The Life Science Rundown

The FDA Group
  • 5.0 (7)
  • Life Sciences
  • Updated Weekly

The Life Science Rundown is a podcast for life science professionals hosted by The FDA Group. We dive deep into topics across the RA/QA/Clinical space, covering news, exploring trends, and picking the brains of expert guests.

  1. 3d ago

    Managing AI Risk Across Global Quality Systems

    How do you manage AI risk across global quality systems while the tools change every week? Julio Salwen, SVP and Chief Quality Officer at MiniMed, brings 35 years in pharma, devices, and diagnostics to a conversation about governance, risk tolerance, and what quality leaders need to learn right now. Julio and Nick get into why building for the auditor is the wrong instinct, how to introduce AI 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 produceStop asking what the auditor will think. Control the real risk and compliance follows as a byproductYou can't ChatGPT compliance. Turning people loose on AI without defined intended use is a serious unintentional riskStart AI where risk is low, research and drafting, and build confidence from there. Decisions stay with qualified professionalsDrop the control tower. Hybrid governance needs standards, decision rights, and escalation, not central control of everythingAutomating a broken process just gives you a faster broken processQuality leaders need risk management depth plus enough technical literacy to ask hard questionsInventory your AI use cases and classify them by risk. That's the practical starting point About Julio SalwenJulio 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 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/

  2. Aug 13

    The Case for Engaging Regulatory Early

    Most companies bring in regulatory expertise when they're ready to file. Leland Keyt, VP of Regulatory Affairs and Quality Assurance at Apreo Health, makes the case that by then you've already absorbed costs you didn't need to, and explains what early regulatory partnership actually looks like in practice. Leland and Nick get into why risk tolerance is the thing that catches scaling 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 submissionCompanies often run more testing than they need. Efficiency means answering the right questions with the least dataRisk tolerance is what gets companies in trouble. What's acceptable in development isn't acceptable at PMAPost-market obligations happen underneath the water, and they're a resourcing problem more than a regulatory oneRework isn't just timeline, it's product cost and a supply chain issueBiocompatibility interpretation varies by geography and can change what you develop and whenAI, usability, and management review are all getting closer regulatory attentionBuild a scalable QMS. It's the bedrock, and it isn't an afterthought About Leland KeytLeland 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 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/

  3. Aug 6

    Why Quality and R&D Default to Conflict (and How to Fix It)

    Why do quality and R&D fall into adversarial roles even when both are working toward patient safety? Shawn Fuller, who spent 24 years at Surmodics and rose from regulatory manager to VP of Quality, Regulatory and Clinical Affairs, is candid about how both sides create the problem and what it takes to break the pattern. Shawn and Nick get into the learned behavior behind the roadblock stereotype, 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 otherA regulatory conclusion delivered without the risk logic or alternatives behind it guarantees a defensive responseIf 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 doQuality gets the last timeline and it rarely gets extended, which builds the speed-versus-quality conflict into the scheduleQuality plans are prescriptive, which cuts both ways. Consider folding quality into the project plan insteadTrust is built outside the meeting, over time, and you can't assume it when you walk in the doorDon'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 FullerShawn 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 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/

  4. Jul 3

    Leading Through the AI Shift with ASQ's CEO Sid Bhatnagar

    A special one for us: we sat down with Sid Bhatnagar, CEO of ASQ, the American Society for Quality. Sid is an engineer and longtime technology executive who now leads the global body at the center of the quality profession, and he brought a sharp, practical view of how AI is reshaping what leadership requires. Sid and Nick get into why AI pressure now comes from boards and investors rather than the 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 downKeep humans on both ends: ideation from people, work from the tool, validation back to peopleLean toward critical decision-making, not tasks. Pilots and anesthesiologists get paid for what they know when things go wrongHire for innovation, change management, and system thinking. Lead by pulling people along, not pushingExecutives owe their teams upskilling; employees owe the effort. When there's no seat left, be transparent and generousYou can't retrofit ethics, and data isn't power, good data isThink about return on time, not just return on investment. Operations and customer service pay off fastest; talent is the long play About Sid BhatnagarSid 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 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/

  5. Jun 15

    Why Your CAPA System Isn't Driving Improvement (and How to Fix It)

