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.

In this episode, Jeremy sits down with Sara Russo and John Mock from Network for Hope, an independent nonprofit organ procurement organization. Together, they explore the life-changing work of organ and tissue donation — from the hospital bedside to the recipient's second chance at life.

Learn how the organization evolved from a merger between LifeCenter and KODA, now serving 7 million people as one of the largest OPOs in the U.S.

00:00 Jeremy introduces the episode and the theme: highlighting breakthroughs in healthcare through the lens of organ donation.

00:36 Sara Russo (Hospital Partnership Liaison, Network for Hope) and John Mock (organ recipient and ambassador) join the conversation.

01:14 Sara shares her journey from CTI and Cincinnati Children’s to her current role at Network for Hope.

02:19 John reflects on his personal connection as a liver transplant recipient and how clinical trials played a role in his journey.

03:01 The guests discuss how Network for Hope has impacted their lives and shifted their perspectives on organ donation.

04:16 John shares his transplant story, touching on survivor’s guilt and the powerful impact of donation.

06:26 The 2024 merger between LifeCenter and KODA forms Network for Hope — now serving nearly 7 million people.

08:21 Sarah discusses the launch of the first donor care unit in the region, housed in UC’s Flex ICU, and how it's improving organ recovery rates.

11:37 Addressing common misconceptions about donation — from faith concerns to mistrust in hospitals.

14:56 A look at the compassionate approach taken when working with grieving donor families.

15:38 Network for Hope provides six weeks of support followed by a minimum of 18 months through their aftercare team.

17:05 Families participate in honor walks and remembrance ceremonies, recognizing the heroism of donors.

18:11 John shares his unique post-transplant bond with his donor’s family and how they now advocate together.

21:01 Network for Hope encourages transplant recipients to write to their donor families through a new writing station initiative at UC.

23:03 A thoughtful explanation of how donor-recipient relationships are carefully managed and supported.

24:14 Sara and John share what they look forward to most in April — from flag-raising ceremonies to educational outreach.

26:41 Listeners are encouraged to register as donors, volunteer, and speak to their loved ones about their wishes.

27:56 Network for Hope is spotlighted as CTI’s North American Charity of the Quarter. Closing thanks and resources.

In this episode of “Moving Medicine Forward” – The Podcast, Monica Rodriguez, Managing Director of Global Laboratory, Pharmacometrics, and Site Services at CTI, and Andy Supp, Vice President of Global Laboratory Services at CTI, join the conversation to discuss the unique structure and capabilities of CTI’s global laboratories. They share insights into their respective backgrounds, the strategic importance of CTI’s labs in Cincinnati, OH, and Bilbao, Spain, and how having two lab locations equips CTI with the resources needed to conduct complex clinical trials. The discussion also dives into the benefits these global facilities provide to sponsors conducting clinical trials and the industry at large. Monica also shares her excitement about her new role and the opportunities it presents, while both she and Andy look ahead to the future of CTI and CTI Labs.

0:36 – Introduction of podcast guests: Monica Rodriguez, Managing Director of Global Laboratory, Pharmacometrics, and Site Services, and Andy Supp, Vice President of Global Laboratory Services.

1:03 – Monica shares her background and career journey.

2:08 – Andy shares his background and experience.

3:27 – Discussion on the global lab setup, including CTI’s laboratories in Cincinnati, OH, and Bilbao, Spain.

5:17 – Exploration of how two lab locations benefits sponsors conducting clinical trials and the industry.

6:35 – Monica discusses her new role and the benefits it will bring.

8:54 – A look ahead at what they are most excited about for the future of CTI and CTI Labs.

In this episode of “Moving Medicine Forward” – The Podcast, Pat Dearing, Chief Human Resources Officer at CTI, discusses his career journey and the unique challenges of HR in healthcare. He shares insights on recruiting top talent, "people-first leadership," and CTI's DEIB council. Pat also talks about the future of remote work, HR’s role in acquisitions, and emerging trends shaping the future of HR.

0:23 – Introduction to the podcast guest, Pat Dearing, Chief Human Resources Officer at CTI.

0:40 – Pat shares his career journey and how he discovered CTI.

4:05 – A discussion on the differences and similarities between human resources in healthcare organizations and other industries.

5:19 – Strategies used by CTI HR to recruit top talent for specialized positions.

6:47 – Pat explains what "people-first leadership" means to him.

