The Road Less Traveled: How I Found My Way Into Drug Development

Photo by Anjie Webbie on Unsplash

Can you put a value on the quality of life? I began my post-baccalaureate life searching for a purpose and reason for choosing “science” as a career. I was still searching for my “why”. How could I use what I learned to make my imprint on the world? As luck would have it, my first corporate experience proved to be an amazing learning experience at a cosmetic manufacturer. No idea was too small nor concept too crazy, and thus my career as a formulation chemist began to flourish. As part of the product launch team, my role also required knowledge of appropriate safety testing, labeling requirements, claim substantiation, all regulatory considerations.

Caution: Bump Ahead

While all of this appeared to be a decent effort at fulfilling my career goals, I still craved something more. Project by project, I felt this pull towards the regulatory world. Attempting to decipher the Code of Federal Regulations (CFR) was fascinating to me. I eventually found my way into a pharmaceutical company where the regulatory environment was more complex, but no less compelling. Here, my Chief Scientific Officer decided to entrust me with a new endeavor for the company, bring a medical device to market.

The Map is Just a Guide, the Real Adventure is in the Unknown

While I was enthused to have been given this opportunity, I had a few concerns:

Concern #1: My experience formulating and providing regulatory guidance up to this point did not include anything related to medical devices.

Concern #2: I need to learn everything there is to know about how to submit a 510(k) to the FDA within the next 12 months.

Yikes! The easy part was locating FDA published guidance documents. Interpreting them is a different story. For the next 6 months, I was all in. I read blogs, listened to podcasts, watched YouTube videos, and attended webinars. If the topic related to medical device submissions, I was there. Finally, I compiled nearly 250 pages of required documents onto a USB drive with specific technical requirements and mailed off my submission to the FDA. After just 3 minor revisions, the submission was accepted and our product was cleared to market, just before the end of the year. Success.

“It is never too late to be what you might have been.” -George Eliot

Without realizing it, this became my “why”. What I didn’t mention earlier were the details of the actual product. Due to confidentiality reasons, I am not able to disclose information about the product, however, what I can say is that it is intended to help improve the quality of life of some cancer patients. This project inspired me to seek a graduate degree in Drug Discovery and Development. There is more that goes into a medication than the drug itself. It takes careful navigation within a regulatory roadmap to successfully bring a drug from bench to bedside. I am forever grateful to those that believed in my abilities and gave me the opportunity to develop a skill I didn’t know existed. Sometimes, even though the road is not paved, it still exists as a path that leads to your final destination.

Christine Vu is a Senior Product Development Scientist at PCCA Inc. with 15 years of experience in formulation and product development. Her primary focus involves regulatory compliance in the US and global environment. Currently, an MSDDD student at UNTHSC, Christine intends on further advancing her knowledge by studying other aspects of the drug development process.