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Trilogy Writing & Consulting

TriloTalk

A Life Sciences and Science podcast

#71 in Life Sciences · 🇫🇷 #114 in Life Sciences · 🇸🇬
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About the show

Conversations to bring medical writing topics to the forefront and hopefully spark wider conversations in the domain of medical writing. TriloTalk episodes will range from the value of medical writing to apprenticeship. TriloTalk will also cover document-specific topics such as lay summaries and how to tame CTD dossiers. 

Newest episodes

Episode 46: Medical Writing: Yesterday, Today, and Tomorrow. Reflecting on its evolution and where the profession is headed.

22 min

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. 

Episode 45: Inside NEXT Medical Writing Automation: The Decisions You Don’t See

23 min

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.

Episode 44: 10 minutes, 5 Medical Writing Lessons

10 min

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.  

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All episodes

Episode 46: Medical Writing: Yesterday, Today, and Tomorrow. Reflecting on its evolution and where the profession is headed.

22 min

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. 

Episode 45: Inside NEXT Medical Writing Automation: The Decisions You Don’t See

23 min

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.

Episode 44: 10 minutes, 5 Medical Writing Lessons

10 min

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.  

Episode 43: More Than Words: The Real Work of Health Literacy

33 min

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. 

Episode 42: Journey to Leadership in Medical Writing

25 min

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!

Episode 41: Breaking Down the One-Click Submission Dream

31 min

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. 

Episode 40: The CDx Files: Decoding Companion Diagnostic Devices

21 min

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!

Episode 39: Unlocking the Power of Storytelling in Medical Writing: the PRISM Framework

32 min

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.

Episode 38: Explaining the Evidence - Using AI for Lay Summaries of Clinical Trial Results

28 min

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! 

Episode 37: Primer on Writing for Drug-Delivery Systems

26 min

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.  

Episode 36: Being Transparent About Clinical Trial Transparency

24 min

Clinical trial transparency is a delicate balance of getting the right data to the right resources at the right time. Senior Partner Lisa Chamberlain James sits down with the President of Holtzople Consulting, Julie Holtzople, to discuss how to do just that. They discuss standardizing information for researchers, building trust, advice for best practices, and whether all this transparency is legally mandated – or simply the right thing to do.  

Episode 35: Introducing the AMWA Apprentice Program Framework – A step-by-step guide to training medical writers

32 min

The demand for experienced medical writers is outpacing the availability of experienced writers. In TriloTalk episode 35, Julia Forjanic Klapproth, Senior Partner at Trilogy, and Kim Jochman, Senior Director of Medical Writing at Merck, raise awareness of two new essential AMWA resources: the apprentice program framework and the job leveling framework. As members of the workstreams who developed these, Julia and Kim bring insights and the rationale from behind the scenes. Tune in and learn about these important initiatives for the medical writing community.  

Episode 34: AI Agents - the future that's being used today!

27 min

For episode 34 of the TriloTalk podcast, Lisa Chamberlain James, Senior Partner at Trilogy, sits down with the AI Agent expert Nikesh Shah, VP and Global Head, Generative AI at Indegene. They discuss everything you need to know about AI Agents – the day-to-day usage, project confidentiality, when it will become mainstream, which industries are using it now, and how it will enrich our lives. It's an episode you don’t want to miss!  

Episode 33: Are Medical Devices from Venus and Pharmaceuticals from Mars? Important things to know when writing for medical devices.

28 min

This episode focuses on writing for medical devices. Playing Sherlock Holmes, conducting usability studies, following regulations, working closely with the manufacturers and much more are all in a day's work when writing for devices. Listen to Trilogy's medical writing managers, Heidi Chapman and Laura Collada, and Senior Partner, Julia Forjanic Klapproth, discuss the similarities and differences between writing for devices and writing for drugs. Listen up!   

Episode 31: What You Need to Know About AI Agents & Medical Writing

14 min

Join Julia Forjanic Klapproth as she gives a useful overview of what everyone is talking about these days – AI agents. You’ll hear about the benefits they bring and their limitations, how it will dramatically change everyone’s day-to-day work, and what this means for the medical writing world.  

