy. About 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: ⁠⁠https://www.thefdagroup.com/
	Building Phase-Appropriate Quality from Preclinical to Commercial with Jackie Klecker	12 janv. 2026	00:35:24
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 can build robust, phase-appropriate quality systems without over-engineering early or under-preparing later. Drawing on decades of experience across pharmaceutical drug products, medical devices, APIs, and biologics, Jackie shares practical guidance on knowledge transfer, risk management, QMS maturity, and regulatory expectations across the U.S. and EU. The conversation focuses on what actually prevents costly delays—and how disciplined communication and documentation make scaling achievable. A few key takeaways: Early quality work should be right-sized, not commercialized prematurely Design space, material variability, and sensitivities must be understood and documented early FMEA works best when it evolves with the product—not when it’s treated as a one-time exercise FDA and EU requirements can diverge in ways that materially affect submission timing Clear documentation and regular, direct communication prevent avoidable delays Jackie Klecker is Executive Vice President of Quality and Development Services at Lifecore Biomedical, a fully integrated CDMO with decades of experience supporting pharmaceutical drug products, medical devices, biologics, and APIs. She has led quality systems and development programs across multiple global manufacturing sites and brings deep expertise in FDA 21 CFR 210, 211, and 820, ISO 13485, EU GMP, and ICH Q7 environments. Her background spans chemical engineering, process development, validation, risk management, and cross-functional leadership. About 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: ⁠⁠https://www.thefdagroup.com/
	Preparing the Workforce That Will Shape Pharma’s Future with ISPE President & CEO Mike Martin	06 janv. 2026	00:42:34
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 entering a new industrial era — often referred to as Pharma 4.0 — and what that means for engineers, operators, and leaders at every level. The discussion explores how automation, robotics, and AI are reshaping day-to-day work, why deep technical expertise remains critical in an AI-driven environment, and how organizations must move beyond reactive reskilling toward more intentional “pre-skilling” of future talent. Mike also reflects on the enduring importance of character, integrity, curiosity, and trust, arguing that these traits matter as much as technical competence in a highly regulated industry. Nick and Mike examine the evolving role of professional organizations like ISPE in building global communities of practice, sharing knowledge across borders, and supporting lifelong learning. The conversation also addresses how learning itself is changing — from long-form training to bite-sized, modular education — and what leaders must do to engage a new generation of professionals with different expectations around purpose, speed, and technology. Throughout the episode, Mike emphasizes a unifying theme: innovation and compliance are not opposing forces. When approached correctly, innovation strengthens quality, improves compliance, and ultimately enhances patient safety. This episode is a must-listen for anyone responsible for building teams, modernizing operations, or preparing their organization for the future of pharmaceutical manufacturing and engineering. About 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: ⁠https://www.thefdagroup.com/
	How to Build (and Sustain) a Quality-Centric Culture with Chris Masterson	09 déc. 2025	00:43:27
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 leadership experience, Chris has led global quality organizations at Ipsen, Cubist (Merck), and now Tolmar, as well as his own consultancy. Across the U.S., Europe, and Asia, he has managed large CMO networks, established inspection-readiness programs, and led cultural change within complex, matrixed organizations. Nick and Chris explore what truly defines a quality-centric culture, how leadership and accountability shape it, and the practical, long-term steps required to sustain it. In this conversation, Chris shares insights on: What “quality culture” really means—and how to make it visible at every level of an organization. The leadership behaviors that create alignment and consistency across global teams. How to embed compliance and continuous improvement into daily operations. Managing uncertainty, pressure, and change without losing focus on the patient. Practical methods for measuring and improving quality culture over time. Why humility and transparency are non-negotiable for sustainable performance. About 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
	From Molecule to Market: A Commercial-Readiness Playbook for Biotechs with Carlos Carrillo	02 déc. 2025	00:48:45
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 has prepared IND/IMPD/CTA/CTR/BLA/MAA submissions across multiple regions, secured expedited designations, managed FDA and ex-US health authority meetings, and built RA/QA systems for growing biotech organizations. Carlos shares practical, experience-tested guidance on how small and mid-size biotech companies can build regulatory resilience: strengthening governance, preparing for FDA interactions, improving documentation discipline, and integrating external partners without losing control. He also breaks down how to evaluate vendors, structure joint governance, embed QA into outsourced workflows, and design audit-ready data flows that prevent institutional knowledge loss. Topics discussed include: Why early regulatory infrastructure prevents costly rework Leadership behaviors that shape regulatory culture How to prepare for high-stakes FDA and ex-US health authority meetings The risks of “tribal knowledge” in fast-moving organizations A structured model for evaluating and managing external partners How small companies can stay inspection-ready with lean teams One takeaway: External partners can be force multipliers or liabilities—the sponsor’s structure and oversight determine which. About 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 on staff augmentation, auditing, remediation, QMS, and specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/
	How Regulators Are Bringing AI Into Review (Without Losing Trust) with Maria Vassileva	17 nov. 2025	00:51:29
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-funded clinical research, and biomedical science programs—spanning patient registries, clinical trials, multi-stakeholder consortia, DEI initiatives, and regulatory strategy. As the head of DIA’s global science and regulatory portfolio, she works closely with regulators, industry sponsors, academia, and technology developers to advance responsible, evidence-driven innovation. In this conversation, Maria breaks down the reality behind AI in the regulatory ecosystem: what’s currently in use, how agencies are evaluating and validating tools, why risk-based tiers matter, and how the field is moving toward lifecycle oversight rather than one-time checks. She also highlights the ethical and equity considerations that must be embedded from the start and shares insights from global regulatory trends and DIA’s convening role. Key topics discussed include: How regulatory agencies are already using AI internally for document-heavy workflows, safety surveillance, and information retrieval Why validation must focus on end-to-end workflow integrity, not just the model The emerging role of risk-based tiers for AI-enabled tools The importance of lifecycle control frameworks such as TPLC and PCCPs Global convergence themes around transparency, bias mitigation, and human accountability How agencies are preparing for increasing AI adoption—and what industry teams should be doing now DIA’s role as a neutral convener helping harmonize expectations and accelerate responsible innovation About 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/
