Moving Medicine Forward

In this episode of Moving Medicine Forward, host Jeremy Schrand welcomes Dr. Rich Curry to discuss how CTI is helping redefine what’s possible in clinical research. From the complexities of cell and gene therapy to the human stories behind the science, Dr. Curry shares how CTI’s expertise in rare diseases and regenerative medicine is accelerating innovation and improving patient outcomes. Discover how CTI’s patient-first approach and global regulatory insight are shaping the future of advanced therapies.

01:03 Dr. Curry explains how his background in neuropsychology and oncology research led him to clinical trials and CTI. 

03:08 Dr. Curry highlights why cell and gene therapy excites him, emphasizing its potential to transform treatment approaches. 

04:20 He explains how CTI’s full-service research model supports complex, high-risk cell and gene therapy trials. 

05:39 Dr. Curry describes the critical safety considerations in cell and gene therapy trials, particularly around immune system risks. 

09:31 He explains how CTI approaches long-term follow-up and risk mitigation, sometimes monitoring patients for up to 15 years. 

10:51 Dr. Curry shares how CTI stays ahead of global regulatory expectations through its dedicated regulatory and scientific affairs team. 

12:03 He gives an example of how CTI helped a sponsor overcome regulatory challenges by identifying risk factors to ensure trial continuation. 

13:16 Dr. Curry explains how CTI’s focus on regenerative medicine and rare disease expertise sets it apart in gene therapy support. 

14:01 He discusses how CTI’s patient-first philosophy shapes trial design to improve patient experience and trial success. 

14:54 Dr. Curry shares excitement for future innovations, especially in treating solid tumors, autoimmune diseases, and neurodegenerative disorders. 

17:00 He explains how CTI prepares for the next wave of therapies by building strong sponsor partnerships and providing excellent service. 

In this episode of “Moving Medicine Forward,” SavannahDoliboa, Chief Commercial Officer at CTI, shares her career journey and what led her to CTI, a company that combines the strengths of both large and mid-sized CROs. She reflects on the rewards of working with rare disease sponsors, CTI’s diverse client base, and its reputation for flexibility, expertise, and lasting partnerships. Savannah also highlights CTI’s global growth and commitment to advancing clinical research through innovation and collaboration, while navigating regulatory challenges and embracing trends such as AI and patient-centricity.

00:52 Savannah shares her career journey and what led her to join CTI, highlighting her experience at both large and mid-sized CROs and how CTI offered the best of both worlds.

02:39 She discusses what makes working with rare disease sponsors so personally and professionally rewarding, particularly the close connection to patient communities.

03:57 Savannah outlines who CTI’s clients are, explaining that they range from biotech startups to large pharmaceutical companies, with a common thread of complexity and innovation.

04:46 She explains why clients choose CTI, citing the company’s niche expertise, flexibility, and ability to retain skilled team members throughout long and complex trials.

05:48 Savannah talks about how CTI’s agility helps meet client needs, especially when navigating regulatory challenges or changing trial strategies mid-study.

06:33 She identifies current trends in the clinical research industry, such as AI and reducing patient burden, that are creating new opportunities for both CTI and its clients.

07:51 Savannah shares how CTI’s global growth strategy aligns with its mission to go where clients need them most, supported by a strong track record of repeat businessand comprehensive services.

08:56 From a commercial lens, she explains where CTI is headed in the next 3–5 years, emphasizing innovation, quality partnerships, and staying at the forefront of clinical research.

09:33 She sums up why clients choose to work with CTI: a trusted mid-sized partner that delivers global reach, personalized service, and an extensive commitment tobringing treatments to market.

In this episode of “Moving Medicine Forward,” Audrey Davidow shares how her son’s diagnosis led to her co-founding the Pitt Hopkins Research Foundation. She explains the rare genetic disorder, the foundation’s focus on research and family support, and major breakthroughs such as a gene therapy trial. Audrey also reflects on advocacy, leadership challenges, and the hope driving their mission forward. 

Support the Pitt Hopkins Research Foundation by visiting PittHopkins.org or donating to the CTI Employee Fund.

01:09 Audrey Davidow shares how her son’s diagnosis led her to co-found the Pitt Hopkins Research Foundation. 

02:45 She explains Pitt Hopkins Syndrome as a rare genetic disorder caused by TCF4 gene mutations. 

04:35 Audrey recalls the early days of the foundation, driven by grief and an urgent need to act. 

06:01 The foundation remains focused on research while still offering family support. 

07:54 She highlights major breakthroughs, including a gene therapy trial. 

09:41 Funding is directed only to research with a clear path to patient impact. 

11:00 Support includes clinics, online communities, and global family conferences. 

12:22 Advocacy efforts aim to boost diagnosis rates and raise awareness among medical professionals.  

13:12 Challenges include translating science into treatments and navigating leadership without a science background. 

14:18 Audrey stays motivated by her son’s resilience and the progress made. 

15:31 How grassroots fundraisers have been highly successful. 

16:54 Top priorities include launching the gene therapy trial and advancing other genetic treatments. 

17:16 She encourages donations and everyday acts of inclusion for those with disabilities. 

