Still, the consensus is that the firms are at least heading in the right direction. What no one yet knows is if it is too
little, too late. Or what "too little, too late" might actually look like. Or what else might work. Given this sense of uncertainty,
in which each step into the unknown may be a step off a cliff, Pharm Exec went looking for the boldest, riskiest, most radical blueprints for rebuilding the industry. The following two fit the bill
R&D FOR THE COMING MARKET: A model for real-world drug design
Are the drug giants scientific organizations or sales machines? As Big Pharma downsizes to focus on core competencies, will
each company eventually face a Solomon's choice between its R&D and its commercial sides? Will we see a Pfizer that is all
sales force and no pipeline? A Merck focused exclusively on drug development?
In hopes of helping pharma escape such ultimatums, Omar Chane, vice president of life sciences at Capgemini, has developed
a new model built around early commercialization in drug development. "We need to bridge the gap between R&D and the commercial
side," he says. This is a common enough industry complaint, but Chane means nothing less than reforming the entire R&D process
to incorporate the profound transformations in the marketplace. "A company needs to develop not only the right product but
the right evidence to show its value to consumers, doctors, and especially third-party payers," he says. "And that process
has to start at the preclinical phase."
In surveying or interviewing 200 industry execs on both sides of the medical/marketing equation, Chane and his colleagues
discovered that while everyone agrees there is a serious problem, that is where the agreement ends. Most disturbing, he says,
is that Big Pharma's attempt to increase R&D productivity by streamlining pipelines into therapeutic areas may be doomed to
fail without a revolution in medical-marketing integration.
Chane sketches the big trends in the blockbuster model. About 15 years ago, he says, the drug-discovery engine began losing
steam. With fewer breakthrough compounds, the industry focused on line extensions—and pumping up sales forces to differentiate
products that were often essentially indistinguishable. Meantime, discovery techniques (screening, genomics, proteomics, molecular
biology, etc.) matured to the point where there are now ample new candidates in Phase I.
What makes the status quo unsustainable, in his view, is not that pipelines are tapped out, but that late-stage development,
marketing, and sales are too expensive—especially in light of the unprecedented pressures and competition that products now
face. The old R&D-centric focus on delivering a single compound to the FDA doesn't cut it anymore. What the marketplace now
demands is not just an approval letter but an entire portfolio of data to support and sustain its viability. Proving cost-effectiveness
and real-world value is the name of the game. And increasingly the game is centered on the consumer, not the compound.
"Companies can no longer rely on bringing a product to market and then waiting several years for Phase IV to prove its value,"
he says. "The commercial perspective on access to the market must be introduced as soon as you think of a development plan
for the compound." For example, since third-party payers are increasingly running comparative trials and health-outcomes studies,
it pays for drug makers to do their own version first, as a component of Phase III.
According to Chane, development is the weak link in the decade-long lab-to-pharmacy adventure, and its massive inefficiencies
will only increase with the in-licensing of products from outside biotechs. No pharma firm is still fat enough to swallow
a $500 million investment in a Phase III flop or to strangle a promising compound prematurely due to low commercial valuation.
If faster failing is the mantra, then a model built around early commercialization is the best way to master it. "A more systematic
approach that integrates R&D and commercial must replace scientists' traditional reliance on serendipity," says Chane. "That's
how you get more products out of preclinical and better products into Phase III."