    Why do so many CAPA systems pass their metrics while the same problems keep coming back? Dan Eagles, a medical device quality VP and longtime CAPA mentor, breaks down where these systems quietly fail and how to rebuild them into tools that actually drive improvement. Dan discusses why the problem statement is where most CAPAs go wrong, how teams back-engineer root cause analysis to match a fix they'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 systemMost CAPA trouble starts with a poorly worded problem statement, train your owners to write good ones and you get value across NCRs tooHumans back-engineer root cause analysis to justify the fix they already wanted, the J&J forklift story shows how that goes wrongTrade retrospective "wait three months and see" verification for process validation that proves capability with objective evidenceKnow 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 moneyTrack whether your VOEs are effective, not just whether CAPAs closed on timeAbout Dan EaglesDan 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 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/

  6. May 18

    TerSera's VP of Quality on the Audit Risk Hiding Inside Your Own Procedures

    Why do life science companies still scramble when an inspection is coming, even when their quality systems are solid on paper? Yeime Martich, a 25-year quality veteran, makes the case that readiness is a logistics and culture problem, not a documentation problem, and that the procedures you wrote may be creating more audit risk than you realize. Yeime discusses why "minimally compliant" 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 followQuality should come to the table with options, not just a no — release to warehouse on risk while the investigation closes, for exampleLeadership shapes culture through what they ask about, what they fund, and what they tolerateThe strongest quality culture signal: people voluntarily surfacing problems without fear of blameAI 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 letterDesign your QMS around flexibility — rigid procedures that block product release unnecessarily are self-imposed constraints the regulation never requiredAbout 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/

  7. Apr 28

    What Auditors Are Actually Looking For — and the Psychology Behind How They Find It

    Why do audits still trigger panic even at companies with strong quality systems? Sneha Saggurthi — a quality compliance manager and lead auditor in cell therapy — breaks down the gap between being compliant and being audit ready, and shares the psychology, patterns, and logistics that actually determine inspection outcomes. Sneha discusses how auditors think and prioritize, why logistics matter 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 approachAuditors think in terms of SISPQ (safety, identity, strength, purity, quality) — everything rolls up to whether the product has those attributesLogistics are the make or break — fast document retrieval, defined roles, and coordinated teams create more auditor confidence than perfect systems with slow accessBatch records are the most common rabbit hole — have a storyboard ready for anything you put in front of an auditorTrain your floor staff to be comfortable with auditors, not to hide from them — use internal audits as practiceAuditors use strategic silence, open-ended questions, and deliberate friendliness to get people talking — train your team to give concise answers and redirect to documentationThe 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/

  8. Apr 10

    Why Kidney Disease Innovation Is a Tale of Two Cities — and What It Would Take to Change That

    Why are there over 400 phase three oncology programs but only one in dialysis? John Butler, who has spent over 30 years in the kidney disease space, breaks down the regulatory and reimbursement dynamics that have created a surge of innovation in rare kidney diseases while leaving dialysis patients behind, and what it would take to change that. John discusses how FDA clarity on endpoints transformed 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 landscapeThe dialysis bundle is structurally hostile to innovation — at $280 per session for all services, supplies, and drugs, there's no room for new therapiesThe Corsuva story is a cautionary tale — a good product at a reasonable price failed because the payment mechanism didn't workK-CAPA could change the calculus by extending the TDAPA window to three years and shifting to pay-per-use reimbursementInvestors are willing to take clinical risk, but they need a clear path to both approval and paymentFDA and CMS are generally better when they don't try to coordinate — FDA should focus on science and benefit-risk, not system costThe science is moving upstream — SGLT-2s, GLP-1s, porcine kidney transplants, and wearable kidneys all point toward a future with fewer patients on dialysisAbout 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/

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Ratings & Reviews

5
out of 5
7 Ratings

About

The Life Science Rundown is a podcast for life science professionals hosted by The FDA Group. We dive deep into topics across the RA/QA/Clinical space, covering news, exploring trends, and picking the brains of expert guests.

Information

  • Creator
    The FDA Group
  • Years Active
    2020 - 2026
  • Episodes
    81
  • Rating
    Clean
  • Copyright
    © The FDA Group
  • Show Website
    The Life Science Rundown

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