FanLin "Emi" Kong

• Support the compilation, review and filing of INDs, CTAs, briefing documents and maintenance of development and approved applications. • Coordinate and contribute to the authoring of submission documents such as protocol, DSUR, IB, etc. • Develop and manage project timelines for regulatory submissions. • Provide regulatory assistance and review of clinical study documentation, including review of clinical protocols, informed consent documents, and clinical study recruitment materials. • Review and approve the essential documents for initial clinical trial material shipment. • Track submissions, correspondence, and commitments with health authorities. • Provide guidance to project teams to ensure regulatory documentation is complete, accurate, of high quality and electronically functional. • Write and maintain standard operating procedures and associated forms, as appropriate.

• In charge of drug substance section of an NDA, which was approved with zero CMC deficiency question; MAA of the same drug product is currently reviewed by EMA. • Manage 17 drug substances manufactured by 4 GMP manufacturers (2 new molecular entities and 15 generics). • Oversee the regulatory filings to USFDA, EMA, Health Canada, TGA and other regulatory agencies - Drug Master File (DMF) and CEP submission, Amendment, Annual Report, etc. • Correspond to the requests from the health authorities including but not limited to the deficiency letters of the DMF and manufacturing site inspections. • Provide regulatory support to clients - complaints, investigations, deviations, CAPAs, change controls, supplier qualification, quality agreements, regulatory submissions and facility inspections. • Provide regulatory guidance and support for drug substance development and production activities; advise personnel in other departments regarding the applicability and impact of the regulatory guidance.

• Review, publish and submit DMFs and CEP dossiers to US FDA, Health Canada, TGA, EDQM and various EU authorities; assist with deficiency letter responses and maintain the lifecycle of the DMFs and CEPs. • Compile and review quality agreements and supplier qualification questionnaires. • Liaise with the clients and manufacturing sites in response to clients’ technical questions, audit requests, and complaints. • Assess change requests from the manufacturing site and develop implementation plan (i.e. client notification, post-approval change, etc.) • Track the regulation updates and regulatory news and share the updates with team members via weekly newsletters. • Organize and host weekly team meeting, prepare for the meeting agenda and minutes.

Development of Technetium-99m, Gallium-68 and many other radioisotope-labeled tumor-targeting compounds for diagnosis and treatment evaluation in various types of cancers.

Synthesized more than twelve Technetium-99m labeled tyrosine analogues for breast cancer imaging and evaluated such compounds in vitro and in vivo using animal breast cancer models.