This week we look at a new feature on the Apple Watch that could benefit diabetes patients, a newly approved hemophilia drug and calls for a new regulatory process for artificial intelligence-based medical technology. We also continue to explore concerns about clinical trial diversity. Finally, we highlight the reasons contributing to delayed Food and Drug Administration reviews of cell and gene therapies.
Each week we feature five things affecting the life sciences industry. Here’s the latest.
Bloomberg reported this week that Apple has made significant progress on a project to add blood glucose monitoring technology to the Apple Watch. This would create an alternative for diabetes patients who currently monitor their blood sugar by drawing blood, usually with a finger prick. The project has been underway for over 10 years and began while Steve Jobs was still at the helm of Apple.
The FDA announced this week that it has approved a hemophilia therapy. The drug prevents and treats bleeding episodes in patients with hemophilia. Treatments for the disease that are on the market require dosing several times a week, but this new product will require only one dose per week, significantly improving the quality of life for those afflicted with the disease.
Researchers suggested that the FDA create a new process for regulatory approval of medical devices that are driven by AI. This new model could reduce the time taken to assess AI by at least one month, but would be costly to implement and would require collaboration between developers of this technology and regulators.
Last week we discussed potential FDA regulations that would require diversity in clinical trials. A recent study from Yale School of Medicine noted that while most study results indicate gender representation, less than half provide information regarding participants’ age, race or ethnicity. Further, of the trials that did report race and ethnicity data, a significant number indicated a lack of diversity among participants.
With a record number of cell and gene therapy trials underway, the FDA is struggling to review trials and applications in a timely manner. The agency is looking to hire additional reviewers but has stated that it may take several years to work through the reviews that are in the pipeline. There has also been an increased number of clinical holds over the last year which has added to the workload.
For more on the life sciences industry, check out our outlook.