Design and execute pre-formulation work and formulation optimization, API characterization and stability studies, controlled / targeted release from polymer matrices or coatings (in-vivo and in-vitro), and CMC related work for combination medical devices and dosage forms on a consulting basis. Expertise in ocular, oral and vascular drug delivery product and process research and development.

Analytical method development, validation and transfer for combination medical devices

•Developed formulations for vascular drug delivery from the reservoir based Conor stent platform employing polymers (i.e., PLLA, PLGA, PEVA, PCL, SAIB, Poly (aspirin)) for small (i.e., paclitaxel and rapamycin) and large (peptide and protein) molecules•Developed and validated methods for characterization and assay of a biodegradable polymer (PLGA)•Spearheaded drug formulation and analytical methods to ensure compliance with US and international regulatory requirements in order to achieve regulatory approvals for human clinical trials for four controlled release vascular stent products: CoStar, Corio, SymBio, and NEVO™•Developed and validated in-vitro (i.e. USP-7, USP-4 apparatus) and in-vivo drug release assays to support Quality Control and IVIVC work

•Conducted research that contributed to the elucidation of the mechanism of protein folding: designed peptide substrates, optimized protein expression and purification and developed spectroscopic methods.•Developed biospectroscopic (FTIR, DSC, CD and NMR) methods for analysis of biophysical changes associated with cataract