AI
With the roll out of agentic AI, the US FDA continues to expand its capabilities, following the launch of Elsa, its generative AI tool in May.
New approach methodologies are increasingly shaping the future of medicine development by making drug testing less reliant on animals.
Aspen Neurosciences and BlueRock Therapeutics see hope for artificial intelligence to improve the quality of cell therapies to replace dopaminergic neurons in Parkinson's disease.
Smaller datasets are being leveraged to develop and train artificial intelligence models, which can help overcome the limitations of small patient numbers in rare disease settings, CDER staffers wrote in NEJM AI.
A subfield of AI aims to explain why complex models make predictions, which will increase their interpretability and auditing ability, AI researcher Su-In Lee said during a National Academies of Sciences workshop.
AI is moving from blue-sky potential to specific applications in drug development, streamlining pharmacovigilance and clinical trial design, but strong governance remains essential to ensure transparency and reliability.
Brazil’s medicines regulator, ANVISA, has hired new staff to help halve the time it takes to register a new medicine in Brazil.
Pharmaceutical companies will be expected to phase out certain animal tests in the drug development process under a UK roadmap aimed at pivoting towards using alternative models, such as organ-on-a-chip systems and artificial intelligence.
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.
A new government-backed initiative is set to explore the use of AI in predicting side effects from drug interactions – a development that could cut costs and late-stage trial failures for pharma companies.
The UK MHRA is looking to support drug sponsors in using in silico data during the drug development process – a move that will reduce the use of animal models.
Clinical trial sponsors could soon benefit from a streamlined clinical trial approval process in Australia, Canada, Singapore, Switzerland and the UK under a new ACCESS Consortium project.
The European Medicines Agency is using artificial intelligence (AI) to screen scientific literature for safety signals and is also developing guidance for manufacturers on using AI in pharmacovigilance.
Ireland, which according to industry experts has an “outsized” voice in representing the pharmaceutical sector, is set to take over the presidency of the Council of the European Union next summer.
The US FDA may ask sponsors for permission to train AI models using data from new drug applications. Alternatives to animal testing could be a test case.
Experts discussed challenges and requirements around adoption of AI and big data tools in South Korea's biopharma sector at a recent forum in Seoul, amid a broader push towards an AI-powered economy by the country's new government.
The agency is creating two new AI councils to facilitate its role in responsible AI adoption and regulation.
Generative artificial intelligence tools, such as ChatGPT, have “democratized” AI, and contract research organizations are wholeheartedly embracing these tools, given their focus on efficiency, says Stephen Pyke, who chairs the AI committee at the Association of Clinical Research Organizations.
The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.
Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.