Background <p>Across the U.S., pharmacy students have limited access to education and experiential training in non-patient facing roles that support the drug development and regulatory sectors. As a result, few cite jobs in industry or government among their career goals after graduation. Advanced pharmacy practice experiences (APPE) have been demonstrated to inform decision making and enhance confidence in pursuing opportunities outside of traditional pharmacy practice settings.</p> Objective <p>In this report, we discuss the career outcomes of students having participated in APPE within the Office of Clinical Pharmacology (OCP) at the U.S. Food and Drug Administration.</p> Methods <p>Data on former rotation students’ most recent roles and employment sectors were aggregated from May 2013 to January 2025. The analysis relied principally on internet searches focusing on professional and scientific networking platforms (e.g. LinkedIn®, ResearchGate), professional society membership directories, other social media content, or university experiential offices.</p> Results <p>From 2013 to 2025, 199 students participated in the OCP rotation at the FDA. They came from 42 colleges and universities across 22 states and the District of Columbia with relative parity between public and private institutions (52% vs. 48%). Their most recent work sector was available for 182 participants. 51% of students were working in the pharmaceutical industry, 6% were in government, and 4% were consultants. 24% of students were working in healthcare.</p> Conclusion <p>We observed entry into the drug development and regulatory sectors occurring at much higher rates in our graduates as compared with national surveys. Non-patient facing opportunities of public health relevance remain an important alternative to careers in community and hospital pharmacy. Ensuring sustained access to APPE in research &amp; development, public policy, and regulatory affairs can contribute to the pipeline of competent and confident graduates who seek roles in drug development and regulatory science.</p>

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Career Paths to Drug Development and Regulatory Science Through the U.S. Food and Drug Administration

  • Susan M. Abdel-Rahman,
  • Gelareh Abulwerdi,
  • Issam Zineh,
  • Gilbert J. Burckart

摘要

Background

Across the U.S., pharmacy students have limited access to education and experiential training in non-patient facing roles that support the drug development and regulatory sectors. As a result, few cite jobs in industry or government among their career goals after graduation. Advanced pharmacy practice experiences (APPE) have been demonstrated to inform decision making and enhance confidence in pursuing opportunities outside of traditional pharmacy practice settings.

Objective

In this report, we discuss the career outcomes of students having participated in APPE within the Office of Clinical Pharmacology (OCP) at the U.S. Food and Drug Administration.

Methods

Data on former rotation students’ most recent roles and employment sectors were aggregated from May 2013 to January 2025. The analysis relied principally on internet searches focusing on professional and scientific networking platforms (e.g. LinkedIn®, ResearchGate), professional society membership directories, other social media content, or university experiential offices.

Results

From 2013 to 2025, 199 students participated in the OCP rotation at the FDA. They came from 42 colleges and universities across 22 states and the District of Columbia with relative parity between public and private institutions (52% vs. 48%). Their most recent work sector was available for 182 participants. 51% of students were working in the pharmaceutical industry, 6% were in government, and 4% were consultants. 24% of students were working in healthcare.

Conclusion

We observed entry into the drug development and regulatory sectors occurring at much higher rates in our graduates as compared with national surveys. Non-patient facing opportunities of public health relevance remain an important alternative to careers in community and hospital pharmacy. Ensuring sustained access to APPE in research & development, public policy, and regulatory affairs can contribute to the pipeline of competent and confident graduates who seek roles in drug development and regulatory science.