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

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.

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.

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 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.

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.

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.

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.

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.

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.

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.