Moderator: Welcome! We are delighted to have two experienced guests with us: Dr. Richardus Vonk, a seasoned expert in quantitative decision making in pharmaceutical clinical development, and Dr. Bertram Weiss, Vice President of the Health Vertical at Merantix Momentum. Both have decades of experience, making them ideal to explore how AI is transforming medical writing. Thank you so much for joining us today.

To start, let’s set the stage. Bertram, could you explain to those unfamiliar with the field what medical writing is and why it is so crucial in the pharmaceutical industry?

Dr. Bertram Weiss (BW): Certainly. Medical writing involves preparing the critical documentation that pharmaceutical companies must submit to regulatory agencies to gain approval for new drugs. The data that has been collected over years of research and development must be transformed into understandable, scientifically accurate documentation while meeting the stringent requirements set by regulatory bodies like the FDA or EMA. This also includes translating complex data into layman's terms so that healthcare practitioners and the public can clearly understand the drug's safety and efficacy.

Moderator: That’s a great overview. Richard, from your perspective, how does data play a role in this process, especially when it comes to regulatory approval?

Dr. Richardus Vonk (RV): Data is foundational in demonstrating the safety and efficacy of new drugs. During clinical trials, we collect vast amounts of data to measure outcomes like survival rates, reduction in symptoms, and quality of life improvements. Regulatory bodies review these data before granting market approval. Ensuring the data is detailed and reliable is critical in every step of drug development, and it’s up to medical writers to communicate these complex findings effectively.

Moderator: Before diving deeper into AI’s role, why is medical writing so important not only for regulatory authorities but for society as a whole?

BW: Medical writing is all about transparency and trust. It ensures that society - patients, healthcare providers and regulators - has access to scientifically validated information about the safety and efficacy of a medicine. Over the years, we have learned that this transparency is critical to protecting public health. Regulatory agencies like the FDA and EMA ensure that companies adhere to these standards, and medical writers are responsible for creating the documents that make this evaluation possible.

RV: Absolutely. Medical writing makes sure that scientific findings are communicated clearly and accurately, whether it's for regulatory submissions or patient information leaflets. These documents help ensure that the correct treatments reach patients and are used safely.

Moderator: Now that we understand the importance of medical writing, what are the biggest challenges that medical writers face on a daily basis?

RV: One of the biggest challenges is the enormous complexity of the data. Medical writers need to have a strong scientific foundation to interpret clinical trial results and statistical analyses correctly. At the same time, they need to translate these into clear and concise language for different audiences, including regulators and healthcare professionals. Another challenge is complying with the different regulatory requirements in different regions, such as the FDA in the US and the EMA in Europe, which each have their own guidelines.

Moderator: Bertram, what role do you see AI playing in addressing these challenges?

BW: Large language models (LLMs), like ChatGPT, have shown remarkable potential in assisting with repetitive, tedious tasks in medical writing. AI can summarize vast amounts of scientific data, translate technical jargon into understandable language, and even ensure consistency across multiple documents. By automating these tasks, AI allows medical writers to focus more on value-driven activities, like interpreting complex clinical trial data and crafting narratives that emphasize a drug’s benefits and risks.

Moderator: Richard, what are your thoughts on AI’s potential in medical writing?

RV: I agree that AI can support medical writers in many tasks, especially in summarizing data and ensuring consistency. However, AI is not yet ready to replace human expertise. There is still a risk of "hallucinations" or inaccuracies in AI-generated content. The real value of medical writing lies in interpreting data in context, and that requires human oversight. AI can take care of the repetitive aspects, but nuanced interpretation will always require a human approach.

Moderator: You've both mentioned specific ways in which AI can support medical writers. Can we now take a closer look at three or four specific challenges where AI can make a difference?

BW: Firstly, AI is excellent at summarizing large amounts of scientific data. Medical writers often have to deal with clinical protocols, patient reports and regulatory documents that can span hundreds of pages. AI tools, especially LLMs, can distill this information into different formats, whether for regulatory authorities or a lay audience. While human review is still necessary, this can save a lot of time.

RV: Yes, AI can also help with language clarity and ensuring consistency in vocabulary across documents. It can adapt to different writing styles, making it easier to switch between regulatory language and layman-friendly explanations. However, we are still facing challenges with the use of specialized ontologies, something AI is improving on but hasn’t yet perfected.

BW: Another area is cross-reference processing. When medical writers create a document, this often requires linking to specific data sources. While AI is good at summarizing text, it currently struggles to keep these cross-references intact. However, new tools are emerging to improve this, but there is still a lot of work to be done in this area.

Moderator: Bertram, where do you see Merantix Momentum fitting into this transformation?

BW: At Merantix Momentum, we believe that AI can assist medical writers with many tedious tasks, such as text summarization and rewriting. This frees up writers to focus on more valuable tasks, such as creating a compelling narrative about the risks and benefits of a new drug. We see ourselves as a partner that helps pharmaceutical companies implement these AI solutions.

Moderator: Richard, from your experience, are pharmaceutical companies already adopting AI-assisted systems, or is this still in its early stages?

RV: Many pharma companies are beginning to invest in AI-assisted systems, particularly for medical writing and regulatory submissions. AI is being used to streamline document creation and ensure that submissions meet regulatory standards. I believe we’re on the cusp of seeing AI transform clinical development, making processes more efficient without compromising quality.

Moderator: Thank you both for your insights into the future of medical writing and AI. While AI holds great promise, the human element remains crucial. We look forward to seeing how these technologies continue to evolve and support the pharmaceutical industry in delivering safe and effective treatments.

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Dr. Richardus Vonk is a respected expert in quantitative decision making in pharmaceutical clinical development with more than 30 years of experience. A passionate advocate of using data to improve the success of drug development programs, he is well versed in the application of statistics, data science and AI to create value for patients.

Dr. Bertram Weiss leads the Health Vertical at Merantix Momentum, a leading AI solutions company that helps organizations integrate AI into their strategy and day-to-day operations. Over the past 25 years, he has built and led biomedical data science and deep learning teams in pharmaceutical research and development and supported the IT organization of a global pharmaceutical company.