Kristin Nuyens’ Post

Happy to share this article co-authored with John April from Eli Lilly and Company, and vanessa de langsdorff from Yseop. The focus is unlocking the full potential of AI in medical writing, focusing on the clinical study report (CSR). The article underscores the importance of prioritizing data and content readiness, and establishing a content ecosystem with clear purposes of each. Optimization of the CSR document content includes eliminating subjectivity and repetitions. Without optimizing the document first, GenAI will mimic what we have always done, and the efficiency gain will be modest. If we spend time optimizing the writing approach first, before implementing automation, document development is accelerated. #NovoNordisk #digitaltransformation #medicalwriting #regulatorywriting #digitalization #contentmanagement #GenAI

I'm excited to share the article I have contributed to with John April at Eli Lilly and Company and Inger Ødum Nielsen at Novo Nordisk detailing the key points to implement #genAI at scale in #MedicalWriting. https://lnkd.in/ecNPMVTg

Thank you to my colleagues and partners from Pfizer, Takeda, AstraZeneca, and Novo Nordisk for making the PHARMA NETWORKING & DEGUSTATION event in Almaty such a meaningful and enjoyable experience. The combination of insightful discussions and a relaxed wine-tasting format—including some impressive non-alcoholic options—set the stage for truly valuable conversations. During our discussions, we delved into fascinating topics, including trends in #KOLmanagement, #AIpoweredtransformations in Medical Affairs, and new approaches to training. Here are some key insights I’d love to share: 🩻 Evolving KOL Engagement: KOLs management has changed. KOLs are increasingly participating in virtual events: conferences, advisory boards, and online platforms. This shift enhances accessibility, breaks geographical barriers, and fosters more inclusive discussions. Beyond traditional (speakers) roles, KOLs now play vital parts in RWE, data generation, drug lifecycle management. 🩻 Real-World Evidence (RWE): KOLs are pivotal in generating RWE, which validates the safety and efficacy of therapies in real-life settings, strengthening evidence-generation practices. 🩻 Digital Opinion Leaders (DOLs): The rise of DOLs has expanded outreach to younger, tech-savvy audiences, integrating experts from diverse fields to tackle complex healthcare challenges. AI in Medical Affairs: The future lies with specialized systems that will perform certain functions of a medical advisor that take a lot of time. 📊 Time-Saving Tools: AI is already simplifying tasks like annotating presentations, ensuring compliance, and scanning competitive information. 📊 Personalized Content: AI-driven solutions are tailoring learning materials to individual needs, making education more impactful. 📊 Faster Insights: Advanced tools are accelerating literature reviews and data analysis, enabling quicker, better-informed decisions. Key Trends in Training Programs: Several key trends are driving changes in learning approaches: The emergence of AI and the acceleration of content creation processes. The complication of information flows and the increase in their volume, leading to the appearance of a large amount of "garbage data". This has led to the most requested trainings that clients ask from us as a company: · How to read articles and analyze scientific and medical information. · Critical analysis of scientific and medical information. · AI-driven data interpretation and generation. · Visualization of scientific and medical information. · Interpretation of the complicated graphs I am interested in how much you agree with the trends I proposed for discussion above? If anyone needs the slides I showed to start this discussion, let me know in the comments  or by message , and I will send them. #KOLManagement #MedicalAffairs #AIinHealthcare #PharmaTrends #MedicalAffairsTrainings

An insightful article showcasing Medical Affairs' crucial role in driving pharma value https://lnkd.in/geFd2vWg According to the article, there are three key areas for improvement in Medical Affairs: - Strengthening skills in emerging technologies/ AI, real world evidence, and big data - Performance metrics to deliver qualitative impact - Enhancing communication with C-suite executives

🚀 Exciting News for AI in Healthcare! 🚀 FDA has released new guidance on Marketing Submission Recommendations for a Predetermined Change Control Plan (PCCP) for AI-enabled device Software Functions (AI-DSFs). This is a significant step towards ensuring the safety and effectiveness of AI technologies in medical devices. Here are the key takeaways: 🔹 Scope: Applies to AI-DSFs intended to be modified over time, whether automatically, manually, or both. 🔹 Key Components of a PCCP: Description of Modifications: Detailed plans for future changes, including performance specs and rationale. Modification Protocol: Methods for developing, validating, and implementing changes, covering data management, re-training, and performance evaluation. Impact Assessment: Evaluates the benefits and risks to ensure continued safety and effectiveness. 🔹 Policy for PCCPs: PCCPs must be reviewed and authorized as part of a marketing submission. Modifications consistent with an authorized PCCP do not require a new submission, ensuring flexibility and innovation. 🔹 Implementation and Monitoring: Manufacturers must follow quality systems for modifications. Real-world monitoring plans are recommended to track device performance post-implementation. As someone passionate about the intersection of AI and healthcare, I believe this guidance is a game-changer. It paves the way for more innovative and adaptive medical devices, ultimately improving patient care and outcomes. 🌟 Did you know? The AI healthcare market is projected to grow from $20.9 billion in 2022 to $148.4 billion by 20291. This exponential growth highlights the transformative potential of AI in healthcare. What are your thoughts on the FDA’s new guidance? How do you think it will impact the future of AI in healthcare? Document issued on December 4, 2024. https://lnkd.in/d-QSNA5N