	A Playbook for FDA Inspections and Remediation with Jeff Hines	16 oct. 2025	00:52:24
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 environments and keeping people confident under pressure. He outlines the four-room model for inspection management, strategies for responding to observations, and proven methods for closing data-integrity gaps while daily operations continue. Jeff and Nick also explore the leadership mindset that sustains progress beyond the initial response—fostering transparency, prioritization, and a culture of accountability that prevents repeat findings. Topics discussed include: The leadership posture that steadies teams during inspections and remediation How to stand up the four-room inspection model (Front, Back, Doc-QC, SME-Prep) Responding to 483s: when to push, when to accept, and how to align internally Data-integrity vulnerabilities and effective interim controls Balancing remediation with production demands Building transparency and accountability into quality culture Keeping systems current to avoid backsliding into repeat observations About 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: ⁠https://www.thefdagroup.com/
	Leading Cross-Functional Teams from Concept to Commercialization with Marwan Fathallah	06 oct. 2025	00:46:19
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, clinical, scientific affairs, and operations. He brings a rare, holistic view of how leadership, culture, and systems thinking come together to drive successful outcomes in complex, regulated environments. Their conversation explores how to balance innovation and compliance, structure cross-functional teams for consistent execution, and foster cultures that prioritize transparency, collaboration, and patient focus. About 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/
	Breaking Down FDA’s E21 Draft Guidance: Including Pregnant and Breastfeeding Women in Clinical Trials with Regina Atim	29 sept. 2025	00:28:35
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 FDA/ICH’s new E21 draft guidance, Inclusion of Pregnant and Breastfeeding Women in Clinical Trials. Regina explains why pregnant and breastfeeding women have historically been excluded from research, how that has left clinicians and patients with insufficient evidence, and why E21 represents a cultural and scientific shift toward safe, risk-based inclusion. Read the draft guidance here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e21-inclusion-pregnant-and-breastfeeding-women-clinical-trials Regina shares practical insights on: How physiologic changes in pregnancy alter drug absorption, distribution, metabolism, and elimination. The dangers of underdosing, overdosing, or avoiding treatment altogether in the absence of trial data. Why clinicians should avoid inappropriate substitutions (e.g., some NSAIDs) and instead rely on evidence-based dosing. How E21 encourages continued monitoring of participants who become pregnant during a trial rather than automatic withdrawal. The stepwise approach to lactation studies—starting with breast milk concentration, then estimating infant dose, and eventually assessing infant exposure and safety. The role of PK/PD modeling, nonclinical data, and real-world evidence in bridging evidence gaps. How sponsors can engage FDA early to align on inclusion triggers and maternal–fetal expertise. About 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/
	Staying Ready for the FDA (When Inspections Are Less Predictable)	19 sept. 2025	00:28:02
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 predictable today—with more variability in inspector experience and a higher likelihood that minor issues become formal observations—and how leaders can respond without overreacting. He explains how to prepare documentation so that it’s understandable to any inspector, what makes a quality system truly “robust” in practice, and why culture, accountability, and simplicity matter as much as compliance. Nick and Jeff also explore practical steps for keeping data integrity controls sharp, building efficient systems that don’t overburden teams, and fostering engagement so quality is seen as a partner, not just a policing function. About 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/
	Building the Next-Gen Lab: AI in a GLP Environment with Catherine Lunardi	19 sept. 2025	00:38:00
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 fragmented data, manual processes, and costly compliance reviews—and how AI can help orchestrate data, surface anomalies, and accelerate insights without replacing the people at the center of science. She outlines a step-by-step approach to identifying the right challenges, aligning AI projects with company strategy, piloting solutions with clear ROI, and managing change so teams embrace and sustain new tools. Nick and Catherine also discuss the balance between innovation and regulation, how to keep humans in the loop, and why strong governance and explainability are essential to ensuring AI adds real value in GLP environments. About 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: ⁠https://www.thefdagroup.com/
	How to Build High-Performing Quality Teams with Marcus Gesner	08 sept. 2025	00:49:35
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 quality—and how high-functioning teams go further by protecting a company’s right to compete, preventing manufacturing and supply disruptions, enabling speed to market, and building trust across the business. He discusses the metrics that matter most (like defect rates, back orders, holds, complaints, and R&D delays), how to structure incentives that drive the right behaviors, and practical strategies for recruiting, onboarding, and retaining people with the drive, courage, and creativity to lead meaningful change. Nick and Marcus also explore how leaders can create the right balance of accountability and innovation, foster collaboration across functions, and ensure quality is seen as a value-driving partner rather than a cost center or policing function. About 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/
	The 4 Cs of MedTech Leadership with Sean Gallimore	18 août 2025	00:54:16
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 directly impacts growth, culture, and execution. Listeners will learn how to: Pressure-test whether your strategy is actually winnable. Match organizational capabilities to goals (and pivot when they don’t). Use KPIs and OKRs to diagnose execution gaps. Build stronger trust and culture through connectedness, from “gemba” walks to multi-channel communication. Sean also shares real-world stories—from transforming an underperforming ultrasound launch to shifting a company’s culture from “play not to lose” to “play to win.” Whether you’re leading in medtech, life sciences, or beyond, this episode delivers actionable insights you can bring straight back to your team. About the Guest: Sean Gallimore, MBA is an executive consultant with 30 years of leadership across Fortune 500, mid-cap, and private equity–backed companies in medical devices, life sciences, and industrial technology. He has held senior roles at Medtronic, Smith & Nephew, Philips, Parexel, PDI Healthcare, and Dynisco, driving growth through strategy execution, turnarounds, innovation, and building high-performing teams. Today, he advises early-stage medtech companies on scaling operations, commercial strategy, and organizational development. About 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/
