The U.S. FDA has had its sights on artificial intelligence (AI) for some time, but an upcoming advisory hearing will review questions such as the regulatory status of a generative AI (GenAI) algorithm. This is just one of several AI-related dilemmas facing the agency in the next few years.
The Nov. 20-21 meeting of the digital health advisory committee will discuss the use of generative artificial intelligence algorithms in medical devices with a focus on the total product life cycle – a theme that suggests a concern on the agency’s part regarding the reliability of these algorithms’ output.
The European Medicines Agency advised its member state regulatory partners to closely track how they use LLMs in making regulatory decisions – a clear signal that some regulatory decisions may be inappropriately torqued by their well-known shortcomings.
“Aging is not only slow, but it is irreversible, and that is what most people have been suspecting,” Gero Pte Ltd.’s CEO Peter Fedichev recently told BioWorld. “[But] aging is not an inevitable part of human existence.” By setting limits to what science can do – and not do – for aging, the Palo Alto, Calif.- and Singapore-based generative artificial intelligence (AI) biotech Gero is trying to figure out and, at the same time help the industry, “see what is actionable, reversible and what may not be” to help people avoid “hitting their heads against the wall” when tackling aging and aging-related diseases.
“Aging is not only slow, but it is irreversible, and that is what most people have been suspecting,” Gero Pte Ltd.’s CEO Peter Fedichev recently told BioWorld. “[But] aging is not an inevitable part of human existence.” By setting limits to what science can do – and not do – for aging, the Palo Alto, Calif.- and Singapore-based generative artificial intelligence (AI) biotech Gero is trying to figure out and, at the same time help the industry, “see what is actionable, reversible and what may not be” to help people avoid “hitting their heads against the wall” when tackling aging and aging-related diseases.
Insilico Medicine Inc. struck an out-licensing deal with Exelixis Inc. for its small-molecule USP1-inhibitor candidate called ISM-3091, the company said on Sept. 12, standing to gain $80 million in up-front payments.
In its second big pharma deal to date, Shape Therapeutics Inc. drew Otsuka Pharmaceutical Co. Ltd. to the table in a potential $1.5 billion-plus collaboration initially aimed at developing gene therapies for ocular diseases. The multitarget agreement, which includes options for additional targets and tissue types, will combine Shape’s AI-driven adeno-associated virus (AAV) platform and Otsuka’s expertise in ophthalmology to develop intravitreally delivered AAV therapies.
As a pioneer of harnessing artificial intelligence (AI) to drug discovery, Insilico Medicine Inc. recently made breakaway progress to bring a generative AI-designed drug to life, announcing the progression of its INS018-055 candidate to phase II trials for idiopathic pulmonary fibrosis.
