I spent yesterday afternoon at the Forum for Medical Innovation in downtown Chicago, hosted by the Council for American Medical Innovation and moderated by former U.S. House of Representatives majority leader Dick Gephardt. The event also featured AstraZeneca CEO David Brennan as a guest speaker. David Brennan

Pfizer’s downsizing in Ann Arbor and the state of the economy have some punk rockers raging against the Big Pharma machine.

Four universities--Hawaii, MIT, Purdue, and Rutgers--are collaborating on an effort, with support from the National Science Foundation, to apply modern analytical methods to traditional medicines in order to learn more about their properties. The researchers will use informatics and bioinformatics to establish a more cohesive database on traditional medicines.

End Pharma Parochialism: Think Globally, Act Globally

Researchers at the Salk Institute in La Jolla have discovered a drug (for more, read on) that appears to provide the same benefits as exercise:  improved endurance and metabolic function-----in mice. What's next?

U.K physics professor Jim Al-Khalili recently visited the Royan Institute in Tehran to witness their work in stem cell  research, and described the differences in approach in an interesting commentary in the Guardian.

Fierce Vaccines  just spotlighted an article from this week's Scientific American, on a clinical trial of a vacccine for non Hodgkins lymphoma, which was derived by tobacco plants. Researchers produced tumor-fighting antigen within the plants by first extracting the gene coding for the antigen from white blood cells in patients' tumors, then inserting it into a tobacco mosaic virus in the plant.  As the virus spreads throughout the plant, more of the antigen is generated. 

Harvesting the protein involves grinding up the leaves and separating out the antigen. So far, around 70% of participants showed improvement when injected with antigens targeting their tumors. For more from the source, read on.

Clinical trials may have uncovered a possible link between inhaled insulin and lung cancer. In testing its blockbuster manque Exubera, Pfizer said six of the 4,740 Exubera-treated patients versus one of the 4,292 patients not treated with Exubera developed lung cancer. One lung cancer case was also found after Exubera reached the market.  However, all those affected were smokers, so connections are still somewhat unclear, although Pfizer is adding to warning labeling for whatever product might still be out there.  More from a news brief issued this morning.

What might be clear, though, is the role that a true Quality by Design approach could have played in developing this product.  Pfizer's "Right First Time" appears to have failed, utterly, in this case.  This is not playing Monday morning quarterback but pointing to a case where pharma lost billions by failing to connect more closely with customers and with its own work force.  There's another case playing out right now, which shall remain nameless, with huge implications for industry professionals , particularly those based in New Jersey.  

The Exubera product concept was brilliant, from the stabilization process that allowed its active ingredient to be manufactured to the delivery device itself.  But nobody wanted a large device with complicated dosing instructions, so Exubera violated Toyota's "customer focus" rule.  (Not to mention the fact that Pfizer transferred some manufacturing folks from its Brooklyn location to a fairly remote site to make the product.  In the end the company only wound up laying them off...so it wound up violating Toyota's "respect for the worker" rule, too.)

Both Lilly and Novo Nordisk have reportedly stopped inhalable insulin development, and Nektar has suspended discussions with other potential partners.  A shame because, if the kinks were worked out, inhalable insulin could solve a great many problems and be much easier for patients to take, particularly in parts of the world where needle availability and safety might be in question (assuming its costs went down, of course). 

 So perhaps it's time to go back to the drawing board.  But, this time, maybe with the right tools (and many more physician and patient customer focus groups) in place? (And an eye to "right sizing" staffing requirements for the next blockbuster, up front)

Question of the day:  Why do some people react to devastating news by turning inward and shutting out the world, while others "take arm against a sea of troubles, and by opposing, end them. " 

For anyone suffering from seasonal affective disorder (SAD) or struggling through the dog days of February in need of an inspiring story, here's someone to take note of.

Josh Sommer had planned to major in environmental engineering when he started his studies at Duke University. He switched to biology in freshman year after he was diagnosed with chordoma, a rare form of cancer. He is now devoting all his time to lab research on a fellowship. He and his mother have established a foundation dedicated to finding a cure for the disease; the organization earned $300,000 in a short time, but the Sommers hope the figure will soon reach $3 million.  For more from a recent Associated Press article, read on.   More from the News & Observer. 

Big and not-so-big pharma, take note (perhaps some orphan drug research programs and donations might be forthcoming?)

AMS

Experimental drugs and therapies are flourishing in China, and patients who feel they have little to lose are flocking there to try them, according to an article in the Asia Times, which references a study published in Nature Biotechnology. Click here to read.

One of the players? China's Beike Biotechnologies, which reportedly harvests stem cells from the umbilical cord or amniotic membrane and injects them into patient's spinal region. More than 1,000 patients, including 60 foreigners, have been treated for a variety of conditions, the article says.

China also has the world's first commercialized gene therapy, Gendicine, and is manufacturing one of the only two oral cholera vaccines available.