Category Archive

The following is a list of all entries from the Clinical Trials category.

A Brief FDA History Lesson

Filed in Clinical Trials, General, Legal, Research, October 23, 2007, 11:29 pm by Mariano DiFabio

Just before a presentation I gave on Monday concerning Virtual Reality and its use in medicine, the group that had assembled was discussing a variety of current topics in the pharmaceutical and biotechnology industries. One of the attendees, Peter Castellano, caught my interest when he described an article he found in the October 2007 [...]

Ethical Dilemma

Filed in Clinical Trials, Legal, Personal Health, Research, September 11, 2007, 3:21 pm by Mariano DiFabio

In my second post ever on this site, I wrote about the FDA Fast Track program called Pay-For-Review, and I questioned whether drug companies who took advantage of this program were being given enough scrutiny for the products they were putting to market. Interestingly, in a Boston Globe article yesterday called “Burden of Proof,” [...]

Don’t Forget to take This Vaccine

Filed in Clinical Trials, Research, July 27, 2007, 12:01 am by Mariano DiFabio

On July 19th a small pharmaceutical company based in Austria, Affiris, announced the beginning of clinical trials for a new drug intended to halt the onset of Alzheimer’s disease in humans. The drug, currently known as Affitope AD01, will be administered to 24 patients diagnosed with mild to moderate symptoms of the disease. [...]

Why Outsource Clinical Development Programs?

Filed in Clinical Trials, Research, June 8, 2007, 10:54 am by Mariano DiFabio

Today’s blog comes to use from Lisa Miele, a Managing Partner at Collaborative Management Solutions, LLC. Her company provides outsourcing and management consulting for a variety of pharmaceutical and biotech companies as well as Clinical Research Organizations. Prior to starting her company, Lisa worked for 12 years as a Vice President at PRA [...]