Drug development has become such a daunting process that the world’s largest and most competitive pharmaceutical companies are banding together to streamline the pathway.

On Wednesday, the companies announced the launch of TransCelerate BioPharma, a nonprofit organization to be located in Philadelphia, Pennsylvania. Its mission will be to overcome the inefficiencies in clinical trials that contribute to the 10- to 15-year-long, $1.2 billion journey that a drug makes from discovery to market.

Pharmaceutical Research and Manufacturers of America

TransCelerate will begin with a handful of projects to set norms for how to describe patients and drug effects in trials. “We [drug companies] will continue to compete when it comes to bringing innovative drugs to market, but by standardizing things, we feel everyone will win,” says Garry Neil, head of TransCelerate.

Doctors who help conduct trials for various companies will require less specific training if the charts they fill out share similar measures, Neil explains. For instance, females might consistently be labeled with an ‘F’ and males with an ‘M’, as opposed to a ‘1’ or ‘0’ sometimes. And if results such as tumor shrinkage, were measured in an identical way study-to-study, companies could more efficiently compare one drug to another when the US Food and Drug Administration (FDA) requests this type of information.

Scientists have attempted to unclog the drug pipeline through various measures over the past two years. In January, the National Institutes of Health (NIH) opened a new center for translational research to help push drugs through the early, pre-clinical phases of development. The FDA has also been presented ways to decrease paperwork involved in submitting a drug, a step that would lessen the load at the tail end of the pipeline.

Streamlining clinical trials has also been a priority for NIH director Frances Collins. Earlier this month, Collins told Nature that one of his highest priorities “is to try to reengineer the way we do clinical trials.” One way that Collins suggested was to aggregate medical records, with patient consent, so that people who want to participate in trials can be located.

Neil concocted the plan for TransCelerate around this time last year when he was corporate vice president for science and technology at Johnson & Johnson. He invites smaller companies to join. The all-star group currently consists of US-based Pfizer, Johnson & Johnson, Bristol-Myers Squibb Co., Eli Lilly, and Abbott Laboratories, and European drugmakers GlaxoSmithKline, AstraZeneca, Sanofi, Boehringer Ingelheim and Genentech.

“The more efficiency we create, the more drugs we can study, and the faster we can get those drugs to patients who need them,” Neil says.

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Bacteria living naturally within the gut provide a gateway to flab, according to a few reports this week. These bacteria may explain how antibiotics fatten farm animals and perhaps people too, and how certain genes predispose organisms to obesity.

In a study published 22 August in Nature, researchers mimicked what farmers have been doing for decades to fatten up their livestock: they fed young mice a steady low dose of antibiotics. The antibiotics altered the composition of bacteria in the guts of the mice and also changed how the bacteria broke down nutrients. The bacteria in treated mice activated more genes that turn carbohydrates into short-chain fatty acids, and they turned on genes related to lipid conversion in the liver. Presumably, these shifts in molecular pathway enable fat build-up. Just as farm animals get fat, the antibiotic-fed mice put on weight.

Martin Blaser, a microbiologist at New York University in New York, says that parents might unknowingly be promoting a similar phenomenon when they treat common ailments and ear infections in their children. To back that idea up, he points to another study he authored. The study, published on 21 August, found that a disproportionate number of 11,000 kids in the United Kingdom who were overweight by the time they were 3 years old had taken antibiotics within their first 6 months of life.

“Antibiotics are extremely important drugs,” Blaser says, “but especially when given early in life, I believe they come at a cost that parents, doctors and patients should be aware of.”

Microbes also seem to be an accomplice in genetically induced pudginess, according to a study published today in Nature Immunology. When researchers rid mice of a gene encoding a gut molecule called lymphotoxin, segmented filamentous bacteria overwhelmed the normal microbial community. These bacteria may gobble up excess fat like tapeworms — the mice remained thin no matter what they ate. What’s more, mice with lymphotoxin intact were able to keep their slim figures when the researchers implanted the segmented filamentous bacteria in their guts.

Although the papers provide tantalizing links, Peter Turnbaugh, a microbiologist at Harvard University in Cambridge, Massachusetts, says that there’s more work to be done before microbes enter the limelight in the fight against obesity. “These studies suggest mechanisms by which different bacteria promote adiposity, but they don’t fully define pathways,” he says. “What really excites me about these papers is that now we have two new mouse models to do the follow-up experiments.”

Digestible microchips embedded in drugs may soon tell doctors whether a patient is taking their medications as prescribed.  These sensors are the first ingestible devices approved by the US Food and Drug Administration (FDA). To some, they signify the beginning of an era in digital medicine.

“About half of all people don’t take medications like they’re supposed to,” says Eric Topol, director of the Scripps Translational Science Institute in La Jolla,California. “This device could be a solution to that problem, so that doctors can know when to rev up a patient’s medication adherence.” Topol is not affiliated with the company that manufactures the device, Proteus Digital Health in Redwood City,California, but he embraces the sensor’s futuristic appeal, saying, “It’s like big brother watching you take your medicine.”

The sand-particle sized sensor consists of a minute silicon chip containing trace amounts of magnesium and copper. When swallowed, it generates a slight voltage in response to digestive juices, which conveys a signal to the surface of a person’s skin where a patch then relays the information to a mobile phone belonging to a healthcare-provider.

Currently, the FDA, and the analogous regulatory agency in Europe have only approved the device based on studies showing its safety and efficacy when implanted in placebo pills. But Proteus hopes to have the device approved within other drugs in the near future. Medicines that must be taken for years, such as those for drug resistant tuberculosis, diabetes, and for the elderly with chronic diseases, are top candidates, says George Savage, co-founder and chief medical officer at the company.

“The point is not for doctors to castigate people, but to understand how people are responding to their treatments,” Savage says. “This way doctors can prescribe a different dose or a different medicine if they learn that it’s not being taken appropriately.”

Proponents of digital medical devices predict that they will provide alternatives to doctor visits, blood tests, MRIs and CAT scans. Other gadgets in the pipeline include implantable devices that wirelessly inject drugs at pre-specified times, and sensors that deliver a person’s electrocardiogram to their smartphone.

In his book published in January, The Creative Destruction of Medicine, Topol says that the 2010s will be known as the era of digital medical devices. “There are so many of these new technologies coming along,” Topol says, “it’s going to be a new frontier for rendering care.”