AMG World’s Post

NEW! Beyond the benchmark: How Innovative Trial Designs are Transforming Clinical Research: https://ow.ly/Ejkp50UfVMt. Access exclusive insights from the 2024 Annual Global Trends in R&D Report, plus learn why biotechs must focus on innovative strategies, new regulatory frameworks and advanced technologies like AI, to remain at the forefront of clinical development. | In partnership with IQVIA Biotech.

✨ If you know me, you know how much I love talking about AI in health! ;) That's why I am excited to share that Johnson & Johnson has been featured in Artefact and AI for Health's new report: "Revolutionizing Drug Development with AI: The Future of Clinical Trials". Check out the screenshot below for J&J’s perspective, and don’t forget to explore the full report at this link: https://lnkd.in/exNeVvtr This report takes a deep dive into how AI is reshaping clinical trials—making them faster, more efficient, and more inclusive. It was an honor to represent Johnson & Johnson and contribute to such an important discussion alongside industry leaders like Pfizer, Servier, and innovative tech partners like Deemea, Elaia, Google, Inato, and Klineo.

Generative AI is reshaping clinical documentation and regulatory submissions, offering faster, more efficient processes. However, its true success lies in addressing critical challenges: data readiness, optimizing content ecosystems, and eliminating inefficiencies in CSR creation. vanessa de langsdorff of Yseop recently collaborated with John April of Eli Lilly and Company and Inger Ødum Nielsen of Novo Nordisk to publish an article in Applied Clinical Trials Magazine, exploring how organizations are overcoming these challenges and maximizing the return on GenAI investments. 📖 Read the full piece here: https://lnkd.in/eD8i4QiG #GenerativeAI #MedicalWriting #RegulatoryAffairs

📢 Are you ready to explore how Big Data, AI, and Machine Learning are transforming drug safety? I am coordinating together with Faisal Khan, PhD (Novo Nordisk) and Morten Andersen (University of Copenhagen) the upcoming course "Big Data, AI, and Machine Learning in Drug Safety" offered by Atrium (Lone Rex and Louise V. Petersen). This course brings together an outstanding lineup of speakers from industry and academia, including: ✨ Rajendra (Raj) Hattarki, COO, ArisGlobal ✨ Lucie Gattepaille, Head of Data Science, Uppsala Monitoring Centre ✨ Andrew Bate, VP & Head of Safety Innovation & Analytics, Global Safety, GSK ✨ Sameer Thapar, Oracle Health Science ✨ Jan Petracek, Chief Executive Officer, iVigee Throughout the course, we’ll dive into how AI tools are being applied to drug discovery, pre-clinical and clinical development, and post-marketing surveillance to improve patient safety. 💡 Don’t miss the opportunity to learn from leading experts and gain cutting-edge insights into how data science and AI are shaping the future of drug safety. 👉 Enroll now and join us: https://lnkd.in/dw7iND3z Looking forward to seeing you there! 🚀 #DrugSafety #AI #MachineLearning #BigData #Pharmacovigilance #Innovation

We are proud to be working with Eli Lilly and Novo Nordisk to drive industry awareness around maximizing efficiencies in Medical Writing using AI.

🌐 Attention Therapeutic Area Leaders in Biopharma! 💊 Are you facing the daunting challenge of efficiently navigating the complexities of clinical trials and drug development? 😰 You’re not alone! As leaders in your field, you’re deeply invested in finding innovative solutions to accelerate timelines and drive meaningful outcomes for patients. 🔍 **Top Struggle: Data Overload** In the world of biopharma, the sheer volume of data available can be overwhelming. It often leads to critical insights getting lost in the noise. How do you sift through mountains of information and extract real value that can enhance decision-making and drive successful therapeutic applications? 💡 **The AI Solution!** Here's where AI steps in. By harnessing advanced analytics and machine learning algorithms, we can transform the way you approach data. AI can: 1. 🎯 **Identify Key Patterns:** Spot trends and connections in complex datasets faster than ever before. 2. 📊 **Optimize Trials:** Enhance patient selection and trial design, leading to faster and more efficient outcomes. 3. 🔍 **Predict Outcomes:** Anticipate potential roadblocks and adapt strategies proactively. Let technology do the heavy lifting while you focus on strategic decisions that propel your therapeutic area forward! 🚀 Let’s embrace the future of biopharma together—because improving patients’ lives is the ultimate goal. What challenges do you face? How do you see AI changing the landscape of drug development? Share your thoughts below! 👇💬 #Biopharma #AI #ClinicalTrials #DataAnalytics #TherapeuticArea #Innovation #PatientCentricity

