Bryce Whited - Episode 15 - Regulatory Voices

<p>In the next episode of <a href="https://www.linkedin.com/company/regulatory-voices/" rel="noopener noreferrer nofollow"><b><strong>Regulatory Voices</strong></b></a>, I speak with <a href="https://www.linkedin.com/in/bryce-whited-ph-d-77807244/" rel="noopener noreferrer nofollow"><b><strong>Bryce Whited, Ph.D.</strong></b></a>, Founder at <a href="https://www.linkedin.com/company/wcimedtech/" rel="noopener noreferrer nofollow"><b><strong>WCI MedTech</strong></b></a>, a regulatory professional with 20 years of experience across FDA, medical devices, combination products and consulting.<br /><br />Bryce began his career as a Lead Scientific Reviewer within FDA’s Center for Devices before moving into industry, where his perspective on regulatory strategy became much broader.<br /><br />A large part of our conversation focuses on the point where Pharma becomes MedTech.<br /><br />When a drug or biologic includes a delivery device, the device component can sometimes become an afterthought while the organisation focuses on the traditional clinical, CMC and regulatory milestones.<br /><br />This can catch companies much later.<br /><br />Bryce explains how sponsors can progress through Phase 1 and Phase 2 before suddenly facing significantly greater device expectations around Phase 3, pre-NDA or pre-BLA.<br /><br />That can mean design controls, human factors, risk management, quality requirements and device testing all becoming major issues at a point where timelines are already tight.<br /><br />We discuss why that happens, how the device and drug development pathways differ, and what companies should be doing much earlier to avoid remediation work at the end.<br /><br />We also explore what an effective combination product strategy actually looks like, integrated teams, integrated risk management, early FDA interaction and someone capable of bridging the drug and device worlds rather than allowing them to operate in silos.<br /><br />A really practical episode for anyone working around drug delivery systems and combination products.<br /><br />Join us, 8am ET October 6th.<br /><br />Regulatory Voices is brought to you by <a href="https://www.linkedin.com/company/codon-partners/" rel="noopener noreferrer nofollow"><b><strong>Codon Partners</strong></b></a>, Life Science Staffing.</p>