Devang T. Shah

Accountable for oversight of all small molecule- and oligonucleotide- drug substance and drug product manufacturing within Ultragenyx's global network of contract manufacturers for both clinical and commercial supply Current CMC Lead for both early- and late-stage clinical programs, including GTX-102, for the treatment of Angelman Syndrome Former CMC Lead for Dojolvi, a treatment for Long Chain Fatty Acid Oxidation Disorders (LC-FAOD), guiding it through approval in multiple international markets Responsible for providing strategic input as a leader in Product Supply within the Technical Operations function at Ultragenyx

Provide CMC expertise, strategic direction, and management of QC, Commercial, and Stability group activities for products from clinical trials to commercialization. Successfully executed the company’s move from a semi-virtual to a fully virtual QC model. • Lead a team of more than 10 scientists and lab chemists for co-validation and transfer of methods at phase-appropriate levels to external entities under cGMP. • Directly responsible for managing development and validation of test methods for drug products, drug substances, and excipients, performing multiple supplier qualifications, identifying and implementing method improvements. • Coordinate resource allocation and testing schedules at Heron and at CTLs/CMOs to ensure timelines coincide with process development and production schedules for clinical, registration, validation, and commercial batches. • Accountable for CMO & CTL oversight, data review, external auditing, exceptions management (deviations, investigations, CAPAs), and change control with respect to cGMP quality testing. • Author and review relevant sections of regulatory submissions (IND, NDA, IMPD, AR, APQR, Type C meeting documents) for HTX-011 (ER pain-relief product post-Phase 3 due for NDA filing) and CINVANTI™ (approved) through FDA review and approval.

CMC consultant: polymer and associated drug delivery product, SUSTOL™, during NDA review through approval. Scientific lead for manufacturing scale-up and analytical processes at CMOs, CTLs • Provided scientific expertise for improvements in polymer, drug-product, and raw material processing and characterization; successfully improved product quality with tighter specifications. • Regulatory Affairs: Interacted with FDA via Type C meetings, PAIs, and requests for information on polymer & formulation characteristics, specifications, and associated CMC activities. Met with FDA for discussions on CMC questions from the Agency. • Assisted with regulatory filings and presentation of information during regulatory inspections/partner audits. • Set statistics-based specifications, and authored sections of NDA submissions for polymer and drug-product production. • Provided advice on IP and expertise in new polymer-based drug-product development.

• Designed and taught a two-semester program in Introductory Chemical Technology & Chemical Laboratory Instrumentation for students seeking to pursue vocational training or degrees in chemistry & engineering (2010/11). • Taught Chemistry (General, Organic, and Biological) for Health Science majors (2013).

Led and directed a team of several senior and junior scientists to produce polymer & formulation designs through three INDs, two of which progressed to Phase 2 and Phase 3 clinical trials, & one which led to FDA approval for commercial use (SUSTOL™). • Significantly advanced the design, synthesis, & handling of poly(ortho esters) and their formulations in different physical forms (injectable gels, extruded solids, microspheres, coatings) for use in parenteral, ocular, and cardiac delivery of variety of API types (small molecules, proteins, nucleic acids) for durations ranging from days to months. • Coordinated tech-transfer of monomer & polymer synthesis, drug product formulation, and improved analytical methods from the laboratory to manufacturing under cGMP at CMOs. • Directed more than 10 feasibility studies with medium and large pharmaceutical companies in areas such as ophthalmology, cardiology, pain management, and veterinary medicine. • Contributed to CMC sections of regulatory filings to U.S. and European regulatory agencies.

Oversaw research, development and scale-up of synthetic processes to obtain novel, biodegradable polyesters.

Thesis: gamma-Poly(Glutamic Acid) Ester Derivatives: Solution and Liquid Crystalline Properties