The Life Science Rundown

Are on-body wearable injectors the future of large-volume drug delivery, or will formulation and device advances keep creating alternatives? Aaron Mann, CEO of Windgap Medical joins Nick Capman to compare the approaches and explain where he thinks the line between handheld and wearable delivery will settle.In this episode:Why about 2 mL has historically pushed doses toward wearablesHow formulation, enzyme-assisted delivery, and device design compareThe advantages and trade-offs of enzyme-assisted approachesWhy the 3 to 10 mL range has become so importantWhat a recent wearable-to-autoinjector approval does and doesn’t showWhere wearables remain the better choiceThe costs of committing too early to the wrong delivery formatFive questions to answer before choosing a wearableAbout Aaron MannAaron Mann is CEO of Windgap Medical, which develops handheld autoinjector platforms for complex injectables. He was previously CEO of Kindeva Drug Delivery, President of Drug Delivery Systems at 3M, and Vice President of Corporate Development and Strategy at Phillips-Medisize. He holds an MBA from Harvard Business School and a BA from Carleton 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/

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/

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/

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/

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/