Clinical Pharmacology Reviewer
US Food and Drug Administration
Summary
More than 20 years of pharmaceutical research, education, regulatory affairs, industry and administrative experience in multiple national and international institutions. My current research projects involve regulatory aspects of pediatric and geriatric dosing for biologics, utilizing in vitro and in vivo pharmacological models of the blood brain barrier & the skin along with the development of smart bioconjugate and nanoparticluate formulations that has the capability of by-passing these barriers and enhance their pharmacological and pharmacokinetics profiles. A current branch of my research is the implementation of augmented and virtual reality mobile technology in enhancing clinical practice and pharmaceutical education (Amplified RxTM mobile app).
Highlights
1. Senior clinical pharmacology reviewer at the Food and Drug Administration (FDA) with extensive regulatory experience, handling the reviewing processes of NDAs, BLAs and INDs submissions from sponsors along with evaluating pilot and background ADME studies (adsorption, distribution, metabolism, and elimination), bioavailability and bioequivalence studies, pharmacokinetic studies and clinical trials
2. Lead researcher on the development, in vitro & in vivo, pharmacological and pharmacokientics’ testing of two breast cancer antitumor novel bioconjugates NKTR-102 (Nektar Therapeutics) & BT2111, BTA-P97 Transcend Platform (BiOasis Inc.)
3. Extensive administrative and quality assurance experience at multiple institutions & AAST School of Pharmacy founding faculty
4. Formulation consultant for Pharco Pharmaceuticals & European Egyptian Pharmaceutical Industries (2013-2015)
5. Taught 41 different pharmaceutical courses in 7 universities worldwide. Student mean evaluation score is 4.84/5
6. 8 awards & Scholarships
7. Member of 10 professional organizations
8. Editor for 8 journals & reviewer for 40 journals
9. 58 published articles (Journals: JCR, ADDR, MCT, IJP, CAPR, BMC Cancer, etc.) & 2 book chapters
10. 73 conference abstracts
11. 9 funded grants
12. Supervised 12 master's students, two doctoral student, one FDA ORISE fellow & one postdoctoral research associate since 2013