The Life Science Rundown

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/

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/