Phil Richardson’s Post

The use of artificial intelligence in #clinicaltrials holds immense promise, from accelerating drug discovery to optimizing patient recruitment and trial design. However, the integration of AI also introduces complex ethical considerations that must be carefully navigated. I am delighted to that announce our Exploring the Ethical Implications of #AI Use in Clinical Trials Virtual Roundtable is taking place on 10 December 2024 | Online I 4pm-5pm GMT/ 5pm-6pm CET / 11am-12pm EST. Join us for an insightful discussion as we discuss the ethical implications of AI use in clinical trials, paying particular attention to emerging risks, key considerations, and future trends. Don’t miss the opportunity to hear from the following clinical trials technology leaders: ·Nikita Sharma, Digital Health Solutions Manager, Astellas Pharma ·Alexandre Malouvier, Senior Director Scientific Affairs & Digital Innovation, ICON plc ·Alex Sverdlov, Senior Director, Statistical Scientist, Novartis REGISTER FREE today: https://lnkd.in/ejKTGekK #ClinicalTrialsVRT #AIClinicalTrials #EthicalAI #DisruptiveTechnolgies #DisruptiveCTEurope 

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

𝗛𝗼𝘄 𝗦𝗵𝗼𝘂𝗹𝗱 𝗪𝗲 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗲 𝗚𝗲𝗻𝗲𝗿𝗮𝘁𝗶𝘃𝗲 𝗔𝗜 𝗶𝗻 𝗛𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲? 🏥💡 As generative AI technologies like #ChatGPT and others rapidly advance, regulators face a unique challenge in adapting traditional frameworks for healthcare. Current FDA regulations, designed for specific drugs and devices, fall short when applied to AI models with vast and evolving capabilities. A novel approach is needed — one that treats these AI systems more like human clinicians, requiring rigorous training, supervision, and periodic reassessment. While challenges such as AI "hallucinations" and transparency in training data remain, a thoughtful regulatory framework can ensure these technologies safely enhance clinical practice. I was recently invited to deliver three keynotes during the 82nd International Pharmaceutical Federation (FIP) World Congress of Pharmacy and Pharmaceutical Sciences 2024 in Cape Town, South Africa from 1-4 September. During these sessions, I emphasized that we need a completely new approach and framework to regulate AI in healthcare — fully aligned with these insights. The future of #Healthcare and #HealthTech depends on it. 🚀 Special thanks to my friend Prinesh Reddy for sharing that article with me 🙏 #AIinHealthcare #GenerativeAI #DigitalHealth #Innovation #FIP2024 #FIPCongress Lars-Åke Söderlund (Exec MBA) Vice President Harvey Castro, MD, MBA. Professor Shafi Ahmed Dylan Attard MD, MRCSI, MEnt. Alex Diaconu Dr. Martha Boeckenfeld Dr. Khulood Alsayegh Dr. Mariam Mohamed Fatima Matar MD Phd Dr. Meshari F. Alwashmi Fady Hannah-Shmouni, MD FRCPC Xiaochen Z. Ricardo Moraes Virgilio Gibbon Ana Araujo Hassan Chaudhury HonFAPM Vijay K. Luthra Pilar Fernandez Hermida Jijo James Rémy LEVASTRE

What are the key data sources powering AI in clinical research? Ben Gmeiner, Director of Medical Data at Novartis, shares insights on the critical data sources used to train AI models in clinical trials, driving more efficient research, faster drug development, and improved patient outcomes. 🎥 Watch the full episode: https://lnkd.in/esHhp4J5 #AI #ClinicalResearch #MedicalData #DataScience #AIinHealthcare #Innovation #DrugDevelopment

What are the key data sources powering AI in clinical research? Ben Gmeiner, Director of Medical Data at Novartis, shares insights on the critical data sources used to train AI models in clinical trials, driving more efficient research, faster drug development, and improved patient outcomes. 🎥 Watch the full episode: https://lnkd.in/es7HkZ8P #AI #ClinicalResearch #MedicalData #DataScience #AIinHealthcare #Innovation #DrugDevelopment

Aviv Regev's TED talk recorded at TEDAI San Francisco is live! https://lnkd.in/dNz_CNiN See Aviv's perspective below. Are you working in the field? Are you a patient? What do you think? Aviv's perspective on AI is deeply intertwined with her pioneering work in computational biology and systems biology. She sees AI as a transformative tool for decoding the complexities of biology at a scale previously unimaginable. She envisions AI not just as a tool for analyzing data but as a collaborative partner in scientific discovery, enabling breakthroughs in personalized medicine and treatments. She believes that AI can help us map the intricate networks of genes and cells, ultimately unlocking deeper insights into disease mechanisms. In her view, AI’s greatest potential lies in its ability to integrate massive datasets, revealing patterns that humans alone might overlook. Regev advocates for the synergy between human intuition and AI’s computational power, pushing boundaries in the life sciences. This perspective encourages us to think beyond traditional experimentation, imagining a future where AI accelerates discoveries that improve lives and expand our understanding of biology.

