ALEX AKALU
Washington,UT
Summary
Pharm.D. with 8+ years at the U.S. FDA Oncology Center of Excellence, specializing in oncology drug development, pediatric oncology research, and regulatory science. Conducted review and analysis of IND, NDA, and BLA applications to address regulatory and scientific research questions through evidence synthesis, protocol review, and clinical trial data analysis. Published in JAMA Oncology and other peer-reviewed journals. Core strengths include regulatory strategy, scientific research, advanced data analytics, and AI/ML innovations. Experienced in scientific exchange, stakeholder engagement, and data storytelling to support cross-functional teams and healthcare professionals.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Senior Staff Fellow
U.S. FDA | CDER | OCE
Silver Spring, MD
08.2025 - Current
AI Integration & Innovation Projects:
- Piloting ELSA-assisted drafting of Pediatric Exclusivity reviews across oncology drug applications to inform broader AI integration in regulatory workflows.
- Leading an AI-assisted review initiative using ELSA to streamline Clinical Study Report analysis and reduce reviewer burden across annual safety submissions.
- Piloting a structured three-phase pilot (training, validation, implementation) to integrate ELSA into FDARA-required iPSP review workflows, coordinating cross-functional input from reviewers across divisions.
- Educated FDA staff across Pediatric Oncology and Rare Diseases teams on FDA-ELSA and HHS-ChatGPT, building internal AI literacy and supporting responsible adoption of generative AI tools.
Senior Staff Fellow
U.S. FDA | CDER | OCE
Silver Spring, MD
10.2019 - Current
- 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.
- Developed methodology for assessing molecular target relevance in pediatric populations.
- Synthesized complex scientific literature to inform regulatory strategy and guideline development.
- 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.
- Monitored project timelines and proactively identified potential delays.
- Prepared meeting materials and minutes for the Pediatric Review Sub-Committee. Enabled clear sponsor communication and tracked actions across multiple programs.
- Captured detailed minutes and tracked follow-up actions across multiple divisions.
ORISE Fellow, Pediatrics Research
U.S. FDA | CDER | DPMH
Silver Spring, MD
05.2017 - 09.2017
- Evaluated extrapolation of adult efficacy data for pediatric indications
- Contributed to Pediatric Review Committee packages through systematic evidence reviews
- Produced regulatory briefs and scientific manuscripts supporting pediatric development strategies
- Developed foundational expertise in pediatric drug development and regulatory science
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, Scientific Exchange, Protocol Review, Data Analysis, Real-world Data, Stakeholder engagement
- AI/ML: Prompt Engineering, GenAI, Data Ethics, Security Awareness, Artificial Neural Networks, Deep Learning, Strategic Thinking, Data Science, Engineering Management, Market opportunities
- Research and Data analysis: Systematic literature review, PubMed, ClinicalTrialsgov, trial databases, basic meta-analysis, R, Data Science, Data Ethics, Advanced analytics, Power BI, Data Storytelling, Excel, PowerPoint
- Regulatory: IND, NDA, BLA, Pediatric Written Request, Labeling, Protocol review, Clinical Study Reports, evidence generation support, publications planning
- Collaboration: Meeting facilitation, stakeholder engagement, SharePoint, Teams
Certification
- Pharmacist, MD
- Regulatory Science Excellence-FDA
- OF120: Basic Food & Drug Law-FDA
- Data Analysis & Visualization with Power BI: Microsoft/Coursera
- Ai for Everyone: Deeplearning.Ai/Coursera
- Google Ai Essentials: Google/Coursera
- CPR/First Aid/Immunization
Timeline
Senior Staff Fellow
U.S. FDA | CDER | OCE
08.2025 - Current
Senior Staff Fellow
U.S. FDA | CDER | OCE
10.2019 - Current
ORISE Fellow, Pediatrics Research
U.S. FDA | CDER | DPMH
05.2017 - 09.2017
A.Sc. - Mathematics
Montgomery College
Doctor of Pharmacy (Pharm.D.) - Pharmacy
Howard University College of Pharmacy
Selected 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 External Engagement
Regulatory Group Chair & Engagement Director, EPPAD | 2018 – Present
- Led advocacy efforts that secured EFDA's observer status with the European Pharmacopoeia, marking a significant milestone in diaspora-regulatory engagement.
- Directed international diaspora-regulatory collaboration initiatives with measurable strategic impact.
Regulatory Science Judge, University of Maryland | 2020
- Evaluated student research and provided expert feedback on regulatory applications at the "America's Got Regulatory Science Talent" competition.