Feili Tang

• Lead the analytical development group consisting of M.S/Ph.D. scientists for CMC analytical development of small molecule and oligonucleotide drug candidates from pre-clinical through commercialization. Responsible for staff performance and career development. • Develop project strategies as analytical work stream leads (aWSL) of small molecule and oligonucleotide (siRNA) programs on the CMC team. Assess and manage appropriate project risks, develop control strategies, and collaborate with cross functional teams (chemistry, formulation, quality, toxicological, supply chain, and regulatory) to solve analytical challenges during product development. • Core team member for GSK oligonucleotide control strategy working group and responsible for proposing overall control strategy and late phase DS/DP specification template for siRNA. • CMC due diligence team member to drive completion of the diligence outputs (e.g. risk register, diligence report, future development plan, etc.) upon agreed timelines. Identify the risks on CMC deliverables, propose and execute the mitigation plan to secure a successful project transition and continuous CMC operation. • Manage and oversee analytical activities performed at CROs/CDMOs associated with method development, qualification/validation, transfer, stability, and trouble shooting. • Author and review CMC analytical sections of marketing application and briefing documents. • Coordinate, author, and review responses to the questions from Global Health Authorities. • Propose commercial specification, present the JoS to GSK specification committee and GSK CMC board for the endorsement of commercial specification, filing readiness, and development strategies. • 2023 GSK Transformational Medicines and Vaccines President’s Award Winner.

• Author the CMC sections of regulatory documents (IND/CTA, NDA) for small molecules and biologics ensuring successful regulatory approvals. • Collaborate with SMEs in the authoring and reviewing process to ensure scientific excellence, accuracy, and completeness of dossiers; collate comments, lead discussion and achieve consensus from CMC team. • Prepare and coordinate CMC responses to the questions from Global Health Authorities on designated projects. • Participate in CMC team meetings to provide the strategy and guidance for the timely delivery of CMC regulatory documents (IND/CTA, amendments, annual reports, specifications and responses to questions from Health Authorities). • Lead specification development strategy in alignment with cross-functional teams (Toxicology, Analytical, Process Chemistry, Formulation, and Clinical). Prepare specifications for small molecules (drug substance and drug product) and secure their approval from the BMS specification committees. • Propose new phase appropriate specifications as drug development stage evolves (e.g. new processes, new formulations, new specified impurities). • Open change control records to track specification changes; provide impact assessments to the specification and dossier related quality events.

Chemical Process Development-Analytical Chemistry, Bristol-Myers Squibb, New Brunswick, NJ • Develop project strategies as Analytical Lead on the project team. Plan and manage workload within matrix teams, assess and manage appropriate project risks, develop control strategies, and collaborate with chemists/engineers to solve analytical challenges during process development. • Oversee analytical development activities at CMO to ensure IND tox and FIH drug substance delivery. Review analytical methods, validation protocols and validation reports. Coordinate with GMP testing lab and QA for reference standard qualification, method validation and sample testing. • Lead an analytical team for early phase programs transition from CRO/CMO to internal glass plant production. Evaluate/develop and qualify analytical methods, establish sample plans, oversee starting material and intermediates release, coordinate with IPC testing lab, chemists, engineers and glass plant operation to ensure a successful campaign. • Analytical Lead on the route innovation team (chemistry, engineering, analytical, high throughput screening etc.) to develop second-generation commercial synthetic route for APIs. Accountable for collaborating within route innovation team to develop innovative analytical approach, developing appropriate analytical control strategy, transferring the fit-for-purpose analytical methods and control strategy to full development team/CRO. • Analytical Lead on continuous process team to enable automated analyses during process development and manufacturing. • Core member of Analytical Technical Forum (ATF) to solve department’s most pressing issues, support department scientific initiatives/intern programs and review manuscripts of publications.

