How I Spent My Summer: Fernandez Experiences Clinical Pharmacology at the FDA

Genesee Fernandez at the FDA

August 3, 2016

By Sarah Russell

AUBURN, Alabama – This summer Genesee Fernandez, a rising second-year pharmacy student, travelled to Silver Spring, Maryland, to participate in a fellowship with the Food and Drug Administration (FDA) in the Office of Clinical Pharmacology. Fernandez’s project focused on the development and regulatory evaluation of dermatology, gastroenterology and reproductive products. 

“Every day is different,” Fernandez said. “There are several meetings and lectures that I am able to attend, but a majority of my time is devoted to my project.”

Fernandez, a native of Russellville, Alabama, has been working on a paper that deals with orphan drug approvals. Orphan drugs are therapeutic agents used for the effective treatment of rare diseases/disorders that affect fewer than 200,000 people in the United States.  Through the Orphan Drug Act, the federal government provides incentives for the development/identification of orphan drugs. 

“Specifically, I am collecting data from clinical pharmacology studies for approved orphan drugs from 2011 through 2015,” Fernandez said. “I am looking for trends in the types and numbers of studies being done and in the shift in therapeutic categories for orphan drugs.”

Through her fellowship, Fernandez has been able to gain experience in the academic areas of the pharmaceutical industry with hands-on experience with professionals in the field.

“I am the only student working on this project with my mentor,” Fernandez said. “The end goal of the project is to have a draft of the paper ready to go to the journal, and I will be listed as a co-author on the paper.”

Aside from her project with the paper on orphan drugs, Fernandez’s fellowship also provides other opportunities others may not get until their careers.

“The fellowship offers several on‐site visits on various pharmacy opportunities, such as U.S. Coast Guard Pharmacy, FDA's Medical Device Program and the United States Pharmacopeia,” Fernandez said. “They also offer lecture series that highlight the various functions of each office and allow you to network with other students and pharmacists.”

Of all the experience she’s gained and opportunities she’s explored, Fernandez said her favorite part of the summer so far was sitting in on an office-level clinical pharmacology briefing for a new drug application.

“During the meeting, a reviewer from the clinical pharmacology division gave a presentation on the new drug application,” Fernandez said.  “There were so many departments represented at the meeting, such as medical and toxicology with each department having an equal opportunity to express their opinion.

“I believe this internship will open many doors for me in areas of public health and industry for an atypical career in pharmacy. This internship has definitely been a wonderful experience that has allowed me to broaden my knowledge about other opportunities in the field of pharmacy.”


Genesee Fernandez at her desk at the FDA
Genesee Fernandez works at her desk at the FDA.
Fernandez with other FDA interns
Genesee Fernandez with other FDA interns.

----------

About the Harrison School of Pharmacy
Auburn University’s Harrison School of Pharmacy is ranked among the top 20 percent of all pharmacy schools in the United States, according to U.S. News & World Report. Fully accredited by the Accreditation Council for Pharmacy Education (ACPE), the School offers doctoral degrees in pharmacy (Pharm.D.) and pharmaceutical sciences (Ph.D.) while also offering a master’s in pharmaceutical sciences. For more information about the School, please call 334.844.8348 or visit http://pharmacy.auburn.edu.

Making Medications Work Through Innovative Research, Education and Patient Care

Last Updated: August 3, 2016