That was the collective vow sworn by Big Pharma last December following Pfizer's $1 billion–down–the–tubes withdrawal of the cholesterol compound they had touted as the most important drug of the decade. The question is, What's the right organizational construct to support innovation-or at least to stop Phase III failures?
Have you heard the rumors that all the drugs have already been discovered? Well, forget it. Maybe some of the low-hanging fruit is gone-but in the last few years, science has opened up thousands of new targets, while new technologies have made it possible to treat disease in unprecedented ways.
Scare stories about antibiotic-resistant bacteria are all too common in the mass media these days. In the United Kingdom alone, the number of deaths from methicillin-resistant Staphylococcus aureus almost doubled between 2001 and 2005 to more than 2,000. The situation with Clostridium difficile is even worse, with UK deaths tripling to almost 4,000 over the same period. The big problem is that the incidence is growing, yet few antibiotics are being developed that will be able to kill the resistant bacteria.
As the industry focuses its attention on the upcoming renewal of the Prescription Drug User Fee Act (PDUFA), there is a tendency to overlook two other significant pharmaceutical programs coming up for renewal and a related piece of legislation that has been introduced:
Comparative drug tests make pharma see red. But market pressure to prove a drug's real-world value is likely to force even the most stubborn firm into the ring. Why be bull-headed? Adaptive trials can cut cost, time, and risk in half.
A lot of the viruses that are being worked on today are genetically engineered to target the cell and crank out a drug that will kill it. But in our case, we don’t need a drug-the reovirus does it all by itself.
Doctors want to know what's hot in the market, not read a new brochure on a nine-year product that doctors have already been using.
To one major legal scholar, drug safety regulation isn't just about meeting standards, it's about what you take away from one group of patients in order to benefit the rest.
This year's Pipeline Report profiles 32 compounds that are the early fruit of pharma's investment in targeted drug design. In diabetes, HIV, hepatitis C-and especially oncology-vibrant R&D is set to revolutionize treatment with new classes of drugs over the coming decade. We spotlight today's geeky names-the DPP-IVs and MK-0518s, the Tykerbs and Telaprevirs-that are most likely to be tomorrow's glam blockbusters. Even the year's downers-we're still waiting on Acomplia, Exubera is failing to live up to the hype-are reminders of how improvements in drug development, such as Phase 0, are helping industry in its drive to become more effective. Although riskier than squeezing me-too drugs out of proven products, targeted R&D is lighting pathways not only to cures of killer diseases but to a fresh paradigm of progress and profits, and to renewed confidence in the pharmaceutical industry. From where we stand, the future looks bright.
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.
