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Wyeth's PGx Point Man Considers FDA's Proteomic Biomarker Overture

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Ron Salerno: Director of experimental medicine and worldwide regulatory affairs at Wyeth Research.
Ted Burczynski: Principal scientist at Wyeth Translational Medicine.

Wyeth's Ron Salerno has long been involved in encouraging the use of pharmacogenomics technologies by pharma, diagnostics, and regulators, and helped draft the pharmacogenomic data submission guidance.

His colleague Ted Burczynski is a biomarker expert at Wyeth, the world's 11th-biggest drug maker.

ProteoMonitor spoke with them this week about the future of proteomic biomarkers after Larry Lesko, director of the Office of Clinical Pharmacology at FDA's Center for Drug Evaluation and Research, last week told participants at the Drug Information Association's annual meeting in Philadelphia that it might be time for the FDA to "rethink" its position on such biomarkers (see story this issue).

The following is an edited version of the interview.

What is the significance of Lesko's comments last week?

RS: I think this is an actual look at the success story of the [Voluntary Genomic Data Submission protocol] and, in the spirit of the Critical Path, [being able to ask] how can the FDA enable new technologies in the discovery of drugs?

From the get-go … since we issued the original [pharmacogenomics guidance] the comments from industry said, 'Why don't you include this to other areas of the -omics technologies, including proteomics and metabolomics?' The consensus of the FDA is 'We'd like to take the first step and look at a process specifically for genomics because there are different properties and charactersistics of all -omics.' They wanted to see how that works, and if it looks good they would open it open it up to other technologies.

Now, two years after the original VGDS was issued, there are fewer VGDSs being submitted. The FDA has noticed that generally once a company submits a VGDS the FDA doesn't really see a follow-up from those companies where they submit data. The FDA see less clinical VGDSs but they're seeing more pre-clinical VGDSs. So the FDA is wondering, 'Did we make our impact? Have we done what we've accomplished? Yes, we've opened doors and learned from each other.

'Now that there's a lull' — and I don't want to use the word lull, but let's say there's some breathing space here — 'let's [start] thinking about if we can apply this process to the other technologies.'

Is the interest in proteomics from researchers in academia and pharma today as the interest was in genomics two years ago when the VGDX program was being discussed?

TB: I think we're two years further on in understanding the limitations and applications of proteomics, but I do have to agree with Larry [Lesko] that there's benefit to be gained at both ends — at industry and at FDA.

There's definitely now than two years ago because these technologies have steadily advanced, and I think there is some exciting results being published especially in the field of metabolomics that is probably is spurring this mood to open up the VXDS to include proteomics and metabolomics.

Has FDA always thought it would be looking at proteomic biomarkers as an add-on to the VGDS when it was composing the VGDS, or has this increase in data driven that thinking exclusively?

RS: [The FDA has always said], 'Well, right now we'll look at genomics, but later on we'll look at those other technologies and develop guidances when appropriate.' So obviously I think we've seen seeds of information from Larry … that [the FDA] is serious about this and are now thinking that our next steps would be to encourage submissions under an umbrella of VXDS.

Do you foresee a guidance document in the near future?

RS: I don't know right now. But it would seem to me that there would be some kind of concept paper issued suggesting that we talk about this, and the next workshop can focus on this. But I'm sure we're a couple of years away from any specific guidance unique tom proteomics or metabolomics.

Considering your position at Wyeth and your relationship with the FDA, do you think Wyeth researchers will feel emboldened to start looking more closely at proteomic biomarkers?

RS: That all depends on our discovery laboratory. We from the [beginning] have been emphasizing gene expression and we're exploring the advantages of proteomics and metabolomics. So I really can't answer for them.

Do you think Lesko's comments will embolden tool vendors to pick up the pace of innovation in anticipation that pharma will see Lesko's remarks as a call to arms?

RS: I think it's a little bit too early, but that's where we want to be. … If I was a diagnostics company I certainly would be in tune to what the latest technologies are. …

TB: I think an accurate assessment right now is that proteomic and metabolomic technologies for biomarker discovery are more difficult than applying genomics right now. … At the other end, when we finally have discovered the biomarkers using whatever technologies there may be, I believe we will find that the development of co-diagnostics in the firm of metabolites or measurable proteins will actually be more facile than developing these perhaps more complex genomic assays.

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