The Life Science Rundown

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 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/

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/

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/

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/

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/

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/

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/

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/

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/