Now that scientists have mapped the human gene, can drug makers map a road to unlimited riches?
For John Lechleiter, Executive Vice President of Eli Lilly and Company's Pharmaceutical Products and Corporate Development, there remain more questions than answers."People ask, 'When will we see new drugs, and will they be less expensive?' My answer is, 'I don't know, and probably not.'"
Lechleiter was one of several panelists to discuss, "Breaking the Genetic Code: The Business of Life Science in the 21st Century" at the 2001 Global Alumni Conference, presented by HBS associate professor Stefan Thomke, assistant professor Jonathan West, and Senior Research Fellow Juan Enriquez-Cabot.
On February 12th of this year, this latest scientific revolution was launched in earnest when two research groups published their work to map the complete human gene. Among their findings: each person has only about 30,000 genes—far fewer than was previously believed. What's more, the genetic difference between people, indeed, between people and animals, is relatively small.
Genomics is the most destructive force in the history of medicine.
With a genetic database at hand, scientists predict a new world where drug treatments are customized to an individual's genetic makeup, and gene-based therapy can root out cancer and other diseases before they take hold in the body. The new science will "revolutionize the way medicine is delivered to individual patients," Thomke said.
The potential influence on drug development in particular, and medicine in general, is enormous, panelists agreed. Today's drugs can reach some 400 to 500 potential disease "targets" in the human body. With genomics, there are up to 20,000 potential targets, creating hope for a host of new drugs and therapies that can be tailored to individuals and result in fewer side effects.
Advances in treatments of cancer and infectious diseases are likely to be early benefits of work in genomics, Lechleiter said. Another potential early benefit: the ability to test people for diseases brought about by abnormal genes, such as Alzheimer's disease or cancer.
Clearly, genomics could be a gold mine for drug makers. Today, drug development is an expensive and long process—it can take up to ten years and $600 million to develop a single new drug. What's more, eight out of ten potential drugs don't survive clinical trials, resulting in the pharmaceutical industry footing enormous bills for failure.
Genomics will be a productivity driver, pushing perhaps a 100 percent increase in drug development, said Alan Crane, Senior Vice President for Corporate Development of Millennium Pharmaceuticals. "Genomics is the most destructive force in the history of medicine," causing massive change, Crane said.
But the business of life science won't change overnight, panel members said. And just who the winners and losers will be aren't at all clear.
For example, it will take at least a couple of years to start getting traction on the data that has been published. Also, it will require significant investments in research to fill in all the "blank spots" in discovering how genes interact with proteins to govern the workings of the body.
And it will take years for companies to re-engineer their drug development processes.
Another wild card is how the US Food and Drug Administration, which holds regulatory approval over new drugs, will change its approval procedures. Theoretically, the regulatory process could be sped up and made more efficient with the new knowledge about genes. Human trials, for example, could involve specially targeted participants who are most likely to benefit or have adverse effects from a potential drug. The question is, said Lilly's Lechleiter: will the FDA accept that process?
"That's the big question," Lechleiter said.