Each week we highlight five things affecting the life sciences industry. Here’s the latest.
FDA consolidates AI efforts
- The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research is merging its artificial intelligence activities under a single AI council to enhance safety and coordination, reports Fierce Biotech.
- This new council will oversee AI use in drug development and internal processes, aiming to improve regulatory submissions and staff education.
Biopharma leaders turn to fractional roles amid market challenges
- Senior-level biopharma professionals are increasingly opting for fractional roles where they work part time for companies, due to downsizing, financial constraints and a tight labor market, reports BioSpace.
- This trend allows experienced leaders to stay engaged and leverage their expertise in smaller organizations that benefit from their skills.
Massachusetts biopharma sector adds jobs despite layoffs
- Massachusetts’ biopharma industry added 3,000 new jobs last year, despite layoffs and funding declines, according to a report by MassBio.
- The job growth was primarily driven by research and development, highlighting the state’s strength in early-stage innovation.
UK pharma-government partnership to boost clinical trials
- A new £400 million public-private partnership aims to enhance UK clinical trials and improve patient access to novel treatments, reports European Pharmaceutical Review.
- The initiative will establish 18 new commercial research delivery centers and focus on sustainable pharmaceutical manufacturing and modernizing health technology assessment approaches.
FDA provides guidance on predetermined change control plans
- The FDA has released draft guidance on predetermined change control plans, allowing companies to make specific updates to medical devices without filing new 510(k) or premarket approval supplements, reports MedTech Dive.
- This guidance aims to streamline the update process for devices, particularly those using AI or machine learning, by pre-specifying allowable modifications.
For more insights in life sciences, check out RSM’s industry outlook.
We will pause publication of our “5 things” post next week because of the Labor Day holiday. We’ll resume the week of Sept. 9.
