While EU preparations are underway to introduce strict legal requirements for all AI systems, the UK has doubled down on its flexible, non-regulatory framework. In this second of a two-part article, a lawyer explains the pros and cons of each for pharma and medtech firms.
From identifying novel drug targets to analyzing clinical trial data, artificial intelligence (AI) has a plethora of uses in pharmaceutical R&D. Due to its relative novelty, however, AI is largely unregulated across the globe – something that many major governments and policymakers have acknowledged as a potential problem.
While most experts agree that the dangers of AI must be somehow mitigated and monitored, there has been little consensus on how exactly this should be done
EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.
Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.
The company’s failure to show its potency assays measured attributes directly related to the mesenchymal stromal cell product’s therapeutic effect highlights the importance of a robust CMC program for complex cell therapies.