	The Power (and Pitfalls) of Real-World Evidence with Dr. Manfred Stapff	28 juil. 2025	00:51:13
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 affairs, clinical trials, and RWE analytics to explain why real-world evidence isn’t a replacement for randomized controlled trials—but a necessary complement. He outlines how to transform raw data into credible evidence, how the FDA is using RWE today, and why quality, transparency, and context are essential in data-driven science. He also offers cautionary insight on common pitfalls—from bias in training data and misinterpreted statistics to the challenges of AI integration in healthcare research. What they cover: What real-world evidence is (and isn’t)—and how it differs from clinical trial data How RWE is being used by the FDA to support label expansions and safety monitoring Key risks around self-reported data, upcoding, and poor data quality Why statistical significance isn’t enough—and how to evaluate clinical relevance How AI can accelerate pattern recognition and predictive diagnostics Why training data matters—and how bias can infiltrate large-scale AI tools The role of educated skepticism in interpreting data-driven claims in both science and society Dr. Manfred Stapff is the founder and principal consultant at a boutique advisory firm focused on real-world evidence strategy, clinical development, and medical data intelligence. He is the author of Real World Evidence Unveiled and a frequent speaker on the role of data integrity, statistical literacy, and AI in advancing medical research. His current work supports life science companies and investors in evaluating drug development strategies, acquisition opportunities, and data-driven innovations. 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. For project or resource needs, visit ⁠⁠https://www.thefdagroup.com⁠⁠
	Quality Is Not a Cost Center—It’s a Culture (with Dr. Kimberly Garko)	15 juil. 2025	00:54:31
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 leadership practices. She outlines the difference between good and poor quality costs, explains how to build ROI-focused metrics, and offers practical ways to foster transparency, psychological safety, and proactive decision-making. From regulatory intelligence and scorecard design to audit readiness and AI integration, this conversation is packed with insights for quality leaders and executive teams alike. What they cover: How to shift your organization’s mindset from compliance to value creation The real financial and operational impact of poor vs. proactive quality How to build scorecards, systems, and reporting processes that drive action Why culture, transparency, and psychological safety are core to sustainable quality Practical approaches to audit readiness, supplier oversight, and training _____ 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. For project or resource needs, visit ⁠⁠https://www.thefdagroup.com/
	From Cost Center to Value Driver: Rethinking Quality in the Life Sciences with Marcia Baroni	08 juil. 2025	00:44:57
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 illustrates the stakes with a $600 million nationwide OTC-drug recall caused by chemically treated pallets—an error frontline staff flagged but a weak quality culture ignored. The conversation dives into building psychological safety and metrics that drive the right behaviors, not under-reporting, shifting quality from “policing” to cross-functional partnership, and practical first steps executives can take to gauge their current maturity and start investing for future yield. _____ 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. For project or resource needs, visit ⁠⁠https://www.thefdagroup.com/
	Managing Royalties in Biotech, Pharma, and Medtech with David Marlin	09 juin 2025	00:44:02
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 simple once-a-year payment can quickly evolve into a tangled web of tiered rates, stacked IP, country-specific rules, and audit requirements. David breaks down where companies most often go wrong—managing rules in Excel, underestimating the operational burden, and lacking traceability across contracts, SKUs, and sales data. He discusses how automation not only reduces risk and effort but also preserves trust with licensors by ensuring accuracy and transparency. The conversation also covers how organizations can recognize when it's time to move beyond spreadsheets, what a successful royalty system implementation looks like, and why experience matters in such a niche space. Whether you're paying or receiving royalties, this episode offers valuable insight into a critical but often misunderstood area of life sciences operations. _____ 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. For project or resource needs, visit ⁠https://www.thefdagroup.com/
	GMP Compliance in 503B Compounding Pharmacies with Jesse Gillikan	20 mai 2025	00:24:23
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 GMP requirements, though major hurdles persist. For 503B facilities, the primary challenge isn't knowledge but cost, particularly testing expenses that might be manageable for pharmaceutical giants making millions of units but become prohibitive for compounders producing just thousands.Jesse highlights practical space constraints, with many facilities not designed for GMP manufacturing. He recommends dedicating one-third of facility space to clean operations and another third to compliant warehousing, which targets many smaller operations that struggle to achieve.Jesse also sheds light on validation has shifted from qualifying individual technicians to validating entire processes, requiring completely new approaches to media fills and documentation. Despite these challenges, Jesse notes the industry's impressive information sharing and collaborative spirit.When discussing FDA inspections, Jesse emphasizes the importance of thorough deviation management — a common citation area. He also addresses the FDA shortage list volatility, sharing how clients invested in automated filling lines for GLP-1 products only to have those drugs removed from the list, creating significant business disruption.Jesse maintains that while compliance is non-negotiable, the FDA genuinely wants compounders to succeed. His practical advice focuses on risk-based prioritization, industry collaboration, and maintaining open communication with regulators._____The FDA Group connects compounding pharmacies with specialized consultants who understand the unique challenges of 503B compliance. Our experts provide practical solutions that balance regulatory requirements with business viability – from GMP implementation and environmental monitoring to documentation systems and FDA inspection support. Visit https://www.thefdagroup.com/ for more information.
