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.
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.
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.
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.
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.