Friday, September 2, 2011

Caught Up In The Regulations

Posted by Eric Zhao at Friday, September 02, 2011

Once again, I find myself in the pharmaceutical industry (surprise!). This time, however, I am with Eli Lilly and the Regulatory Affairs Department, no less.

Eli Lilly and Company, Indianapolis, IN

If you remember from my previous adventures, I spent a summer in regulatory affairs at Abbott in Advertising and Promotion. You're probably thinking, what's the point of doing two regulatory affairs positions? I had the same thought, believe me.

What I didn't know was that I would be working on the complete opposite spectrum of the drug development process. At Abbott, I dealt with the regulations after the FDA approved a drug. At Lilly, I deal with the regulations before and during FDA approval. Yup, I'm working with Investigational New Drug (IND) applications and New Drug Applications (NDA).

I'm currently wrapping up a journal club presentation for this upcoming Tuesday on a competitor's newly approved biologic drug and will finish the rest of the clerkship gathering intelligence on a project that's under Double Secret Probation. I wish I could say more, but these industry folk like to keep to themselves.

I'm sure I'll come up with interesting topics to blog about that won't compromise my employment status, but for now, enjoy a picture of Lilly's entrance fountain.


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