Novartis GSK or other AstraZeneca have done

The ability to innovate of the pharmaceutical industry is measured prior to any number of new products placed on the market, i.e. to its R & D productivity. However, in 2007, 14 molecules only have been approved by the FDA against 30 to 40 each year during the 1990s, and in addition to a higher cost twice. Should we find a decline in the ability to innovate pharmaceutical groups Bionest Partners, firm specializing in pharmaceutical companies and biotechnology, Council has to address the issue through a survey entitled "strategies for pharmaceutical innovation." Conducted by Julian Ozdowski, it looks more or less convincing tracks tested by industry to escape this fate.

"It is true that certain factors explaining the loss of ability to innovative pharmaceutical groups their escape, which brings water to the mill of the fatalists", notes Claude Allary, co-founder and CEO of Bionest.

Focus on biotechnology

This is the case of growing regulatory agencies for risk aversion. It leads to more and more top place the bar for security. The slightest side effect mentioned in a record of registration, the FDA specialists out their magnifying glass and do not hesitate to request additional information which may defer the granting of the authorisation for placing on the market. Thus, in 2006, almost 50 new molecules approved by the FDA have suffered delays in registration and therefore to the launch.

One can also argue that new treatments that have the wind in its sails are today of organic products. They represent nearly half of new products authorized by the FDA, and even up to 75 in some areas such as cancer. However, the pharmaceutical industry, chemical culture, is not comfortable at all with these products whose production is much more complex and expensive than molecules obtained by synthesis. And the permissions of the agencies are more difficult to obtain because they are more suspicious than for synthetic products. "But here, he began to be difficult to invoke the inevitable, as Claude Allary." If do the cultural revolution of chemistry to biology can be regarded as a challenge too, nothing prevented the pharmaceutical groups to tame biology by taking control of biotechnology companies. "Some groups have also done it with success, as rock with Genentech, the Swiss group provides a growth relay. Others have shown less than talent. "Because it must control without sterilization, which is not so simple in terms of management," concedes Claude Allary.

Encourage partnerships

But, without acquisitions of control of the scope of Genentech, pharmaceutical groups can also spend all kinds of alliances and partnerships with companies. Left to then subcontract the production of organic products. Novartis, GSK or other AstraZeneca have done. "The ability to pick out through partnerships target molecules to fill holes in the pipeline, is crucial for the survival of the pharmaceutical groups," said the Bionest study. But this implies a rigorous management of the external programs such as internal. In some groups known for their lack of openness such as Merck and Sanofi, this cultural change may be as radical as from chemistry to biology.

But, even in the management of R & D programs internal required flexibility and flexibility are rarely meet, because repetition mergers led to huge structures. "The size and the completely integrated character of a R & D too rigid became a handicap for the emergence of innovative molecules", observed the Bionest study. "Decide to discontinue the development of a product to focus on another is a heavy decision which can have catastrophic repercussions on the career of the takes." It is seen as an admission of failure. "Then on the different", complete Claude Allary.

Remain the art and science, who turn the heart of the engine is the R & D. Despite the multiple experiences of reorganization, including the most daring as in GSK research remains for the moment part rebel any injunction productivity. On this point, the Bionest study proposes nothing very original, confining itself to assume that a better use of technological platforms (Genomics, proteomics, research in silico screening throughput...) and the multiplication of the tools (molecular imaging, Predictive Toxicology...) will facilitate the identification of molecules for the future.

Target and diversify

At the stage of testing in humans development the margin of progress seems to be more important. The Bionest study mentioned including the central role that may be biomarkers for detecting early toxicity of a product, best stratify the populations included in clinical trials by identifying patients non-respondents or develop predictive testing of efficacy of treatments. The design of clinical trials could also save time by using more innovative statistical techniques.

More overall, Claude Allary believes that many pharmaceutical groups, despite their size, still disperse their effort on one too many therapeutic areas instead of deepening their approach to a few target areas. Left to diversify in parallel in less risky activities but lower margin developing an offer integrated including, for example, for diabetes, a range of medicines, insulin pumps and a distance of blood glucose monitoring system. Still need to convince shareholders to accept a decrease in the margin.