	A Smarter Approach to Supplier Quality Audits with Thermo Fisher's David Festa	28 févr. 2025	00:41:42
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 balances quality, compliance, and business needs through "exception-based" auditing. Rather than rigidly adhering to calendar-based audit schedules, David suggests companies should assess suppliers based on performance metrics, risk factors, and the criticality of materials they provide. He challenges the industry norm that every supplier must be visited at predetermined intervals, arguing that well-performing suppliers with stable processes may not require frequent on-site visits. David emphasizes the importance of matching auditor expertise with supplier categories. For example, an auditor with deep knowledge of plastics manufacturing will provide far more valuable insights when evaluating a plastics supplier than someone familiar only with general standards. This targeted approach has helped Thermo Fisher predict quality issues and decrease the percentage of poor-performing suppliers. The conversation explores how post-pandemic practices have evolved, with companies developing more harmonized approaches to global auditing and implementing centralized audit portals. David also introduces the concept of a "supplier pricing index" that quantifies the true cost of poor quality, providing a more accurate picture of supplier value than piece price alone. While ISO certifications provide a foundation for quality systems, David cautions against over-reliance on certifications or imposing unnecessary standards on suppliers. The most effective approach focuses on whether suppliers can maintain control of their manufacturing processes and consistently deliver quality products, regardless of certification status. For companies looking to optimize their supplier quality programs, the key is putting the right people in the right places, implementing quantifiable metrics, and taking a holistic view that integrates quality with other business functions. ____ 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. For project or resource needs, visit: ⁠⁠⁠⁠⁠⁠thefdagroup.com⁠⁠⁠⁠⁠⁠.
	Mastering FDA and EMA Regulatory Meetings with Ashley Preston	10 févr. 2025	00:40:45
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 the FDA and EMA are both considered first-tier regulatory agencies, they handle meetings differently. FDA offers various meeting types with structured timelines, while EMA takes a more committee-based approach through the CHMP. FDA meetings include several key types, from pre-IND consultations to end-of-phase meetings. The end of phase two meeting, where sponsors agree on pivotal trial designs, and the pre-NDA meeting are considered required interactions. Recent initiatives like Project Optimus have made end-of-phase 1 meetings increasingly critical, particularly in oncology. While FDA meetings are covered by PDUFA fees, EMA scientific advice can cost 70,000-80,000 euros unless the product has orphan designation. Meeting preparation requires careful strategy and timing. Preston emphasizes the importance of having sufficient data to support proposed development plans, noting that companies sometimes seek meetings too early, leading to delays or unfavorable feedback. Teams must craft focused questions and present just enough data to make persuasive arguments without overwhelming reviewers. Effective negotiation during meetings requires understanding agency perspectives and finding a middle ground when disagreements arise. Preston advocates for a partnership approach, recognizing that regulators share the ultimate goal of bringing safe, effective medicines to patients. Teams should prepare for various scenarios and be ready to suggest alternative approaches that address agency concerns while maintaining development efficiency. Documentation has evolved in the post-COVID era, with the FDA often drafting minutes during meetings. This real-time approach allows sponsors to ensure critical decisions and agreements are accurately captured. Follow-up mechanisms, from informal clarifications to formal Type D meetings, provide opportunities to address any remaining questions or challenges that emerge during implementation. Preston recommends that companies prepare for their first agency meetings by viewing these interactions as opportunities to build relationships and understand agency expectations. While virtual meetings have become common and efficient, maintaining professional, science-based discussions remains crucial regardless of format. Companies working with both the FDA and the EMA should consider how to harmonize feedback, potentially using sequential meetings to incorporate initial FDA input into EMA discussions. ——— The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our regulatory affairs expertise spans the entire drug development cycle, from pre-IND strategy through approval. For project or resource needs, visit ⁠thefdagroup.com⁠.
	Working with Chinese CROs: Benefits, Risks, and Best Practices with Harri Järveläinen	05 févr. 2025	00:38:08
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 Chinese CRO partnerships while addressing common misconceptions. Chinese CROs have evolved significantly over the past two decades. Initially focused on medicinal chemistry, they have expanded into full-service providers across all areas of preclinical development. Government support in the mid-2010s fueled rapid growth, leading to an industry that today services both domestic and international clients, including many U.S. biotech and pharmaceutical companies. While some remain hesitant about working with Chinese providers, many of these organizations now operate at a level of quality that rivals their Western counterparts. Regulatory compliance is a key consideration when selecting a CRO. Many of the largest Chinese CROs undergo regular inspections from the U.S. FDA and OECD, ensuring adherence to global standards. For sponsors evaluating potential partners, it is critical to review their inspection history and any recent Form 483 letters to identify potential regulatory risks. Harri emphasizes that working with well-established providers mitigates concerns about compliance and operational transparency. Many companies are drawn to Chinese CROs due to their cost-effectiveness, faster turnaround times, and unique capabilities. During the pandemic, pricing disparities between U.S. and Chinese CROs were extreme, with some U.S. providers charging up to ten times more. Today, the cost advantage remains significant, particularly for studies involving research primates. Faster lead times also make Chinese CROs attractive, as some studies that take six months in the U.S. can be completed in just two months in China. Certain specialized studies, such as continuous infusion studies in rodents or research involving obese primates, are more commonly performed in China than in the U.S. or Europe. While concerns about intellectual property remain, Harri argues that they are largely outdated. Past issues, particularly in the early 2000s, created lasting skepticism, but established CROs today have stringent protocols in place to protect client data. Language barriers present a more tangible challenge. English proficiency among younger study directors has declined in recent years, making communication more difficult. Many CROs now assign English-speaking project managers to facilitate interactions and ensure smooth collaboration. Regulatory uncertainty is another area of concern. The pending Biosecure Act has raised questions about the future of U.S.-China collaborations in life sciences, but Harri clarifies that current discussions primarily focus on manufacturing rather than non-clinical or clinical research. The U.S. FDA continues to evaluate Chinese CROs based on performance and compliance rather than geopolitical factors. For companies considering working with a Chinese CRO, Harri advises starting with well-established providers that have a strong track record and regular FDA inspections. Conducting audits before engagement and maintaining oversight throughout the study process is essential. Cultural differences, particularly around work expectations and communication styles, should also be accounted for to ensure smooth collaboration. ____ 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. For project or resource needs, visit: thefdagroup.com.
