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Though Pharma is Warming to Personalized Medicine, Gaps in Knowledge Temper Hype

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WASHINGTON, DC – Although pharma is getting increasingly excited about the prospect of personalized medicine, some companies are still grappling with how to fit pharmacogenomic strategies in the existing healthcare paradigm, according to an AstraZeneca official.
 
“The questions we’re getting now aren’t so much ‘How can we avoid [pharmacogenomics tools]?’ but that this is a good thing,” Wayne Rosenkrans, business strategy director of external scientific affairs at AstraZeneca, said at the Experimental Biology annual meeting, held here this week. “This can actually help us with access. It is good for patients. What is good for patients should be good for us.”
 
Rosenkrans, who is also chairman of the Personalized Medicine Coalition, said that “now the question isn’t ‘How do we lay down in front of the tracks on this?’ but ‘How can we make this happen?’ ‘How fast is this going to happen?’ What do we need to do to prepare?’ That’s been a sea change that I’ve noticed in the commercial thinking rather than the economics of these things.”
 
However, given the challenges surrounding drug/diagnostic co-development, insurance issues, and patient education, managing expectations about the potential of personalized medicine is the key to its long-term success.
 
The growing optimism is positive but should be tempered with a more realistic outlook of what personalized medicine is currently capable of, Rosenkrans advised.
 
Pharma Mind Shift
 
It has long been thought that pharmaceutical companies would embrace PGx tools to develop personalized medicine in an effort to lower clinical development costs, lower attrition rates, and conduct more efficient trials. With drug-development costs rapidly rising, the threat of generic competition, and several high-profile drug failures like Pfizer’s hypercholesterolemia drug torcetrapib, pharma is now making serious changes in its business model to facilitate PGx and personalized medicine.
 
For instance, Novartis is moving way from the traditional three-phase drug development model to what is calls the “Learn and Confirm” paradigm, and using PGx tools to learn more about investigational drugs earlier in the development process [see PGx Reporter 03-14-07]. Similarly, Bristol-Myers Squibb and Lilly each use PGx to find biomarkers to broaden the indications of their oncologics.
 
During the same meeting, Felix Frueh, head of the FDA’s Interdisciplinary Pharmacogenomics Research Group, said that agency leaders had predicted a “PGx explosion,” but that is now fast becoming a “PGx avalanche.”
 
However, the outlook wasn’t always so rosy for PGx. Rosenkrans said he remembers a time at AstraZeneca when the commercial side was not at all enthusiastic about the changes required to invest in personalized medicine.
 
“Four years ago I’d go into a leadership meeting and I’d talk about personalized medicine and most of the commercial leaders would make a sign of the cross and would tell me to get out of there,” he reflected.
 
Personalized medicine “was going to be the ruination of the megabrand model, which they had made an enormous investment in. It was going to change the way we did our sales and marketing. There were lots of scary things they saw emanating from personalized medicine … Economics, yes, people forget the most powerful ‘omic’ of all.”
 
The dying blockbuster model has recently been on the minds and lips of industry leaders at many large pharmaceutical companies. Novartis officials have placed a 10-year expiration date on the blockbuster paradigm and are preparing for the era of the “niche-buster,” which relies on biomarkers with broad applicability to target subpopulations in many disease areas [see PGx Reporter 03-28-07].
 
The Challenges
 
“Although the dialogue [about personalized medicine] has changed dramatically,” many large pharmaceutical companies still have knowledge gaps about how to align the business models of diagnostics and pharmaceutical companies, how to reimburse for genetic testing, and  how to educate physicians and patients about the value of using predictive technologies to personalize therapy, Rosenkrans noted.
 
“The question I get asked most … which everyone seems to be grappling with, and which no one seems to have a good answer for, is, ‘What’s the business model for this? How do you make money off this thing?’” Rosenkrans said. “The diagnostic business model is very different from the pharmaceutical business model. The two seem antithetical. …We have to figure out how to do that.”
 
Some industry insiders believe that the ingredients for a successful drug-diagnostic collaboration require market need, economic benefit, and operational freedom for the involved parties. Pfizer and Monogram’s drug/diagnostic partnership for the investigational HIV drug maraviroc is often upheld as a positive example of a symbiotic Rx/Dx partnership [see PGx Reporter 12-13-06].
 
Additionally, pharmacy benefit managers like Medco and PharmaCare are conducting their own genomic and pharmacogenomic studies to investigate the value of incorporating such technologies into treatment decisions [see PGx Reporter 12-06-06].
 

“Four years ago I’d go into a leadership meeting [at AstraZeneca] and I’d talk about personalized medicine and most of the commercial leaders would make a sign of the cross and would tell me to get out of there.”

“Tests aren’t black and white. There is a certain level of specificity associated with each test. We don’t know really what an appropriate threshold is in terms of sensitivity [or] specificity in terms of guiding prescribing behavior,” Rosenkrans said. In this regard, large insurers such as Aetna are demanding that diagnostic companies prove the value of their tests by conducting randomized controlled trials [see PGx Reporter 04-25-07].
 
Rosenkrans noted that in some cases personalized medicine is being unnecessarily forced on patients. In Australia, for example, patients prescribed the lung cancer drugs Iressa and Tarceva must first prove they are EGFR-positive, even though it is well-established in clinical trials that EGFR does not predict for response.
 
“That’s using personalized health care as a cost block, and we don’t [want] to go there,” Rosenkrans said.
 
Given the rapid advances and numerous challenges surrounding PGx, estimates of when personalized medicine will take hold have ranged from the optimistic —  a decade — to a more cautious outlook that the science will not fully mature until 2050.
 
Ultimately, Rosenkrans said that stakeholders should “manage the expectation set around what is really going to be possible.
 
“I believe we are already seeing the tip of the iceberg here,” he said. “We are going to see a lot more in the next five years. I think you’re going to see genuine products from Lilly, GSK, and at least AstraZeneca.”
 
However, he cautioned that “there is a lot of space in between. If the hype gets ahead of what the promise is, the whole thing can get flushed away and then no one is going to benefit.”

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