Fady Ibrahim Email & Phone Number

Manager of the Translational Biopharmaceutics group to assess bioperfomance of drug products through linking in vitro and in silico modeling tools Gastroplus and Simcyp

Groton, Ct

Served as Biopharmaceutics project leader for discovery and clinical programs. Responsibilities includedesign of IR/MR oral formulations, constructing and verifying absorption/PK models, identifying and addressing biopharmaceutical risks, and coordinating multi-disciplinary activities among functional groups for preclinical and clinical studies. Responsible for authoring biopharmaceutics sections of the biowaiver justification documents for site and/or formulation change. 1- Develop Biopharmaceutics risk management strategy for projects at discovery to development. 2- Utilize simulaitons to assess the correlation between physicochemical properties of the molecules to achieve the required PK profile utilizing GastroPlus, simCYP, WinNonlin and gCOAS.3- Design IR formulations and dosing regimens to mitigate Biopharmaceutics risks4- Design release profiles of MR dosage forms to meet PK/PD needs5- Designed in-house tools to identify the proper API forms (salts vs free base) and polymorphs6- Coordinate with multiple teams to design PK, toxicology and clinical plans to address the identified biopharmaceutics issues with the programs7- Provide support for the design of clinical studies (phase I and II) to address the identified Biopharmaceutics issues8- Provide and draft Biowaiver Justification document for site transfer and/or formulation changes for FDA and EMEA.

Postdoctoral Fellowship Projects (May 2011-Present):o Assessment of the population pharmacokinetics of doxorubicin in patients with hepatic cancer (Phase II clinical trial)o Pharmacokinetics of Amphotericin B following oral administration of lipid-based formulations to rats: Correlation to Amphotericin B solubilization using in vitro lipolysis modelo Pharmacokinetics and pharmacodynamics evaluations of a novel lanthanide compounds in osteoporosis rat modelo Assessment of intestinal absorption and pharmacokinetics of cholesterol and vitamins following the administration of cholesterol adsorbent agento Assessment of in vivo efficacy of a novel lipid based formulation of Amphotericin B in disseminated candidiasis disease model in rats.o In vitro characterization of intraluminal processing of lipophilic drugs in lipid based formulations using in vitro lipolysis model.

University Of Houston

o Formulation development and characterization (microspheres, liposomes and nanosuspension). o Design and data analysis of pharmacokinetic (PK) studies. o Experience in PK modeling, statistical data analysis and reporting using WinNonLin and ADAPT II.o Experience in population PK modeling using NONMEM Software.o Experience in pharmaceutics and regulatory affairs o Animal handling: Experience with performing jugular vein cannulationo HPLC and UPLC/MS/MS method developments and validations o Microdialysis application for in vitro studies

Houston, Texas Area

I have been rewarded my Ph.D. degree from the College of Pharmacy, University of Houston in May 2011. My Ph.D. project involved the formulation and pharmacokinetics (PK) evaluations of Lazaroid U-74389G (LAZ), a drug of the 21-aminosteroid family with radioprotective and potential chemotherapeutic properties. I developed nanosuspension, microspheres and liposomal formulations of LAZ to study its PK and biodistribution in mice from each formulation. Two assays for HPLC and UPLC/MS/MS were developed for LAZ quantification. In PK studies, the non-compartmental PK parameters of LAZ nanosuspension and liposomes were evaluated using WinNolin. Then, a custom-built model was developed for co-modeling of the drug distribution between the plasma and the brain using ADAPT II. At the end stage of the study, we developed brain tumor bearing mice with bioluminscent transporter gene for non-invasive tracking of the tumor size. The study design was so tight that we were not able to withdraw more than two blood samples from each animal at different time intervals. NONMEM software was used to predict the PK parameter of LAZ liposomes in different treatment groups. Also, NONMEM was used to estimate the various covariates of the experiment which affected the model fitting such as the tumor size, the animal weight and the concomitant therapies. The outcome of the project was that, the liposomal formulation was able to increase the brain exposure by 13 fold as compared to the unformulated solution. On the other hand, LAZ nanosuspension with cationic charged surfaces was able to target the lung tissues and increase the exposure by 4 times.

Tanta, Egypt

Development and characterization of tablet and capsule formulations for hospital use only.Collaboration with Bioavailability Center to provide the human PK studies for drug licensing in Egypt.Teaching Assistant for the Pharmaceutics, Biopharmaceutics and Industrial Pharmacy courses in the College of Pharmacy, Tanta University, Egypt

Ph.D., Pharmaceutics

Bachelor Of Science, Clinical Pharmacy