DERRICK AFFUL
Frederick,MD
Summary
Accomplished FDA regulatory professional with expertise in regulatory compliance and CMC strategy. Proven track record in securing first-pass approvals and resolving complex deficiencies. Skilled in technical writing and stakeholder communication, driving impactful quality assessments and enhancing submission efficiency. Committed to advancing pharmaceutical standards through strategic insights.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Senior Product Quality Assessor
FDA/CDER/OPQ
Silver Spring, Maryland
09.2022 - Current
- Led critical Quality/CMC assessment for over 100 original INDs, ANDAs, and NDAs, influencing agency decisions and first-pass approvals.
- Managed complex CMC deficiencies and Information Requests by delivering strategic, science-based feedback to sponsors.
- Interpreted ICH guidelines and cGMP regulations to ensure product compliance, advising on process validation and QMS standards.
- Conducted regulatory impact assessments for major post-approval changes and NDA/ANDA supplements involving drug substance synthesis and manufacturing sites.
- Possesses comprehensive knowledge of eCTD Module 3 structure and content requirements, facilitating effective regulatory submissions.
- Provided subject matter expertise in radiopharmaceutical CMC requirements, interpreting 21 CFR Part 212 (PET Drugs cGMP) to guide sponsor IND and NDA/ANDA submissions, and successfully resolving complex technical deficiencies related to short half-life product release and stability.
- Assessed aseptic processing and analytical method validation for over 20 radiopharmaceuticals and PET drug products, shaping global CMC strategy for compliance.
- Coordinated organization of over six webinars for FDA staff as Vice Chairman of OPQA Education Committee.
ORISE Fellow
FDA/CDER/OPQ
Silver Spring, Maryland
08.2020 - 08.2022
- Contributed to U.S. Pharmacopeia modernization by reviewing 20+ proposed monograph changes and generating 10+ new USP monographs for FDA-approved medicines.
- Utilized informatics tools to extract impurity data, improving efficiency of NDA, ANDA, and IND reviews through a robust internal quality management system.
- Researched FDA databases and applied analytics tools to support regulatory functions, including NDA, ANDA, IND reviews, Controlled Correspondences, and Citizen Petitions.
- Directed a team of fellows in developing an MS Access-based database tool, enhancing workload allocation and management efficiency.
Research & Classification Consultant
SSRN
Remote
05.2019 - 05.2021
- Consulted and led the launching of Pharmaceutical Science Research Network (PharmSciRN) to enhance research collaboration.
- Reviewed over 2,500 paper submissions, categorizing them into relevant subject areas.
- Screened more than 1,000 clinical papers to ensure adherence to established research standards.
- Identified collaboration opportunities with journals and professional societies for SSRN database enhancement.
Scientific Writer and Compliance Coordinator
Trilogy Health Services, LLC
Louisville, Kentucky
06.2019 - 07.2020
- Assisted in developing annual grant and operational strategies for Workforce Development and Foundation programs.
- Authored eight federal grant proposals totaling $15 million to secure funding from CMS, HRSA, and U.S. Department of Labor.
- Secured $6.5 million grant for autonomous temperature screening devices in Kentucky long-term care facilities to combat COVID-19.
- Obtained $1.1 million grant from Michigan Department of Labor for healthcare apprenticeship programs management.
- Researched and identified new grant opportunities while cultivating relationships with key stakeholders.
- Created Microsoft Power BI and Salesforce reports to monitor Foundation funding and employee performance.
Graduate Research Assistant
University of Georgia College of Pharmacy
Athens, Georgia
08.2014 - 05.2019
- Executed research experiments in drug development and clinical sciences.
- Designed and executed experiments to evaluate drug formulations and their pharmacological effects.
- Conducted comprehensive data analysis and statistical evaluations to support research findings.
- Maintained accurate laboratory records and ensured compliance with institutional safety protocols.
- Collaborated with faculty and fellow researchers on interdisciplinary projects to enhance research quality.
- Participated in weekly team meetings to discuss research progress, challenges, and strategic planning.
- Trained and supervised over 10 undergraduate students on laboratory techniques and research methodologies.
- Created and maintained detailed project documentation, including research protocols and standard operating procedures.
- Conducted literature reviews and synthesized research findings in preparation for data analysis.
- Evaluated and implemented new laboratory techniques to improve research efficiency.
- Prepared and presented research findings at seminars, contributing to academic discourse in the field.
- Assisted in the preparation and submission of grant applications, resulting in successful funding opportunities.
