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The Life Science Rundown: Daily Summaries Delivered
by The FDA Group
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.
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- 1 weeks ago17 min
Pharma Tech Transfer Is Knowledge Transfer
Why does tech transfer remain so hard in pharma , even when every document is neatly in order? Paige Kane, PhD, CPIP, Associate Vice President of Technical Excellence & Transformation at CAI, has spent about 25 years on technology transfers for clinical and commercial supply, and earned a PhD studying exactly that question.She joins Nick Capman to talk about moving the knowledge a receiving site needs, not just the documents and processes.They discuss:Why tech transfer could happen by FedEx if documents held everythingThe difference between know-what and know-whyTreating risk assessments as knowledge capture documentsUsing a structured pre-job brief to surface what teams need to knowHow a facility ran 47 batches right first timeWhy QC and QA are so often left until the endThe case for plant-floor video as a knowledge transfer toolMaking lessons learned travel with the productAbout Paige Kane, PhD, CPIPPaige Kane is Associate Vice President of Technical Excellence & Transformation at CAI, with more than 30 years in biotech and pharma. She previously led Merck’s Knowledge Management Center of Excellence, is a regulatory science researcher at Technological University Dublin, where she earned her PhD, and has authored and contributed to numerous ISPE guidance documents, including GAMP 5 and the ISPE Knowledge Management Good Practice Guide.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 weeks ago1h 3m
The Adoption Assumptions Hiding in Your Regulatory Strategy
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 changeThe questions a substantial equivalence claim raises with buyersWhy “for everyone” usually means “for no one”Validating behavior instead of interest in market researchWhy a narrow initial indication can be the stronger commercial positionThe “magic triangle” of product design, regulatory design, and adoption designA spinal fusion case where changing one variable transformed a launchAbout Holley Proctor MillerHolley 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 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/
- Oct 5, 202633 min
Dr. Robert Califf on What It Will Take for GLP-1s to Become a Public Health Success
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 healthWhy obesity was long treated as a moral failing, and why earlier drugs fell shortWhat GLP-1 research may reveal about cravings and behavior more broadlyWhy early access followed resources rather than needHow compounding was permitted during the shortage, and why it no longer is for approved drugsHis concern about untested peptides sold onlineWhy trust follows trustworthy behaviorWhat success could look like over the next decadeOur sincere thanks to Dr. Califf for his time and insight.About Dr. Robert CaliffRobert 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 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/
- Sep 18, 202634 min
Is Your Biotech De-Risking or Just Delaying?
What stops a promising platform from becoming an investable company? Kevin Walton, CEO of Baseimmune, has watched this from both sides, first as an investment banker and now running a 23-person biotech through a strategic pivot he led himself.He and Nick Capman get into beachhead decisions, why most preclinical teams run their experiments in the wrong order, how to keep a distributed team aligned 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 existsAccumulating incremental data feels like de-risking and mostly isn'tPick fast and cheap on a CRO and you'll pay for it twiceBuild culture from where you actually are, not from where you'd like to beWrite decisions down, name one owner, and accept that ambiguity compounds faster at distanceHire a scientific advisory board that will argue with youScience gets you the meeting. Team, strategy, and execution decide what happens afterAbout Kevin WaltonKevin 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 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/
- Sep 14, 202624 min
Reg Ops Has Been Kept in a Box. This Is the Way Out.
As the FDA takes its first steps toward receiving clinical data in real time, what happens to regulatory operations professionals? Carla Griffin, CEO of The Sugar Water Operations Team, argues that reg ops has been kept in too small a box for years and that this shift is the opening to change that.Carla and Nick Capman get into why the hardest adjustment is professional rather than technical, how 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 constructionThe instinct that makes reg ops strong, wanting everything systematic, is what will make this shift hardestGetting reg ops and IT into decisions earlier isn't optional if the goal is getting data to FDA fasterWhen evaluating technology, look for options rather than solutions, then eliminate risk to make an option viableAsk vendors whether they understand the regulations you're held to. If they can't answer, move onPut 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 nowNote 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 GriffinCarla 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 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/
- Sep 1, 202628 min
QA Is Not a Gate — It’s a Technical Partner, with Dr. Andrea Bell
How do biotech companies move QA from late-stage gatekeeper into an early, risk-appropriate technical partner? Andrea Bell, VP and Global Head of Quality Assurance for BioNTainer at BioNTech, 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 cheaplyMost of the cost of poor quality sits below the waterline in scrap, cycle time, investigations, and reputationEarly means early in the decision forums, not just early in the lifecycleRisk-based rigor isn't looser rigor. Uniform checklists are a weaker position and agencies will challenge themThe barriers to embedding QA earlier are quality culture and reporting structure, not procedureData only makes QA proactive if people are empowered to act on itQA earns credibility by co-authoring the argument you'll make to the regulator, not by signing off at the endAbout Andrea BellAndrea Bell is Vice President, Global Head of Quality Assurance for BioNTainer at BioNTech SE, with more than 25 years in biotechnology building quality and CMC organizations across RNA, biologics, and small molecule programs. She previously held leadership roles at Vir Biotechnology, Alnylam Pharmaceuticals, and Biogen. 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 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/
- Aug 17, 202632 min
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 pointAbout 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/
- Aug 13, 202622 min
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 afterthoughtAbout 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/
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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.
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