RegASK’s Post

FDA’s Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, and Office of Combination Products recently published a joint discussion paper on artificial intelligence and medical products. Read our insights here. https://lnkd.in/ede_VVyB #AI #medicalproducts #devices

FDA’s Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, and Office of Combination Products recently published a joint discussion paper on artificial intelligence and medical products. Read our insights here. https://lnkd.in/e_guKHhy #AI #medicalproducts #devices

FDA Publishes AI White Paper ◾ “Artificial Intelligence & Medical Products" discusses the use of AI across the product life cycle of “medical products.” The white paper describes the FDA's (U.S. Food and Drug Administration) intent to use a "risk-based" regulatory framework to evaluate AI in medical products. The four areas of FDA focus discussed are: ▪ Fostering Collaboration ▪ Advancing Innovation ▪ Harmonized Standards And Guidelines ▪ Supporting AI Research If this is your area of work or interest, the King & Spalding article can be found here: https://lnkd.in/eu4WrqPM #ai #artificialintelligence #aimedical

Generative AI in Action in Biopharma, today! We have developed a robust Gen-AI tool to robustly provide L1 support in medical writing, across clinical development, medical affairs, regulatory submissions/responses, medical communication and information. This self measured standalone tool reduces the labor need by 35%, increases the efficiency, proficiency, accuracy/precision of the articulations, and consistency of the documents across your API- generated vault by more than 100%. Case studies are available upon an NDA. AI institute level collaboration and fund raising is under way. Collaborations is greatly emcouraged. Some of our recent success in the approval real have been benefited from this tool. We have reduced the R&D cost by about 48% across our current programs, while raising the bars in accuracy, consistency, and reliability of the presented data/medical- clinical assessments and articulation. Visit: https://lnkd.in/eYJPh3Wt

𝐀𝐈 𝐢𝐧 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥𝐬 𝐚𝐧𝐝 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬: 𝐃𝐫𝐚𝐦𝐚𝐭𝐢𝐜 𝐄𝐟𝐟𝐢𝐜𝐢𝐞𝐧𝐜𝐲, 𝐓𝐢𝐦𝐢𝐧𝐠, 𝐚𝐧𝐝 𝐂𝐨𝐬𝐭𝐬 𝑰𝒎𝒑𝒓𝒐𝒗𝒆𝒎𝒆𝒏𝒕𝒔 𝐢𝐧 𝐌𝐃𝐑 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝑰𝒏𝒕𝒓𝒐𝒅𝒖𝒄𝒕𝒊𝒐𝒏 Artificial Intelligence (AI) is pivotal in revolutionizing tasks mandated by EU Medical Device Regulation (MDR) No. 2017/745 for the pharmaceutical and Medical Device Industries. It optimizes timelines, cuts costs, and mitigates Compliance Risks. This marks a significant development in the expanding application of AI within Pharmaceuticals and Medical Devices. See also: a) https://lnkd.in/gj9idAtr b) https://lnkd.in/gCBwfgzS c) https://lnkd.in/gvhPRHFA 𝑨𝑰'𝒔 𝑹𝒐𝒍𝒆 𝒊𝒏 𝑴𝑫𝑹 𝑷𝒐𝒔𝒕-𝑴𝒂𝒓𝒌𝒆𝒕𝒊𝒏𝒈 AI optimizes post-marketing surveillance and clinical evaluation processes, making bureaucratic activities more efficient and less risky. It includes: 𝘾𝙝𝙖𝙩𝙗𝙤𝙩𝙨 for efficient global complaint management. 𝑨𝑰-𝒅𝒓𝒊𝒗𝒆𝒏 precise 𝘾𝙤𝙢𝙥𝙡𝙖𝙞𝙣𝙩 𝘼𝙣𝙖𝙡𝙮𝙨𝙞𝙨 for timely interventions. Rapid and accurate 𝑺𝙮𝙣𝙩𝙝𝙚𝙨𝙞𝙨 𝙖𝙣𝙙 𝑰𝙣𝙩𝙚𝙜𝙧𝙖𝙩𝙞𝙤𝙣 𝙤𝙛 𝑹𝙚𝙥𝙤𝙧𝙩𝙨 with AI, identifying trends and safety or performance issues. Through 𝙁𝙞𝙚𝙡𝙙 𝘿𝙖𝙩𝙖 𝘼𝙣𝙖𝙡𝙮𝙨𝙞𝙨 AI speeds existing products' improvement, enhancing treatment outcomes. 𝑨𝑰 𝑰𝒏𝒕𝒆𝒈𝒓𝒂𝒕𝒊𝒐𝒏𝒊𝒏𝒕𝒐 𝑶𝒓𝒈𝒂𝒏𝒊𝒛𝒂𝒕𝒊𝒐𝒏𝒂𝒍 𝑺𝒕𝒓𝒖𝒄𝒕𝒖𝒓𝒆𝒔 The Pharmaceutical and Medical Devices sectors are increasingly investing in AI-specialized talents and forming strategic patents and agreements for AI integration, highlighting the shift towards AI tools for Business development and Regulatory Compliance. And this is not only in R&D but also to maintain alignment, in the most simple and efficient way, with all the regulatory and normative activities linked to the sector's dynamism. 𝑪𝒐𝒏𝒄𝒍𝒖𝒔𝒊𝒐𝒏 AI is an indispensable ally for the Pharmaceutical and Medical device Industries, enhancing operational efficiency, accelerating innovation, and ensuring safety and rapid revenue in Post-Marketing Regulatory Activities. : 𝘈𝘯𝘢𝘭𝘺𝘴𝘪𝘴, 𝘍𝘪𝘦𝘭𝘥 𝘐𝘯𝘵𝘦𝘳𝘷𝘦𝘯𝘵𝘪𝘰𝘯𝘴, 𝘛𝘢𝘳𝘨𝘦𝘵𝘦𝘥 𝘛𝘳𝘦𝘢𝘵𝘮𝘦𝘯𝘵𝘴 𝘰𝘳 𝘗𝘳𝘰𝘥𝘶𝘤𝘵𝘴' 𝘐𝘮𝘱𝘳𝘰𝘷𝘦𝘮𝘦𝘯𝘵. So, the obtained efficiency and speed allows for the reallocation of resources to other high-value activities. Feel free to contact me to discuss your development ideas, current or potential. #ArtificialIntelligence #MDRInnovation #HealthSector #AIOptimization #FuturisticPharmaceuticals #MedicalDevices

