Decision Science Group

Led ANDA lyophilization (achieved Q1/Q2 equivalence from FDA) and extended release capsule projectsDesigned and developed innovative PLGA nanoformulations and liposomes for compounds require specific bioavailability via i.v. injection. Surface modification using PEG and targeting peptidesDesigned and developed modified release multiparticulate capsules and participated in GMP manufacturing for Phase I/II clinical trialsLipid, amorphous formulation design and development to enhance oral drug bioavailability.

Optimized small peptide (targeting: dry eye disease) formulation and packaging conditions (currently finishing Phase II clinical trial)Coordinated preclinical bioanalysis, PK/PD studies with CROsPerformed QC review of data and assisted FDA pre-IND briefing package preparationParticipated in randomized, double-blind, multicenter Phase I/II study (currently ongoing) designCompleted series A financing and secured partnership with Santen Inc.

Applied biopharmaceutical and polymeric science in ophthalmologyDissertation title: Development of protein polymer therapeutics for the eyeCo-author on several successfully-funded DOD and NIH grant proposalsPublished high impact factor peer-reviewed articles and co-invented patentsLed research projects and presented at international conferencesMentored master and PharmD studentsAAPS, CRS and ARVO member