MENTOR

Femi Morakinyo

PhD
Regulatory Affairs Specialist
Applied Pharmaceutical Innovation, Alberta
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.

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