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How Pharma Firms Using AI Should Navigate Regulatory Submissions

 
• By Eliza Slawther

Global regulators have yet to develop hard and fast rules for the use of artificial intelligence in drug development. Until they do, pharma companies should be guided by transparency and best practice principles when preparing submissions, a consultant says.

The artificial intelligence health care market is expected to grow by more than 500% from $29bn in 2024 to $187bn by 2030, and could bring much value to the pharma industry by streamlining drug discovery, clinical trials, and supply chain management, according to a report from global consulting firm Berkeley Research Group (BRG).

Despite these impressive predictions, BRG noted in its ‘AI and the Future of Healthcare’ report that uptake of AI has...

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More from Europe

NICE Breaks New Ground In England As Abiraterone Becomes First Generic Drug To Win Funding

 
• By Neena Brizmohun

As more medicines come off patent in the coming years, the UK generics and biosimilars industry association is hoping to see more generic products evaluated for reimbursement by the health technology assessment institute, NICE.

England’s NICE Defends Its Processes, But Recognizes ‘Tough’ Climate For Industry

 
• By Eliza Slawther

Sam Roberts, chief executive of England’s NICE, has defended the health technology assessment institute’s cost-effectiveness thresholds and the country’s ranking against other nations when it comes to market access, while acknowledging that the UK’s pharma ecosystem is “really tough.”

Denmark: QALY Brings HTA Transparency But Industry Wants More Willingness To Value Innovation

 
• By Francesca Bruce

Rare disease drugs with limited evidence are most likely to be awarded a negative reimbursement recommendation in Denmark following a QALY-based health technology assessment, finds an analysis from industry group LIF.

AI’s Attempt To Decode EU Pharma Reform Called A ‘Car Crash’

 
• By Eliza Slawther

Sanofi’s EU regulatory science and policy head draws on a “nightmare” experience with using a generative AI tool to compare versions of the draft EU pharma reform text to explain the benefits and limitations of artificial intelligence tools in regulatory affairs.

More from Geography

NICE Breaks New Ground In England As Abiraterone Becomes First Generic Drug To Win Funding

 
• By Neena Brizmohun

As more medicines come off patent in the coming years, the UK generics and biosimilars industry association is hoping to see more generic products evaluated for reimbursement by the health technology assessment institute, NICE.

England’s NICE Defends Its Processes, But Recognizes ‘Tough’ Climate For Industry

 
• By Eliza Slawther

Sam Roberts, chief executive of England’s NICE, has defended the health technology assessment institute’s cost-effectiveness thresholds and the country’s ranking against other nations when it comes to market access, while acknowledging that the UK’s pharma ecosystem is “really tough.”

FDA Office of New Drugs Director Mary Thanh Hai Not Interested In CDER Director Job

 
• By Sue Sutter

The 27-year agency veteran has not been formally approached about filling the vacancy created by George Tidmarsh’s resignation, but also is not interested in the position, the Pink Sheet has learned.