AI is reshaping clinical development, creating new opportunities to enhance patient recruitment and streamline clinical data management. At the Indegene Digital Summit, life sciences leaders from GSK, Bayer, and J&J discussed real-world AI applications that are transforming trial workflows, reducing costs, and accelerating timelines. Read our latest blog to discover how AI is bringing operational excellence within reach for clinical trials! https://lnkd.in/dc7Th_t9 #FutureReadyHealthcare

Exciting news! 🌟 Dive into the world of AI/ML in clinical trials with our latest white paper authored by my colleague Patrick Brady. Learn about the regulatory expectations, strategic implementation, and benefits of AI/ML across the drug development lifecycle. Keys to Success: 1) Consider the regulatory climate in the markets where you seek approval 2) Design risk-based approaches 3) Develop a set of standards 4) Apply good ML practices 5) Leverage AI/ML strategically in your trial 6) Prepare your project teams for success (don't forget the people component!!) Discover insights on patient recruitment, dose optimization, regulatory compliance, and risk management. Stay ahead in the evolving landscape of drug development by downloading now! #AI #ML #ClinicalTrials #DrugDevelopment #Innovation #IQVIA #RegulatoryAffairs #BigPharma Eliza Silvester, Matthew Smith, Matt Doyle, Nick Mageras, Carmen Sivakumaren, PhD Abir Yamak, Ph.D. Eric E. Bayir, MSc, MBA, Gonzalo Lemus, Charles Vizzini, Greg Plante, Aziz Mallik, Elyse Muñoz, PhD, Leah Magid Herbert Valerie Eng John DeMarrais Ian Fisher Reid D'Amico, Ph.D. Rob Glik Erin Gerardo Rounak Baid Thomas J. Franco Terry Shea Luke Greenwalt Michel Denarie Jun G. Adrian McKemey Paul Villa Kelley Coalier, MS, MBA Gopa Radhakrishnan, MPH Daniel Feld, MBA, MPH Angela Donato James Noll Aakansha Nangarlia, PhD Amritha J. Yash Dave, Elizabeth Powers, Patrick Dunn, Bill Jensen

🔬 AI adoption is accelerating across life sciences, with growing enthusiasm in departments leveraging open-source data - competitive intelligence, medical affairs, R&D, BD, new product planning, etc. In my recent talks at the Pharma CI Conference and Pharma and MedTech Information (PhMTI) conferences, I discussed how various AI levels can be effectively used across these functions. Few key takeaways from my talk and recent industry observations: 👥 The AI spectrum (simple to general) requires task-appropriate application, balancing AI capabilities with domain expertise for the right use cases 🎯 Successful AI implementation requires clear business objectives, strategic implementation, and ongoing ROI measurement 🚀 AI workflow development and pilot project selection are crucial steps in the execution phase #AIinLifeSciences #DigitalTransformation #OpenSourceAI #CompetitiveIntelligence #AIStrategy #kognitic #pharma

Recently, I tuned into the Financial Times US Pharma and Biotech Summit 2024. Having worked in healthcare communications for #pharma and #medtech clients for over a decade, I find it compelling to see how advanced technologies like #AI and machine learning are evolving the drug development industry. One highlight from the Summit was the keynote, "The AI View from the FDA," which discussed how the FDA considers the use of AI in product development. Here are a few key takeaways for healthcare communicators: ➡️ The FDA increasingly embraces AI in drug development, having received over 300 submissions utilizing AI and machine learning since 2016, primarily in clinical research. While this momentum is promising, companies need to build credibility and trustworthiness in this evolving landscape by communicating transparently about their AI methodologies and validation standards, and by demonstrating a clear benefit to patient outcomes. ➡️ The FDA will publish guidance later this year on the agency's role in enabling the responsible use of AI technology and its considerations for regulatory decision-making. Healthcare communicators have the opportunity to emphasize their organization's proactive approach and adherence to these standards, showcasing their dedication to responsible innovation and patient safety. ➡️ The FDA also faces challenges, such as attracting and upskilling talent in AI and data science to ensure data and model security. Multi-disciplinary industry collaboration will be key to ensuring stakeholders can effectively evaluate product decisions on behalf of patients. For healthcare communicators, staying on top of AI and its impact within the regulatory landscape is essential as we guide health companies navigating this space. At Global Gateway Advisors, we closely monitor AI and its impact on the health industry. In case you missed it, check out our latest newsletter on AI and health trends in the link below in my comments. #Pharma #Biotech #AI #DrugDevelopment #HealthcareCommunications #FTPharma