Connecting and Learning
The 61st EMWA Spring Conference brought together medical writers, regulators, biotech leaders, and service providers from across Europe and beyond for several days of workshops, panel discussions, and networking in Barcelona. We spoke with Phil Burridge, Operations and Strategy Director at Morula Health, who attended the conference and was also invited to speak at the CORE Reference session, to get his key takeaways from what was a busy and thought-provoking week.
Phil, how would you describe the overall mood at this year’s conference?
Conferences like EMWA are really valuable because people tend to speak more openly than they would in a formal meeting. You get a genuine read on where the industry is, what is keeping people up at night, and what is working. The mood in Barcelona was positive and forward thinking, and the conversations were very collaborative and informative. For me, that combination of structured sessions and informal networking is where the real value lies.
You were invited to speak at the CORE Reference session this year. What did you cover?
I focused on the fact that two-thirds of 2024 FDA drug approvals came from small and mid-size biotech companies. That is a significant figure, and it reinforces something we feel strongly about at Morula Health: these companies need Clinical Study Reports (CSR) that are genuinely high quality, not just functional documents that pass review. A CSR written in accordance with CORE Reference will be a transparent and durable record, one that outlasts the tenures of the people who worked on it and sometimes even the company itself. Getting that right matters enormously, especially for smaller sponsors, starting with the end in mind and ensure their CSRs are submission-ready from the outset.
Based on your own experience at the conference, what stood out most to you?
Several things came up repeatedly. The first was the central role of biotech in driving this industry forward. When you listen to what those companies actually want from medical writers, it is very clear: document leadership, real expertise in the source data, and writers who ask thoughtful, well-informed questions. They are not looking to be educated about regulatory guidelines in the abstract. They want solutions. If a medical writer comes to them with more problems to think about rather than answers, that creates stress rather than value. That message came through consistently.
ICH M11 was on the agenda. What are your thoughts on the new protocol template?
It was definitely a hot topic across everyone at the conference. There was a genuine interest in what the new protocol template is trying to achieve and how it can be applied in practice. My honest view is that the conversation needs to be proportionate. If you have eight weeks to finalize a protocol, there is a reasonable case for sticking with an approach that everyone on the team already knows. ICH M11 is a guideline first and foremost, and adoption will happen gradually over time. Let’s remember why we do this: the goal has always been to get patients access to new medicines to improve their lives. That means producing a high-quality, investigator-friendly, consistent protocol. How you get there should be guided by what serves that goal in each specific situation.
One practical note worth sharing: TransCelerate has put together a Word version of the ICH M11 template that is genuinely useful for medical writers working through what the guidance means in practice.
AI was again a main theme of the conference, similar to the last few years. Did you come away with any new knowledge on where AI is heading for medical writing?
Honestly, not really although I was more focused on the protocol and ICH M11 workshops and sessions this year. I think the conversation still needs to mature is around the idea of AI-generated first drafts of clinical documents. The first draft of a CSR represents roughly 30 to 40 percent of total hours and typically takes around two weeks. A faster first draft does not meaningfully increase the likelihood of a faster final draft. And for a biotech company writing a single Phase 3 CSR, rather than a large pharma organization producing hundreds of similar documents, the calculus is even less compelling.
More fundamentally, the drafting process is where a medical writer builds the expertise to lead a document, understand the data, and ask the right questions. If that work is delegated to an AI, the writer loses the foundation on which good document leadership is built. The real challenges in clinical and regulatory writing are complex study designs, data inconsistencies across multiple sources, getting the right people to review documents, and reaching agreement across a wide range of opinions. Those are the problems I would love to see AI companies focus on. I am genuinely curious to hear more about that at next year’s EMWA conference in Amsterdam.
Any final reflections?
The conversations I had in Barcelona, across biotech, pharma, freelancers, and service providers, reinforced something we already believe: expert medical writers provide enormous value to this industry. The demand is real and growing. What biotechs need are partners who understand their data, lead their documents, and bring answers rather than additional complexity. That is exactly what Morula Health is built to do.
Get in touch
If you’d like to learn more about Morula Health’s medical writing services, from regulatory and clinical writing to specialist support across rare disease, oncology, and complex submissions, get in touch or explore our recent case studies to see how we support teams at every stage of development.
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