	The Smart Way to Adopt AI in Clinical Trials and Regulatory Affairs with Keith Parent	22 nov. 2024	00:38:24
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: Industry Adoption Patterns: Keith contrasts how large pharma companies are establishing AI centers of excellence for major cost-saving initiatives while smaller companies are experimenting with tools like ChatGPT. He emphasizes the importance of solutions that can scale from large to small organizations. Privacy and Compliance: The conversation explores critical considerations around using AI tools within company firewalls, protecting intellectual property, and the evolving attitudes of regulatory groups toward AI-generated documentation. Practical Applications: Keith details several real-world use cases, including (1) TMF auto-classification to reduce manual document processing time, (2) automated labeling information compilation from multiple systems, (3) regulatory correspondence analysis for identifying commitments, and (4) historical submission analysis to improve future applications. Implementation Strategy: Keith recommends starting with "low-hanging fruit" - manual processes that can be automated - rather than attempting large-scale projects initially. Keith stresses the importance of demonstrating success with smaller projects to build momentum. Human Oversight: Keith highlights the importance of maintaining "human-in-the-loop" verification for lower confidence AI decisions while using machine learning to improve system accuracy over time. ____ 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. For project or resource needs, visit: thefdagroup.com. Court Square Group is a managed service firm specializing in infrastructure management for life science companies, working with both large pharmaceutical companies and small biotech firms for about 30 years. Visit: courtsquaregroup.com RegDocs365 is a specialized provider of regulatory solutions for the life sciences industry. Visit: regdocs365.com
	Demystifying AI in Life Sciences Supply Chain with Jennifer Chew	14 nov. 2024	00:39:10
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 emphasizes the importance of starting with simple, tactical applications before moving to complex strategic implementations. She advocates for a focused departmental approach rather than scattered company-wide experimentation. Data Quality and Regulatory Compliance: A major focus is placed on the critical role of data quality, particularly in regulated environments. Jen stresses that life sciences companies must build robust, FDA-validatable datasets before implementing AI solutions. Transforming Core Processes: The conversation explores how AI could revolutionize key operations like Sales and Operations Planning (S&OP), potentially reducing multi-day sessions to just hours through pre-run scenarios and more efficient planning. Organizational Readiness: Jen discusses how companies can assess their AI readiness and build internal capabilities, warning against the temptation to wait for enterprise vendors like SAP to provide complete solutions. Future Outlook: Looking ahead to 2025, Jen predicts massive data projects will be crucial, emphasizing how organizations must combine industry-specific knowledge with their unique data to create competitive advantages in AI implementation. ____ 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. For project or resource needs, visit: ⁠⁠⁠⁠⁠thefdagroup.com⁠⁠⁠⁠⁠.
	Streamlining Promotional Reviews in the Life Sciences with Annalise Ludtke	25 oct. 2024	00:35:28
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 regulatory, often lead to bottlenecks, making it essential to streamline feedback and improve claim management. Role of Claims Matrices and Version Control: Effective claims matrices and version control processes are critical for pre-approved content to ensure accuracy, avoid compliance delays, and maintain consistency. Managing Team Size and Risk Tolerance: Annalise explains the varied team sizes and the different levels of review needed based on content type, from high-stakes conference presentations to quick social media posts. Efficiency Best Practices: Annalise shares actionable tips, including the use of concept reviews to create shared ownership, digital asset management systems to centralize content, and strategies to address recurring review delays. Future Role of AI in Compliance: While cautious about AI’s application in compliance, Annalise discusses its potential for handling pre-checks, such as spelling and logo verification, allowing human reviewers to focus on more complex compliance tasks. ____ 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. For project or resource needs, visit: ⁠⁠⁠⁠thefdagroup.com⁠⁠⁠⁠. Check out Vidori's Amend & Progress podcast: https://www.vodori.com/amend-and-progress.
