James Bourassa Email & Phone Number

Cambridge, Massachusetts, United States

Senior Director of Analytical Development

Watertown, Massachusetts, United States

Waltham, MA

Founding member Kala Pharmaceuticals from its inception - established successive and growing analytical and characterization capabilities as Kala grew from academic technology to launch of two commercial products

Watertown, Massachusetts, United States

• Led the analytical development and method validation of the commercial INVELTYS and EVESUVIS launches.
• Managed analytical development of the INVELTYS and EYESUVIS commercial drug products, enabling release methods, ICH stability studies and method transfer and validation at GMP compliant CROs.
• Wrote and reviewed CMC sections of the INDs and NDAs, particularly analytical and stability relevant sections, for the FDA approved launches of EYESUVIS and INVELTYS
• Led internal analytical R&D work on on Kala’s portfolio of early development drug product candidates for additional ophthalmic indications, both internally developed and external partnerships

Waltham, Massachusetts, United States

• Led Kala’s team of analytical scientists and expanded R&D analytical capabilities bringing multiple projects to the drug product development stage.
• Developed analytical methods used to characterize the nanoparticle mucus penetrating drug product candidates in Kala’s pipeline, two of which led to INVELTYS and EYESUVIS commercial products.
• Managed external analytical and bioanalytical CROs for preclinical studies to support drug product pipelines for ophthalmic product candidates.
• Led team of scientists on setting up R&D phase appropriate stability studies for NCE and drug product candidates.

Watertown, Massachusetts, United States

• Characterized Kala’s novel mucus penetrating nanoparticle technology for a wide variety of possible therapeutics including ophthalmic, pulmonary and oral indications in close collaboration with Chemistry and.
• From the initial creation of Kala, set up and managed the analytical sciences used by internal R&D for all future technology development and eventual drug product development efforts
• Worked closely with the Chemistry team on characterizing the growing library of new chemical entities for Kala’s drug substance portfolio.
• Trained and mentored a new team of analytical development scientists

Analytical representative for drug substance and drug product early development support from API nomination to handoff to late development for J&J pipeline. Solid dosage form development for IR and CR tablets, drug in capsule and novel drug delivery concepts. Liquid dosage form support for solutions, suspensions and reconstituted powders for oral and IV.

Analytical support for discovery efforts

High throughput screening of small molecule drug candidates for ADME properties. Development of novel quantitation methods, primarily using LC-MS and LC-MS-MS methods, for drug targets, proteins, peptides and biomarkers to support discovery stage research. Evaluation of methods for the screening of metabolic stability. Presentation and reporting of these.

Photochemical and mechanistic studies on iron-sulfur-nitrosyls, examination of materials as potential photochemical delivery agents of nitric oxide to biological targets, electrochemical detection of nitric oxide, photophysical properties of luminescent materials and electron transfer candidates. Extensive productive collaborations with other research.

Postdoc, Chemistry

Activities and Societies: Postdoc in Prof. John Groves' laboratory

Ph.D, Inorganic Chemistry

Research Advisor: Prof. Peter C. Ford. Dissertation Title: "Photochemistry of Iron Sulfur Nitrosyls: Roussin's salts and related compounds."

B.S., Highest Distinction, Chemistry

Undergraduate Research with Prof. Howard H. Patterson... Photoluminescence of Transition Metal Dicyanides