PHARM EXEC SAYS: » The Vioxx withdrawal and increased focus on persistence and compliance—rather than public discourse and debate over DTC advertising—will influence companies to start moving away from the blockbuster marketing model. In general, the industry will struggle to make that transition, but companies and agencies with excellence in integration and marketing insight are more likely to be successful.

JOANNA BREITSTEIN, SENIOR EDITOR

» James Karis Chief Executive Officer, Entelos

For every 13 drugs that start out in animal testing, only one makes it to market, compared with one in eight during 1995. Fewer drugs and biologics are making it from the lab to the marketplace, which has dramatically pushed up the cost of drug development. The cost of getting drugs to market has been estimated to be $800 million, and some estimates take it as high as $1.7 billion when you include commercialization costs.

I believe technology can be the key to reinventing the pharmaceutical R&D process. But if you want to get to the moon, you can't take a submarine. In other words, achieving significant efficiencies in pharmaceutical research and development will require the right technology. The industry is going to have to be more willing then ever to borrow from other industries.

One critical step will be embracing technologies that begin to solve the predictability problem inherent in the discovery-to-development phase of the R&D process. This preclinical phase is the critical point at which targets (and their therapeutic compounds) are transitioned, or translated, into human in vivo disease states. This preclinical phase can be better characterized as the predictability gap between in vitro and animal experimentation and human clinical response.

While some believe that simply advancing technology the industry already knows or has (like genomic/proteomic databases, data mining, or visualization) will close this gap, it will not; the experiences of the last 10 years are evidence of that. What is required is exactly what FDA has called for in its white paper on innovation: "A new product development toolkit . . . is urgently needed to improve predictability and efficiency along the critical path."

Drug development takes too long and costs too much. It’s time to learn from other industries.

PHARM EXEC SAYS: » Pharma will increasingly target employers with their marketing and educational initiatives as more restrictive formularies force workers to be more responsible for paying for medicines and, consequently, less likely to take them.

SIBYL SHALO, SENIOR EDITOR