The Life Science Rundown

QA Is Not a Gate — It’s a Technical Partner, with Dr. Andrea Bell

How do biotech companies move QA from late-stage gatekeeper into an early, risk-appropriate technical partner? Dr. Andrea Bell, a VP and Global Head of Quality Assurance, breaks down what phase-appropriate quality looks like across the lifecycle and why the barriers to getting there are cultural rather than procedural. Andrea and Nick get into the real cost of late QA involvement, how risk-based 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

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

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)

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

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)

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/

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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 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/

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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 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

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/

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Syncing Global Regulatory Filings Across FDA, EMA, and PMDA with AJ Acker

What does it actually take to navigate global regulatory filings across the FDA, EMA, and PMDA, and why do so many programs stumble despite technically harmonized dossiers? AJ Acker draws on about 30 years of rare disease regulatory experience to break down the real differences between regions and the strategies that drive successful multi-regional approvals. AJ discusses why ICH compliance doesn'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/

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Navigating Regulatory Leadership Across Large and Small Life Science with Tammy Sarnelli

What actually changes for regulatory leaders when they move between large pharma and small biotech, and what stays the same? Tammy Sarnelli draws on over 35 years of experience across organizations of every size to break down the real differences in workload, risk tolerance, resource access, and culture. Tammy discusses how organizational silos create friction in large companies, why limited 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/

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Getting Data Governance for Regulatory Submissions Right Before AI Gets it Wrong with Cary Smithson

How should life science companies govern their data to meet increasingly structured regulatory submission requirements and actually get value from AI? Cary Smithson shares lessons from decades of helping organizations modernize their regulatory, quality, and R&D operations. Cary discusses why data governance has become urgent across three fronts — structured submissions, cross-functional 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/

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Building Resilient Biotech Teams in Cell and Gene Therapy with Nelly Viseux

How do you build an organization that can absorb change, learn from failure, and keep patients at the center—even when the science is uncertain? Nelly Viseux shares lessons from over 20 years in biotech and a decade leading cell and gene therapy development. Nelly discusses how she structured a 100-person CMC organization at Regeneron to balance innovation with operational execution, why 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/

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Building Phase-Appropriate Quality from Preclinical to Commercial with Jackie Klecker

Scaling a product from preclinical development to commercial manufacturing is one of the most complex transitions life science teams face—and one of the easiest places to lose time and momentum. In this episode of The Life Science Rundown, host Nick Capman speaks with Jackie Klecker, Executive Vice President of Quality and Development Services at Lifecore Biomedical, about how sponsors and CDMOs 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/

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Preparing the Workforce That Will Shape Pharma’s Future with ISPE President & CEO Mike Martin

The FDA Group's Nick Capman sits down with Mike Martin, President and CEO of ISPE, for a conversation on how the pharmaceutical industry must rethink workforce development amid rapid technological and cultural change. Drawing on nearly four decades of global experience in pharmaceutical engineering, operations, and manufacturing leadership, Mike shares his perspective on why the industry is 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/

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How to Build (and Sustain) a Quality-Centric Culture with Chris Masterson

The FDA Group’s Nick Capman sits down with Chris Masterson, Senior Vice President of Quality and Chief Quality Officer at Tolmar, for a wide-ranging conversation about how to create and sustain a quality-centric culture that drives compliance, operational excellence, and long-term resilience in the biopharmaceutical industry. A microbiologist by training with more than 35 years of BioPharma 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/

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From Molecule to Market: A Commercial-Readiness Playbook for Biotechs with Carlos Carrillo

The FDA Group’s Nick Capman sits down with Carlos Carrillo, PhD, MSc, Senior Vice President of Regulatory Affairs & Quality Assurance at SAB Biotherapeutics. With nearly 30 years of experience across Operations, R&D, Regulatory Affairs, Quality Assurance, and Project Management, Carlos has led global regulatory strategy for small- and large-molecule programs from Phase 1 through launch. He 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

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/

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A Playbook for FDA Inspections and Remediation with Jeff Hines

Coruna Medical’s Vice President of Quality, Jeff Hines, joins host Nick Capman to share a leadership-driven playbook for navigating FDA remediation—without overwhelming teams or losing focus on long-term improvement. Drawing from nearly four decades in pharmaceutical quality, including more than 30 years at Eli Lilly, Jeff offers practical guidance for building calm, effective inspection 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/

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Leading Cross-Functional Teams from Concept to Commercialization with Marwan Fathallah

The FDA Group’s Nick Capman speaks with Marwan Fathallah, President and CEO of DIA Global, for a wide-ranging discussion on what it takes to lead effectively across the life science product development cycle—from concept to commercialization. With nearly 30 years of leadership experience spanning pharmaceuticals, medical devices, and diagnostics, Marwan has held senior roles in R&D, regulatory, 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/

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