Episode 30: Exploring the Role of Women in Science  

25 min

It’s International Day of Women and Girls in Science! To celebrate, TriloTalk episode 30 is a conversation with Trilogy’s two female Senior Partners discussing what sparked their interest in science, barriers to entry (or lack thereof), clinical research gaps, female representation in the medical writing industry and more. Listen up!   

Episode 29: What's Hot & What's Not for Regulatory Medical Writing in 2025

17 min

The rapidly growing industry of regulatory medical writing calls for a 2025 prediction podcast! Listen up for “What’s Hot and What’s Not” from our experts Lisa Chamberlain James, Julia Forjanic Klapproth and Sonica Batra and get a glimpse of what Trilogy, an Indegene Company and Indegene will be up to this year.  

Episode 28: Exploring the Past, Present and Future of Orphan Drugs

17 min

Long time friends and industry colleagues, Lisa Chamberlain James with Trilogy and Cheryl Roberts with BioMarin Pharmaceutical sit down to discuss orphan drugs. They go over clinical trial hurdles, key incentives for health authorities, the medical writing process and start with an important question – why are orphan drugs called orphan drugs? Find out on episode 28 of TriloTalk!  

Episode 27: Clinical Overviews - What are they & why are they so important?

22 min

Join Julia Forjanic Klapproth, Barbara Boggetti, and Bhawna Basin as they take a closer look into Clinical Overviews. Since many agree it’s one of the most interesting documents medical writers prepare, they dive right into many topics like strategy, FDA vs EMA requirements, graphics, working with sponsors, and even page count challenges. Listen up!  

Episode 26: The Future of Lay Summaries - Leveraging AI for Patient-Friendly Language

29 min

Welcome back to TriloTalk! In this episode, Lisa Chamberlain James from Trilogy and Vladimir Penkrat and Ritesh Dogra from Indegene dive into the role and future of lay summaries. AI technology, new EUCTR requirements, graphic creation, and much more will affect how medical writers create patient-friendly language documents. Tune in to gain valuable insights and tips on how to navigate this changing environment.  

Episode 25: Exploring the Intersection of AI & Medical Writing

18 min

In this episode, Julia Forjanic Klapproth and Lisa Chamberlain James from Trilogy and Vladimir Penkrat and Tarun Mathur from Indegene chat about the intersection of AI and medical writing. They cover historical evolution, current needs, automation strategies, essential skills, regulatory compliance, and unique use cases. Tune in to catch the insights and join the conversation!  

Episode 24: Navigating the Global Transparency Landscape

30 min

Welcome to Trilotalk Episode 24! In this episode, Douglas and Nidhi will take you through an overview of the recently introduced EU-CTR (Clinical Trial Regulation) - a hot topic in our industry these days! As medical writers, we need to be aware of not only what the EU-CTR is but also how it impacts the documents we often write. Join us to find out more about it! We will talk about what the EU-CTR is, the pros and cons of the new process, how a CTA in the EU is structured, and touch upon associated transparency and public disclosure requirements.

Episode 23: Speaking of Buzzwords in Medical Writing, What About AI? – Part II

25 min

Welcome back to TriloTalk! As promised, we are continuing the conversation about buzzwords in medical writing. In this episode, our guests Lisa and Art explore the topic of medical writing and artificial intelligence in Part II of our series, 'Speaking of Buzzwords in Medical Writing'. Beyond mere catchphrases, they will reflect on the trending use of generative AI, its benefits and potential pitfalls, and the evolving role of medical writers. Happy podcasting! 

Episode 22: Exploring Patient-Centricity: Beyond Buzzwords in Pharma's Decision-Making

23 min

In this episode, Lisa Chamberlain James, Senior Partner at Trilogy Writing & Consulting, and Art Gertel, Principal at MedSciCom, discuss the pivotal role of patients in pharmaceutical decision-making. Despite knowing the importance of patient-centricity, their perspectives are frequently overlooked in crucial stages of drug development. How can pharmaceutical companies integrate patients' unique insights to enhance their processes? Tune in as they engage in this vital discussion. Interested in exploring the topic ‘Communicating with patients’ deeper and beyond our podcast episode? Here's the link to our dedicated Medical Writing Supplement of ICT on this very topic. Also, stay tuned for Part II of Lisa and Art’s conversation in Episode 23, coming up in April 2024.

