Nancy Nongying Wu MD, MS

•Serves as safety medical expert to evaluate ICSRs for all company products either marketed or in clinical development • Perform regular medical case review for all ICSRs reported from any source including clinical trials, literature, post marketing studies and post marketing spontaneous adverse event reports to ensure complete and timely review aligning with internal and external reporting timelines • Identify important/critical cases with potential safety signals at single case level (i.e. first line signal detection), escalating Product Safety Lead Physician/Safety Scientist and Medical Monitors, and upper management as necessary • Provide medical input and review RSI in Investigator Brochure • Provides the medical input and review needed for the creation aggregate reports (PBRER, DSUR, PADER) as needed to support compounds in clinical development or post approval • Prepare and review answers to safety queries from regulatory authorities and IRBs as needed • Prepare and review any aggregate safety analysis in regulatory submissions as needed

In charge of 40 Postmarked products; performed individual case safety reports (ICSRs) including the determination of seriousness, expectedness, listedness, causality and medical assessment of adverse events in compliance with international regulatory authority regulations. Directed, supervised and trained vendor on ICSRs; Contributed to signal detection activities • Performed individual case safety reports (ICSRs) • Familiar with safety databases system and management (AERS, Argus) • Participated in study document preparation and review, including protocol, eCRF, Central Monitoring Plan, Data Management plan, Safety Management Plan, Risk Management Plan and Benefits/Risks Assessment, setting-up E-Notification, writing study and product summary, requesting configuration. • Contributed to signal detection activities and safety analysis through immediate notifying SUSAR and providing the aggregated safety data to Global Safety Officer (GSO), including performing initial signal analysis of similar events (AoSE) and Development Safety Update Reports (DSUR), attended Safety Analysis Team (SAT) meeting • Performed SAE Reconciliation between Clinical and safety data • Performed Dedicated AE review to discover potential SAE and AESI • Worked with PV QC group to review and participate Root Cause Analysis (RCA) and Correction Action and Preventive Action (CAPA) • Worked with GSO, CSD and CTOM to identification of the critical PV queries to ensure DBL timelines. • Thorough knowledge of international regulatory authority regulations (e.g FDA, EMA and PMDA) • Knowledgeable of industry principles of product safety, Periodic Benefit-Risk Evaluation Report (PBRER), Risk Management Plan, Risk and Evaluation Mitigation strategies (REMS)

Extensive experienced with Coding systems and has a good understanding of clinical data management processes and tools; applied coding knowledge to clinical eCRF designation and case medical analysis •Completed medical and drug coding for multiple projects and review outsourced project coding by MedDRA and WhoDD; completed coding review and pool review by retrieving data by SQL •Completed designation of Insulin eCRF page and generation of Custom Drug Groupings (CDGs) and Custom MedDRA Queries (CMQs) for multiple projects, reviewed protocol, data management plan, eCRF completion guidelines (AE, MH and Medication session), data review and surveillance report (DRSR), extended synopsis (ES) and safety reconciliation plan and data coding guidelines •Attended CTT and MO meeting and interacted with CTOMs, CME, GSO, CSD, Clinical Scientist and Biostatistician for data collection, management and cleaning and medical review •Coordinated Dedicated AE Review process and worked with CME, GSO and CSD to identify potentially unreported SAE and AESI •Participated AE pooling activities and reviewed integrating the data for clinical studies •Reviewed and contributed CDISC Terminology Package

Senior Scientist, Neuroimmunology Genzyme-Sanofi, Framingham, MA; Immunology and Inflammation Experimental Pharmacology, Biological Sciences

Set up the GENSET transgenic mice facility for human gene expression atlas in central nervous system.

Research Shh and Wnt gene family using transgenic mice for cancer and developmental biology