Many of the generic manufacturers started years back with knock off drugs to sell locally in India, but now the game is changing to where US Pharma is using some of the talent, which costs less than R and D individuals here in the states, to further develop existing work, in other words somewhat continue the work that has begun here as a lesser cost.

Filling the pipelines can be done with less cost, and perhaps more potential candidates being developed at one time might be an additional factor.  Also, as stated, four failures can come at the price of one here in the US, so the math is somewhat speaking for itself.  Some companies are asking their U.S. partners to toss that paperwork in the trash.

"We can't do it the Lilly way," Jasti says. "Innovation comes from freedom."

Many may have just though that all the technology would rest here in the US, but globalization of R and D is expanding as well as the manufacturing arm.  Many companies are doing similar or the same in China.  As Intellectual Property is exchanged and shared, this puts a whole new face on the future.  The US is still very strong with pharmacogenomics and building from the ground up, but once the basic rules are set, Pharma is finding alternative routes overseas to continue the process.  This is part of the reason we are starting to see layoffs and buyouts with R and D with many companies here in the US.  Without the restrictions and red tape in the US, development is slated to move at a much faster pace, but there's no mention of safety here, just a new group of clinical trials outside the US.  This all comes at a time when the FDA has embraced a more conservative mode of operation to ensure safety, so which is the correct business model?  I guess that might depend on whether cost is the only driving factor, or if the value of consumer safety is involved. 

This somewhat puts the FDA between a rock and a hard spot, amongst all other recent developments and restructuring, and one has to wonder a bit if the old methodologies of past practices are now working an additional hardship when it comes to having to play "catch up" at the FDA.  We have already heard many times that Congress has been working in a style that resembles the 50s and perhaps there's a bit of that past here too. 

On the other side of the coin, our global citizens may need to hold on to their hats as the R and D roller coaster begins, as mentioned above there will be room for 4 additional failures for the same cost, and with shorter times to collect and evaluate clinical information before releasing to clinical trials, there could be some real issues in time evolve, again reflective on what class of drug and what diseases are being treated.  BD 

Five Western companies have formed drug discovery partnerships with Jubilant, including Eli Lilly, Amgen and Forest Laboratories. Lilly is also partnering with Piramal, as is Merck. Every month, deals are signed with India's elite pharmaceutical companies. The goal is to take promising compounds discovered by the multinationals, run tests to weed out the weakest candidates, and develop some of the others into marketable drugs. Eventually the Indian partners also hope to rack up scientific breakthroughs that lead to entirely new medicines for diseases such as Alzheimer's, cancer, or diabetes.

Some Western companies are volunteering to share intellectual-property rights on new discoveries and even divvy up the profits. "It's a transformation of the R&D enterprise," says Robert W. Armstrong, Lilly's vice-president for global external research. "We have to think in a totally different mode."

The rush east, where five PhD chemists can be had for the cost of one in the West, entails risks. At a time when Pfizer , AstraZeneca, and others are slashing U.S. R&D jobs by the thousands, the buildup in Asia is bound to set off alarms that America is sacrificing another key industry through radical outsourcing. But if the strategy works, it could save the drug industry billions of dollars, bring down the prices of new drugs, and accelerate breakthroughs.  China has "extraordinary potential," says Eric J. Topol, former chief cardiologist at the Cleveland Clinic, who advises HUYA Bioscience, a drug licensing venture based in San Diego. China could yield "a flood of potentially important therapies. It's just a matter of time".

NTV - KHGI/KWNB/WSWS-CA - Where your news comes first. - Grand Island, Kearney, Hastings, Lincoln | U. S. Drugmakers Try Outsourcing Basic Research


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