Alemayehu Akalu
Washington,DC
Summary
Experienced Oncology Staff Fellow with a Pharm.D. and a strong background in research, program management, and global health. Proven track record of leading complex projects in therapeutic development with a focus on low-income countries. Adept at collaborating with diverse stakeholders and regulatory bodies to bring innovative, cost-effective treatments to market. Seeking to leverage my expertise in a leadership role at the Bill & Melinda Gates Foundation.
Overview
9
9
years of professional experience
1
1
Certification
Work History
STAFF Fellow, Pediatrics Oncology
FDA/CDER/OCE
09.2017 - Current
- Lead and manage oncology research initiatives with a focus on developing new therapeutic interventions.
- Oversee program management activities, ensuring compliance with regulatory standards and alignment with global health goals.
- Collaborate with international partners, regulatory agencies, and internal teams to drive product development from concept to clinical trials.
- Provide technical and strategic guidance on CMC-related activities, including formulation, manufacturing, and regulatory submissions.
- Successfully led the development of several FDA-approved oncology therapeutics, with a focus on cost-effective and scalable solutions.
- Networked and built strong presence with peers to facilitate professional relationships.
- Collaborated with team to optimize workflow and achieve objectives.
- Authored professional scientific papers for publishing in peer-reviewed journals.
ORISE Fellow, Pediatrics research
FDA/CDER/DPMH
05.2017 - 09.2017
- Provided consulting services on oncology research projects, focusing on program management and regulatory compliance.
- Worked closely with biotech companies and non-profit organizations to develop strategies for CMC-related challenges.
- Played a key role in securing funding and partnerships for global health initiatives, particularly in low-income countries.
- Contributed to research activities by providing specialist input based on professional expertise, practice, experience, and qualifications.
Certified Pharmacist Technician
Bridge Point Hospital
10.2015 - 05.2017
- Provided patient care and medication management in a clinical setting.
- Conducted research on drug interactions and treatment efficacy, contributing to improved patient outcomes.
- Collaborated with healthcare professionals to develop and implement treatment plans for patients with complex medical conditions.
- Vaccinated patients to provide immunity against influenza, pneumonia, and other diseases.
- Educated patients about possible drug interactions and gave special administration instructions.
- Effectively prioritized tasks and organized workflow to increase efficiency.
- Provided consultations and answered inquiries from patients, healthcare professionals and physicians regarding drugs, potential side effects, and specified use.
- Performed technical processes required to dispense medications to patients.
- Displayed patient-oriented and comprehensive clinical pharmacy services and pharmaceutical care.
Education
PharmD -
Howard University College of Pharmacy
05.2017
Associates in Science - undefined
Montgomery College
06.2013
Skills
- CMC Expertise: Formulation, manufacturing, regulatory submissions, quality systems, GMP compliance
- Therapeutic Development: Oncology therapeutics, infectious diseases, women’s health, global health
- Leadership: Team management, strategic planning, stakeholder engagement
- Regulatory Affairs: FDA submissions, international regulations, compliance
- Project Management: Program management, cross-functional collaboration, funding and partnership development
Certification
- Pharmacist, MD, 07/2018
- Pharmacy Technician, DC, 09/2015
- Pharmacy Intern, VA, 05/2015
- Pharmacy Intern, DC, 05/2014
- Vaccine/Immunization Certification, DC, 03/2014
- CPR/First Aid Certification, MD, 06/2017
Affiliations
- Ethiopian Pharmacist & Pharmaceutical Scientists Association in the Diaspora (EPPAD)
- American Society of Clinical Pharmacologist & Therapeutics
- Rho Chi Pharmaceutical Honor Society
- Phi Theta Kappa an International Honor Society
- American Society of Health-System Pharmacists (ASHP)
- American Pharmacist Association (APhA)
- Student National Pharmaceutical Association (SNPhA)
Selectedpublications
- Fashoyin-Aje, Lola & Akalu, Alemayehu & Boehmer, Jessica & Pazdur, Richard & Donoghue, Martha & Reaman, Gregory. (2024). Review of Racial and Ethnic Representation of Participants Enrolled in Pediatric Clinical Trials of Oncology Drugs Conducted Through FDA Written Requests. JAMA oncology. 10. 10.1001/jamaoncol.2023.5781.
- Heiss, Brian & Pan, Lili & Akalu, Alemayehu & Vallejo, Jonathon & Cheng, Joyce & Balcazar, Pamela & Rahman, Nam & Shord, Stacy & Shah, Mirat & Pazdur, Richard & Theoret, Marc. (2023). Dosage optimization in drug development: An FDA Project Optimus analysis of postmarketing requirements issued to repair the cracks. Journal of Clinical Oncology. 41. 1598-1598. 10.1200/JCO.2023.41.16_suppl.1598.
