FDA Emphasizes Need for More Basic Science Research in Diabetes

Twitter Summary: New @US_FDA report states need for more #diabetes research & biological understanding, lays out 4-step acceleration plan

The FDA recently released a report emphasizing that more basic science research is required to understand the complex biological pathways involved in diabetes, Alzheimer’s, and other diseases. The report states that while science research in diabetes is “progressing,” more work needs to be done on understanding the exact relationships between biological factors (e.g., genetics, immune system, metabolism, etc.) and environmental factors. Notably, the FDA also highlights four steps to accelerating diabetes drug development, including working more closely with companies throughout the development process and creating more efficient and flexible clinical trials.

Excitingly, the report also states, “The diabetes drug pipeline is among the strongest for any disease category and includes potentially transformative advances for type 1 diabetes.” We aren’t sure which therapies for type 1 the FDA is referring to here (type 2 drugs for type 1, e.g., Victoza? Smarter insulin? ViaCyte’s stem-cell therapy? Innovative glucagon? There are many to choose from!), but it’s certainly telling that the FDA is giving the current type 1 diabetes drugs in development this vote of confidence.

It’s encouraging to see the FDA thinking about how diabetes drugs can be developed faster – this has already been happening on the device side of the FDA, particularly on the artificial pancreas and CGM. As we pointed out in a previous learning curve, diabetes research continues to be underfunded, and more coordination on making our research as efficient and impactful as possible would be a great step forward. We’d like to see even more happening on the type 2 front, especially with medicines that could be “disease modifying” – particularly drugs that could help reverse complications or slow the progression of the disease. On that note, we also believe that the FDA would benefit from gathering a group of experts to discuss cardiovascular outcome trial requirements – we hope this may happen in 2016, as Dr. John Jenkins (Director, Office of New Drugs at FDA) acknowledged in 2014 that this gathering should take place. We applaud the FDA for doing such good work, particularly when so under-resourced. –AJW/KC