18:50 Audrey offers a message of hope, emphasizing that meaningful progress is underway. 

Alaa Assem, Managing Director for CTI in the Europe & MEA regions, joins us to discuss the evolution of clinical trials in the Middle East and Africa. With over a decade of experience in pharma and CROs, Alaa shares how CTI has built a strong regional presence, the impact of COVID-19, and why sponsors should consider the region for future trials.

Topics Covered:

• CTI’s history and expansion in the Middle East & Africa
• Local expertise and regulatory evolution
• Vaccine research and biotech investment
• Gene therapy, AI, and the future of clinical trials

Click Here for more Info about CTI in the MEA Region

Timestamps:

• 00:00 – Meet Alaa and his background
• 00:56 – CTI’s regional roots and growth
• 02:19 – Why local presence matters
• 03:20 – Clinical research evolution in the region
• 05:02 – COVID-19’s transformative impact
• 06:44 – Vaccine research and biotech hubs
• 08:33 – Advice for sponsors entering the region
• 10:33 – Changing perceptions and realities
• 12:52 – CTI’s readiness and expansion strategy
• 14:06 – Future growth and innovation
• 15:42 – Alaa’s excitement for the future of research

In this episode of “Moving Medicine Forward,” Tara Mink,expert in cell and gene therapy for more than 25 years, joins to discuss the science, promise, and challenges of CAR-T therapy. Tara explains how CAR-T works, its remarkable durability, and the side effects clinicians manage. She also discusses the future of gene therapy, barriers to access, and how the field is expanding into new disease areas.

01:05 Tara explains the CAR-T process, including how T cells are collected, genetically modified with a chimeric antigen receptor, expanded, and then reinfused into the patient.

01:49 Discussion of CAR-T’s efficacy, described as both remarkable and durable. It’s positioned as a “one and done” therapy that typically requires no maintenance.

02:30 Tara outlines common side effects like cytokine release syndrome and neurotoxicity, emphasizing their manageability with proper early intervention.

03:18 The future of gene therapy is promising, with projections of 1,500 new therapies emerging by 2030, according to the Cardinal 2025 report.

04:00 Key challenges include the high cost of research and treatment, limited insurance coverage, accessibility to treatment centers, and widespread misinformation in the medical community.

06:37 Solutions include expanding treatment access, supporting outpatient models, partnering with third-party services, and improving insurance and patient education.

09:25 Commercial hurdles are explored, such as the need for better technologies that reduce side effects and the importance of building provider confidence in administering CAR-T in community settings.

10:08 An overview of where CAR-T is headed, including gastrointestinal conditions, prostate cancer, neuroblastoma, lung and breast cancer, and autoimmune diseases.

12:00 Tara shares how patient outcomes have dramatically improved over the last decade, with some blood cancer patients now living 25–30 years post-treatment.

13:06 Encouragement for patients to seek expert guidance, confirm the treatment fits their diagnosis, and work closely with their provider teams for the best path forward.

In this episode of “Moving Medicine Forward,” host Jeremy Strand sits down with Brian Lawrence, Chief Financial Officer at CTI, to explore how strategic financial planning is critical to advancing clinical trials, particularly in rare disease research. Brian shares insights on balancing profitability with purpose in one of the world’s most highly regulated industries, reflecting on early career decisions, global expansion, trial funding challenges, and the growing influence of AI in finance. 

00:36

Brian shares how early interests in math and accounting, along with a few great mentors, led him into finance and the clinical research space. 

02:17

Why Brian opted for a smaller accounting firm over a Big Four company and how that decision shaped his career. 

03:16

How his love for process improvement and early experiences with digital transformation prepared him for the dynamic contract research organization (CRO) environment. 

04:03

Brian discusses CTI’s evolution: growing four times in size, expanding globally, and staying true to its rare disease focus. 

05:00

The challenge of maintaining profitability while upholding the highest standards in research and compliance. 

06:00

Brian explains the hidden costs of operating globally, including banking, compliance, and cybersecurity.  

07:10

Why financial planning is critical in biotech, where projects can be halted suddenly due to safety or funding concerns. 

09:00

How investment trends and economic shifts post-COVID have tightened budgets and forced CROs and sponsors to adapt. 

10:00

Brian breaks down the financial implications of trial diversity, especially in rare diseases with complex study designs. 

11:12

The role of AI and digital tools in modern CRO operations, and why CTI is taking a deliberate approach to adoption. 

13:00

Brian sees technology as a way to eliminate low-value tasks and empower finance teams to focus on strategic insights. 

14:00

Through initiatives like CTI Cares and “Mission Moments,” Brian explains how CTI connects internal teams to the bigger picture of patient impact. 

What makes a clinical trial site successful when managing complex transplant studies? In this episode of “Moving Medicine Forward,” host Jeremy Schrand is joined by 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 working in clinical research or simply curious about medical breakthroughs, this episode offers a compelling look at the strategy behind meaningful science. 

Show Notes: 
00:36 Meet Shawna Bredeck, VP Global Site Activation & Clinical Document Management at CTI 
00:52 Feasibility in the context of a clinical trial 
01:18 Why choosing the right site and Private Investigator 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 The shared mission of 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.