Life Sciences Spotlight: BR Team Examines FDA Guidance on Individualized Therapies

In an article for Outsourced Pharma,  Adam Schoen, and Robert Ruh, examine the U.S. Food and Drug Administration’s guidance on chemistry, manufacturing and controls (CMC) for individualized therapies.

The April 26 article also appeared in BioProcess Online, Pharmaceutical Online and Cell & Gene. The authors noted that the FDA published the guidance in December in recognition of a conflict for pharmaceutical companies facing large expenses and a hefty time commitment to safely develop personalized medicine for patients afflicted with diseases that cannot otherwise be sufficiently treated.

“This creates a conflict between the need for these therapies and the lack of a large patient population that may participate in clinical trials and ultimately purchase an approved treatment to offset the initial development costs,” they wrote.

The guidance “acknowledges the difficulties inherent in manufacturing these individualized treatments and offers researchers and manufacturers the opportunity to create policies and procedures that are more likely to be condoned by the FDA in an IND submission.”

Read the full article here.