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Career Path on Translational Research in Industry. Advice Sought

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Career Path on Translational Research in Industry. Advice Sought

Postby James K. » Sat Jul 11, 2015 5:17 pm

I am applying for industry positions, and I came across various job descriptions with the title of "translational research". I have networked and discussed with some of my friends in industry, and it seems that definitions seem vague in many places, and many times, it conflicts with the role of a discovery lead, given that they also cover areas from discovery to the IND. Can someone offer me a clear view of what a translational scientist's job is like, and what their career paths are like?

Much appreciated.
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Re: Career Path on Translational Research in Industry. Advice Sought

Postby D.X. » Mon Jul 13, 2015 8:17 am

Hi -

I can give you a very helicopter view.

In my experience, translational research, in terms of definition and practice have been different in the various companies have been in.

However, most share in common the objective to get a lead drug candidate into First in Human (FIH) or Phase I study with an IND as key step in getting that authorization to FIH. Most of these activities are then centered on solidifying all pre-clinical data to include animal PK/toxicity studies, pre-clinical dose-finding studies, chemistry and manufacturing data, basically all data up to FIH.

In the IND you may set up your FIH proposal/and clinical development program, on the translational clinical side, these are usually Pharmacokinetic and Safety studies probably both in healthy volunteers/disease-states usch as renal/hepatic impaired, even disease target folks - a background in PK/safety is helpful. If on this side, your focus would be PK clinical studies in Human, looking at dosing aspects (ie. dose and frequency), impact of renal insuffiency/hepatic insuffiency, drug interactions etc etc. ON this side you may bridge to the more clinical folk who are also planning the more pharmacodynamics studies - a lot of initial FIH studies will feed into that. A lot of work here goes into the PK and Safety part of the Prescribing Information of a marketed drug (aka Summary of Product Characteristics outside US).

So a lot of things here, it depends on where the focus for the specific position is, but its really gearing up to go into clinical investigation for the first time - with the broader end-goal of a NDA and hopefully Market Authorization (MA) if the product hits all milestones.

Hope this helps, but in my experiences this is a key team to get lead products into the clinical investigation path.

Hope others can contribute here.

DX
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Re: Career Path on Translational Research in Industry. Advice Sought

Postby D. Douglas » Mon Jul 13, 2015 4:21 pm

Thank you for starting this thread!

I heard that translatonal research can also refer to biomarker analyses on patient samples.
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Re: Career Path on Translational Research in Industry. Advice Sought

Postby James K. » Mon Jul 13, 2015 9:54 pm

Thanks for the overview. That was very helpful. Can you also, DX, comment on the career path of this type of work? I am only aware of the discovery biology project leads, and the physicians that run the clinical trials. Would this type of work fall under "support" functional groups, then? In my view, there is nothing wrong in being a support group, but if you are keen on eventually be in key leadership positions (such as head of discovery, or head of early clinical development), would this type of position stereotype you away from these positions? That's what some of my friends suggest. Thoughts?

James
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Re: Career Path on Translational Research in Industry. Advice Sought

Postby Parker » Tue Jul 14, 2015 12:16 am

I agree the term is used loosely and it means different things in different companies. In my job, it means up to IND-enabling studies (GMP scale-up, GLP Tox, etc). Some folks in Pharma might say anything earlier than Phase II is not translational. I think most people use it to mean "applied" research that is not basic. Research that has to do with biomarkers and patient samples might still be considered basic if there is no end-product in mind.
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Re: Career Path on Translational Research in Industry. Advice Sought

Postby D.X. » Tue Jul 14, 2015 4:06 am

HI James,

I don't think its necessarily support function, each function has their role and driving objective.

Regarding biomarker on patient samples, that can be an element in Translational and Clinical Development depending on what the objective is etc. (i.e. toxicology implications, response predictor as in companion diagnostic drugs etc. etc.).

I don't know enough to answer career path questions here, but usually a lot of this functions as far as I understand are highly specialized, I guess you can port those experiences elsewhere, i.e Regulatory specific roles, Drug Safety, Pre-clini toxicology, I guess.

But again, these functions are not part of my daily life, i'm more on the side where products are in Phase III or post marketing Phase IV if we're talking clinical trials.

As a note, you don't have to shoot so high for leadership positions, there are many teams below your proposed levels were there are many leadership opportunities from a people management perspective is that's what you're interested in, each being s stepping stone of course.

Usually heads of Clinical programs are physicians (just to manage expectations) but certainly there are exceptions. Aim to get experience as see where the path takes you.


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Re: Career Path on Translational Research in Industry. Advice Sought

Postby Ana » Wed Jul 15, 2015 2:51 am

I agree with DX, if those are your career targets (head of a large division) you should aim for people management roles over technical details.

Translational science often goes from candidate compound to designe of a clinical proof of concept (so past phase I). Biomarkers are involved when they are used to measure target exposure (e.g. can we hit the receptor enough at the tolerable dose?) and compound efficacy (e.g is neuroinflammation reduced after treatment?). As such it is one of the tools translational scientists use to be able to provide the right answers for designing and interpreting a proof of concept in the clinic.

In general it is not a support department and they have regular career ladders. And if you want to be come the head of a division you a re likely not to follow the career ladder of a company anyways, but to move to other companies when you need a jump in responsibilities. So see it as a stepping stone. I think a position where you can manage people and where you can get involved in a high visibility project is the best choice to prepare for the next jump.
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Re: Career Path on Translational Research in Industry. Advice Sought

Postby James K. » Fri Jul 17, 2015 5:16 pm

Thank you for your insight on translational research. This was very helpful, or maybe I am still a bit confused. This would then, appear to be a position in which you would need some degree of drug discovery experience, right? And if so, going back to the career ladder (at least on the technical side), then perhaps I should first gain experience in early discovery processes before going off the deeper end into translational research and/or biomarkers?

James
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