The Life Science Rundown

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 health
• Why obesity was long treated as a moral failing, and why earlier drugs fell short
• What GLP-1 research may reveal about cravings and behavior more broadly
• Why early access followed resources rather than need
• How compounding was permitted during the shortage, and why it no longer is for approved drugs
• His concern about untested peptides sold online
• Why trust follows trustworthy behavior
• What success could look like over the next decade

Our sincere thanks to Dr. Califf for his time and insight.

About Dr. Robert Califf
Robert 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 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/

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 exists
• Accumulating incremental data feels like de-risking and mostly isn't
• Pick fast and cheap on a CRO and you'll pay for it twice
• Build culture from where you actually are, not from where you'd like to be
• Write decisions down, name one owner, and accept that ambiguity compounds faster at distance
• Hire a scientific advisory board that will argue with you
• Science gets you the meeting. Team, strategy, and execution decide what happens after

About Kevin Walton
Kevin 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 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/

As the FDA takes its first steps toward receiving clinical data in real time, what happens to regulatory operations professionals? Carla Griffin, CEO of The Sugar Water Operations Team, argues that reg ops has been kept in too small a box for years and that this shift is the opening to change that.

Carla and Nick Capman get into why the hardest adjustment is professional rather than technical, how to vet technology vendors who don't understand your regulations, and the three things reg ops professionals should do in the next twelve months.

A few of Carla's key takeaways:

• Reg ops specialists are problem solvers who've been siloed into links, bookmarks, and document construction
• The instinct that makes reg ops strong, wanting everything systematic, is what will make this shift hardest
• Getting reg ops and IT into decisions earlier isn't optional if the goal is getting data to FDA faster
• When evaluating technology, look for options rather than solutions, then eliminate risk to make an option viable
• Ask vendors whether they understand the regulations you're held to. If they can't answer, move on
• Put on your FDA hat: where do the data integrity questions come from, and can you show a human was in the loop?
• Old technology isn't the enemy. It's just at a disadvantage now

Note that this was recorded in September 2026. The FDA's real-time clinical trials work has been developing quickly, and Carla's forward-looking comments are her own assessment rather than announced agency policy. New developments may supersede the information provided here.

About Carla Griffin
Carla Griffin, M.A., M.S., is CEO and Principal Operations Consultant at The Sugar Water Operations Team (SWOT), supporting emerging biotech and pharmaceutical companies across regulatory operations, submissions management, and quality systems. She has close to two decades of experience, including eight years at Esperion leading development and regulatory operations, with earlier roles at Sarah Cannon Research Institute, LIQUENT (a PAREXEL company), and Human Genome Sciences. She holds a master's in regulatory science from Johns Hopkins.

About The FDA 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/

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/

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/

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 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/

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 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/

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/