Thomas Goetz asks, Is pharmacogenomics for real?. I left a long comment with the post, so I won’t repeat myself here, but I did want to add a few additional words.
Pharmacogenomics is for real, but like all things omic, the hype is always amplified. One thing to note is that it takes a long time for a drug to come on to the market, so the impact of pharmacogenomics is still small when it comes to drugs on the market. That said we are still some ways away from seeing a significant number of drugs being released with companion diagnostics (which is what I believe Thomas was curious about). There are several reasons for that. Some are
1. We don’t quite understand which biomarkers are the right ones. There are multiple prognostic tests for breast cancer. Which one is more robust? In the end it depends as much on the classifiers used as it does on the gene expression signature
2. Finding biomarkers is the easy part. Validating them is a different story and a huge challenge. The guidelines around biomarker validation are just being fleshed out (pdf)
3. Right now the emphasis seems to be on applying PGx to existing drugs and making sure they are given to the right people
4. Clinical trial design is being impacted as we speak and will continue to be. Even if there is no companion diagnostic, being able to design trials and better select patient populations is a clear impact. I am in the “if they can select patients on some criteria, they can release it as a test” camp
5. Last but certainly not the least, the industry has still not decided what the impact of PGx on business models will be. By and large everyone wants personalized medicine; pharma, FDA, etc. However, there will be an impact to the cost of drug development, the way drug portfolios are planned, etc. Until the industry figures out that problem, the explosion of drugs targeted at specific populations is probably not going to happen. I believe that we will start seeing more PGx drugs come into play around 2010, with the floodgates opening in the decade to follow.
The usual disclaimer
Technorati Tags: Pharmacogenomics, Personalized Medicine
3 Comments
Hey Deepak!
Would you be please so kind as to send me the pdf about biomarker validation?
I’m working on some biomarkers and would love to read more about the hard and complicated process of validation.
Thank you in advance!
Berci
I fixed the link to the PDF. You should be able to download it now. If now, drop me an email and I will send you the file.
Berci
I fixed the link to the PDF. You should be able to download it now. If now, drop me an email and I will send you the file.
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[...] Your personal health: Thomas Goetz is curious about PGx (bbgm): Deepak Singh’s answer to Thomas. We don’t quite understand which biomarkers are the right ones. There are multiple prognostic tests for breast cancer. Which one is more robust? In the end it depends as much on the classifiers used as it does on the gene expression signature. [...]