	Navigating Supplier Audits in Japan with Derek Wessman	17 oct. 2024	00:27:40
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: Derek explains how the significant language barrier and cultural differences can impact audit efficiency and effectiveness, often doubling the time required for audits. Strengths of Japanese Suppliers: The conversation highlights the strengths of Japanese suppliers, including their focus on quality, well-organized facilities, and widespread ISO certifications. FDA Inspections in Japan: Derek provides insights into the frequency and nature of FDA inspections in Japan, emphasizing the time constraints and logistical challenges faced by inspectors. Data Integrity Challenges: The discussion covers common data integrity issues in Japanese companies, including shared logins and the use of unvalidated Excel files for critical calculations. Cultural Impact on Quality Systems: Derek shares how Japanese business culture, including long-term employment and collective mindset, can influence quality management systems and CAPA processes. Strategies for Effective Audits: The conversation provides practical advice for companies looking to audit Japanese suppliers, emphasizing the importance of local resources and cultural understanding. Derek has been based in Japan since 2004 and has run his own consultancy since 2009. He specializes in helping Japanese companies navigate regulatory hurdles, FDA inspections, and compliance issues in the pharmaceutical, medical device, and combination product sectors. Derek's expertise bridges the gap between Japanese suppliers and global life science companies, offering unique insights into conducting effective audits in Japan. ____ 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. For project or resource needs, visit ⁠⁠⁠thefdagroup.com⁠⁠⁠.
	Small Lots, Big Risks: Rethinking Statistical Sampling in Biopharma	29 août 2024	00:18:54
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 Root of n + 1: Gary explains why this commonly used method is inadequate for small biopharmaceutical lot sizes, leading to potential risks in sample representativity and patient safety. Importance of Proper Sampling: Gary highlights the need for statistically valid sampling plans considering lot size, inspection levels, and acceptance quality levels (AQLs) to ensure representative sampling and compliance with regulatory requirements. Cost and Risk Management: The discussion emphasizes how improper sampling can increase business costs and risk to patients, while proper sampling can offer significant cost savings and better risk management. Adoption of ANSI Standards: Gary encourages the industry to adopt ANSI standards for sampling, demystifying the complexity of statistical methods and emphasizing their importance for compliance and efficiency. Practical Implementation: Gary shares insights from his experience, recommending resources and literature for better understanding and applying statistical sampling in the pharmaceutical industry, including Dan O'Leary's paper "Attributes Acceptance Sampling: Understanding How It Works" and Ron Snee's "Solving Statistical Mysteries: What Does the FDA Want?" Gary Ritchie is a veteran pharmaceutical scientist with nearly 30 years of experience in the life sciences industry. He specializes in statistical sampling, analytical chemistry, and pharmaceutical waters. Gary's expertise spans various areas, including process analytics, quality control, and regulatory affairs. Gary’s held key positions at the United States Pharmacopeia, where he served for five years on expert committees for waters, statistics, and general chapters. His experience as a liaison allowed him to work closely with the FDA, industry leaders, and academia. — 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. For project or resource needs, visit ⁠⁠thefdagroup.com⁠⁠.
	Quality Metrics that Matter with Kimberly Wallbank	19 août 2024	00:41:35
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 with Business Goals: Kimberly discusses how to connect quality metrics to financial impacts and overall business objectives. Optimal Number of Metrics: Kimberly advises on starting with a few key metrics and gradually expanding, while regularly reassessing their relevance. Frequency of Metric Reviews: Kimberly recommends monthly reviews at minimum, with the possibility of more frequent checks for critical metrics. Balancing Value and Effort in Data Collection: Kimberly explains the importance of weighing the potential insights against the resources required to collect and analyze data. Essential Quality Metrics: Kimberly outlines key categories of metrics that should always be included in a quality scorecard. Adding and Removing Metrics: Kimberly provides guidance on how to determine when to update the metrics on a scorecard. Common Implementation Challenges: Kimberly addresses issues such as stakeholder understanding, data structure, and involving the right people in metric discussions. Continuous Improvement: Kimberly stresses the importance of viewing the quality scorecard as a living document that evolves with the business. Practical Application: Kimberly shares real-world examples from her experience to illustrate effective metric implementation and use. — 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. For project or resource needs, visit ⁠thefdagroup.com⁠.
	Applying AI in the Life Sciences with MasterControl's Matt Lowe	15 juil. 2024	00:30:35
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 events. Risk-Based Approach to AI: Matt emphasizes the importance of applying a risk-based approach to AI implementation, similar to other processes in the life sciences industry. Low-Risk, High-Value Use Cases: Matt provides examples of low-risk, high-value AI applications, such as automated exam generation for employee training and document change summarization. Human Oversight in AI Systems: Matt stresses the critical role of human oversight in AI implementations to catch errors, ensure regulatory compliance, and maintain control over critical processes. The "3% Problem" and AI Hallucinations: Matt explains the challenges of AI errors and "hallucinations," emphasizing the need for strategies to detect and manage these issues. High-Risk AI Applications: Matt discusses the potential risks of using AI for critical processes like manufacturing recommendations, highlighting the need for thorough understanding and validation. Gradual AI Implementation: Matt advises on starting with simpler AI applications and gradually progressing to more complex use cases as organizations gain experience. AI as a Competitive Tool: Matt explores how AI implementation might affect a company's competitive position in the market, balancing potential benefits against adoption risks. Regulatory Considerations: Matt addresses the importance of aligning AI implementations with regulatory requirements in the life sciences industry. Future of AI in Life Sciences: Matt shares his perspective on the evolving role of AI in the life sciences industry and the importance of continuous learning and adaptation. — 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. For project or resource needs, visit thefdagroup.com.
