In this episode of Moving Medicine Forward, host Jeremy Schrand sits down with Shawna Bredek, a 20+ year veteran in clinical trial operations, to explore how feasibility assessments shape the future of life-saving research. Shawna shares how her team evaluates sites, navigates post-COVID challenges, tackles regulatory hurdles, and builds lasting relationships that help bring rare disease treatments and transplant innovations to life. Whether you're in clinical research or simply fascinated by medical breakthroughs, this episode offers a powerful look at the strategy behind impactful science.

00:00 – Welcome to Moving Medicine Forward
00:36 – Meet Shawna Bredeck and her background in transplant research
00:52 – What is feasibility and why does it matter?
01:18 – Why choosing the right site and PI is critical
02:12 – Post-COVID challenges: site fatigue, turnover, and timelines
03:34 – Sponsors’ expectations vs. site realities
04:03 – Asking tough feasibility questions upfront
05:17 – Transplant-specific logistics: 24/7 coverage and site readiness
05:54 – Navigating regulatory red tape across countries
07:28 – How regulatory delays can stall important trials
08:12 – Global differences: why it’s easier to start in Brazil than the US
08:54 – Engaging rare disease sites through relationships and reputation
09:56 – Partnering with advocacy groups for trial success
10:58 – Shawna’s proudest career moment: a major transplant drug approval
12:21 – The human side of transplant research
12:50 – Shared mission: patients, sponsors, sites, and scientists
13:02 – Final thoughts and how to connect with CTI