R&D/Clinical Trials

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.

In general, it will take two or three trials in a new location to develop a solid base offshore.

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.

By leveraging EDC's features, sponsors can manage study progress better, adapt to opportunities, reduce trial times, and monitor patient safety.

This prediction model will allow developers to recoup costs and enjoy a longer life cycle under patent protection.

Three friends are talking over lunch. The first person declares, "I'm donating blood," to which his friends reply, "That's good." The second says, "I'm donating an organ." They all agree that it's great. When the third person announces, "I'm participating in a clinical drug trial," his statement is met with silence, confusion, then skepticism.

While execution quality doesn't deal with the protocol from a scientific standpoint, it is nonetheless critical to a successful outcome.

The plaintiffs argued that Amgen breached its fiduciary duty to ameliorate their pain and treat their illness with the best medicine available.

Did you know that the first clinical trial was carried out between 605 and 562 B.C.? According to HealthandAge.com, King Nebuchadnezzar II ordered his subjects to follow a strict diet of meat and wine for three years. It wasn't until four children in his court convinced him to allow them to switch to bread and water instead that an endpoint was reached. After ten days, those in the bread-and-water group appeared resplendent-better nourished than those who had followed the meat and wine regimen.

It's busy at merck these days- and not just in the Vioxx legal department. Instead, the entire office buzzes with activity: Executives work late hours, finalizing the regulatory submission; conference calls echo throughout the Whitehouse Station compound, dialed in to local affiliates around the world. In other offices, scientists write up scientific papers, while communications execs buzz in on intercoms, patching the flood of media calls to top scientists.

Genomic researchers are developing tools to determine whether the right patients are taking statins.

Mergers have cut the field of companies with real marketing and manufacturing muscle from 25 to five. The 2004 vaccine market will double by 2009.

Before clinical trials began to cross international lines, recruiting patients was fairly simple. Recruiters had to research only one country's cultural and regulatory standards. But as trials go multinational and the various players in the global study community begin working together for the first time, sponsors discover new levels of complexity. Divergent regulations, cultures, and languages hamstring efforts to find a single approach to patient-outreach communications.

All of the companies with inhaled-insulin drugs must perform two-year safety studies. Not because their drugs show troubling data, but because Exubera has caused slight, temporary decreases in lung function.

Genzyme has an impressive international record in regions with intact healthcare systems. but so far, algeria is one of very few countries where genzyme's drugs have gone from free to paid for. the company is basing a huge investment on faith.

In The Small, Dusty, District Hospital In Temeke, Tanzania, head nurse Sarah Wilson Ochogo is carrying out her morning ritual. She drags a table outside the hospital's tuberculosis (TB) unit, sets out big, white, plastic bottles of pills, and opens a pencil-lined ledger that tracks her patients, their drugs, and their doses. By seven, more than 100 patients are lining up. They place their green patient cards under a stone near the table, and sit down on wooden benches to wait until Ochogo calls their name, gives them their medication, and watches while they take it. By a bit after nine, the patients are off to their daily routines-drawing water, tending crops, or just getting by the way people always have in Africa. And all of them, with luck, are one more day closer to curing their TB.

Pharma has an enormous backlog of drugs that never made it out of clinical trials. At Gene Logic, these discontinued drugs spell opportunity. Not only are they the foundation of a new business unit at Gene Logic, such failed compounds may become the cornerstone of a new approach to R&D as the industry confronts its latest productivity crisis.

In Europe, seven of the top-10 injectible drugs are biologics. Generic versions could be priced 25 to 40 percent lower than prescriptions.