Name: Conferencing Standards: From CDISC to Chicken & Waffles - Inside the push to standardize TMFs—and rediscovering the human side of biotech. by Happy Biotech
Duration: 32 min 59 s
Description: 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.

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?

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.

From lab tech to Pharma Exec: Happy Biotech Interview with Harry Wisse

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.

Happy Biotech - Audits, Inspections, and Dead Bodies in Closets

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.

When AI Becomes Your Lab Partner (and Finds Your AirPods)

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.

Black Roses, Paper CRFs & the Drama of Doing Good

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.

ICF: The Most Important Thing You’ll Never Read Twice

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.

Conferencing Standards: From CDISC to Chicken & Waffles - Inside the push to standardize TMFs—and rediscovering the human side of biotech.

Happy Biotech

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