Name: TMF: The Filing Cabinet That Summarizes Your Trial — Because who doesn’t love a little light reading… of 8,000 PDFs? by Happy Biotech
Duration: 32 min 46 s
Description: Suus and Micah take on the mighty TMF — the Trial Master File — in this deep-dive episode of Happy Biotech. From binders and bureaucracy to QC checks and that sweet, sweet feeling of being inspection-ready, they unpack why this three-letter acronym is the unsung hero of clinical trials.

In the first episode recorded of Happy Biotech, Micah and Suus introduce themselves and the vision for the show—sharing stories, laughter, and behind-the-scenes insights from the biotech and pharma world. They dive into the new normal of video meetings: the pros, the awkward mishaps, and whether we’ll all be replaced by vegetable-shaped avatars. It’s biotech meets reality… with a webcam.

Happy Biotech -  Moving to video

On this week’s Happy Biotech, hosts Suus and Micah sit down with Dr. Nathaniel Katz, whose career has been devoted to improving pain management. Nat breaks down how subjective reporting, flawed protocols, and groupthink can undermine trial reliability—and outlines patient-centered, rigorously calibrated strategies to ensure that new therapies truly work.

Are Clinical Trials Reliable?  Happy Biotech interview with Dr. Nathaniel Katz

Introducing the Happy Biotech podcast, hosted by Micah and Suus, aims to provide insights into the world of clinical operations and the biotech industry. In this introductory episode, they discuss their backgrounds, the purpose of the podcast, the target audience, and the vibe they aim to create. The hosts emphasize the importance of storytelling and humor while navigating complex topics in the industry, inviting listeners to join them on this journey.
Takeaways:
The podcast will feature interviews with industry professionals.
They aim to make complex topics accessible and entertaining.
Episodes will be released weekly.

Happy Biotech Begins: Who We Are and Why We’re Here

Micah and Suus dive into the wild world of CROs—those mysterious entities every biotech loves, tolerates, or just can’t live without. From cost structures to accountability, training to trial execution, they explore what makes CROs essential, frustrating, and—dare we say—kind of lovable.

Happy Biotech - Working with CROs in R&D

On Happy Biotech, hosts Micah and Suus sit down with Quality executive Angela Repa to trace her journey from electron microscopy through clinical operations and QA leadership. She demystifies regulatory inspections, offers career advice for biotech newcomers, and even shares a memorable ride in a driverless car.

Dark Rooms to Drug Trials:  Happy Biotech Interview with Angela Repa

Suus and Micah take on the mighty TMF — the Trial Master File — in this deep-dive episode of Happy Biotech. From binders and bureaucracy to QC checks and that sweet, sweet feeling of being inspection-ready, they unpack why this three-letter acronym is the unsung hero of clinical trials.

TMF: The Filing Cabinet That Summarizes Your Trial — Because who doesn’t love a little light reading… of 8,000 PDFs?

Happy Biotech

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