𝐀 𝐍𝐞𝐰 𝐄𝐫𝐚 𝐨𝐟 𝐀𝐈 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧 𝐢𝐧 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞: 𝐀𝐫𝐞 𝐖𝐞 𝐑𝐞𝐚𝐝𝐲? As generative AI transforms healthcare, it brings incredible potential—but also unprecedented challenges. The FDA’s traditional regulatory frameworks just aren’t built to handle AI models like ChatGPT or Gemini, which evolve rapidly and have countless applications. Why the Current System Fails: Generative AI isn’t like a new drug or device that gets approved for one specific use. These AI models continuously learn and change, making them almost impossible to regulate with existing methods. The stakes are high, and we need a new approach. A New Way Forward: Imagine if we regulated AI like we do human intelligence in healthcare. Before being “licensed,” AI could undergo: • Specialized Training: Models would be trained on healthcare materials like clinicians. • Supervised Practice: Just like medical residencies, AI would operate under expert supervision. • Ongoing Evaluation: Periodic retraining and testing would ensure AI remains accurate and up-to-date. Why This Matters: Creating a new regulatory framework isn’t just bureaucracy—it’s about ensuring safety and trust in healthcare innovations. As generative AI becomes more prevalent, a robust regulatory system could be key to unlocking its true potential while minimizing risks. Special thanks to my friend Prinesh Reddy for sharing this insightful article with me! Breakthroughs like these require equally groundbreaking policies. Let’s discuss how we can navigate this new era together! #AI #HealthcareInnovation #FutureOfMedicine #DrGPT

Sorcero Announces New Scientific Sentiment™ to Revolutionize Pharma Engagement Strategies — MediaContacts.co — Leading #Life Sciences #AI #Platform enables strategic decision-making and targeted #communication with #realtime #analytics on KOL/HCP #product #perception in #Spring #2024 Release WASHINGTON, #April #25 2024 Sorcero, the leading provider of #advanced AI #solutions purpose-built for life sciences, #today announced the #release of Scientific Sentiment, enabling Life Sciences #teams for the first time, to quantify product perception across KOLs and the #market to more accurately measure #trends identify evidence gaps, and quantify the #ROI of #outreach efforts. By leveraging the most advanced medically-tuned #large #language models

SAVE THE DATE! 🗓️ We are so excited to announce "The State of AI in Precision Health," our upcoming conference in Boston on October 10, 2024 exploring how #AI is revolutionizing the fields of #health, #lifescience, #drugdiscovery and more! 🧬 Designed for industry leaders, researchers, policymakers, administrators, and #healthcare decision-makers, this special event will ask important questions about the relationship between #data, AI, life, and health, and how to chart a course for future discovery that works for stakeholders and patients. “The next few years will bring a new health ethos in which clinical care providers and individuals leverage AI to make more informed and personalized decisions," our Director of AI + Health, Eugene Tunik said. "This conference is an opportunity to step back and look at where we are now and where we want to be in 10-20 years." "AI and drug discovery is front-page news in 2024," our Director of AI + Life Sciences, Samuel Scarpino said. "We will continue to read about the impact of AI throughout the pharmaceutical lifecycle, including various stages of R&D, clinical trial design, regulatory approval, and the identification of novel combination therapies." Learn more about this must-see event: https://lnkd.in/g9xhzEeu #artificialintelligence #AIevents #AInews #BostonAI #research #policy #precisionhealth

Clinical trials are notoriously slow and expensive. Our latest market map highlights 96 tech companies transforming this process, making trials faster, cheaper, and more patient-centric. Decentralized clinical trials (DCTs) are gaining major traction. AstraZeneca’s $80M investment in Huma and the acquisitions of Science 37 and Emvenio Research signal a wave of consolidation. Digital twins and AI-driven analytics are also emerging as game changers—enabling faster, more efficient trials and improving patient recruitment. Explore the full report to see how clinical trials tech is reshaping the industry (link in comments, accessible for CB Insights clients, but reach out to discuss!) #ClinicalTrials #HealthcareInnovation #DigitalHealth #AI #PatientCentricity #ClinicalResearch