Episode 40: The CDx Files: Decoding Companion Diagnostic Devices

A lot can change in 30 years, and medical writing is no exception. In this episode of TriloTalk, Julia Forjanic Klapproth and Douglas Fiebig look back at how the profession has evolved, from what it was like to enter the field decades ago to the skills today’s medical writers need to succeed. We also look ahead to what’s next, what makes the future of medical writing exciting, and the lessons and experiences that stay with you long after the writing stops. 

AI is transforming medical writing, but how do you build a solution that's trusted enough to support high-stakes work? In this episode of TriloTalk, Lisa Chamberlain James, VP Medical Solutions, and Tarun Mathur, Chief Technology Officer at Indegene take you behind the scenes of NEXT Medical Writing Automation to explore the philosophy, decisions, and safeguards that shaped its development. Hear how NEXT MWA balances speed with compliance, transparency with innovation, and why keeping humans in control remains central to the future of AI-powered medical writing.

Short on time? We’ve condensed five valuable medical writing lessons into one quick 10-minute episode. We explore mentorship, purposeful writing, patient-focused communication, medical device document challenges, and translation considerations.  

This episode of TriloTalk explores how health literacy goes far beyond simplifying language. It requires consistency, testing, and truly meeting patients where they are. Poor communication can have serious consequences, from medication misuse to reduced trust and engagement in clinical trials. Lisa Chamberlain James, Senior Partner at Trilogy, Elizabeth Brown, Executive Director Clinical Transparency at Merck, and Maureen Kashuba, Senior Director Health Literacy at Merck, discuss this and the importance of partnering together, regardless of what organization you are a part of, to best serve patients across the world. 

What does it really take to move into leadership in medical writing? Nidhi Johal, Medical Writing Manager of North America, and Kleopatra Kouroupaki, Senior Medical Writing manager, explore just that in this TriloTalk episode. They cover real-life paths, how to effectively manage former peers, lessons behind career growth, and much more. Listen up!

Everyone is talking about “one-click AI,” but is it real or just a conference buzzword? In this episode of TriloTalk, Lisa Chamberlain James, Senior Partner at Trilogy, and Vladimir Penkrat, Associate VP Regulatory Affairs at Indegene, cut through the hype and explore what AI can actually do today in medical writing and regulatory affairs, where the biggest gaps are, and how organizations can actually make real progress. 

This episode of TriloTalk explores companion diagnostics and what makes them medical devices. Join Julia Forjanic Klapproth, Senior Partner at Trilogy, Laura Collada, Senior Medical Writing Manager at Trilogy, and Raquel Billiones, Director of Medical Writing at AstraZeneca and learn how in vitro diagnostic tools help pair the right treatment with the right patient and why we can’t just test drugs and their companion devices all in one go. Tune in!

Humans communicate through stories and medical writers help teams crystallize the story out of the data: this is the essence of what they bring to the table. Join Julia Forjanic Klapproth, Senior Partner at Trilogy Writing & Consulting, and Eleanor Steele, a freelance consultant working as the Med Comms Mentor, for TriloTalk episode 39 where they explore the power of storytelling in medical writing and explain the PRISM framework, which is a useful system for medical writers to make each story hit the mark.

For TriloTalk episode 38, Lisa Chamberlain James, Senior Partner at Trilogy, and Sudipta Chakraborty, Head of Literacy & Plain Language Center of Excellence at Biogen, talk about how to use AI in the creation of lay summaries of clinical trial results. Scalability, change management, prompting, biases, realistic attitudes, and human involvement are all touched on so listen up! 

TriloTalk episode 37 focuses on a specific type of medical device, the drug-delivery system. Writing for drug-delivery systems is all about being fluent in two languages – drugs and devices. Julia Forjanic Klapproth, Senior Partner at Trilogy, Laura Collada, Senior Medical Writing Manager at Trilogy, and Raquel Billiones, Director of Medical Writing at AstraZeneca, talk about this and what medical writers need to understand when crafting these regulatory documents.