Two significant additions to the Library: - AI in Healthcare: The transformative power of artificial intelligence, shedding light on its potential to enhance diagnostics, personalize patient care, and streamline medical processes. - AI in Precision Medicine: The tailored approach to patient care, emphasizing the customization of healthcare, with medical decisions, practices, and products being tailored to the individual patient. https://buff.ly/3OCdykA #skyhealthacademy #pharmaceutical #pharmaceuticalindustry #medicalaffairs #MSLs #career #careerdevelopment #medicalmanagers #medicaladvisors

From ideation to implementation, my colleague Dayna Larson shares how #CorticoXplorations guided a pharmaceutical company in building a culture of AI-driven innovation, resulting in 8 business cases moving into production. #AI #Innovation #MedicalAffairs

Predictions for the Life Sciences 2024: Science and Technology 1)AI in Patient and Professional Engagement 2) The Competitive Pharmaceutical Landscape 3) Data Sharing and Cross-Industry Collaboration 4) Market Access Models for Digital Therapeutics (DTx) 5) DCTs: Evidence versus Hypotheses and New Focus on “How” 6) Generative AI Coupled with Quantum Computing 7) Health Economics and Outcomes Research (HEOR) in DCTs 8) Diversity in Clinical Research Participation 9) Personalized Medicine Development 10) Zero-Knowledge Proofs #lifesciences #pharmaceutical #pharmaceuticalindustry #lifesciencesindustry #clinicalresearch #2024predictions #2024out #aiml #generativeai https://lnkd.in/ece8bvKB

As the brokers of insights within their companies, medical teams have a unique opportunity to be true strategic partners to their cohorts in clinical and commercial teams. Within3 #medicalaffairs #pharma #insights #ai https://lnkd.in/gnDH3E2s

𝐅𝐃𝐀'𝐬 𝐂𝐨𝐨𝐫𝐝𝐢𝐧𝐚𝐭𝐞𝐝 𝐀𝐩𝐩𝐫𝐨𝐚𝐜𝐡 𝐭𝐨 𝐔𝐧𝐥𝐨𝐜𝐤𝐢𝐧𝐠 𝐀𝐈'𝐬 𝐏𝐨𝐭𝐞𝐧𝐭𝐢𝐚𝐥 𝐢𝐧 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐏𝐫𝐨𝐝𝐮𝐜𝐭𝐬 The U.S. Food and Drug Administration #FDA recently released a paper outlining its collaborative strategy for promoting the responsible and ethical use of #ArtificialIntelligence in developing and regulating #medical products. Recognizing AI's vast potential to revolutionize healthcare, the agency's Centers for Biologics Evaluation and Research (CBER), Drug Evaluation and Research (CDER), Devices and Radiological Health (CDRH), and the Office of Combination Products (OCP) are aligning their efforts to safeguard public health while fostering innovation. In the paper, titled "Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together," the FDA highlights four key areas of focus: 𝟏. Fostering collaboration to safeguard public health by soliciting input from stakeholders, promoting educational initiatives, and collaborating with global regulators. 𝟐. Advancing regulatory approaches that support innovation by monitoring emerging trends, supporting regulatory science efforts, leveraging existing initiatives, and issuing guidance on various aspects of AI in medical products. 𝟑. Promoting the development of harmonized standards, guidelines, best practices, and tools for evaluating AI's safe, responsible, and ethical use across the medical product life cycle. 𝟒. Supporting research related to the evaluation and monitoring of AI performance through demonstration projects that address bias, health inequities, and ongoing monitoring of AI tools. 𝐓𝐡𝐞 𝐩𝐚𝐩𝐞𝐫 𝐞𝐦𝐩𝐡𝐚𝐬𝐢𝐳𝐞𝐬 𝐭𝐡𝐞 𝐅𝐃𝐀'𝐬 𝐜𝐨𝐦𝐦𝐢𝐭𝐦𝐞𝐧𝐭 𝐭𝐨: 𝟏. Developing patient-centered, collaborative, and equitable regulatory approaches for #AI in medical products. 𝟐. Providing regulatory predictability and clarity to support #innovation while protecting public health. 𝟑. Upholding safety and effectiveness standards across AI-enabled #medical products. 𝟒. Gaining insights into AI's impact on medical product safety and effectiveness through research and demonstration projects. By fostering cross-center collaboration and engaging with developers, patient groups, academia, global regulators, and other stakeholders, the #FDA aims to unlock AI's transformative potential while ensuring the quality, safety, and efficacy of #medicalproducts. The full paper, "Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together," is attached for your reference.