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 Formulation teams•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 delivery. Delivery and support of analytical data for filings of preclinical and clinical trials to the end of Phase IIb, including assay, content uniformity, purity, stability, dissolution/release kinetics and others. Design, execution and problem solving with complicated drug substance and drug product stability challenges. Extensive method development and validation experience with reverse and normal phase HPLC, mass spectrometry, GC, SEC, ion chromatography, water activity and many other techniques. Working closely with pharmaceutical sciences representatives on solid form screening efforts for drug substance.

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 results to team members and leaders in chemistry and biology. Advisory position for analytical chemistry questions from project team leaders.Awarded Research Fellowship by National Institute of Health: "How do Phenoxyl Radicals interact with Nitric Oxide?", August 2000. Discovered nitration of native metmyoglobin and mutant strains during interactions with peroxynitrite. Examination of the interactions of oxymyoglobin with nitric oxide. This modification of the protein leads to considerable changes in its ability to interact with other proteins and may play a role in determining the onset of apoptosis.

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 groups and supervision of both graduate and undergraduate researchers.

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