Innovation and Quality: How Long Should We Wait?

"Quite honestly, that would have been very helpful in my father's situation. Had he known that chemotherapy would not work for him, he would have spent that last 18 months of his life not going through the trials and tribulations of chemotherapy," Boutin said.

"But the reality is that negatively impacts your business market. If you're going to determine who your product does not work for, you have less of a market share. So we have to look at some other incentives for industry," he said.

"We need to create a new business model. We need to figure out how we can develop trials...that give conditional approval to these kinds of biomarkers, with the subpopulations that have been identified where it works," he said.

"We need to speed up the development of these new diagnostic mechanisms and put them out into the market and test them," he said. "I can tell you from this perspective that people with chronic conditions . . . are much more willing to accept risk than we give them credit."

Many of these individual are "very interested" in having diagnostics developed—if not for themselves but for their children who may have the same conditions down the road, he said. "There are real opportunities here to create incentives to get these into the marketplace far quicker than 11 years from now."