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Happy Biotech - From Toilets to Trials: The Weirdest Things That End Up on a Risk Register
What do clinical trials and broken office toilets have in common? Apparently, a risk register. In this episode, we unpack how risk management really works in clinical operations—likelihood, impact,…
From Molars to Metadata - TMF Tales with Pooja
Pooja Khemchandani joins Happy Biotech to share her journey from dentistry in India to TMF leadership in biotech. She breaks down what TMF health really means, how sponsor-side work differs from…
Conferencing Standards: From CDISC to Chicken & Waffles - Inside the push to standardize TMFs—and rediscovering the human side of biotech.
Micah returns to the conference world after twenty years, diving into the CDISC/TMF Interchange in Nashville. From acronyms to alignment debates, Suus and Micah unpack how the industry’s drive for…
ICF: The Most Important Thing You’ll Never Read Twice
Micah and Suus unpack the informed consent form—what it is, why it exists, and how IRBs/ECs shape it—plus the new plain-language summary trend, vulnerable-population rules, translations, and version…
Black Roses, Paper CRFs & the Drama of Doing Good
From three-ply CRFs to three dudes and a compound, Doris Sánchez joins Suus and Micah for a candid tour of biotech’s real backstage: why passion (and sane meeting habits) matter, how consulting buys…
When AI Becomes Your Lab Partner (and Finds Your AirPods)
Micah and Suus dive into how AI is reshaping biotech—from drafting protocols and decoding legalese to planning trips and even rescuing lost earbuds on airplanes. With equal parts curiosity and…
Happy Biotech - Audits, Inspections, and Dead Bodies in Closets
Suus and Micah dive into the surprisingly dramatic world of biotech audits and inspections, where FDA investigators can show up unannounced, silence is a weapon, and everyone's trained not to…
From lab tech to Pharma Exec: Happy Biotech Interview with Harry Wisse
On this episode of Happy Biotech, Suus and Micah sit down with biotech veteran Harry Wisse who’s gone from lab technician to pharma leader—to pull back the curtain on drug development’s 90% failure…
TMF: The Filing Cabinet That Summarizes Your Trial — Because who doesn’t love a little light reading… of 8,000 PDFs?
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…
Dark Rooms to Drug Trials: Happy Biotech Interview with Angela Repa
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…
Happy Biotech - Working with CROs in R&D
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…
Happy Biotech Begins: Who We Are and Why We’re Here
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…
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Happy Biotech has published 12 episodes since July 2025, covering topics in Science.
Happy Biotech is currently moderate with new episodes every 2 weeks. Average episode length is 34m.
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