- Angione, Sara & Akalu, Alemayehu & Gartrell, Jessica & Fletcher, Elimika & Burckart, Gilbert & Reaman, Gregory & Leong, Ruby & Stewart, Clinton. (2021). Fusion Oncoproteins in Childhood Cancers: Potential Role in Targeted Therapy. The Journal of Pediatric Pharmacology and Therapeutics. 26. 541-555. 10.5863/1551-6776- 26.6.541.
- Akalu AY, Meng X, Reaman GH, Ma L, Yuan W, Ye J. A review of the experience with pediatric written requests issued for oncology drug products. Pediatric Blood Cancer. 2021 Feb;68(2): e28828. doi: 10.1002/pbc.28828. Epub 2020 Nov 27. PMID: 33245181.
- Akalu A, Maritsa D, Keturah E, and Uweh K. “Should medications be co- administered with albumin in hypoalbuiminemic patients”. Journal of pharmaceutical & health systems. 1000167th ser. 4.1 (2016): 1-4. (https://www.omicsgroup.org/journals/should- medications-be-coadministered-with-albumin-inhypoalbuminemic-patients-2376-0419- 1000167.pdf) 12/2016
Leadershipexperiences
- EPPAD members engagement director, 10/2018, Present
- Class President: Class of 2017, 05/2016, 05/2017
- Vice President: Rho Chi Howard University Chapter, 05/2015, 05/2016
- Chairman: Community Service, 05/2015, 05/2016
- Student Representative: Assessment Committee, 05/2014, 05/2016
Professional Development
- Pediatric Trial Design and Modeling workshop, FDA, 09/2017
- Statistical Software's: R & SAS, Metrum Institute, 06/2017
- Programming Foundation with Python, Udacity, 05/2017
- Inter-professional Healthcare Informatics, Coursera, 04/2017
- An Introduction to Global Health, Coursera, 02/2017
Honorsandawards
- Dean's Leadership Award, 05/2017
- Dean's Scholarship, 08 2013, 2014, 2015, 2016
- NIH Endowment Scholarship, 08 2013, 2015
- Alumni Scholarship, 09/2016
Clinicalexperiences
- Community, QOLRx, Washington, DC, 03/2017, 04/2017, Terri L. Peters, R.Ph.
- Ambulatory Care, ATH, Washington, DC, 02/2017, 03/2017, Erika Romeus, PharmD.
- Industry, Sandoz Pharmaceuticals, Washington, DC, 01/2017, 02/2017, Alan, Ryan, PharmD.
- Health Systems, Bridge Point Hospital, Washington, DC, 10/2016, 11/2016, Helena, Lee, PharmD.
- Regulatory & Health Policy, FDA, Silver Spring, MD, 08/2016, 09/2016, CAPT Stanley Shepperson, PharmD.
- Administration, CVS Caremark, Upper Marlboro, MD, 07/2016, 08/2016, Brienna Chapell, PharmD.
- Critical Care & Internal Medicine, VHC, Arlington, VA, 06/2016, 07/2016, Brian Caruth, PharmD.
- Internal Medicine, HUH, Washington, DC, 05/2016, 06/2016, Maritsa Serlemitsos-Day, PharmD. BCPS
- Internal Medicine, Black Lion Hospital A.A, Ethiopia, 06/2015, 07/2015, Hailemeskel, Bisrat, PharmD.
- Internal Medicine, VHC, Arlington, VA, 05/2015, 06/2015, Michael Mireku, PharmD.
- Community Pharmacy, Wal-Mart, Washington, DC, 05/2014, 06/2014, Alexandria, Gallien, PharmD.
Volunteer Experience
Organized the Howard University College of Pharmacy students to participate in the Empower the Community Weekend Event held at the Washington DC convention center, 08/2017
References
Up on request
Timeline
STAFF Fellow, Pediatrics Oncology
FDA/CDER/OCE
09.2017 - Current
ORISE Fellow, Pediatrics research
FDA/CDER/DPMH
05.2017 - 09.2017
Certified Pharmacist Technician
Bridge Point Hospital
10.2015 - 05.2017
PharmD -
Howard University College of Pharmacy
Associates in Science - undefined
Montgomery College
- Pharmacist, MD, 07/2018
- Pharmacy Technician, DC, 09/2015
- Pharmacy Intern, VA, 05/2015
- Pharmacy Intern, DC, 05/2014
- Vaccine/Immunization Certification, DC, 03/2014
- CPR/First Aid Certification, MD, 06/2017
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