The Tea in STEM

 In this episode, we dive into a chilling case where a promising T-cell therapy showed remarkable results in adolescents and pediatric patients — but when tested in adults, the outcome was tragically different. Phase 1 looked fine, Phase 2 turned deadly. To this day, we still don’t fully understand why. Was it biology? Trial design? Or something deeper about the risks of pushing boundaries in science? Join us as we unpack what went...

“Good Intentions, Bad Paperwork”
Meet the city doc everyone loved — champion of public health, hero of harm reduction, and the driving force behind making Narcan accessible without a prescription. But when his passion for helping people collided with the rigid rules of an HIV clinical trial, things got messy. This episode dives into how one man’s altruism, while admirable, ran head-first into FDA regulations, resulting in a 48...

In this powerful installment of Dark History of Clinical Trials, we examine one of the most tragic and transformative episodes in pharmaceutical history: the thalidomide disaster.

Marketed as a safe sedative and morning sickness treatment in the late 1950s, thalidomide was distributed to thousands—only to cause severe congenital deformities and pregnancy losses across the globe. This catastrophe exposed critical flaws in drug testin...

When 26-year-old Markinson suffered a psychotic break, he was given a choice no one should ever face: participate in a clinical trial or face long-term involuntary confinement. What followed was a tragic chain of events—his worsening condition, the helpless fight of a mother trying to save her son, and ultimately, a suicide that would spark a national conversation about ethics, consent, and mental illness in clinical research.

In th...

In this chilling episode of Dark History of Clinical Trials, we explore the devastating 2016 Phase 1 clinical trial in Rennes, France, that left one man dead and several others with lasting neurological damage. Designed to test a new painkiller, the study went catastrophically wrong after investigators escalated the dose without properly analyzing earlier data. We uncover what went wrong, the oversight failures, and how it shook pu...

In Part 3 of our series on government-funded clinical trials, we shift the focus to the upsides of working in publicly funded research. From greater patient diversity and broader public health impact to mission-driven work and long-term study follow-through, we highlight what makes this space both rewarding and unique.

We also explore what kind of professionals thrive in this environment. Is it the detail-oriented? The mission-focus...

 In this continuation of our deep dive into government-funded clinical trials, we explore real-world examples of how these studies operate differently from private pharma-sponsored research. Our guest shares firsthand insights into challenges like proving adverse events without medical records, navigating patient compensation differences, and the disconnect between research benchmarks and real-life feasibility. We also discuss the ...

Part 1: Regulatory

 In this episode, we sit down with a clinical research coordinator from a government-funded hospital to explore the unique challenges and regulatory differences between publicly funded and private pharmaceutical company-sponsored trials. We discuss key topics such as study selection, start-up timelines, and the distinct approval processes that shape the landscape of government-backed research. How do these differe...

Episode 7: Big Pharma… in a Kitchen?! 🍳💊🚔

What happens when a man decides to skip the lab, the regulations, and basic ethics—and mass-produce fake medication in his own kitchen?

The FDA found out. And let’s just say… he fked around and definitely found out.

In this episode, we unravel the insane true story of a DIY “pharmaceutical empire,” the dangerous fake drugs that hit the market, and how it all ended with a one-way ticket to p...

 In this episode of Tea in STEM, we're joined by Nikki Jundt, a seasoned regulatory specialist, to delve into the complexities of Investigator Site File (ISF) maintenance. Nikki shares her expertise and highlights critical challenges faced by research sites, drawing from her recent experience on a CDISC conference panel alongside FDA auditors and CRO representatives. This episode discusses DOA regulations, Re-consenting issues...

 In this episode, we dive into the latest FDA guidance expanding flexibility for clinical trials by allowing healthcare providers (HCPs) to conduct visits under Principal Investigator (PI) oversight. What does this mean for patients, research sites, and sponsors? Join us as we sit down with Ted Barduson, COO and Co-founder of Medvector to discuss the practical implications of this groundbreaking change. From improving patient acces...