Pharmaceutical Executive-06-01-2006

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.

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.

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.

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.

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.

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.

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.

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."

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.

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.

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

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

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.

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