Job Title:
Regulatory Affairs Specialist
Institution:
Applied Pharmaceutical Innovation, Alberta
Year elected:
2024

CONTACT:

Femi Morakinyo | Faculty

BIOGRAPHY:
Dr. Femi is an experienced scientist and regulatory affairs professional
providing expert support and hands-on strategies for health products from ideation,
clinical trial/investigation, regulatory submission, to post-approval activities.
Previously, he served as a principal investigator in numerous research projects and
published more than 30 peer-reviewed journal articles. Femi’s transition from the lab
bench to the industry has equipped him with a unique perspective. He excels in
guiding companies through complex regulatory pathways, ensuring compliance
with stringent requirements. His proficiency extends to product category feasibility
assessment, regulatory pathway optimization, and strategic planning, leading to
successful submissions to both the FDA and Health Canada. Femi actively supports
sponsors in adhering to good clinical practices, conducting well-designed clinical
trials, and achieving the goals of the trial. A collaborative professional, Femi aligns
regulatory strategy with business priorities. His commitment to excellence ensures
robust compliance across board. Femi is an active member of the Regulatory Affairs
Professional Society. His deep knowledge and unwavering passion for regulatory
excellence drive meaningful contributions to the dynamic biotechnology landscape.

What is your interest in clinical trials?
As a regulatory professional with a background in Biomedical science, I am
fascinated by the intricate dance between scientific rigor and regulatory
compliance within the domain of clinical trials. My deep understanding of
physiological processes allows me to appreciate the nuances of drug
development and safety assessment. I am committed to contributing to the
advancement of medical science through meticulously designed clinical trials
that ultimately benefit patients worldwide.

Why do you think clinical trials are important?
Health research aims to find safe and effective treatments for human
diseases. This involves a multi-stage process, with clinical trials playing a
crucial role in the final stages. Clinical trials, which assess the efficacy and
safety of therapies through repeated application, provide an objective basis
for decision-making. Over the past 60 years, clinical trials have significantly
contributed to medical progress and remain essential for today’s medical
research.

What is your personal philosophy about clinical trial training specifically ormentorship in general?
As a regulatory professional with a foundation in biomedical research, I view
clinical trial training as a transformative bridge between scientific inquiry and
patient impact. It’s not merely about imparting procedural knowledge; it’s
about nurturing a mindset—an unwavering commitment to scientific rigor,
ethical conduct, and patient well-being. In mentorship, I believe in fostering
curiosity, resilience, and empathy. Each mentee is a potential torchbearer,
carrying the flame of progress forward. Together, we illuminate the path
toward safer, more effective treatments, leaving an indelible mark on the
landscape of healthcare.

FUN FACT:
I love to DIY small projects.