The Life Science Rundown

00:17:58

Pharma Tech Transfer Is Knowledge Transfer

The Life Science Rundown ·

2026/10/26

Why does tech transfer remain so hard in pharma , even when every document is neatly in order? Paige Kane, PhD, CPIP, Associate Vice President of Technical Excellence & Transformation at CAI, has spent about 25 years on technology transfers for clinical and commercial supply, and earned a PhD studying exactly that question.She joins Nick Capman to talk about moving the knowledge a receiving site needs, not just the documents and processes.They discuss:Why tech transfer could happen by FedEx if

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01:03:37

The Adoption Assumptions Hiding in Your Regulatory...

The Life Science Rundown ·

2026/10/20

Can the fastest path to FDA approval end up being the slowest path to market adoption? Holley Proctor Miller, Founder and President of Grey Matter Marketing, has spent more than two decades helping medtech companies get new products adopted, starting with the early days of surgical robotics.She and Nick Capman get into the adoption assumptions built into every regulatory pathway decision, why approval evidence and adoption evidence aren’t the same thing, and what regulatory, quality, and commercial

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00:33:22

Dr. Robert Califf on What It Will Take for GLP-1s to...

The Life Science Rundown ·

2026/10/05

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

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00:34:57

Is Your Biotech De-Risking or Just Delaying?

The Life Science Rundown ·

2026/09/18

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

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00:24:00

Reg Ops Has Been Kept in a Box. This Is the Way Out.

The Life Science Rundown ·

2026/09/14

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

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00:28:11

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

The Life Science Rundown ·

2026/09/01

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

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00:32:07

Managing AI Risk Across Global Quality Systems

The Life Science Rundown ·

2026/08/17

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

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00:22:15

The Case for Engaging Regulatory Early

The Life Science Rundown ·

2026/08/13

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

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00:30:29

Why Quality and R&D Default to Conflict (and How to...

The Life Science Rundown ·

2026/08/06

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

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00:49:13

Leading Through the AI Shift with ASQ's CEO Sid...

The Life Science Rundown ·

2026/07/03

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

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00:27:51

Why Your CAPA System Isn't Driving Improvement (and...

The Life Science Rundown ·

2026/06/15

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

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00:30:38

TerSera's VP of Quality on the Audit Risk Hiding...

The Life Science Rundown ·

2026/05/18

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

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00:19:30

What Auditors Are Actually Looking For — and the...

The Life Science Rundown ·

2026/04/28

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 —

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00:35:12

Why Kidney Disease Innovation Is a Tale of Two Cities...

The Life Science Rundown ·

2026/04/10

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

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00:28:53

Syncing Global Regulatory Filings Across FDA, EMA,...

The Life Science Rundown ·

2026/03/30

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

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00:32:46

Navigating Regulatory Leadership Across Large and...

The Life Science Rundown ·

2026/03/19

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

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00:28:05

Getting Data Governance for Regulatory Submissions...

The Life Science Rundown ·

2026/03/05

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

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00:37:59

Building Resilient Biotech Teams in Cell and Gene...

The Life Science Rundown ·

2026/02/09

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

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00:35:24

Building Phase-Appropriate Quality from Preclinical...

The Life Science Rundown ·

2026/01/12

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

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00:42:34

Preparing the Workforce That Will Shape Pharma’s...

The Life Science Rundown ·

2026/01/06

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,

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