	Navigating Challenges in Raw Material and Finished Product Storage with Eric Busenburg	03 juil. 2024	00:32:55
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: Understanding Storage Challenges: Eric explains the common storage issues that arise as life science manufacturers grow, including unexpected large orders and fluctuating production demands. Evaluating Storage Options: Eric outlines the pros and cons of building additional infrastructure versus outsourcing to third-party providers, including considerations of control, cost, and time. Quality Considerations: Eric emphasizes the importance of maintaining high-quality standards when outsourcing, and how third-party providers can align closely with manufacturers' in-house processes. Time and Cost Implications: Eric discusses the extended timelines for building new infrastructure post-pandemic and how outsourcing can provide more immediate solutions. Selecting the Right Provider: Eric provides key factors to consider when choosing a third-party storage provider, including proximity, size, expertise, and flexibility. The Importance of Location: Eric explains the strategic advantage of providers located within a one-hour radius of manufacturing facilities, particularly in biotech hubs like Massachusetts. Long-term Cost Analysis: Eric shares insights on the long-term cost comparison between building and outsourcing, including the typical 10+ year crossover point. Flexibility and Risk Management: Eric discusses how outsourcing can provide more flexibility to adapt to market changes and mitigate risks associated with long-term investments. Leveraging Outsourced Expertise: Eric explains how manufacturers can benefit from the immediate access to expertise that outsourcing provides without the need to hire and train new staff. Future Outlook: Eric shares his perspective on the future of storage needs in the life science industry, including the role of government initiatives and the importance of support services. For project or resource needs, visit thefdagroup.com.
	Building and Leading Effective Quality Assurance Teams with Aaron Snyder	20 juin 2024	00:55:00
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: Aaron explains how to identify early signs of strain in the quality system and the importance of transitioning from a small to a larger, more structured QA team to support business growth. The Interview Process: Aaron emphasizes the importance of vetting potential employers by asking direct questions about management styles, conflict resolution, and organizational support. First 90 Days in a New Role: Aaron outlines the initial steps for understanding team dynamics, identifying stakeholders, and learning the organization's goals to set a solid foundation for improvements. Creating a Strategic Plan: Developing a strategic plan with tools like Gantt charts and accountability charts, and engaging team members for feedback to ensure alignment and progress. Effective Communication and Meeting Cadence: Aaron stresses the need for a structured meeting schedule, including daily stand-ups and weekly reviews, to maintain momentum and accountability. Building the Right Team: Assessing team members' roles and reallocating based on strengths, while supporting career development to ensure high performance and job satisfaction. Making the Business Case for Team Expansion: Preparing a comprehensive business case for hiring additional staff, using metrics and workload analysis to justify the need for expansion. Utilizing Contractors: Leveraging contractors to manage immediate workload increases while recruiting full-time staff, and using their insights to refine job descriptions and onboarding processes. Continuous Improvement and Adaptability: Implementing continuous improvement initiatives, regularly updating processes, and engaging in feedback sessions to keep the quality system effective and relevant. Leveraging Experience and Young Talent: Combining experienced leadership with young talent to foster innovation and create a dynamic team environment. For project or resource needs, visit ⁠thefdagroup.com⁠.
	The Pharma Startup Playbook: Advice from the Field with Taggart McGurrin	18 juin 2024	00:50:33
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 strong foundation for a pharmaceutical startup in today’s economic environment. Discussion points include: Access to Capital: Tagg emphasizes the crucial role of securing capital in starting a pharmaceutical company. He shares strategies for identifying and cultivating relationships with high net worth investors and specialized investment groups. Tagg highlights the importance of prioritizing "smart money" – investors who understand the long-term nature of pharmaceutical investments. Board and Leadership Structure: Tagg discusses the need for a committed board with proper governance and checks and balances. He recommends separating the roles of CEO and executive chairman to ensure accountability and effective oversight. Additionally, Tagg underscores the necessity of having a dedicated full-time team with a long-term vision, avoiding reliance on part-time or fractional roles for key positions. Clear Mission and Objectives: Establishing clear, dynamic annual goals and objectives aligned with value inflection points is vital. Tagg highlights the importance of setting specific, measurable, attainable, relevant, and timely (SMART) goals and revisiting them regularly to ensure alignment with the company's progress. He also advocates for a structured meeting schedule with weekly, annual, and substantive quarterly meetings to maintain focus and accountability. Effective Investor Pitching: When pitching to investors, Tagg advises highlighting the executive team, commercial opportunity, and technical aspects of the asset. He emphasizes the importance of transparency and objectivity to build and maintain trust with investors. Tagg also suggests including a detailed business model in the pitch, outlining expected outcomes and the company's strategy for achieving them. Due Diligence and Investor Relationships: Tagg stresses the importance of conducting thorough due diligence to avoid nefarious individuals posing as well-connected investors. He recommends asking detailed questions to understand potential investors' past performance and seeking references from other companies they have supported. Transparency and regular communication with investors are key to maintaining trust and support. Leadership Synergy and Conflict Management: Tagg underscores the importance of a management team that is committed to the company's mission and strategy. He advises proactively addressing potential conflicts of interest to maintain the integrity and performance of the company. Ensuring independence in both fact and appearance is crucial to prevent personal motives from hijacking investor value. Growth and Communication Strategies: Maintaining efficient communication and growth is essential. Tagg highlights the importance of keeping investors informed with regular updates, even during slow periods, to sustain trust and support. He also emphasizes the need to stay nimble and efficient, avoiding bureaucratic complexities. Incentivizing Key Players: Tagg advocates for using innovative incentive structures, such as reverse vesting, to retain top talent and ensure their long-term commitment to the company's success. This approach helps align the interests of key players with those of the company and its investors. Combining Experience with Young Talent: Tagg emphasizes the value of combining experienced leadership with young talent to drive innovation and success. This synergy blends the wisdom of experience with the energy and creativity of younger team members, fostering a dynamic startup environment. For project or resource needs, visit thefdagroup.com.
