Pharmaceutical Executive-06-01-2006

July 01, 2006

Adaptive 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.

June 01, 2006

Trust is something that must be earned, and it seems as if online medical information has finally earned legitimacy in the eyes of patients.

June 01, 2006

Patient 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.

June 01, 2006

Despite Rituxan's initial success, the brand team considered the long-term opportunity for future indications. Equity research studies demonstrate that a significant "halo" exists around the brand, which is bolstered by greater optimism and excitement for all B-cell mediated conditions.

June 01, 2006

Home and abroad, the US Pharmacopeia is stepping up to maintain quality control. But it's not so easy. USP's Roger Williams discusses Medicare formularies, drug safety, international drug production, and the organization's changing role.

June 01, 2006

Pharma follow-through? As of September 2005, drug manufacturers had promised to perform 1,200 post-marketing studies. Companies hadn't even started 65 percent of them, and only 200 were completed.

June 01, 2006

Self-management programs have been shown to develop confidence and motivation by teaching participants how to use their own skills and knowledge to take control of their healthcare.

June 01, 2006

Under King's old strategy, there was no link between business opportunity and R&D. Today, the company only goes after drugs that meet the criteria of its targeted approach to acquisition.

June 01, 2006

Personalized 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.

June 01, 2006

It's difficult to terminate an associate, be it a new colleague or someone you've worked with for years. But if you can't do it, you risk losing the respect of your top performers. They'll look elsewhere for a level playing field.

June 01, 2006

In 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."

June 01, 2006

Staggering doses in clinical trials may prevent large numbers of people from experiencing serious side effects. But it presents practical and ethical dilemmas, such as determining who is going to be first in line for their dose.

June 01, 2006

At the rate science is progressing, there may be more new knowledge in the next 25 years than in the past 100. That's great news, but not if you are planning to run your business as you run it today.

June 01, 2006

Pharma's ultimate customers are overweight and can't sleep. Ever wonder what they say about that? The National Health and Wellness Survey asked.

June 01, 2006

Companies are in a near-impossible situation-trying to define, follow, and track existing and pending legislation.

June 01, 2006

Meeting Spend: Take stock of how much your company can and does spend on promotional meetings. And look carefully at the effects of new compliance regulations on audience recruiting. Among survey respondents, about half work for companies that spent less than $1 million a year on promotional meetings. The other half spent more, sometimes in excess of $5 million a year. About half of the respondents forecast a 15-percent rise in meeting budgets next year. The other half did not expect changes in the budget.

June 01, 2006

Scott Gottlieb called RFID implementation "disappointing." Now, FDA is moderating its view of RFID as a cure-all for the industry.