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/