	Navigating FDA Regulations for SaMD AI and Machine Learning with Adam Foresman	15 mai 2024	00:28:37
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 diagnostic market. Discussion points include: The Regulatory Landscape for AI in Dental Diagnostics: Adam shares his insights on how AI and ML are becoming integral in dental diagnostics, aiding in identifying previously missed detections, enhancing patient education, and streamlining administrative tasks. He highlights that early adopters in healthcare and dental organizations are reporting significant benefits from AI, encouraging broader adoption. FDA Clearance for Pediatric AI Applications: Adam sheds light on VideaHealth's recent 510(k) clearance for a dental AI application for pediatric patients. he offers pointers for successful software as a medical device (SaMD) submissions, emphasizing the importance of Q-submissions, thorough software documentation, and specific considerations for pediatric applications. Predetermined Change Control Plans (PCCPs): Adam explains the concept of PCCPs, allowing manufacturers to include future design changes in pre-market submissions, potentially avoiding re-submissions. While he sees broader applications outside of AI, he notes the challenges AI manufacturers face in predicting future design changes accurately. Comparative Regulatory Approaches — US vs. EU: Adam compares regulatory frameworks between the US and the EU, noting that while both aim to ensure clinical benefits outweigh risks, their methodologies differ. He praises the EU’s focus on post-market surveillance and risk management processes, suggesting the FDA could benefit from similar approaches. AI Transparency and Bias Considerations: With growing concerns about AI transparency and bias, Adman discusses the FDA's recent emphasis on these issues. He advocates for clear communication of AI test results by subgroups and suggests that the FDA might develop more detailed transparency guidelines in the future. Role of Regulatory Affairs Professionals: Adam encourages regulatory professionals to promote AI understandability and transparency within design teams, ensuring that patient and clinician perspectives are considered in AI development. Future Trends and Recommendations: Adam predicts an increase in AI submissions that bundle multiple models, urging adherence to FDA guidelines for such complex submissions. He also emphasizes the importance of engaging with regulatory bodies early in the design process and maintaining robust QMS processes. Adam Foresman is the Head of Quality & Regulatory Affairs at VideaHealth. with over 15 years of experience in the medical device industry, Adam excels in product quality, quality systems, and regulatory compliance. His expertise encompasses design controls, statistical analysis, internal and external auditing, CAPA management, product performance, metrology program management, cGMP practices, and ISO 13485 & 21 CFR 820 quality management activities. At VideaHealth, Adam has co-developed and executed business strategies, globalization, and the clinical roadmap. He leads efforts in product quality, quality systems, pre-market approvals, and regulatory compliance for cutting-edge artificial intelligence and machine learning diagnostics. Adam is also a champion of cybersecurity and HIPAA activities, ensuring robust protection and privacy for sensitive health data.
	Crafting Quality Systems for Each Phase of Drug Development with Carlos Yuraszeck	30 avr. 2024	00:18:36
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 Institute of Regenerative Medicine, Carlos provided profound insights into the pivotal role of phase-appropriate quality systems in managing drug development from research to commercialization. Our discussion focused on how these systems facilitate the rapid delivery of treatments to patients in urgent need. Discussion points include: Defining Phase-Appropriate Quality Systems: Carlos detailed these systems as strategic frameworks designed to adapt to the requirements of different stages of drug development, emphasizing their critical role in accelerating the development process. Regulatory Framework and Impact: Insights into how FDA guidelines are tailored to expedite the transition from laboratory research to market, highlighting the regulatory nuances that allow for such flexibility. Handling Variability in Drug Development: Strategies for managing the inherent variability in early development phases were discussed. Carlos emphasized the necessity of flexible, responsive quality systems that facilitate quick adaptations. Analytical Testing and Development Oversight: Carlos explored the significant role of analytical testing in early phases, focusing on controlling and understanding variability to improve assay development continuously. Challenges in Preclinical to Clinical Transition: He underscored the importance of maintaining consistency in the quality of preclinical materials to ensure seamless progression into clinical trials. Importance of Effective Change Control Systems: The conversation covered how early-stage quality systems should anticipate and manage frequent changes to support rapid learning and adaptation. Strategic Approach to Quality System Design: Carlos discussed designing quality systems that reflect the company's risk tolerance and the urgency of patient needs, effectively balancing speed, cost, and compliance. Future Trends in the Life Sciences Sector: Carlos provided predictions on the evolution of quality systems to meet the dynamic needs of ongoing and future drug development projects. Carlos Yuraszeck is a distinguished leader in biopharmaceutical compliance, operations, and quality assurance, specializing in cell therapy manufacturing. Over his extensive career spanning more than two decades, Carlos has significantly impacted the biopharmaceutical industry through his leadership in various pivotal roles. As the Executive Director of GMP Operations at Astellas Pharma US, he led the transformation of research groups into fully operational GMP manufacturing facilities. Earlier, as Senior Vice President of Technical Operations at Talaris Therapeutics, he managed operations focused on groundbreaking organ transplantation therapies. At Celgene, Carlos directed clinical production and supply, where he scaled up manufacturing operations to support the delivery of life-saving CAR T-cell therapies. His tenure in the industry is marked by a commitment to excellence, deep regulatory knowledge, and strategic oversight, which have driven the successful development and commercialization of novel therapies. Carlos's leadership style emphasizes collaboration, transparency, and continuous learning, aiming always to enhance patient outcomes and advance the field of biopharmaceuticals through innovative and efficient manufacturing practices.
	Leading Through Transition: Strategic Insights from Novartis's Front Lines	01 avr. 2024	00:47:25
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 aimed at creating 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 include 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. Poor 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.

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