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Biomarkers versus Blockbusters

By Malorye Allison

Bio-IT World is pleased to introduce our latest regular columnist, Malorye Allison. A founding member of Bio-IT World’s editorial staff, Malorye is vice president and editor-in-chief of CHI’s PharmaWeek.

April 12, 2007 | Is the blockbuster finally doomed? Proponents have been sounding the call for an alternative approach — ‘personalized medicine’— for several years. Meanwhile, the rise in biomarker research is indisputable. But are the two trends connected, and are companies really changing their strategies and using biomarkers to target smaller, better defined patient sets with their new drugs? Or is the vast majority of pharma biomarker studies just aimed at culling bad drugs from their pipelines?

At CHI’s recent Translational Medicine meeting*, panelists debated the future of the blockbuster. The discussion showed just how much controversy and uncertainty remains surrounding this question.

“I’m not sure the age of the blockbuster is dead,” said Hugo Stephenson, president of strategic research and safety at Quintiles, one of the world’s largest CROs. Stephenson sees lots of unmet need and opportunity in areas such as hyperlipidemia and hypertension. “These are major areas for industry growth,” he said. “We’ve been treating LDL levels and blood pressure, but we know there have to be better mechanisms we can target.”

“I do not buy that the biomarker alone is the answer,” he added. “If you have a family history of Alzheimer’s, and someone launches a product that will delay onset of the disease if taken from age 40 onward, well, that is a product that will sell $5 billion at least.” 

But others are not so sure those mega markets still exist. “Our position is that those ‘big’ diseases like Alzheimer’s are really driven by many different factors that will respond to different drugs,” said Bob Schmouder, executive director of exploratory clinical development at Novartis. “If you are giving people a drug that works on a different factor than what is driving their disease, you might as well be giving them bottled water.”

Schmouder described how Novartis has shifted to the type of “learn and confirm” model of drug discovery and development that Wyeth is also using (see Ten Years After: Learn and Confirm, Bio-IT World, February 2007, p. 36). The old model, he said, was not so much parallel as stepwise. The new model puts an emphasis on early proof-of-concept and the intelligent use of biomarkers throughout the process. According to what Peter Kim described at last year’s BIO CEO, Merck is taking almost exactly the same approach of greatly increasing the biological evidence around any project, and looking more closely at how individual differences affect response to drugs. 

New Wave
It is increasingly evident that there is a new way of doing things in large pharmaceutical R&D. One of the most striking aspects of this is a greatly reduced emphasis on the traditional phases of drug development. “The FDA is not hung up on seeing exactly Phase, I-II-III-IV,” said Schmouder. “Now, we often dovetail the Phase I and proof of concept by using adaptive trial design.” To do this wisely, he counseled, requires a lot of interaction with FDA but “they are reasonably receptive.” As the number of subjects in a trial increases, the agency will demand more evidence that the drug actually works.

While this strategy can deliver earlier proof-of-concept, it doesn’t necessarily protect companies from the other big challenge in this field — drug safety. And there are still huge problems deciding which drugs to bring from preclinical development into trials. “We’ve made a lot of progress, but first in man is still the great unknown,” Schmouder said. 

Still, it is encouraging that pharmaceutical companies are changing their strategy, and it seems to be based on a very logical premise. “The greatest incremental value of any compound is accrued during the translational phase,” Schmouder said.

Ironically, big pharma’s place at the blockbuster banquet may be taken by biotechnology instead. “It’s true that most pharmaceutical companies are shifting that way, toward targeting specialized segments,” said Stephenson. “But personally, I’m optimistic that there will be more blockbusters, given some of the programs I’ve seen at a biotech level.”

Schmouder remained pessimistic though. “I sure hope I’m wrong,” he said. “But personally, I’m afraid the blockbuster era is behind us. We expect to see about ten more years’ worth of blockbuster markets, then the companies who evolved into using more focused approaches will succeed or fail based on that strategy.”

*Translational Medicine, Bridging the Gap Between Discovery and Clinical Development (CHI), Philadelphia, March 6-7, 2007.

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