Phase 0/I trials

[threecoins]

I am interested in learning more about Phase 0/Phase I trials. I am particularly interested in eventually becoming the guy who runs a phase I program. I am trying to figure out what qualifications should I develop during my upcoming fellowship to get there. The path to becoming such an investigator is somewhat blurry. But I would imagine I will need:

1- Some bench research experience: is 18 months enough for that purpose ? any particular type of research that would be more suitable for this?

2- A certficate or masters in clinical investigation?

I am trying to learn more about this area ...any input, papers would be appreciated.

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[gutonc]

I am interested in learning more about Phase 0/Phase I trials. I am particularly interested in eventually becoming the guy who runs a phase I program. I am trying to figure out what qualifications should I develop during my upcoming fellowship to get there. The path to becoming such an investigator is somewhat blurry. But I would imagine I will need:

1- Some bench research experience: is 18 months enough for that purpose ? any particular type of research that would be more suitable for this?

2- A certficate or masters in clinical investigation?

I am trying to learn more about this area ...any input, papers would be appreciated.

Bench research is nice, but clearly not a pre-requisite. Knowing who to go to for the basic/translational stuff and having good, reliable collaborators is just as (or perhaps more) important.

Some sort of formal (or semi-formal) training in clinical research (MCR/MCI, etc) is also a good thing to have but, again, is not a formal requirement.

What you need more than anything is experience with Phase 1 during your fellowship. So you either need to be at a place that does a lot of Phase 1 work (placed I know of who do this include Colorado, UTSA, MDACC and Wayne St/Karmanos but there are plenty of others) or you need to get some experience at a place like that (1-3 months of elective time during your research years). You could also do an extra unofficial 1 year of fellowship in something like drug development. You also need contacts in pharma so that you have access to pre-clinical data and pipelines so that you can get involved at the Phase 0/1 level more easily.

 

[threecoins]

Thanks Gutonc, excellent advice as usual. I was advised to do bench research to develop the " basic science language" as tool to communicate with future basic science collaborators. I will look for places that have an active phase I program and try to work there for a few months. I will be in NYC so Sloan definitely comes to mind...

The drug development fellowship sounds like a great idea. Do you know of any institutions that offer that kind of training?

How would you envision the challenges and the job prospects for such a career choice?

And my last question; how does one develop contacts in pharma?

 

[gutonc]

The drug development fellowship sounds like a great idea. Do you know of any institutions that offer that kind of training?

I'm sure there are others, but I have a friend who did one @ UNC in collaboration with GSK. You'll find them where you find pharma so I imagine Boston, Research Triangle Park, NJ, the Bay Area and San Diego are all places where they exist.

How would you envision the challenges and the job prospects for such a career choice?

As with all things in academia, it can be hard to get started, but once you have something established it's easier to maintain a career. But you have to be committed to it or you won't get far.

And my last question; how does one develop contacts in pharma?

A lot of it is choosing the right adviser and being in the right place at the right time.

I also want to expand on something I said in my last post regarding connections (not just with pharma but in general). It's all well and good to know the people in your division/department, but you really need to get outside of that and make connections in other oncology-related disciplines. If you're at a place like MDACC where the "Dept of GI Oncology" already includes Med Onc, Rad Onc and Surg Onc, that's not as much of an issue. But that's not really the standard model in academic oncology. Know, talk to and work with your surgical and radiation colleagues.

I will give you a personal, concrete example. As you may have gathered from my username, my interest is in GI oncology, particularly pancreatic cancer. I'm at a small/medium institution with a strong Cancer Institute and there are some big names in my division in leukemia, thoracic and prostate but the GI group is 2 people, neither of whom are particularly well known in the field. What we do have here however is a Rad Onc chair who is a past president of ASTRO and sits on their GI working group and a pancreatic surgeon who is a huge name in that field. In the course of going to conferences and discussing cases and research, I made it known to them that I was interested in pancreatic cancer translational research as a career goal.

And what did that get me? $500K in grant money from the surgeon to do molecular correlative research as part of a clinical trial I'm writing and a connection with Merck's European pancreatic clinical trials director who wants to set up new sites for early phase trials in the US from the Rad Onc guy. This world is all about connections...make them and your on your way...don't make them and you don't stand a chance.