8:19 – Insights into CTI’s DEIB (Diversity, Equity, Inclusion, and Belonging) council and its progress.

12:42 – Pat’s perspective on the evolving landscape of remote and hybrid work.

14:36 – How Pat manages constant change while focusing on people.

16:15 – What Pat is looking forward to in the future of CTI.

17:20 – How HR plays a role in acquisitions.

18:33 – Trends Pat sees shaping the future of HR.

In this episode of “Moving Medicine Forward” – The Podcast, Christine Eby, Director of Clinical Project Management & Therapeutic Strategy Lead at CTI, Anna Sowa, Chief Mission Officer at CurePDE, Curtis R. Coughlin II, PhD, MS, MBE, Associate Professor, Department of Pediatrics and Center for Bioethics and Humanities, and Kristy McCay, mom of a two-year-old living with pyridoxine-dependent epilepsy (PDE), join together to discuss the ongoing efforts to raise awareness and provide support for those affected by this rare condition. They share insights on the challenges of PDE diagnosis, the importance of newborn screening, and the role of gene editing in treatment. The conversation also explores CurePDE’s advocacy work, its partnerships with organizations like CTI, and the significance of community and patient education in advancing their mission.

0:36 – Introduction of podcast guests: Christine Eby (CTI), Anna Sowa (CurePDE), Dr. Curtis Coughlin II, PhD, MS, MBE, and Kristy McCay (mom of a child with PDE).

1:20 – Overview of CurePDE, a family advocacy organization focused on raising awareness and support for pyridoxine-dependent epilepsy (PDE).

2:29 – Dr. Curtis introduces himself and discusses his involvement with PDE research and the impact of CurePDE’s work in the field.

3:45 – Explanation of PDE from a medical perspective, including common symptoms and challenges faced by patients.

6:40 – Kristy McCay shares her personal journey with her child's PDE diagnosis and the ongoing experience.

7:59 – Kristy reflects on navigating her child’s diagnosis and the challenges of managing a postpartum experience with a new diagnosis.

10:42 – The medical community’s awareness of PDE, including key insights into best practices for diagnosis and treatment.

12:34 – Progress made in advocating for the inclusion of PDE in newborn screening programs.

15:34 – Discussion on a federally recommended panel for states to consider adding to their newborn screening protocols.

16:59 – Lessons other advocacy groups can learn from CurePDE’s work and the importance of understanding each group’s unique journey.

22:06 – How CurePDE is collaborating with organizations like CTI to advance gene editing technology for PDE treatment.

28:06 – Family feedback on gene editing treatments and how families have embraced these new options.

30:44 – The role of organizations like CTI in supporting advocacy groups to further their missions.

36:23 – The significance of community building and patient education in successful advocacy efforts.

41:24 – Activities and support offered to families involved with CurePDE.

43:04 – Advice for other advocacy groups looking to gain recognition and connect with doctors and patients.

44:54 – CurePDE’s fundraising initiatives, where families work together to raise money for the cause.

50:05 – Long-term goals and vision for the future of CurePDE.

In this episode of "Moving Medicine Forward" – The Podcast, Jill Black, Validation IT Principal Auditor at CTI, shares the deeply personal story of her daughter, Emma, and their journey navigating this rare disease. She offers valuable insights into the challenges and impact of Rett Syndrome, while discussing her work at CTI and how being part of an organization focused on rare diseases fuels her hope and purpose. Jill reflects on her experience speaking at the 2024 Rett Syndrome National Summit, supported by NORD, and highlights the critical role of connecting with other parents and advocates. Tune in as Jill explores the exciting progress in Rett Syndrome research, including the FDA-approved drug and the work of pharmaceutical companies aiming to find a cure.

1:19 – Jill shares the powerful story of her daughter, Emma, and her journey with Rett Syndrome, including key insights into the condition and its impact.

6:10 – Jill discusses her role at CTI and how working with an organization that focuses on rare diseases has given her a sense of hope and purpose in making a real difference.

6:33 – Reflecting on her experience speaking at the 2024 Rett Syndrome National Summit, Jill talks about how NORD supported her attendance, enabling her to connect with other parents and advocates in the Rett Syndrome community.

7:50 – After 25 years of research, one FDA-approved drug is available for Rett Syndrome. Jill explains how 20 pharmaceutical companies are currently working to find a cure and the progress being made.

9:00 – Jill shares ways listeners can get involved and support families living with Rett Syndrome.