Tuesday, September 29, 2009
Guest Speaker!
(OOPS - Our speaker will be postponed until 10/6. Until then.. just ME ...)
Students: Please do a little background work so you are ready to ask questions and partipate in our class discussion !!
DO know the basics about the clinical trial process:
(1) The FDA's New Drug Development Process = a great diagram from Novartis that gives an overview of the whole clinical trial process; be sure to click on each square in the diagram for more info!
The FDA LOVES acryonyms ..and therfore, we do too! HOMEWORK! Look up these mysterious acronyms...!
| M.A.* | Meaning | Purpose |
| ADME: | ||
| IND: | ||
| NDA: | ||
| BLA: | ||
| CDER: | ||
| ANDA: |
* Mysterious Acronym, of course
(2) Background Information on Clinical Trials from the National Cancer Institute
Tonight's speaker - and clinical trials in beautiful Indianapolis:
Interested in participating in a Clinical Trial? You might be qualified - and do something worthwhile in the process:
(3) IU CLinical Trial Listings andSimon Cancer Center Listings
(4) IU School of Medicine Office of Clinical Research
- Click around! Here are somethat might fit YOU!
- This could be the start of your investment career as well - double duty! :)
- Guidelines for Clinical Trials from the National Cancer Institute
- Compassionate Access, or Access to Investgational Drugs
(5) A useful image: and MORE EXPLANATION HERE
1. Geron gets green light for human trial of ES cell–derived productNature Biotechnology (Jan 2009) FDA approves the first human trials of embryonic stem (hES) cells, a surprise decision. Here's hoping!
2. J&J's billion dollar punt on anti-amyloid antibodyNature Biotechnology 27, 679 - 681 (2009)
3. FDA holds court on post hoc data linking KRAS status to drug responseNature Biotechnology (Feb 2009)
4. Wyeth, Elan and Bapineuzumab -- How to Lie With (Drug) Statistics29 July 2009: Hmmm...slimy, or not? Bonus point for using the phrase "post hoc analysis" in your team project!
5. Drug Development Chart: Acronyms explained!
6. Ouch!It costs how much?Boston Globe, 6 May 2007
7. VERY sad:End of Drug Trial Is a Big Loss for PfizerNYT 4 Dec 2006