My fellow panelists at the Milken Institute Global Conference made excellent points, especially these: we are in the early era of the "exponential curve" that will accelerate drug discovery with the help of AI, and it is going to take whole new models and innovative approaches to take maximum advantage of the potential. Great write up:
Noubar Afeyan’s Post
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With 203 regulatory submissions including #artificialintelligence or #machinelearning in 2023, some interesting insights fromthe FDA's Tala Fakhouri about the exponential growth in this realm and a risk-based approach for the future. The approach will assess the #AI model's influence or how much the process depends on the AI model. Fully automated processes are considered higher risk than those that produce results to be used by humans in the process. The approach will also evaluate the consequences of the decisions; in other words, what happens if the AI is wrong. #clinicalresearch https://lnkd.in/efUSse9X
Q&A: How the FDA is approaching AI in clinical trials and drug development
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This video discusses the evolving landscape of Biotech and the integration of AI technology. Many Biotech clients are transitioning towards electronic systems across the product life cycle. Check out this insightful video on the future of Biotech and the role AI is set to play: [Link to the video] #Biotech #AI #Innovation
Carl Sailer on AI, market trends, and strategic planning in biotech
fiercebiotech.com
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Harnessing AI in Pharmaceutical Innovation: Insights and Implications 🚀🔬 The recent webinar on the integration of Artificial Intelligence (AI) in the pharmaceutical industry offers a deep dive into how AI is reshaping the landscape from drug discovery to market access. Here are the key takeaways: ✔ Broad Impact Across Functions: AI is expected to add significant value across various pharmaceutical functions, potentially up to $110 billion, enhancing everything from commercial operations to clinical development. 📈 ✔AI in Drug Discovery: AI's role in accelerating drug discovery is profound. By analyzing vast datasets, AI can identify promising drug candidates faster, significantly reducing the time for preclinical stages and enhancing drug efficacy and safety through more personalized medicine. 💊🧬 ✔ Enhancing Clinical Trials: AI improves patient trial matching and the efficiency of clinical trials by analyzing patient data to identify those most likely to respond to therapies, thus optimizing recruitment and operational efficiencies. 🧪📊 ✔ Medical Affairs and Market Access: In medical affairs, AI helps in mining key insights from interactions with healthcare professionals, enhancing stakeholder engagement. For market access, AI supports the formulation of strategies that navigate reimbursement hurdles more effectively. 🏥💡 ✔ Post-Market Surveillance: AI supports the monitoring of drug safety and efficacy post-launch by analyzing social media and other digital platforms, aiding in real-time signal detection and adverse event tracking. 📢🔍 ✔ Legal and Compliance Considerations: The webinar also highlighted the importance of considering legal aspects when integrating AI, emphasizing compliance, intellectual property rights, and data integrity. 📜⚖️ ✔ Future Trends and Predictions: The integration of AI within pharmaceutical workflows is expected to become more prevalent, necessitating careful implementation to align with existing business processes and regulatory requirements. 🌐🔮 *This discussion underscores the transformative potential of AI in enhancing drug development and market strategies, while also pointing out the need for robust frameworks to manage associated risks and ensure compliance. Special shout out to the key contributors: William Soliman Alex Shandro Kiana Dixson, PharmD, BCMAS #AIinPharma #DrugDevelopment #HealthcareInnovation #Pharmaceuticals #ArtificialIntelligence
The Next Frontier: Generative AI in Pharma and Legal Considerations
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Usage of Artificial Intelligence/Machine Learning, shortened to AI/ML, has accelerated in drug development during the past few years. There are even more potential AI drug development applications forthcoming. Want to learn more about the future of AI and drug development?
AI and Drug Development Updates and Opportunities
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The FDA can help innovative clinical trials and drug development with AI tools, or it can hinder. The interview below shows there's still a big learning curve for them. My concern is do they have the expertise to adequately address AI? They can't take years to develop a framework. #ai #drugdevelopment #clinicaltrials
Q&A: How the FDA is approaching AI in clinical trials and drug development
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Chapter 3 of our 10th Anniversary Celebratory feature, "The Multifaceted Future of Pharma" is now live on The Medicine Maker This time, we explore how the use of AI, ML, and other digital and automated technologies will transform drug development and manufacture. https://lnkd.in/eZ7SURei
The Multifaceted Future of Pharma – Chapter 3: A World of AI, Data, and Automation
themedicinemaker.com
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In Parexel's latest edition of the "New Medicines, Novel Insights" newsletter, Mwango Kashoki and Stephen Pyke provide insights into the latest guidance from global health authorities on the regulatory approval of AI in clinical trials. Discover the challenges faced by biopharma companies and essential considerations when planning for the use of AI in drug discovery and development.
Regulatory acceptability of AI: Current perspectives
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From protein structure prediction to clinical trial recruitment to regulatory compliance - discover the potential for AI in pharma R&D.
Explore the potential for AI in Biopharma R&D
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I've been immersing myself in AI trainings and discussions lately, so this article caught my attention at the perfect time. My mind is filled with questions about AI, especially in the context of my industry. Excited to see what unfolds in this space! #AI #DrugDevelopment #Innovation
FDA plans to release AI drug development guidance this year
raps.org
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🚨 𝘉𝘳𝘦𝘢𝘬𝘪𝘯𝘨 𝘕𝘦𝘸𝘴 𝘧𝘰𝘳 𝘵𝘩𝘦 𝘉𝘪𝘰𝘱𝘩𝘢𝘳𝘮𝘢 𝘊𝘰𝘮𝘮𝘶𝘯𝘪𝘵𝘺! We’re excited to introduce 𝐭𝐡𝐞 𝐟𝐢𝐫𝐬𝐭-𝐞𝐯𝐞𝐫 𝐟𝐫𝐞𝐞 𝐀𝐈-𝐩𝐨𝐰𝐞𝐫𝐞𝐝 𝐬𝐞𝐚𝐫𝐜𝐡 𝐞𝐧𝐠𝐢𝐧𝐞 𝐟𝐨𝐫 𝐭𝐡𝐞 𝐁𝐢𝐨𝐩𝐡𝐚𝐫𝐦𝐚 industry, Hypothesus AI! 🎉 🔬 Hypothesus AI is our cutting-edge tool set to transform how you discover and leverage critical information, enabling faster, more informed decisions and accelerating your research efforts at no cost. But that’s not all… we’re also enhancing our landing page to provide an even more seamless and user-friendly experience. Our revamped design will make it easier than ever for you to access the tools and insights you need to drive innovation and advance your research. 👉 Explore Hypothesus AI for FREE and our updated platform here: https://bioknow.io/ #biotech #biopharma #ai #HypothesusAI
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Co-Founder at Embark Healthcare
7moAll good points, particularly as it relates to de novo discovery, but if we're talking about reducing the time and cost of drug development, repurposing needs to be a part of that discussion. As much as new technologies have brought amazing drugs to market and hold great promise for the future (i.e., CRISPR, mRNA, AI, etc.), the fact is that repurposed drugs play a big role too (unfortunately, because of the issue of defining "repurposed," no reliable stats are available on the percentage of repurposed drug approved versus de novo), and rather than 10% of de novo drugs historically gaining approval, it's 30% for repurposed drugs, plus the clinical development route is shorter and cheaper.