• More than three years of experience at the FDA. Currently a CMC reviewer at CDER. • Review safety INDs, NDAs, DMFs, amendments, etc. Participate in pre-IND, end-of-phase 2, pre-NDA and NDA meetings with sponsors/applicants. • Participated in the review and approval of many commercial NDAs, including multi-billion dollar blockbuster drugs Sovaldi (Sofosbuvir, HCV) and Stribild (elvitegravir/cobicistat/ emtricitabine/tenofovir DF, HIV). • Won FDA Group Recognition Award in 2014 for my review work on Sovaldi. • Participated in FDA Pre-Approval Inspection (PAI). • Broad knowledge of cGMP, CMC drug regulations, guidelines , etc. • Fourteen years of pharmaceutical industry experience, served as an Associate Director - API project management and technical integration at Johnson & Johnson. • Represent API Development in CM&C teams. Responsible for API project deliverable; including timeline, budget, quality (impurity control including genotoxicity evaluation), API characteristics, etc. Lead project review and summary report. • Experience in IND/CTA dossier preparation. • Point of contact with other functional areas (analytical development, pharmaceutical sciences, formulation, dossier, regulatory, external partners). • Experience in API outsourcing/vendor (India, China) management. Responsible for technical transfer to external partners. • People management skills - setting goals/objectives and motivate team to maintain/achieve high working standard. • Strong organization/planning skills. Strong communication skills. • Independent problem-solving capability and a team player. • Fluent in English (oral and written) & a Chinese native speaker (mandarin). • Familiar with API process development. Lead synthesis team to ~ 20 kg GMP APIs to support clinical studies. • Lead 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).

CMC reviewer @ From July 2011 to Present (4 years 6 months) Associate Director, API Small Molecule Development, Technical Integration @ From December 2009 to July 2011 (1 year 8 months) Associate Director/ API Project Manager, API Development @ From November 2007 to December 2009 (2 years 2 months) Principal Scientist, Chemical Development @ From September 2005 to November 2007 (2 years 3 months) Team Leader, Chemical Development @ From June 2005 to November 2007 (2 years 6 months) Senior Scientist, Chemical Development @ From January 2000 to September 2005 (5 years 9 months) Scientist, Chemical Development @ From 1997 to December 1999 (2 years) Graduate student @ From 1991 to 1996 (5 years)

Ph. D., Organic Chemistry @ Emory University From 1991 to 1996 M.S., Inorganic chemistry and Crystal Growth @ Beijing Polytechnic University From 1987 to 1990 B.S., Chemistry @ Peking University From 1983 to 1987 Fuqiang Liu is skilled in: NDA, IND and DMF review, GMP, Process chemistry, Organic Chemistry, Analytical Chemistry, Drug Development, Drug Discovery, R & D outsourcing, Management, Project managemnt, Technology Transfer, genotoxicity evaluation, salt selection and solid state screening, English and Chinese, Pharmaceutical Industry