Name: Happy Biotech - Working with CROs in R&D by Happy Biotech
Duration: 29 min 43 s
Description: 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.

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?

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.

Happy Biotech - Working with CROs in R&D

Happy Biotech

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