R&D/Clinical Trials

New partnerships with nanobiotech firms are helping pharma companies overcome solubility problems and extend profitable product lifecycles.

A new European collaboration of biotech, pharma, academia, and government takes up the challenge of boosting R&D.

In revamping its R&D department, Wyeth "really looked for people who were not going to give us the same old, 'This is how you do pharmaceutical development, dah-dah-dah,' but who could really think of different ways of doing things."

The PPP approach asks pharma to identify promising drugs and conduct pre-clinical tests, instead of paying for costly late-stage clinical trials.

Figuring out the right drug for each manifestation of the disease is going to be critical. Because then patients know they're getting something that works.

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.

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.

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.

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.

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.