Generics and Biosimilars Initiative (GaBI)’s Post

Definitely a must read: https://lnkd.in/dgzk9VRC "For example, the Korea Health Industry Development Institute (KHIDI) has created a national artificial intelligence (AI) platform that integrates data from several healthcare institutes to support clinical trials, match patients with studies, and monitor trial progress." If you've missed Dr. Yooni Kim's presentation on APAC capabilities at OCT UK and Ireland, feel free to reach out to her. #Novotech #APAC #AI #clinicaltrials

EFPIA advocates for the effective use of AI in medicine development: - A supportive regulatory framework - Emphasizing exemptions for dedicated scientific research AI - Minimal high-risk AI applications - Existing robust regulatory systems - Forthcoming EMA AI guidance -The need for dynamic governance aligned with AI's evolving landscape.

I'm impressed by the expertise of my US Pharmacopeia colleagues who developed this report analyzing the economic factors behind drug shortages in the U.S. The report leverages USP's Medicine Supply Map, an innovative tool that employs #AI and predictive analytics to identify, characterize, and predict risk in the complex medicine supply chain. The data and insights in our inaugural report shed light on the market forces perpetuating the issue. Get the facts and read the report. https://ow.ly/PPWS50S7Nit #DrugShortage #SupplyChain #USPMedicineSupplyMap #ProudToBeUSP

The FDA’s Center for Drug Evaluation and Research (CDER) has announced it is establishing an AI council to bring together the agency’s AI-based activities into one domain. Read more about the council here: https://buff.ly/3z9qJF0 #FDA #AI #ArtificialIntelligence

"Algorithmovigilance", lessons from pharmacovigilance AI systems are being widely implemented in high-risk areas like healthcare, but post-deployment issues and effective mitigation strategies remain challenging. Drawing from the well-established field of pharmacovigilance, which focuses on monitoring and preventing adverse drug effects, this paper proposes adapting these methods to monitor AI systems. This approach aims to enhance responses to adverse effects and potential risks associated with AI in healthcare and other sectors. https://lnkd.in/eV-iYmaG

#AI greatest potential - specifically in context of scientific research - is in its ability to uncover insights that would be overlooked by conventional approaches - the main driver for innovation. While the entire world is making pitches on how to approach AI, its paramount to make sure that the rules are known, clear, precise, stable, certain and predictable. We need to maximize the benefits while mitigating risks to use the AI responsibly to generate #trust across all affected. Read EFPIA - European Federation of Pharmaceutical Industries and Associations statement referring to the rapidly evolving #EU landscape on AI and aspects that require further attention #AIAct

Innovation is essential in #clinicaltrials to expedite #drugdevelopment. However, slow progress in the U.S. system has caused frustration among stakeholders. Read our Senior Government Affairs Lead, Jess Ross's article in MedCity News, discussing the need for #innovation and advocating for expanding user fee programs to include #AI and other technologies to give the #FDA the resources for effective evaluation. https://bit.ly/3YnWFQg

Inovalon's Teton Analytics: RWD and RWE are pivotal in bridging the gap between clinical research and everyday healthcare. As you can imagine, technology, like AI and machine learning is revolutionizing RWD analysis, identifying patterns and trends invisible to the human eye. So, how do you make sense of it all? Welcome Teton Analytics by Inovalon. #ai#RWD#RWE#cro#clinicalresearch#EMR#analytics#healthcare

#EFPIA has today published an important and valuable position on the use of #AI in R&D. The exception in the #EUAIAct for #AI for sole purpose of scientific research and development is important to ensure freedom of science. Medicines development in Europe is already a highly regulated area and even if it would fall within the scope of the #EUAIAct, it is low risk under the #EUAIAct. It is worth reading!

Exciting news! AI is revolutionizing FDA processes, including clinical trials, by enhancing data analysis, interpretation, and utilization for regulatory decision-making. AI-powered tools enable advanced analytics, predictive modeling, and real-time monitoring, empowering regulators to evaluate data integrity, identify risks, and ensure compliance. Collaboration between AI innovators and regulatory bodies demonstrates a synergistic approach to driving innovation while maintaining safety and efficacy standards. By leveraging AI, pharmaceutical companies can navigate regulatory pathways more efficiently, accelerate drug development, and deliver breakthrough therapies to patients. #AI #FDA #ClinicalTrials #Innovation