* Presented a retrospective analysis of FDA-submitted pediatric trials from 2012 to 2021 to evaluate and characterize contributing factors to pediatric trial failures * Authored reviews of recent pediatric clinical pharmacology articles for weekly published FDA newsletters * Attended advisory committee meetings, IND/NDA meetings, clinical pharmacology briefings, scoping meetings, and lectures * Evaluated recommendations and educated the pediatric clinical pharmacology team on iPSP reviews, waivers, and deferral requests submitted by sponsors prior to weekly PeRC meetings

* Conducted data review by utilizing index match and pivot tables to perform cohort cleaning for a phase 3b study for DURYSTA , an SR formulation bimatoprost for the treatment of open-angle glaucoma or ocular hypertension * Performed quality control for study documents and assisted carrying out an 80-participant Allergan in-house study developing tear biomarker assays to support phase 2a studies investigating strategies for the treatment of dry eye disease (DED) * Provided clinical trial support to a phase 3b study for VUITY , a pilocarpine ophthalmic solution for the treatment of presbyopia * Presented and educated the clinical team on a 2020 study investigating the efficacy of topical bevacizumab 0.05% eye drops in DED

* Spearheaded research to conduct a cross-sectional analysis of ClinicalTrials.gov data to examine the impact of COVID-19 on the U.S. pharmaceutical clinical trial landscape * Presented on research trends between COVID-19 and non-COVID-19 clinical trials in funding type and pharmaceutical utilization

* Explored food effects of low solubility drugs on bioavailability to categorically predict positive and negative food effects based on Biopharmaceutical Classification System (BCS) class. * Developed models to predict pharmacokinetic properties of new drugs using physiologically based pharmacokinetic (PBPK) modeling and simulation software GastroPlus, DDDPlus, and PKPlus.

* Conducted PK research on ocular solutions to compare permeation and bioequivalence of CEQUA and Allergan’s RESTASIS * Designed optical drug delivery simulations using GastroPlus Ocular Compartmental Absorption and Transit (OCAT) Model to predict ocular absorption and extraocular loss of drug doses

* Investigated the utilization of social media as support networks and information centers for Sickle Cell Disease (SCD) patients and caregivers to identify treatment awareness. Worked alongside patient advocacy organizations to bring awareness to SCD-related topics and connect patients to SCD-specialized providers. Assisted the development of an SCD educational campaign to assess change in public perception of ENDARI and hydroxyurea for SCD by examining the impact of drug advertisements and educational campaigns on ENDARI market potential.

Contributed to team and study deliverables including pharmacy manuals, informed consent forms, site training materials, and review of clinical trial data trends. Prepared safety management documents for site initiation visits, REMS enrollment forms, informed consent forms, and patient wallet cards for a phase 1 first-in-human global Amgen study in late-line metastatic castration-resistant prostate cancer. Researched and presented to the early development and global development teams on the long-term impact of the COVID-19 pandemic on the operation of Amgen’s early phase clinical trials.

* Contributed to drafting ODD Request, PRIME Eligibility Request, DSUR, and IMPD for phase 1 allogeneic CAR T programs * Coordinated the authoring, adjudication, and document processing of General Investigational Plan appendix of annual DSUR * Presented to CD19 clinical team on US pediatric regulatory requirements, including updates to PREA involving the implementation of the pediatric molecular target list as it relates to Allogene’s phase 1 allogeneic CAR T programs * Conducted clinical trial and competitive intelligence research on developing CAR T therapies targeting CD19 and CD70

* Preparing FDA submissions to INDs for Allogene’s phase 1 investigational allogeneic CAR T-cell therapy candidates, including drafting 1571 forms and cover letters for SUSAR reports, protocol amendments, information amendments, and new/updated investigator submissions. * Archiving global regulatory submissions, correspondences, and sponsor commitments throughout product development using Veeva Vault Rim Suite and internal trackers. * Supporting the review and finalization of regulatory documents including IND submissions, SUSAR reports, protocol amendments, and information amendments.