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