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
In 2005, the pharmaceutical industry must finally come to grips with the unsustainable economics of its current research and
development paradigm. It takes too long and costs too much to develop drugs.
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."
In 2005, the pharmaceutical industry will have to look at the lessons learned from other R&D intensive industries, such as
telecommunications, aerospace, and automotive. They must use technologies that are developed using disciplines that lie outside
traditional pharmaceutical R&D (i.e., mathematics, physics, and engineering) and use the right technology to close the predictability
gap. So what we learn in discovery is immediately translated into development, and ultimately, into an effective therapy in
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