Qi Xu, MS, MBA

Global Regulatory Lead for a novel oncology therapy in clinical development

• Lead the planning and coordination of inter-company global regulatory affairs team meeting. • Lead regulatory submissions to US IND&BLA, EU CTA, and Health Canada. • Led/supported the initial US BLA and Canada NDS for an orphan drug towards successful approval. - Supported preparation and submission of pre-BLA meeting requests and briefing package. - Led BLA Module 1 preparation, and managed completion of the eCTD filing dossier in a short time limit. - Coordinated sponsor’s correspondences with FDA and Health Canada during BLA and NDS review process, such as response to Information Requests and Health Canada Clarifax, BLA Mid/Late-Cycle meetings, and labeling negotiations. - Led regulatory documentation arrangement in eTMF system in preparation of FDA BIMO inspection. - Supporting US and Canada postmarketing activities. • Led the preparation of key regulatory documents: e.g. BLA and NDS reviewers’ guide, US priority review voucher (PRV) request, and EU investigational medicinal product dossier (IMPD) • Managing IND/BLA/NDS/ODD/CTA maintenance activities: e.g. annual reports, agency correspondences, substantial amendments, and end of study activities. • Regulatory representatives on global clinical study management team (SMT) meetings. Provided regulatory strategic support on clinical study start-up, operation, and close out. • Regulatory intelligence and strategic support for drug clinical development and marketing application. - Conducted regulatory review of key clinical documents: e.g. protocol amendment, clinical study reports. - Provided regulatory scientific input in support of senior management’s decision in clinical development.

• Lead and manage project planning and meeting coordination within regulatory affair functional teams (RAFT). • Support IND and sBLA filing dossier preparation: - Support creating US/Global filing timeline with clear defined activities and durations. - Lead US eCTD Module 1 documentation authoring and planning process. - Familiar with eCTD structure and filing requirements for both IND and BLA. • Lead FDA pre-submission Type B meeting request and briefing package preparation. • Managed various types of FDA submissions: - E.g. protocol/information amendment, investigator submission, DSUR, PBRER, labeling supplement • Coordinated US label (USPI) updating processes through Prior Approval Supplement (PAS) submission. • Completed drafts of regulatory documents (e.g. pediatric study plan, FDA meeting requests, updated US label) • Facilitated post-market FDA correspondences such REMS, PMR, and pediatric exclusivity. • Regulatory representative on several cross-functional study management team meetings. • Familiar with FDA regulation/guidance for drug, biologic and medical devices.

• Performed IRB staff preliminary review for biomedical clinical researches. • Coordinated researches and communication between clinical investigators and IRB reviewers. • Familiarity with GCP requirements. Participated in drafting the new GU IRB manual.