LyrArc Article Gist
Novartis is taking a new approach to drug research and drug discovery. The old one which was popular in the drug industry was to go directly for blockbuster drugs for large numbers of users, with a long time in the research pipeline because the area of research was largely an unknown. This was costly and becoming less and less productive. Dan Vasella who heads Novartis, is taking a different approach which comes from his understanding of medical science as a physician, in an industry run by accountants, lawyers and business people. This is to go after wellknown molecular pathways identified by Dr Fishman at Harvard in his research, and do this by taking on problems in diseases that afflict small numbers of people. These drugs have some established medical science to work with, and the research work takes a shorter period. Once the drug proves its effectiveness in one illness, it is tested for other illnesses that afflict a large number of people but which shares some of the same underlying phenomena that cause the disease in the two situations. Dr Vasella stumbled on this approach after the development of the drug Gleevec by Novartis. Gleevec was originally approved for a rare blood cancer, but has now shown to be effective against six other dieases. Gleevec brought 3.7 billion in revenues in 2008 for Novartis.
In 2002 Vasella made a bold move to discard the old drug development model. The basis of this approach was to go after new drugs that were desperately needed and where the genetics of the illness were well understood. Whereas pursuing rare dieases is considered foolhardy by most drug company leaders, Vasella's idea is to use the common genetic underlying arrangements for that drug to go after other diseases that would be good prospects for the now proven drug. The known genetics makes it possible to complete the research in a shorter time. In 2009 Novartis has 93 drug candidates in the pipeline, 40% more than 3 years ago and 80% of Novartis' drugs last year made it from early testing to late stage development. This was a 60% improvement over 2005.
The new approach fits the current regulatory climate, with regulators concerned more about safety, and Medicare and Medicaid and other payor less willing to pay for treatment with modest benefits or with uncertain outcomes.
The approach had to be executed in terms of organization and staffing. Vasella moved the R&D global research operation from Basel to Cambridge, Massachusetts, and spent $4 billion on the move. He recruited a renowed researcher and cardiologist at Harvard University, Dr Mark Fishman, who had done research on the genetic mutations in the cardiovascular systems, to run the center and set the new direction for global research. Fishman convinced Vasella that medical research should focus on a small number of molecular pathways- the complex suquences of interactions among chemicals, proteins, and larger cell structures in the body that are behind all illnesses. Says Fishman, there are 24,000 genes in the genome, but only a few dozen pathways conserved through evolution. Fishman's theory is that you find all the links in a pathway and then locate the signals that can turn the genes on or off to develop medicines for illnesses. Bercause disease after disease share a common pathway, the knowledge gathered can then be applied across that region with more accuracy and directly, to address a range of illnesses.
Fishman's approach means marketing and sales no longer make the decisions. There is a new method for doing things. Fishman focusses on clinical data and insists that commercial analysis comes after sufficient clinical data. A major restructuring in 2007 led to shedding 1260 sales and marketing jobs, as clinical science now takes precedence and medically trained scientists take senior leadership positions. The new approach is being used for a drug developed for Muckle-Wells syndrome. Computer simulations are shortening the time to late stage trials. The drug has applications for Type 2 diabetes and severe arthritis. The whole process will take many years, as its a sea change for the industry and for Novartis, a fresh approach when the approach used by the pharmaceutical industry for so long is failing. An oral drug treatment for multiple sclerosis is being developed along these lines. Afinitor. approved by the FDA for kidney cancer in March shows potential in six other diseases, including lymphoma where Afintor shrank tumors by 50% in one third of the patients in a trial.
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