More than 25 years of experience in Process Development of cGMP manufacturing processes for Biologics (upstream and downstream), scale up of Mammalian cell culture processes, technical transfer to manufacturing facilities and conducting cGMP manufacturing campaigns. Proficient in Microbial Fermentation and Downstream Processing (Inclusion bodies). Documentation: SOPs, Batch Records and NDAs. Root cause analysis for Deviations, development of Corrective Action and Preventative Action Plans (CAPAs) and implementation of Change Controls. Whenever necessary and appropriate, statistical analysis of relevant data is applied. Broad experience with Scientific and Regulatory/Compliance aspects of the Biotechnology industry: molecular biology for Construction of Expression Vectors, Expression of Therapeutic Proteins and Recombinant Vaccines, Pharmacokinetic studies, Assay Development, Process Development, Manufacturing Science and cGMP Manufacturing. Fluent in Chinese: Mandarin and Cantonese dialects.

Consultant @ • Technical Transfer - formulation/Compounding, Primary Package/Fill, small molecules (Bayer Healthcare) • Microbial Fermentation and Downstream Processing: Investigation of Deviations, set up Preventative Action and Corrective Actions (CAPA) and implementation of Change Controls; Process Description Documentation, Process improvement and Streamline (Lonza). • Documentation: Process Validation, Chemistry, Manufacturing and Control (CMC), Process Description, NDA – Viral Cancer Vaccine (Therion Biologics). • Project Coordinator: Nutrient Analysis of Recombinant Tetrahymena Culture – Amino Acids (HPLC), DO & Metabolites (NOVA FLEX), Nutrients (YSI) (Massachusetts Institute of Technology). • Senior Staff: Bioreactor/Bioprocess Summer Course (Massachusetts Institute of Technology). • Product Development of Sugarless Fruit Mixture by Yeast Fermentation (Bananalogix). • Defend Patent Litigation: Longer-Acting tissue Plasminogen Activator (Genzyme). • Product Development: Automated Reactor Sampling System for the Biotechnology Industry, Promote FDA’s Process Analytical Technology (PAT) Initiative (Groton Biosystems). From January 2007 to Present (9 years) Director of Process Development @ Directed a 7 member team for the development of a commercial manufacturing process for recombinant viral cancer vaccines. • Developed a high yield phase 3 manufacturing process for rVaccinia and rFowlpox viral vaccine production. • Negotiated and executed a complex a joint development agreement for prophylactic AIDS vaccine. • Coordinated with the CMC Team and the regulatory department for CMC amendments and BLA/CTD planning and submission. • Developed alternative core manufacturing technologies – stir tank bioreactor. • Developed a proprietary continuous primary chicken cell line. • Engaged in assay development: plaque assay, residual DNA quantification assay. • Increased vaccine production efficiency by more than 100 fold. From 2003 to 2006 (3 years) Director of Protein Production @ Directed a professional team for multiple recombinant protein production for high throughput screening using multiple expression technologies. The purified recombinant proteins include integral membrane proteins and hormone receptors such as GPCR, kinase, phosphatase, nuclear hormone receptors, transcription factors, viral proteins, etc., spanning multiple therapeutic areas. Managed internal activities as well as outsourcing coordination, including a significant budget. From 2001 to 2003 (2 years) Director of Process Development and Manufacturing @ Led a 12 member team and directed all process development for a $10 million recombinant factor VIII contract and cGMP manufacturing contracts. • Developed an efficient manufacturing process for Factor VIII with only 2 major downstream steps. • Organized a 25-member cross functional team for full-scale cGMP manufacturing campaigns. • Successfully coordinated with the Marketing Department to develop new business. • Participated in the design of a 15,000 sq. ft. cGMP/commercial manufacturing facility. From 2000 to 2001 (1 year)

Ph.D., Biology @ Northeastern University From 1995 to 1999 B.A., Biochemistry @ Brandeis University David Lau is skilled in: Biotechnology, Product Development, Vaccines, GMP, Process Development, Molecular Biology, Protein Chemistry, Purification, Cell, R&D, Life Sciences, Protein Purification, Cell Culture, ELISA, cGMP