Anyone looking for some insight into the way the FDA is examining new cancer therapies should check out the interview BusinessWeek has published with Dr. Richard Pazdur, director of the FDA's Office of Oncologic Drugs. He's looking for developers to shift paradigms, gaining a better understanding of the disease rather than focusing solely on the drug. And keep it real, he advises small biotechs.
"One of the things we have seen is a reluctance, sometimes, of smaller companies to make really critical decisions regarding their drugs, whether to curtail the development of a drug," says Pazdur. "Large companies, because they have a portfolio of drugs, generally if a drug fails to meet specified goals they'll look to abandon that drug--i.e., cut their losses. Whereas as a smaller company, if you only have one drug, then sometimes that is not an option."
- read the Q&A [1] in BusinessWeek
Related Article:
FDA's Pazdur in the middle of intense debate [2]
Links:
[1] http://www.businessweek.com/bwdaily/dnflash/content/may2008/db20080521_549448.htm
[2] http://www.fiercebioresearcher.com/story/fda-s-pazdur-in-the-middle-of-intense-debate/2008-03-18