FDA: Basic Research Needed to Speed Cures for Some Diseases

The FDA is calling for increased focus on the underlying biology of diseases like Alzheimer’s and diabetes, noting that the discovery of biomarkers has led to important breakthroughs for cancer and HIV/AIDS.

Scientists don’t understand the causes of Alzheimer’s disease and ways to slow its progress, thwarting attempts to predict clinical improvement using biomarkers in that population, the agency says in a new report. As a result, some patients have been unnecessarily exposed to serious toxicity, “underscoring the difficulty in predicting clinical response based on the existing state of knowledge,” the report says.

For diabetes, scientists understand its major factors, but haven’t discovered the genetic, molecular and environmental causes. As a result, certain tools such as surrogate endpoints can be used, but biomarkers can’t be developed to target specific subsets of patients who are less likely to suffer a drug’s side effects.

Basic research is also lacking for many rare diseases, preventing the use of drug targets and biomarkers to make clinical trials more efficient and successful, the report says. Hepatitis C was poorly understood, but HIV/AIDS research helped to unravel its genetic and molecular base, resulting in targeted treatments such as Gilead’s Sovaldi.

Read the report here: www.fdanews.com/7-15-FDA-Report.pdf. — Jonathon Shacat

$1,695 $1,395

Bonus

Subscribe to Drug Industry Daily and save $300 off the regular one-year price of $1,695 — plus receive a FREE copy of our webinar CD, Understanding CDER's "Super" Office of Pharmaceutical Quality and Its Effect on You — a $287 Value!

Key Benefits

LINKS TO KEY DOCUMENTS — You get links to key documents that support DID's articles such as draft and final guidances, 483s and warning letters, proposed rules, closeout letter, full text of proposed legislation and GAO reports.

ONLINE ACCESS — Consider our newsletter archive your personal library! Search your current issue — and hundreds of past issues — by keyword and relevancy.