Fuqiang Liu

• Vice President of Betta Pharmaceuticals Co., Ltd. Leading Betta Pharma's CMC activities and all three U.S. IND submissions along with company's first NDA submission to the FDA. • Former President of FB-HRS, L.L.C. Led 505(b)(2) projects; managed CROs on CMC, clinical, RA, etc. Company's first IND: received the FDA's "Study May Proceed" letter in June 2020. • Former Head of International Medicine at Simcere Pharmaceutical Group. Recruited for Simcere corporation; New Jersey team setup/management; project selection; due diligence; 505(j) project management including BE studies, etc. • Former Director of Global CMC RA at GSK. R&D, regulatory filing strategy, etc. • Former CMC reviewer at FDA/CDER. Reviewed INDs, NDAs, DMFs, etc. Participated in pre-IND, EOP 2, pre-NDA and NDA meetings with sponsors/applicants. Participated in the review/approval of many commercial NDAs, including blockbuster drugs e.g. Sovaldi (Sofosbuvir, HCV) and Stribild (HIV). Won FDA Group Recognition Award in 2014 for the review on Sovaldi. Participated in FDA's PAI activity. • Former Associate Director at Johnson & Johnson. Represented API Development in CM&C teams. Was responsible for project deliverable; including timeline, budget, quality, API characteristics, etc. Led project reviews & summary reports. Experienced in IND/CTA dossier preparation. Was point of contact with other functional areas (analytical, preformulation, formulation, dossier, regulatory, CROs). Experienced in API outsourcing/vendor (India, China, e.g. WuXi AppTec, Porton) management, responsible for technical transfer. Team/people management skills. Strong organization/planning & communication skills. Familiar with API process development. Led synthesis team to ~ 20 kg GMP APIs for clinical studies. Led salts/polymorphs studies by collaborating with other functional teams (XRD, DSC, TGA, DVS, SS NMR, in-situ salt screening, etc.). Proficiency in analytical methods (NMR, IR, UV, MS, HPLC, GC, TLC, GC/MS). Specialties: Management experience on R&D, team, project & CRO, etc. Company/team setup and operation. Talent recruiting, project selection, due diligence. Management experience on both innovative and generic drug programs, including 505(b)(2) projects. U.S. FDA/CDER CMC review process. IND, NDA and DMF review. Project management & technical transfer. cGMP. Liaison role in CMC team. CMC document preparation. Outsourcing/vendor management. Fluent in both English and Chinese. Genotoxicity evaluation and control strategy. Solid state screening/characterization.