What You Need to Know About Adaptive Trials
July 1st 2006Adaptive trials aren't just for propeller-heads anymore. They're one of the issues that need to be top-of-mind for the whole executive suite, as a driver of new processes and timelines, as a hot-spot on the budget, and as a battleground where public policy on drug safety and efficacy will be fought out.
Back Page: The "Help is Here" Express
June 1st 2006Patient assistance programs have been around for a quarter of a century. But many patients have failed to reap the benefits because of confusion over eligibility and the mechanics of joining. But all that has become much easier with the Partnership for Prescription Assistance (PPA), a one-stop-shop for industry-sponsored assistance programs.
Personalized Medicine Meets the Real World
June 1st 2006Personalized medicines often come to market without much safety information. Small populations mean less data. Genzyme, for example, received FDA approval for Cerezyme, to treat Gaucher disease, based on a pivotal trial with only 30 patients.
Thought Leader: Paul Chang, IBM
June 1st 2006In a product recall, manufacturers would know which retailers and hospitals got bad bottles. Instead of clearing shelves everywhere, they could call specific customers and say, "Hey, we know you have five of these bottles. We want them back."