EPISODE 21: Pen to Paper: Insights on Recognizing, Addressing, and Avoiding Medical Writer Burnout

31 min

 Join Nidhi Johal, Director of Medical Writing for North America at Trilogy Writing & Consulting, and Heidi Chapman, Medical Writing Manager at Trilogy in a conversation about a topic that resonates with professionals across the industry – burnout. In this episode, Nidhi and Heidi draw from their own experiences, sharing personal stories, exploring the signs of burnout, and helping listeners identify red flags early on. From setting boundaries to embracing self-care practices, they discuss practical strategies they've learned to prevent burnout, ensuring a healthy work-life balance. Whether you're a seasoned writer or just stepping into the world of medical writing, this episode provides valuable insights to keep you thriving in this profession. Happy listening! 

Episode 20: Q&A With TriloTalk: Focus on General Medical Writing Principles

16 min

In this episode, Julia and Lisa take a deep dive into General Medical Writing Principles. Join them as they navigate through a diverse range of topics that are crucial in the everyday practice of crafting clear and concise regulatory documents. Our hosts will generously share their personal insights, experiences, and invaluable tips that have positioned them as Masters in the field of medical writing. Happy podcasting! 

Episode 19: Elevating the Voice of Patients: The role of medical writers in making a difference

18 min

In this episode, Lisa Chamberlain James, Senior Partner at Trilogy Writing & Consulting, and Magnolia Correa, Marketing Communications Manager at Trilogy Writing & Consulting, delve into their shared passion for patient communication. They explore this topic from their different perspectives and discuss how medical writers contribute to enhancing health outcomes by crafting clear and impartial documents intended for the general public.  

Episode 18: Clinical Study Protocol Development from a Writer's Perspective

34 min

Join Julia and Jonathan for the 2nd part of a discussion dedicated to the development of Clinical Study Protocols, as they delve into the intricacies of writing these crucial documents. In this discussion, they explore the level of involvement a writer should have to ensure a well-written protocol. Tune in to gain valuable insights and guidance on creating effective protocols that drive successful clinical studies.

Episode 17: The Importance of Training Medical Writing Leaders

23 min

In this episode, our host, Julia Forjanic Klapproth, and our special guest, Angela Winnier, Senior Director, Medical Writing Lead for Rare Disease at Pfizer, come together to share their conviction and valuable experiences as medical writing leaders. Join them as they dive into the crucial topic of organizations providing training that goes beyond technical writing skills. Together, they will explore the significance of creating “safe spaces” where medical writers can truly spread their wings and thrive. 

Episode 16: AI Tools for Medical Writing - Turkeys Voting for Christmas?

53 min

In this special episode, Lisa and Barry, Senior Partners at Trilogy, along with Jamie Norman, Chief Product Officer at TriloDocs joined Network Pharma at its webinar: AI for Medical Writing, Turkeys voting for Christmas? During this thought-provoking conversation, they explored and explained the potential impact of AI on medical writing, discussed the opportunities and challenges that come with integrating AI into the field, and shared their expert insights on how to navigate the rapidly changing environment.

Episode 15: How to Streamline Regulatory Authority Meetings: Spotlight on Briefing Books

28 min

Welcome to TriloTalk episode 15, where we will dive into the critical document that plays a pivotal role in pharmaceutical development: The Briefing Documents (or briefing books/packs). Join Barry and Maria as they explore the key elements of well-crafted Briefing Books, their importance in the regulatory process, and how to tailor these documents to the specific regulatory authority. 

Episode 14: The importance of getting clinical study protocols right

24 min

In this episode, Julia and Jonathan cover how making people aware of the many new and updated regulations (such as the ICH E8(R1) and the draft ICH M11 guideline) will help ensure teams are following these, looking for ways to handle the ever more complex studies that are being designed, the importance of focusing on the regulatory objectives of a study over more academic pursuits, the value of using the Transcelerate template to get more standardization across the industry, and the importance of preparing protocols that communicate clearly and effectively not only to help users find the information they need but also to ensure teams are aligned on the full intentions of the study and for downstream use of the protocols in writing study reports and ultimately dossiers.  

Episode 13: Q&A with TriloTalk: Focus on CSRs

23 min

In this special session of TriloTalk, Julia and Barry answer questions sent to them by medical writers around the world. The focus of the questions in this episode is Clinical Study Reports (CSRs), data reporting, and analysis.  Tap into Julia’s and Barry’s vast medical writing experience and make sure to send your questions for future sessions of “Q&A with TriloTalk” to writers@TrilogyWriting.com.

