Alemayehu Akalu
Senior Oncology Staff Fellow @FDA
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WORK HISTORY
Senior Oncology Staff Fellow @FDA
Key Accomplishments- Co-authored Journal of Clinical Oncology paper on dosage optimization and post-marketing requirements (PMRs/PMCs), shaping FDA thinking on lifecycle management- Published in JAMA Oncology on race and ethnicity representation in pediatric oncology trials; findings informed FDA diversity discussions and policy- Built and maintained FDA’s pediatric molecular target list; co-authored a peer-reviewed review on fusion oncoproteins used to guide pediatric oncology development- Applied AI/ML tools (FDA-ELSA, & HHS-ChatGPT) to support regulatory review and evidence synthesis for oncology programs- Educated FDA’s Pediatric Oncology and Rare Diseases teams on the use of FDA’s GenAI tool (ELSA) and HHS’s ChatGPT for regulatory tasks, including protocol reviews, iPSP reviews, and drafting of regulatory documents; improved team efficiency and adoption of AI-enabled workflows.Responsibilities- Contributed to FDA cross-disciplinary review of oncology INDs, NDAs, and BLAs, ensuring compliance with regulatory standards and timelines- Supported preparation and execution of FDA Pediatric Review Sub-Committee meetings, including drafting background packages, capturing minutes, and tracking follow-up actions- Conducted safety and efficacy analyses to support benefit–risk evaluations and regulatory communications- Collaborated with multidisciplinary teams (clinical, nonclinical, CMC, statistics, pharmacology) to align regulatory positions on oncology programs.
EDUCATION
Howard University
Doctor of Pharmacy (Pharm.D.) , Pharmacy
ABOUT ALEMAYEHU AKALU
Pharm.D. with 8 years at the U.S. FDA Oncology Center of Excellence, specializing in oncology drug development, regulatory submissions, and pediatric oncology research. Reviewed and analyzed IND, NDA, and BLA applications while evaluating clinical trial data and development strategies. Published in JAMA Oncology and other peer-reviewed journals. Skilled in scientific communication, literature review, conference engagement, and translating complex data into actionable insights for cross-functional teams, investigators, and healthcare professionals. Recognized for data-driven decision support, cross-disciplinary collaboration, and advancing innovative cancer therapies through both regulatory science and medical affairs.
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