Yuyang Gao

1.Pharmacovigilance (PV) System Establishment 2. Clinical Project Support 3. Team Management

1.PV System Establishment and Optimization 2.Clinical Project Support 3.Post-marketing PV Activities Support 4.Team Management

1. Clinical PV Project Management As PV project manager, lead client communication, contract drafting, pricing, and full project lifecycle operations; Project management activities mainly include SMP preparation, Study information configuration, SAE reconcilation, Medical review, DSUR preparation, and project document delivery. 2. Team Management 3. Supplier Management

As a study director of DMPK Department, is responsible for preclinical PK study requested from domestic or foreign clients. Responsibilities: Oversee daily operation of team, including the proposed research activities, logistics, report generation, and to communicate with sponsor team and coordinate research activities as needed. Experiences: By now, I have been responsible for about 20 clients and managed various types of PK project required by them, such as single, multiple, cassette and infusion dose in rodent or lager animals, tissue distribution PK study, ADME in vitro and so on. Achievements: More than 1,000 compounds have been screened for clients through various PK studies. One compound as a phenomenal candidate was successfully moved into IND phase after 2 years of very hard work, and likely to be tested in the patients.

As an intern, worked in Quality Inspection Center of Vaccine to study bacteria detection and isolation experiments.

As one major participant conducted natural product research with a doctor to screen the active ingredients from extracts of Traditional Chinese Medicine. Three study results had been applied for patents. Appl.No.: 1). CN201110046281.0 2). CN201110036882.3 3). CN201110036881.9