Episode 12 - PIF and PIF TICK. What are These and Why are They Important

22 min

In this episode, Lisa Chamberlain James, Senior Partner at Trilogy Writing & Consulting talks to Dan Wills, Quality Mark Manager at Patient Information Forum (PIF) about the PIF TICK accreditation and its importance – specifically, what it means for organizations to have this certification mark and what it means for people in their search for high-quality health information.

Episode 11: Taming the Complexity of Preparing CTD Submission Dossiers

53 min

Process optimization, effective management, and organisation strategies are all essential components when preparing CTD submission dossiers for drug approval.  In this episode, Douglas, Senior Partner at Trilogy Writing & Consulting, and Johan Telen, President at Improvement at Work, discuss how implementing well-planned, focused, and robust processes can actively de-risk the critical path and contribute to reducing the time needed for dossier preparation.

Episode 10: The Importance of Style Guides

16 min

Restrictive or time-saving? In this episode, Barry reflects on the importance of style guides and how these can serve as a compass to accompany medical writers when deciding on the grammatical or stylistic rules that need to be applied to the documents they are writing. Style guides not only save time (and money) in the writing process but also help improve the document review process. You might also like to listen to Episode 4: The Power of Good Review Practice. "Style guides will not only improve your writing but greatly improve your review processes."

Episode 9: The Ethics of Medical Writing

34 min

Rapid dissemination of scientific information, lower standards in review processes, unvetted information. In this episode, Barry and Art explore the never-ending ethical situations that are deep-rooted in the profession of medical writing.

Episode 8: Responses to Regulatory Authorities

34 min

In this episode, Julia and Douglas, Senior Partners at Trilogy Writing & Consulting, discuss how preparing written responses to questions received from regulatory agencies during the review of application dossiers can be decisive to the outcome of the review, and how medical writers can make a substantial contribution to this process.

Episode 7: A Primer for Writing Oncology Dossiers

15 min

In this episode, Julia Forjanic Klapproth - Senior Partner, and Maurice Löwens - Medical Writing Manager at Trilogy Writing, discuss how experienced medical writers can streamline the planning and writing process, helping the team navigate a minefield of potential problems and letting the subject matter experts spend more time on crafting the messages.

Episode 6: Apprenticing Medical Writers

25 min

In this month’s episode, Julia Forjanic Klapproth, Senior Partner at Trilogy Writing & Consulting, and Joan Affleck, Head of the Medical Writing Department at Merck, talk about the medical writing training programs at the companies they represent and explore how training medical writers help build a brighter future and lift the entire profession of medical writing. Listen now

Episode 5: Lay Summaries

30 min

Writing for a non-specialist audience represents challenges beyond writing in a simpler language. Writing a fit-for-purpose document for the general public involves lay language, lay presentation, and lay science. Join Dr. Lisa Chamberlain James and Dr. Barry Drees as they discuss their knowledge and experiences in writing Lay Summaries.

Episode 4: The Power of Good Review Practice

36 min

In this episode, Julia and Barry, senior partners at Trilogy Writing & Consulting, call for a “revolution and complete overhaul in the way documents are reviewed”. They explain how a focused review process leads to a transformational change in how drugs get approved. Listen now.

Episode 3: The Value of Medical Writing

29 min

“Pay me now or pay me later”. TriloTalk episode 3 features Dr. Julia Forjanic Klapproth and Gretchen Griffin as they talk and discuss the value of medical writing and what a good medical writer brings to the table.

Episode 2: The Role of Artificial Intelligence (AI) in Medical Writing

25 min

Will AI replace or assist medical writers? Join Julia and Barry in this episode as they talk about how AI is going to change the way we write and work as medical writers. You will discover how AI will make writing clinical documents not only faster and more interesting but will aid with the analysis and eliminate human error. Get a sneak-peek into the coming revolution in medical writing. 

Episode 1: Lean Medical Writing

21 min

In this episode, Julia and Barry talk about the importance of lean medical writing to communicate the key messages efficiently. The goal is story, not storage. They discuss how less is more and the importance of giving answers to the questions posed by studies, rather than just spewing data. Lean writing is at the core of how to take aim at inefficient medical writing.

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