Mark Scott

• Head of CMC department; responsible for overseeing the development of Flare’s clinical assets. • Oversees the process design and control strategy (e.g. in process testing, specifications etc.) in order to meet Health Authority requirements for drug substance, drug product, and packaging/labeling processes throughout all phases of clinical development. • Responsible for building out and managing global supply chain spanning from proposed regulatory starting materials through to CTM distribution to investigator sites. • Together with Quality, built out quality system SOPs, as well as led eQMS and 21CFR11 compliant e-signature system computer validation and systems management. • Responsible for authoring of regulatory documents (e.g. Module 3) to support IND, IMPD etc. submissions.

• Member of Process Chemistry Leadership Team. Strives to foster a team centric, science focused environment where diverse perspectives and opinions are openly communicated within the department. • Drug substance CMC lead for late stage NASH candidate. Lead a team of >10 Analytical and Process Chemistry Scientists in the development of a compound from Phase 1 through Phase 2b studies. • Responsible for planning and executing process characterization studies to support regulatory filing strategies: PAR and DoE process characterization studies, impurity control strategies, including the planning and execution of fate and purge studies. • Responsible for authoring regulatory documents (IND, IMPD, IBs etc.) to support regulatory obligations. • Managed CRO/CMO collaborations for GMP manufacture of bulk API, regulatory starting materials and development of new biocatalytic/chemocatalytic processes to support program deliverables. • Proficient in all aspects of GMP manufacturing: MBR authoring/review, process plant equipment selection, specification strategy development and setting.

• Developed new drug entities for respiratory, inflammation and oncology disease targets encompassing G-protein coupled receptors (GPCR), nuclear receptor, and kinase targets. • Proficient in rational, hypothesis driven, structure-based drug design in combination with predictive modeling/property programs to solve potency, advanced pharmacokinetics (PK), and off-target issues. • Proficient in the evaluation of patent claims, drafting of patents (claims, sub-claims, exemplifying bodies, etc.) and determining best strategic patent path forward based on existing literature patent space. • Responsible for the rollout and application of high throughput experimentation (HTE) catalysis platforms at the Boston site. Familiar with Design of Experiments (DoE) analysis for multiparameter optimization of catalytic transformations. • Proficient in working up multiple concurrent high throughput screening (HTS) campaigns - efforts included hit cluster analysis, Spotfire analysis of HTS, as well as focused library synthesis efforts.