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Petricoin Says There s No Place He d Rather Be Than at the FDA



NAME: Emanuel (Chip)

AGE: 37

POSITION: Co-Director FDA-NCI Clinical Proteomics Program, Senior Investigator, Center for Biologics Evaluation and Research, FDA Division of Therapeutic Products

PRIOR EXPERIENCE: Developed use of proteomics for cytokine signaling analysis at FDA, National Research Council Fellow in the Division of Cytokine Biology, FDA, and 1990 PhD in microbiology from the University of Maryland, College Park

In the second installment of an interview, Chip Petricoin discusses his group at the FDA, and his motivation for applying himself to proteomics.

 How big is your group at the moment?

About 25 people. It’s a pretty large group [and] has a lot of eclectic scientists in it. We have pathologists, clinicians, molecular biologists with just their PhDs, pathology residents, medical technicians who are used to working with clinical laboratory devices, information technology specialists, and bioinformaticians. We like to cross-fertilize and have people think outside the box. We [even] have a couple bioengineers. We’re starting to look in earnest at tissue bioreactors. We actually have two bioreactors developed in NASA, [and] we’re taking tissue from patients and growing the tissue in these bioreactors. We can [then] monitor the proteomic changes, and potentially use this as a way to drug patient material ex vivo. We have bioengineers exploring new ways to do tissue remodeling for things like toxicity prediction. We might grow an artificial liver, and drug it with different compounds of known toxicities, and then try to develop proteomic portraits to predict toxicity.

We’re constantly trying to think outside the box, specifically for translational-based research. The focus of our program is bench-to-bedside applications. You won’t find a lot of cell culture systems, you won’t find a lot of animal models. Everybody has to get funded for some reason. The reason why we’re getting funded is to see if we can develop proteomic tools and implement them in the clinic itself, and to test these things to see if any that we think are so exciting have any real impact.


Are there advantages to working in a government laboratory?

Testing [proteomics tools] in the public domain has some real utility. Lance [Liotta] and I are not bound by a lot of conflicts of interest. We can’t own stock in anything anyway. I can’t own stock in any pharmaceutical company, biotech company, or anything that has to do with health science. So that allows us to be unfettered. We’re simply saying, ‘These are the technologies we’re using, this is how we’re using them, so look at it for yourself.’ One of the things we try to do is make sure that for any technology we develop, we get that out there in the public domain as quickly as possible. [Laser capture microdissection] is a perfect [example]. It was invented in the public health system, and through a fantastic public-commercial CRADA success story through Arcturus it is now disseminated to hundreds of laboratories throughout the world. People use it.

We’re trying to take these other technologies [and do the same thing]. We specifically decided for the protein array system to use arraying equipment that we thought people would have the most access to. We used an Affymetrix pen arrayer. It’s fairly low cost, most array laboratories have it in place, and [we wanted to show that] we couple this to proteomic endpoints and publish on it. That’s our model system: to develop a technology, show that it reduces to practice, show it’s clinical utility, and publish that. We have people coming in every day to learn the technology from different universities and pharmaceutical companies. We pretty much will take anybody in if we have the time. We want nothing more than other people to use it. That’s the best way technologies get out there. The ones that really work well, they’re the ones you use, the ones that don’t work well, eventually get dumped.


What’s it like working at the FDA?

Different centers in the FDA have different ways in which they employ their scientists. The Center for Biologics is unique in the sense that Kathryn Zoon [Director of the Center for Biologics] in a very visionary way has implemented what they call a researcher-reviewer model, which is where everyone who does research also does regulatory review work. It allows everyone to wear several different hats. There are only 24 hours in a day, so you may end up sacrificing things either way, but it’s allowed me to [also] have a laboratory where I’m free to do FDA mission-related work, [such as] things that help get products to the clinic faster, and things that help us understand the products that we’re regulating better.

[While] I’m chairing [Product License Applications], and working on [Investigational New Drug applications], I have the ability to sit across the table from big pharma many times a year, and discuss with them their plans for developing biologics and drugs. I’ve seen the failures, and I’ve seen why they’ve failed. Also, it’s almost a tremendous due diligence because we know before almost anyone else in the public domain knows, what the drug industry is working on, what’s not working, and what they’re thinking about. So I can keep my finger on the pulse of what the targets are, the drugs that are being developed, and the biologics that are being developed. At the same I’m able to do research on new technology development that I think will help the public health service. So I love it. It’s a great opportunity to be able to help the FDA and the NCI at the same time. It’s a great niche.


Would you want to do something else eventually?

I’m always going to want to center myself in places where direct clinical benefit is being evaluated and assessed. I want to spend my scientific career in an area where I feel like I’m having the most dramatic impact as close to the patient’s endpoint as possible. Certainly we get tons of requests for opportunities to leave and do other things. We always consider those, but my main focus is that wherever I am, it would be using proteomics to try to drive and direct patient benefit as quickly as possible. Sure, most people would want that, but I specifically would want to align myself in a program and an atmosphere that is truly doing that.

Right now the best opportunity to do this is where I’m at right now. The NCI has a tremendous ability to do bench-to-bedside research, where they discover something and get that into a clinical trial very quickly. I have the ability with my FDA hat to be involved with that type of program and at the same time keep my finger on the pulse of the pharmaceutical industry. I would have to say the Venn diagram that I exist in—the intersection of proteomics, the regulatory arena, and clinical trial-based science—I might be the only individual that is at the intersection of all that knowledge base. There’s a short list of people who are doing proteomics, there’s a short list of people who are doing clinical-based endpoint analysis, there’s a short list of people who are doing molecular profiling in general, and there’s a short list of people who are FDA regulatory scientists. At the intersection of all those things there’s a very short list. I like being at that.


How’d you get involved with HUPO?

Sam Hanash and I probably spent a year [during which] it seemed like every time I [gave a talk] at some place, either I was talking before or after him. We joked around that he could start giving my talk because he’s heard it so many times, and maybe I could give his. We developed a very nice friendship from being at a lot of proteomic conferences. We both have tremendous respect for each other’s work. Sam also has a vision of HUPO that [involved] databases in the public domain, and getting academia, industry, and government all together to try to drive proteomics in specific directions. I think he saw me, being in the government, with Dr. Liotta having a very successful government-sponsored proteomics program, as being someone he would want to be involved with HUPO. I was very interested in the same type of mandate.

I’m here devoting my life as a public servant. I could make a lot more money on the other side. What I like about what I’m doing is that I’m helping the taxpayer public. I really like the fact that HUPO is a not-for-profit organization that’s trying to facilitate specific programs that would hopefully help patients and the public. Open access of databases, sharing technology development, scientific training—all those things are what in the government we try to do. In a sense it was very much in line with my own personal beliefs in science. I thought, ‘This is an organization I’d like to be involved with.’

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