Education
MBA - Data Analytics
University of Louisville
Louisville, KY05-2020
PhD - Pharmaceutical Sciences
University of Georgia
Athens, GA05-2019
MS - Pharmaceutical Chemistry
Kwame Nkrumah Uni. of Science And Technology
Ghana08-2013
BS - Biochemistry
Kwame Nkrumah Uni. of Science And Technology
Ghana08-2009
Skills
- Quality assessment
- Regulatory compliance
- CMC strategy
- Technical writing
- Process validation
- Data analysis
- Project management
- Stakeholder communication
- Quality assurance tools
- eCTD submissions
- Quality management
Websites
Certification
Board Certified Medical Affairs Specialist, Accreditation Council for Medical Affairs, 2020-2030
Extracurricular Activities
- Education Committee Member, FDA Office of Product Quality Assessment, 2022-present
- Abstract Screening Committee Member, American Association of Pharmaceutical Scientists (AAPS), 2018-present
- Judge (Junior and Senior Divisions), Georgia Science & Engineering Fair, 2015-present
- Facilitator, Dean Stuart Feldman Summer Science Institute, University of Georgia, Athens, GA, 2015-2019
- Chapter President, American Association of Pharmaceutical Scientists (AAPS), 2017-2018
- Chapter Vice-President, American Association of Pharmaceutical Scientists (AAPS), 2016-2017
- Co-captain, Relay for Life (Cancer Research Fundraising), 2016-2018
- Team leader, Athens Hunger Bowl, Athens, GA, 2016-2018
Select Research Publications/Conferences
- Sulfur homeostasis in diverse microbes is governed by FinR, a LysR-type transcriptional regulator., Brondani JC, Nune M, Afful D, Neidle EL, Momany C., Cell, 2025, In Press
- Overproduction, purification, and transcriptional activity of recombinant Acinetobacter baylyi ADP1 RNA polymerase holoenzyme., Brondani JC, Afful D, Nune H, Hart J, Cook S, Momany C., Protein Expression and Purification, 2023, 206, 106254
- Overproduction and purification of highly active recombinant Pseudomonas aeruginosa str. PAO1 RNA polymerase holoenzyme complex., Afful D, L. Cai, C. Momany., Protein Expression and Purification, 2019, 163, 105448
- The ubiquitin conjugating enzyme UbcH10 competes with UbcH3 for binding to the SCF complex, a ubiquitin ligase involved in cell cycle progression., Le Feuvre A.Y., Afful D., Shang F. and Taylor A., Journal of the Federation of American Societies for Experimental Biology (FASEB), 2013, 27, 1027.7
- Sero-prevalence of hepatitis B surface (HBsAg) antigen in three densely populated communities in Kumasi, Ghana., Amidu N., Alhassan A., Obirikorang C., Feglo P., Majeed S.F., Timmy-Donkoh E. and Afful D., Journal of Medical and Biomedical Sciences, 2012, 1, 59-65
- The Use of Heterologous Sigma Factors for Over Expression of ncRNA for Structural Studies, Afful D, Momany C, Prater A, Forester M, CURO Symposium, University of Georgia, 2019
- Sulfur Assimilation in P. aeruginosa: The role of FinR, A LysR-type Transcriptional Regulator., Afful D, Cory Momany, PharmSci 360, American Association of Pharmaceutical Scientists, Washington D.C., 11/2018
- Targeting the Bacterial Transcription Activation Complex for Drug Discovery: Production of the Pseudomonas aeruginosa PAO1 RNA Polymerase Holoenzyme., Afful D, Momany C., Annual Meeting 2017, American Association of Pharmaceutical Scientists, San Diego, CA, 11/2017
- Production of the Pseudomonas aeruginosa PAO1 RNA Polymerase Holoenzyme complex for Drug Discovery., Afful D, Momany C., The Graduate Research Association for Students in Pharmacy (GRASP) Conference 2017, Campbell University, Buies Creek, NC, 05/2017
Timeline
Senior Product Quality Assessor
FDA/CDER/OPQ
09.2022 - Current
ORISE Fellow
FDA/CDER/OPQ
08.2020 - 08.2022
Scientific Writer and Compliance Coordinator
Trilogy Health Services, LLC
06.2019 - 07.2020
Research & Classification Consultant
SSRN
05.2019 - 05.2021
Graduate Research Assistant
University of Georgia College of Pharmacy
08.2014 - 05.2019
MBA - Data Analytics
University of Louisville
PhD - Pharmaceutical Sciences
University of Georgia
MS - Pharmaceutical Chemistry
Kwame Nkrumah Uni. of Science And Technology
BS - Biochemistry
Kwame Nkrumah Uni. of Science And Technology