R&D/Clinical Trials

Several leading pharmas may already have a drug for a retrovirus linked to chronic fatigue disease. Has medicine's "problem child" finally earned the industry's respect?

How proper site activation and site enrollment can help you get the most from clinical trials.

Evidence-based medicine is fast becoming one of the key concepts in clinical and reimbursement practices in the developed world

Could physician behavior have a positive impact on Drug Development?

The world is suffering. But just over the horizon is a new access equation that could speed innovative vaccines to where they're needed most.

Sales reps aren't the only ones heading for the unemployment line - Pfizer is eliminating researcher positions as fewer drugs are making it to development. But could streamlining the crux of drug R&D cause more harm than good?

As global regulators set up rules for liability insurance for clinical trials, the playing field has grown complex for sponsors. This article reviews the key issues and offers a look at how European, Asian, and Latin American countries handle clinical trial insurance.

When it comes to working with clinical research sites, pharmaceutical companies should take a page out of the automakers' playbook

The debate over gene sequence patents is leaving investors lost and confused. These strategies will help them find their way

A new study of hundreds of thousands of clinical trial records reveals that the overall length of a trial is directly related to how long it takes to activate the study sites - and that most companies are wasting precious weeks and even months in activation. Here's how to improve your performance.

We scrub industry's pipeline to find the drugs that everyone will be talking about in 2009 and beyond

Some say it's just another pharma facing its patent cliff. But others say this company's got it worse. With new CEO John Lechleiter in charge, can Lilly find its way back from the edge?

Clinical trials need to change. A recent survey shows that industry should address the research supply chain for the greatest gains in effciency.

FDAAA means that you need to register clinical trials-and not only for publication planning

Concerns over quality? It's not stopping Big Pharma outsourcing and venture capital.

Roche has always gone its own way with biologics, deals, and new medicines. Now that the rest of industry has caught on, how can Roche stay ahead of its time?

US officials think they can control MRSA and other "superbugs," but dangerous bacteria know no boundaries. What does the world do when its drugs stop working?

Many say licensing is the new R&D. We've rounded up the unions to watch from the third quarter of 2007.

Pharm Exec asks experts to predict what 2008 has up its sleeve for the industry--from the top line to the bottom line, from R&D to M&As, from Congress to the courts.

Novartis' Paul Herrling talks about how Big Pharma can learn from nonprofit R&D and collaborate to get an edge on the drug safety problem.

Getting innovative drugs into bodies just got a whole lot more interesting. Here's how the delivery biz is keeping up with pharma's R&D.

You couldn't call it a gusher, but the pipeline has still has some life in it, and important new therapies are working their way toward approval. Have we turned the corner? Judge for yourself, with the help of this guide to 61 of the best new products in development.

There are plenty of new vaccines on the market, but for patients to get maximum benefit from them, payers and even physicians need to rethink their roles in prevention.

FDAAA aims to restore public trust in drug safety regulation but may curb investment in R&D

Will CROs continue to operate in India, or will Novartis' pullout send them farther East?

Cancer R&D IS booming right now. At a time of poor ratings on both Wall Street and Main Street, pharma can at least point proudly to its oncology pipeline as proof that it still takes big risks to make big advances against big killers-and win. According to a recent IMS report, the cancer pipeline contains 380 compounds, with nearly 100 in Phase III. The long-established standard of care-surgery, radiotherapy, and chemo-is fast giving way to a high-tech array of targeted therapies. These molecules and antibodies are designed to block specific disease pathways, and they are proving both far more effective and far more tolerable than the sledgehammer status quo. Since 1996, the overall survival rate for patients has jumped by 30 percent, from one-half to two-thirds.

David Barlow is the closest thing you can find to a pharma-industry ecologist. He takes companies that deal with technology that Big Pharma won't touch and turns them into drug powerhouses.

The clinical trials space these days is an alphabet soup of technologies: CTMS (clinical trial management systems); CDM (clinical data management); CDR (clinical data repositories); eCTD (electronic common technical document); and many more. But the technology with the most promise for transforming the way clinical trials are performed (and for driving everyone mad throughout implementation) is EDC-electronic data capture. It's taken more than a decade, but today most big pharma companies-and a fair number of smaller ones-are using some form of EDC in clinical trials. The early adopters might have experienced some growing pains, but the benefits seem to be outweighing the high cost of implementation. Few companies would consider going back to paper-based trials.

The Association of the British Pharmaceutical Industry is challenging the UK government over the financial incentives being offered by the Department of Health (DH) to encourage doctors to switch patients from on-patent medicines to specific generic alternatives. ABPI believes the way the incentives are structured contravenes EU law-if pharma companies were to offer similar payments, they would be in serious trouble.

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?