Happy Biotech

Happy Biotech

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Podcast by Happy Biotech

5 feb

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, and when to mitigate versus move on—while sharing a true story about bathroom plumbing ending up on an R&D risk log, plus a debate on whether unhealthy cafeteria food is a “risk” or just an issue pretending to be one.

39 min.
17-11-2025

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 CROs, why the industry struggles with adopting new tech, and how automation and AI could reshape documentation. She also drops a spooky TMF story (yes—menus and hand scans happen) and reminds us of the ultimate rule: if it’s not documented, it doesn’t exist.

32 min.
30-10-2025

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 standards collides with the messy, very human side of collaboration. Along the way: networking hacks, risk logs, Dutch “poldering,” and yes—chicken and waffles.

33 min.
09-10-2025

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 updates when protocols or safety data change. Short, readable, and actually useful… unlike most fine print.

29 min.
27-08-2025

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 back your time, and the wild CRA tale that arrived with a black rose and a half-smoked cigarette. We also swap myth-busting takes on “Big Pharma,” burnout, and a foodie detour to Boston’s La Bodega.

35 min.
19-08-2025

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 caution, they explore the promise (and pitfalls) of putting large language models to work in clinical research and everyday life.

32 min.
13-08-2025

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 accidentally confess to crimes they didn't commit. From mock inspections to actual warrants being slammed on tables, discover why having zero deviations is more suspicious than having a few, and how strategic coffee breaks can save the day. Warning: No actual bodies were harmed in the making of this podcast, but several egos may have been bruised during quality assurance reviews.

37 min.
06-08-2025

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 rate, the joys (and headaches) of regulatory compliance, and why networking and flexibility are the ultimate career life-rafts in this industry. Along the way, Hari shares war stories, work-life balance tips (golf, travel, and all), and practical advice for anyone plotting their own biotech adventure.

37 min.
29-07-2025

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 inspection-ready, they unpack why this three-letter acronym is the unsung hero of clinical trials.

33 min.
22-07-2025

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 regulatory inspections, offers career advice for biotech newcomers, and even shares a memorable ride in a driverless car.

42 min.
15-07-2025

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 execution, they explore what makes CROs essential, frustrating, and—dare we say—kind of lovable.

30 min.
08-07-2025

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 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.

6 min.

12 afleveringen

Podcast by Happy Biotech

Maker

Happy Biotech
Jaren actief

2025 - 2026
Afleveringen

12
Beoordeling

Veilig
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Happy Biotech