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

In this episode of Moving Medicine Forward, we sit down with Dr. Helios Tedesco, a globally recognized transplant nephrologist from São Paulo, Brazil, who leads one of the world’s largest kidney transplant programs. Joined by CTI experts Dr. Christopher Boshkos, Senior Medical Director, and Clinical Scientist, Erika Aldag, the conversation explores the challenges and innovations behind managing more than 15,000 transplant patients, from telehealth expansion and donor matching to cutting-edge immunosuppressive strategies and the future of surveillance tools such as cell-free DNA and the iBox model. This episode offers a rare look into the science, systems, and human dedication driving transplant care forward.

00:00 Host Jeremy Strand introduces the podcast and this episode’s focus on transplant innovation.

00:35 Dr. Helios Tedesco (São Paulo), Dr. Christopher Boshkos, and Clinical Scientist Erika Aldag join to discuss global kidney transplant practices.

01:13 Dr. Tedesco shares his background, highlighting nearly 40 years in nephrology, performing over 1,000 kidney transplants annually, and a strong foundation in research.

03:17 Managing large transplant populations involves strategic follow-up care, decentralized nephrology networks, and an expanding role for telehealth.

06:30 How patients are matched to regimens, minimizing rejection and addressing regional challenges.

11:49 Dr. Tedesco explains their one-dose thymoglobulin approach and its benefits over traditional multi-dose methods.

18:34 New tools for monitoring graft health include donor-derived cell-free DNA, advanced biopsy techniques, and an examination of barriers to widespread adoption.

24:25 Discussion on the potential of the iBox model as a predictive tool for clinical trials and long-term graft survival.

28:15 Transplant science is headed toward improved long-term therapies, innovative biologics, and more patient-friendly immunosuppression options.

32:15 Successes and learnings from scaling telehealth to support a large patient base.

37:41 Appreciation for the collaboration between CTI and global transplant centers.

In this episode of “Moving Medicine Forward” – The Podcast, Jamie Meisenhelder, Chief Administrative Officer (CAO) at CTI, joins us to reflect on her unique journey from law to leadership and how she oversees CTI’s legal, QA, and administrative functions. She shares how her team supports clinical trials, tackles global regulatory challenges, maintains quality standards, and keeps patient trust as the focus. Plus, we explore the future of clinical research and what it takes to stay competitive in an evolving industry.

00:48 Jamie Meisenhelder, CAO of CTI, joins to discuss the roles of QA, legal, and administrative teams.

01:14 Jamie shares her unique path from litigation and finance to joining CTI as a corporate attorney.

01:40 Overview of Jamie's responsibilities: legal, QA, executive admin, and special initiatives.

02:27 How Jamie manages strategic, legal, and QA duties since stepping into the CAO role.

03:15 Her previous experience as Chief of Staff and how it prepared her for broader leadership.

04:07 Strategies for aligning executive leadership and communicating priorities across departments.

05:33 Moving quickly while maintaining quality in contracts and clinical trial agreements.

06:14 Tackling audits, validations, and regulatory demands in global clinical trials.

07:13 CTI’s approach to managing regulations across regions and the role of QA in this evolution.

08:05 Use of SOPs and how consistency is ensured in global projects.

09:27 How a patient-first approach at CTI mitigates legal and reputational risks.

10:06 Jamie reflects on changes in legal and regulatory landscapes during her time at CTI.

11:02 The critical role of confidentiality and how it supports patient trust and sponsor confidence.

12:14 Challenges and opportunities for contract research organizations, focusing on competition, efficiency, and talent retention.