FDA’s Post

On Tuesday August 6, 2024 from 10 AM to 5:30 PM EDT, the FDA and the Clinical Trials Transformation Initiative are hosting a free hybrid public workshop on artificial intelligence (AI) in drug and biological product development. Exploring the guiding principles that are being applied by innovators and regulators to ensure AI is used responsibly in the field of AI. AI holds great potential to transform how drugs are developed, manufactured, and utilized.

Don’t miss this free workshop on AI in drug and biological product development. Discover the guiding principles that innovators and regulators use to ensure responsible use of AI in drug development, manufacturing, and usage.

We think this workshop on AI would be a good use of everyone's time. Let's learn about application of this powerful technology together.

Tomorrow (2/22) is the Virtual 2024 USDM Life Sciences Summit! Don't miss our CCO and Co-founder Richard Graves session "AI Fueled Use Cases for Intelligent Automation." As AI rapidly transforms pharma, biotech, and med device industries, this virtual summit comes at an opportune time. However, what are the practical AI use cases for today? And how to implement ethically and compliantly? Richard will join Dr. Andrée Bates, Riju Khetarpal, John Petrakis, and moderator Lisa Om for an insightful panel on "AI Fueled Use Cases for Intelligent Automation." They will share real-world perspectives and a live Q&A. With regulators closely monitoring AI, forward-thinking compliance strategies are key to navigating the landscape. By embracing AI, companies can bring innovative treatments to market faster and more confidently. Learn more and register here: https://hubs.li/Q02lQwrN0 #AILifeSciences #AIMedicine #AIDrugDiscovery #PrecisionMedicine #ClinicalTrials #MedicalData #Pharma #Biotech #MedTech #DigitalHealth #MachineLearning #DeepLearning #Bioinformatics #RegulatoryCompliance #DataCompliance #GxPCompliance #ArtificialIntelligence #EthicsInAI #ResponsibleAI #IPLaw #DataProtection

#Predictiveanalytics powered by #ai is emerging as a game-changing tool in #pharma to preserve revenue in the face of patent expiration challenges and market uncertainties. As the development and approval process for new drugs grows longer and more expensive, the need to accurately forecast demand and anticipate challenges to market uptake has never been more pressing. By analyzing the vast and growing volumes of structured and unstructured data now available, AI-driven #predictivemodeling offers an unprecedented ability to peer into the future. See use cases here: https://lnkd.in/e6Ci9JkD

📚🤖 Simplifying the AI Act: A Journey Through 400 Pages 📖🔍 I’ve been diving deep into the AI Act, attempting to distill the essence of its first part. Let’s just say, summarizing 400 pages is no small feat! 😅 The document I’ve produced is an analysis of the initial section of the Artificial Intelligence Act. It primarily focuses on general issues and the management by deployers of the use of AI classified as high risk, with a spotlight on the healthcare sector. 🏥💡 This simplification aims to facilitate understanding of the regulation, comprehend the interactions with other regulations, and how to transition from a theoretical approach to a practical assessment. 🎯 While this is just the first part that may overlook some details, it emphasizes others. I hope it can be of help to you. 🙌 Particular attention is given to new technologies in the pharmaceutical and automotive industries. This initial reading will assist you in identifying the subjects, understanding the scope of application of the regulation, and recognizing the obligations that arise for such subjects. 🚗💊 Stay tuned for more insights! 🚀 #AIAct #ArtificialIntelligence #Regulation #Healthcare #Pharmaceutical #Automotive #AI

Attending FDA-CTTI workshop on AI at the FDA in Maryland. Super workshop on the development of AI in drug development. Initial key message: we need to go beyond multidisciplinary approaches. We need to become Multi-fluent. AI cannot work in silo, the fluency across multiple areas of expertise is now a key requisite to make progress. https://lnkd.in/etBRpv8a

Healthcare is the largest data-generating industry in the world, thanks to an increasing number of digital monitoring and treatment options. Artificial intelligence and machine learning are now empowering the industry to decode vast amounts of data from patients, providers and researchers alike. When applied to their highest potential, these technologies can transform information into insight, helping drive drug discovery, optimize patient interactions and streamline delivery of care. With access to a greater range of medical data becoming more cost-effective and easier to utilize, the benefits for pharmaceutical developers, physicians and patients will expand rapidly. This expansion, coupled with the increasing ability of AI to identify key markers in the store of genomic data—which is becoming cheaper by the year—appears to put us on the cusp of trailblazing advances in how we care for patients and treat diseases. The following chart illustrates how different themes within this section are progressing toward mass adoption. Themes that are earlier in the adoption curve have more room for growth—and potential variance—ahead Source: https://lnkd.in/g-DZcTRh #AI #healthcare #healthcareinnovation #techadvancements #tech

𝗧𝗵𝗲 𝗜𝗻𝘁𝗲𝗿𝘀𝗲𝗰𝘁𝗶𝗼𝗻 𝗼𝗳 𝗔𝗜 𝗮𝗻𝗱 𝗛𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲: 𝗔 𝗙𝘂𝘁𝘂𝗿𝗲 𝗗𝗲𝗳𝗶𝗻𝗲𝗱 𝗯𝘆 𝗘𝗻𝗵𝗮𝗻𝗰𝗲𝗱 𝗘𝗳𝗳𝗶𝗰𝗶𝗲𝗻𝗰𝘆 𝗮𝗻𝗱 𝗣𝗲𝗿𝘀𝗼𝗻𝗮𝗹𝗶𝘀𝗲𝗱 𝗖𝗮𝗿𝗲 In an era where technology continues to intersect with all facets of our lives, it's exciting to see the transformative impact of Artificial Intelligence (AI) in healthcare. This fusion promises not only to enhance operational efficiencies but also to revolutionise patient care through personalisation. As we stand on the cusp of this new dawn, it's crucial to explore how AI can be harnessed within the pharmaceutical realm. From drug discovery and development to patient diagnosis and treatment plans, the potential is boundless. However, this journey isn't devoid of challenges. The integration of AI brings forth questions regarding ethics, data security, and the need for robust regulatory frameworks. Embracing AI in healthcare necessitates a balanced approach that champions innovation while safeguarding patient privacy and trust. As pharmacists and industry leaders, our role in shaping this future cannot be understated. We must actively engage in discussions, collaborate across sectors, and advocate for policies that foster a conducive environment for technological advancements. The road ahead is filled with opportunities. By leveraging AI, we can unlock unprecedented levels of efficiency and personalisation in healthcare. Let us harness this potential responsibly, ensuring we remain at the forefront of delivering superior care in an increasingly digital world. #HealthcareInnovation #AIFuture #Pharmaceuticals #DigitalHealthcare

Game changing: How AI and automation is revolutionising clinical trial admin In the wake of COVID-19, clinical trials deserve our attention more than ever. If there’s one thing to be learned from the pandemic years, it is that effective development and testing of drugs and vaccines can have a tremendous impact.   The succ... https://lnkd.in/egXRUEKh #BioTech #science