ALEMAYEHU AKALU
Washington,DC
Summary
Pharm.D with eight years at FDA Oncology. Strong record reviewing IND, NDA, and BLA submissions and guiding sponsors on study design, labeling, and pediatric development. Published in JAMA Oncology and peer-reviewed journals. Skilled in literature review, clinical data analysis, benefit-risk assessment, and scientific communication to technical and non-technical audiences. Known for cross-functional leadership and clear, timely decision support.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Senior Oncology Staff Fellow
U.S. Food and Drug Administration, CDER, Oncology Center of Excellence
10.2019 - Current
- Supported cross-disciplinary reviews for oncology IND, NDA, and BLA submissions. Drove alignment across clinical, nonclinical, clinical pharmacology, statistics, and CMC teams.
- Led evidence reviews on pediatric molecular targets and fusion oncoproteins. Built a maintained list of molecular targets in childhood cancers and co-authored a peer-reviewed review.
- Prepared meeting materials and minutes for the Pediatric Review Sub-Committee. Enabled clear sponsor communication and tracked actions across multiple programs.
- Assessed race and ethnicity representation in pediatric oncology trials over two decades. Co-authored a JAMA Oncology publication that informed internal discussions on trial diversity.
- Analyzed clinical and safety datasets to surface efficacy trends and safety signals. Summarized findings for regulatory decision making and sponsor feedback.
- Tracked a prospective list of pediatric oncology studies and study status to inform development plans and pediatric written requests.
- Presented scientific and regulatory findings to internal leadership and external partners.
ORISE Fellow, Pediatrics Research
U.S. Food and Drug Administration, CDER, OCE
05.2017 - 09.2017
- Evaluated extrapolation of adult efficacy data to adolescents in schizophrenia and PJIA. Produced analyses and presentations used in Pediatric Review Committee discussions.
- Used R for data analysis and visualization. Contributed to manuscripts and internal briefs.
Education
Doctor of Pharmacy (Pharm.D.) - Pharmacy
Howard University College of Pharmacy
Washington, DC05-2017
A.Sc. - Mathematics
Montgomery College
Takoma Park05-2013
Skills
- Oncology: Pediatrics, Clinical Trials, Evidence Synthesis, Regulatory Strategy, Medical Affairs, KOL Engagement, Scientific Exchange, Competitive Intelligence, Labeling, Protocol Review, Data Analysis, Real-world Data, Health Equity, Meeting Facilitation, Stakeholder Management
- Regulatory: IND, NDA, BLA, Pediatric Written Request, Labeling, Benefit-Risk, Protocol and SAP review, Clinical Study Reports, Advisory and Type meetings
- Medical Affairs: Scientific exchange, KOL mapping, conference coverage, insights capture, medical education, evidence generation support, publications planning
- Research and Data analysis: Systematic literature review, PubMed, ClinicalTrialsgov, trial databases, basic meta-analysis, R, Python, SQL, Excel, PowerPoint
- Collaboration: Meeting facilitation, stakeholder engagement, SharePoint, Teams
Certification
- Pharmacist, MD
- Regulatory Science Excellence-FDA
- OF120: Basic Food & Drug Law-FDA
- Federal Appropriations Law-FDA
- Contract Officer Representative: SOW-FDA
- Opioid Overdose Skills-FDA
- Immunization Certification
- CPR/First Aid
Publications
- Fashoyin-Aje L, Akalu A, et al. Racial and ethnic representation in pediatric oncology trials conducted through FDA written requests. JAMA Oncology, 2024.
- Heiss B, Pan L, Akalu A, et al. Dosage optimization and postmarketing requirements. Journal of Clinical Oncology, 2023.
- Angione S, Akalu A, et al. Fusion oncoproteins in childhood cancers. JPPT, 2021.
- Akalu A, et al. Pediatric written requests in oncology: review of experience. Pediatric Blood and Cancer, 2021.
Leadership and Service
Regulatory Group Chair, & Member Engagement Director EPPAD. Former Class President and Rho Chi VP. Led volunteer vaccination events and student workshops.
Timeline
Senior Oncology Staff Fellow
U.S. Food and Drug Administration, CDER, Oncology Center of Excellence
10.2019 - Current
ORISE Fellow, Pediatrics Research
U.S. Food and Drug Administration, CDER, OCE
05.2017 - 09.2017
Doctor of Pharmacy (Pharm.D.) - Pharmacy
Howard University College of Pharmacy
A.Sc. - Mathematics
Montgomery College
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