“It was the Best Advice Because it was the Worst Advice”

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“It was the Best Advice Because it was the Worst Advice”

By | 2018-10-02T21:43:08+00:00 October 2nd, 2018|Biopharma / Pharma, CGMP, Clinical, FDA Inspection Stories, FDAzilla, Medical Devices|

We wanted to capture the wealth of experience we have in GCP Expert Jamie Colgin (or at least a bit of it). So we fired some questions and got some surprising answers:

How did you get started?

I got started by answering a Help Wanted ad in the Detroit Free Press. I was working at a for-profit business school and was feeling disillusioned about my students’ futures. It was either find another job or go back to grad school at Wayne State University.

After two grueling interview days at Parke-Davis in Ann Arbor for 2 different jobs (which I failed to get), they called me up out of the blue and made me an offer as a preclinical statistician.

Earn 50% more than I was making as a teacher or be a student again? It was an easy decision.

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What got you interested in the Pharmaceutical Industry and FDA regulation?

I got interested in the regulations around clinical trials after I’d been working as a preclinical statistician for a couple of years. It fascinated me that the regulations we operated under experimenting with non-human animals were so much clearer and stricter than the regulations for experimenting on humans. I love puzzles, and this is one I’m still working on.

Do you have any mentors/people you look to for inspiration?

My first boss at Parke-Davis, Dave Pyne, took a big chance on me — I had no experience with SAS at all, and he had hired me to be a statistician and statistical programmer. He was convinced I was smart, highly motivated, and independent.

I taught myself SAS with help from him and my co-workers. He was always willing to let me try new things. Even to the point of leaving his department when I decided to try something different.

Another person I look to for inspiration is Monica Cahilly, President of Green Mountain QA. Her pioneering work in data integrity in the pharmaceutical industry — her passion and integrity — all helped shape my thoughts on data integrity in clinical trials.

What do you think has made you successful throughout your career?

I think it’s my persistence. When I was younger, I earned some pretty unpleasant nicknames. I had to learn (the hard way) to be persistent in a more politically savvy way. Of course, sometimes the velociraptor needs to make an appearance.

What are some things you do to keep you updated and inspired as a leader in your industry?

The Society of Quality Assurance plays a big part in my staying current. The Clinical Specialty Subsection is an especially helpful group of Quality professionals from all over the world. We share regulatory updates and challenging quality issues with each other on a regular basis.

What’s your favorite part about what you do?

My favorite part of my job is teaching. It’s important to me that my work provides opportunities to teach others about what data integrity means and how we can honor the gift of clinical trial participants.

What inspires you personally?

First and foremost are all of the people who have benefited from the medicines I’ve worked on (even in small ways). And the host of others who are still waiting for cures. They inspire me on a daily basis. They help me stay focused on what’s really important – honoring the gift of participation in clinical trials.

What’s the best advice you’ve ever received?

To let go of problems I found during audits. It was the best advice because it was the worst advice. And it challenged me to improve my soft skills and find other ways to help people understand and make things better.

What do you love about this industry?

I love that we’re not just making widgets. That we are searching for, developing, and bringing to market products that cure diseases and alleviate suffering.

What frustrates you about this industry?

One of the things that frustrates me is which diseases get targeted for cures. We have lots of drugs for high blood pressure, but nothing for sickle cell anemia. Lots of choices to lower cholesterol, but over a million people die of malaria every year.

What traits and skills do you think are necessary to be able to succeed in this industry?

Within my field in industry, it helps to be persistent, well grounded in regulatory requirements, and like putting puzzles together. The best auditors I know look at everything broadly and quickly figure out where to focus to find the most meaningful problems.

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About the Author

Jamie Colgin is FDAzilla’s GCP Product Manager and joins us from Colgin Consulting, Inc.

She is the recipient of the prestigious Charles H. Butler Excellence in Teaching Award.

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