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Artificial Intelligence: Industry Wants FDA To Boost Access To Databases, Clarify Use In Assessing Drug Efficacy

 
• By Brenda Sandburg

BIO, PhRMA, Genentech, Regeneron, AAM discuss transparency in use of AI, intellectual property protection, what constitutes AI, and its application in postmarketing safety surveillance.

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Biopharma industry answers US FDA's call for information on use of artificial intelligence in drug development • Source: Shutterstock

The biopharma industry told the US Food and Drug Administration what guidance is needed to advance the use of artificial intelligence and machine learning in drug development, from having regulatory clarity on AI/ML’s use in assessing efficacy to transparency considerations and the scope of FDA’s oversight.

More than two dozen stakeholders responded to a discussion paper the agency issued in May requesting input on the opportunities and challenges with utilizing AI/ML in the development of drug...

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AI Could Be Used ‘In The Deliberation’ Of HTA Reviews In England, Says NICE

 
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England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.

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• By Neena Brizmohun

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EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.

EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
• By Eliza Slawther

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

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• By Sarah Karlin-Smith

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.