The Life Science Rundown

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

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,

Managing AI Risk Across Global Quality Systems

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 phar

The Case for Engaging Regulatory Early

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

Why Quality and R&D Default to Conflict (and How to Fix It)

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 regulator

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

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

Why Your CAPA System Isn't Driving Improvement (and How to Fix It)

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 whe

TerSera's VP of Quality on the Audit Risk Hiding Inside Your Own Procedures

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, m

What Auditors Are Actually Looking For — and the Psychology Behind How They Find It

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

Why Kidney Disease Innovation Is a Tale of Two Cities — and What It Would Take to Change That

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 regul

Syncing Global Regulatory Filings Across FDA, EMA, and PMDA with AJ Acker

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 dossier

Navigating Regulatory Leadership Across Large and Small Life Science with Tammy Sarnelli

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 expe

Getting Data Governance for Regulatory Submissions Right Before AI Gets it Wrong with Cary Smithson

How should life science companies govern their data to meet increasingly structured regulatory submission requirements and actually get value from AI? Cary Smithson share

Building Resilient Biotech Teams in Cell and Gene Therapy with Nelly Viseux

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 lesso

Building Phase-Appropriate Quality from Preclinical to Commercial with Jackie Klecker

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

Preparing the Workforce That Will Shape Pharma’s Future with ISPE President & CEO Mike Martin

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 developmen

How to Build (and Sustain) a Quality-Centric Culture with Chris Masterson

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 ho

From Molecule to Market: A Commercial-Readiness Playbook for Biotechs with Carlos Carrillo

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

How Regulators Are Bringing AI Into Review (Without Losing Trust) with Maria Vassileva

The FDA Group’s Nick Capman sits down with Maria Vassileva, PhD—Chief Science & Regulatory Officer at the Drug Information Association (DIA)—for a grounded, forward-looki

A Playbook for FDA Inspections and Remediation with Jeff Hines

Coruna Medical’s Vice President of Quality, Jeff Hines, joins host Nick Capman to share a leadership-driven playbook for navigating FDA remediation—without overwhelming t

Leading Cross-Functional Teams from Concept to Commercialization with Marwan Fathallah

The FDA Group’s Nick Capman speaks with Marwan Fathallah, President and CEO of DIA Global, for a wide-ranging discussion on what it takes to lead effectively across the l