Cartney Smith Email & Phone Number

Boston, Ma, Us

Bedford, Ma, Us

Led the advancement of small molecule sustained delivery candidates to preclinical studies utilizing Ocular’s ELUTYX bioresorbable hydrogel technology- Oversaw the development of a continuous emulsification process integrated with tangential flow filtration (TFF) purification for precise size control and high yield fabrication of drug-loaded microparticles- Provided strategic direction and guidance to identify clinical targets, conceptualize target product profiles, and orchestrate the assessment of formulation and process design space for injectable suspension and implant formulations- Responsible for setting program goals and timelines, managing project budgets, and fostering growth opportunitiesDefined the sterilization strategy for a sustained release intracameral implant- Directed the evaluation of sterilization on product performance and created predictive models to guide program decisions- Established the sterilization modality, vendor, processing ranges, packaging configuration, and validation pathway through regular communication with CMOs and internal stakeholders, ensuring compliance with regulatory guidelinesAuthored technical documentation in support of process validation, invention disclosures, and investigational new drug (IND) application amendments

Bedford, Ma, Us

Arlington, Massachusetts, Us

Scaled up Kala’s mucus penetrating particle technology (AMPPLIFY) to commercial scale and established the nanomilling manufacturing process for INVELTYS and EYSUVIS commercial ophthalmic products- Identified critical process parameters by performing risk assessment and DoE, established commercial process robustness, and defined in-process controls- Interfaced with CMOs to draft master batch records and serve as person in plant to oversee initial GMP production batches and analytical testing- Authored more than 20 technical reports summarizing formulation and process aspects that contributed to the CMC sections of NDA filings- Provided subject matter expertise to Quality and Manufacturing teams to resolve excursions and OOS investigations and support product improvements- Designed and executed probe stability studies that defined the critical quality attributes and storage conditions of INVELTYS and EYSUVISHeaded technical development as Formulation lead on a multidisciplinary project team and designed an intravitreal extended-release formulation of a tyrosine kinase inhibitor (TKI) NCE- Defined project strategy to ideate and assess controlled release systems, ultimately advancing the program from concept to preclinical readiness in less than one year- Evaluated the design space of prototype formulations including degradable polymer rods and gels- Performed in vitro release studies and kinetic modeling, which provided the basis for understanding release mechanisms, predicting in vivo performance, and determining concept feasibility- Selected lead formulations for preclinical studies through close collaboration with Analytical and Chemistry research teams

Arlington, Massachusetts, Us

Arlington, Massachusetts, Us

Champaign, Il, Us

Advisor: Hyunjoon Kong• Developed lipid, polymer, and inorganic nanoparticle formulation strategies that improved the contrast per dose of diagnostic imaging probes with passive and peptide-mediated targeting capabilities• Evaluated nanoparticle material properties using characterization techniques that included dynamic light scattering (DLS), transmission electron microscopy (TEM), isothermal titration calorimetry (ITC), and magnetic resonance imaging (MRI)• Mentored an undergraduate researcher to examine the morphological control of templated microgels

• Provided analytical method development and support of small molecule immediate and controlled release product concepts, including monitoring of chemical stability and dissolution testing of solid oral dosage forms• Elucidated drug release mechanisms from polymer-based punctal implants through use of fundamental models• Used HPLC, LC/MS/MS, GC, and ICP-OES to characterize drug substance and drug product formulations

Providence, Rhode Island, Us

Advisors: Anubhav Tripathi and Edith Mathiowitz• Researched biodegradable nanoparticle formation via microfluidics as an honors thesis project• Fabricated spherical particles in a cross-flow system and examined the effect of polymer content on particle size by scanning electron microscopy (SEM)

Amherst, Massachusetts, Us

Advisor: Gregory Tew (Summers 2004 and 2005)• Evaluated the effects of a fluorophilic block on the rheology of triblock copolymer hydrogels• Determined terpyridine-metal binding constants by means of fluorimetry and ITC• Synthesized copolymers via atom transfer radical polymerization (ATRP) and calculated reactivity ratios using nuclear magnetic resonance (NMR) spectroscopy and gel permeation chromatography (GPC)Advisor: Helmut Strey (Summer 2003)• Used small angle X-ray scattering (SAXS) to examine morphology of oil-absorbing polyelectrolyte-surfactant complexes• Formulated hydrogels from photocross-linkable polysaccharides

Ph.D., Chemical And Biomolecular Engineering

M.S., Chemical Engineering

Sc.B., Engineering (Chemical And Biochemical)