• Development and feasibility demonstration for a variety of sensitive analytical methods to detect genotoxic impurities at low ppm levels using HSGC-MS, LC-MS, HPLC-UV, ICP-MS and chemical derivatization. • Collaborate with cross-functional team members (Analytical Science, Chemical Development, Toxicology and CMC Regulatory) to develop strategies for assessment and control of genotoxic impurities to support Phase III clinical supply and NDA filing. • Develop and validate drug substance and drug product stability-indicating HPLC Assay/Impurities methods for NDA filing. • Transfer of analytical methods to manufacture sites. • Identification and structure elucidation of unknown impurities in drug substances using LC-MS/MS. • Write technical reports/memos to support regulatory filings. • Represent the analytical department on CMC sub-team to support development strategy and regulatory filing. • Participate in establishment of specifications for drug substances and drug products. • Direct and coordinate analytical activities at CROs. • Lead the update of organic solvent introduction kit for ICP-MS to enhance capabilities in the study of genotoxic impurities and elemental impurities analysis.

Analytical Development and Quality Control, Wilmington PharmaTech Company, Newark, DE • Conducted investigation of unexpected impurities in GMP production batches of a new drug candidate. Preformed HPLC method development to achieve the separation of impurities from the main component. Impurities in the API and intermediates were identified by RP-HPLC-MS; the possible source of the impurities was located. • Summarized GMP campaign lots of a new drug candidate with activities focused (i) Lot history information with starting materials, intermediates, raw materials, process control testing, and API with any available acceptance criteria/specification, impurities, analysis, and methods; (ii) Potential gaps for the process and possible control strategy suggestions for future campaigns. • Worked in a QC lab under GMP conditions performing analysis of Active Pharmaceutical Ingredients (API), in-process samples, production material, intermediates, stability samples and reference standards. • Designed and executed HPLC method qualification/validation; drafted qualification/validation report. • Lead analytical chemist in GMP reference standard release testing; coordinated all analytical activities and generated CoA for QA review. • Lead analytical chemist in GMP campaigns, coordinated cleaning test, in-process control test, intermediate analysis and batch release test; working closely with process chemists to ensure quality met.

Process R&D, Wilmington PharmaTech Company, Newark, DE • Performed GMP production of APIs at multi-kilo scale; designed experiments in order to develop chemical processes for the manufacture of drug substances. • Optimized a scale-up process of ring-closing metathesis reaction forming a macrocycle as a precursor of an API. • Developed an efficient and scalable process for a new drug candidate. Key aspects include (i) a telescoped epoxidation/alkylation sequence; (ii) two isolated crystalline intermediates. • Performed salt screening for new drug candidates. The lead candidate was identified with improved physicochemical properties. • A robust and scalable crystallization procedure from aqueous solution was developed for GMP production of a new salt form at kilo scale. • Performed polymorph screening for new drug candidates. New polymorphic forms of drug candidate were observed and characterized.

Postdoctoral Research with Prof. David W.C. MacMillan 2009-2011 Department of Chemistry, Princeton University, Princeton, NJ • Designed and executed the electrochemical-SOMO catalyzed enantioselective α-allylation of aldehydes. The new protocol use catalytic electron mediator instead of stoichiometric metallic single electron oxidants to trigger SOMO catalysis without losing reaction efficiency and enantiocontrol. • Investigated the total synthesis of (–)-bruceol via asymmetric iminium-SOMO cascade catalysis. The key intermediate towards (–)-bruceol was successfully constructed through enatioselective hydride reduction and SOMO arylation of aldehydes.

Doctoral Research with Prof. Kevin D. Moeller 2003-2009 Department of Chemistry, Washington University in St. Louis, St. Louis, MO • Conducted research towards the total synthesis of ineleganolide using an oxidative cyclization reaction. • Created new strategies for the synthesis of highly functionalized [4.3.0] bicyclic systems bearing four contiguous stereogenic centers via a novel oxidative cyclization. • Investigated the reactivity of new radical cation intermediates derived from ene diol ethers. • Established a new working model of oxidative olefin coupling reactions for generating carbon-carbon bonds.

Graduate Research with Prof. Gu Yuan 1999-2002 Department of Chemistry, Peking University, Beijing, China • Established a new method to distinguish isomeric distamycin analogs based on MS/MS analysis. • Designed and synthesized a novel hairpin polyamide containing chlorophenylsufonyl for photoinduced DNA cleavage.