Title: Navigating Pre-determined Change Control Plans (PCCP) in FDA's Draft Guidance for Machine Learning - Device Software Function (ML-DSF) Introduction: The integration of machine learning (ML) has ushered in a new era of innovation within medical device software functions (ML-DSF), redefining diagnostic accuracy and treatment approaches. However, this rapid evolution presents regulatory challenges, particularly concerning iterative improvements to ML algorithms. To address this, the FDA has introduced a draft guidance on Pre-determined Change Control Plans (PCCP), offering a structured approach for managing modifications to ML-DSF. Significance of PCCP: PCCP offers a proactive approach for managing modifications to ML-DSF, mitigating the need for frequent regulatory submissions for iterative improvements. By providing a structured framework for pre-specifying and seeking pre-market authorization for intended modifications, PCCP facilitates the safe and efficient evolution of ML algorithms in medical devices. Key Components of PCCP: 1. Description of Modifications (SaMD Pre-Specifications - SPS): Anticipated changes to the ML-DSF's performance or input during operation. Referred to as "SaMD Pre-Specifications," these modifications serve as blueprints for outlining intended alterations to the ML algorithm. 2. Modification Protocol: Detailed methodology to control the risk of anticipated modifications delineated in the SPS. The following components are included: A. Data management practices: Such as data collection protocol, auditing, and screening of training and test datasets. B. Re-training practices: Criteria for triggering comprehensive performance evaluation using test datasets. C. Performance evaluation: Setting performance targets, statistical analysis, and assessment metrics. D. Update procedures: Plans for global and local updates, including the timing and implementation process. 3. Impact Assessment: Evaluation of the benefits and risks associated with implementing PCCP for ML-DSF. The following considerations are included: A. Assessment of individual modifications' benefits and risks, including potential social harm. B. Discuss how the activities in the Modification Protocol will continue to reasonably ensure the safety and effectiveness of the device C. Understanding the interplay between different modifications and their collective impact. Conclusion: The FDA's draft guidance on Pre-determined Change Control Plans (PCCP) provides a comprehensive framework for navigating the complexities of modifying ML-DSF in medical devices. By incorporating SaMD Pre-Specifications, Modification Protocols, and Impact Assessments, manufacturers can ensure regulatory compliance while fostering innovation in ML-driven healthcare technologies. #AIML #SaMD #PCCP #Medicaldevicesoftware #devicesoftwarefuntions #predeterminedchangecontrol

Interesting insights on the ethical imperative for pharma companies to improve online information accuracy. Leveraging KOLs and collaborative campaigns are crucial suggestions. However, empowering pharma medics & scientists to engage directly in social communities, including those 15+ years old, is an untapped potential not mentioned. This approach could transform pharma communications and patient support. I've successfully implemented this strategy once in my 15 years of experience. #pharma #medcomms #medaffairs #socialmedia

As 2025 begins, the transformative potential of GenAI in pharma continues to gain significant traction. In that spirit, I wanted to reshare my October interview, where I had the pleasure of sitting down with my client, Writer to discuss what Medical Affairs leaders need to know about harnessing GenAI. It was an insightful conversation with Writer's Life Sciences lead, Zayed Yasin, exploring how GenAI can deliver value for Medical Affairs.

🚀 Driving Success in Clinical Trials: The MSL's Strategic Role As an MSL, you’re more than a scientific expert—you’re a critical link between clinical trials and real-world practice. Here’s how you can maximize your impact: 📣 Bridge the Gap - Connect trial designs with real-world applications to ensure research is practical and impactful. 🩺 Share Actionable Feedback - Bring valuable insights from healthcare professionals directly to the research teams, influencing trial strategies. 💡 Enhance Trial Outcomes - Leverage your scientific expertise to advocate for protocols that improve patient outcomes and data quality. Your role in clinical trials is essential—and evolving. Stay tuned! We’ll soon be launching an exclusive course on AI in Medical Affairs to help you further amplify your strategic impact in research and beyond. #MSLInsights #ClinicalTrials #MedicalScienceLiaison #AIinMedicalAffairs #ExcelInMedicalAffairs #MSLCareer #MSL #ClinicalPharma #Pharma #Biotech #MedicalAffairs

Here's my 2024 LinkedIn Rewind, by Coauthor.studio: This year crystallized my commitment to advancing healthcare through the intersection of traditional pharmacy and emerging technologies. ⭕ My journey through 2024 was defined by relentless learning and practical experience. From my association with Calcutta National Medical College & Hospital to obtaining specialized certifications, I've been mapping the future of pharmaceutical sciences. 📍Key milestones that shaped my professional growth: → Completed certification in Telemedicine and Clinical Pharmacology Practice, understanding how digital platforms are transforming patient care → Obtained In silico New Approach Methodologies certification, exploring cutting-edge drug design techniques → Participated in WHO's Global Neglected Tropical Diseases programme, expanding my understanding of global health challenges 📌 Three posts that captured my professional evolution: 1. National Pharmacy Week Celebration Reflecting on the critical role of pharmacists: "Pharmacists are essential healthcare providers who guarantee that patients receive individualized, safe and efficient care. They are more than just dispensers." https://lnkd.in/dPAfF8PK 2. AI in Pharmaceutical Education Webinar Exploring how technology is revolutionizing learning in our field. https://lnkd.in/dpuZurhM 3. WHO Global NTDs Programme Expanding expertise in addressing critical global health challenges. https://lnkd.in/d-yZh-E3 As I approach my final year of B.Pharm, I'm committed to integrating AI, digital health technologies, and traditional pharmaceutical practices. My goal is to contribute meaningfully to healthcare innovation, bridging technological advancement with compassionate patient care. The pharmaceutical landscape is evolving rapidly, and I'm excited to be at the forefront of this transformation. #PharmacyInnovation #HealthTech #PharmaEducation #GlobalHealth #LinkedInRewind #Coauthor #2024wrapped -- Get your 2024 LinkedIn Rewind! Go to coauthor.studio