Our Team / Associates
Dr. Joly founded Pharma-GPS, LLC after spending 17+ yr as a toxicologist and pharmacokineticist with Procter & Gamble Pharmaceuticals. His broad-based technical skills contributed to the development of the 2 billion dollar brand Actonel®, strategic life-cycle management of many of P&G's marketed products, commercially successful co-development projects with several external partners (US, Korea, Japan, France), and technical assessments for licensing & acquisitions. Most recently, he was the chief assessor for preclinical safety assessment of P&G's technical due diligence team (for in-licensing opportunities) from 2004-2009, identifying risks and developing contingency plans to strengthen negotiating positions for acquisitions and partnering opportunities. Dr. Joly has global regulatory toxicology expertise in development of small molecules, biologics, and botanical products, and experience in submissions and addressing concerns with filings to FDA, EMEA, JMHLW, and several other country-specific agencies (German BfArM, French AFSSAPS, Swedish MPA, and UK MHRA). His familiarity with the customs and business practices in Japan and China was achieved over the course of several projects and extensive travel in these countries over the last 15 yr. Dr. Joly received his Ph.D. in Pharmacology and Toxicology from the University of Louisville. He continues to serve as Adjunct Associate Professor in the Department of Pharmacology and Toxicology, Wright State University School of Medicine. He has presented several invited talks in the US, China, and Japan on a variety of drug development topics.
Dr. Lui joined the Pharma-GPS team with 12 years of experience in CMC product development (including medical devices and diagnostics), regulatory, technology and intellectual property assessment, and management at Battelle, Columbus, Ohio. She has significant experience in technical due diligence, freedom-to-operate analysis, licensing, and commercialization. Her breadth of expertise covers oral, pulmonary, parenteral, topical, transdermal, sublingual and intranasal delivery of small molecules and biologics, and includes the development of quick-dissolve, controlled-release, particle technologies. Her broad-based technical skills have rapidly transformed several early stage experimental drugs into clinical development programs for a wide range of global clients (US, Korea, Malaysia, Singapore, and Japan). She also has worked with many start-up companies to advance their drug discovery, intellectual property protection, product development, regulatory filings, and manufacturing programs. Dr. Lui is experienced in the preparation of IND and NDA submissions, CMC planning and execution, and quality systems requirements. Most recently, she founded a pharmaceutical start-up company working on a proprietary technology platform for a variety of diseases (including HIV, HCV, antimicrobials, and antihypertensives). Dr. Lui is a dual citizen of Hong Kong and the US and has close ties to a network of experts and technology companies in China. She received her Ph.D. from The Ohio State University (Chemistry/Biochemistry), her Postdoctoral Fellowship from the Massachusetts Institute of Technology, and her MBA from Fisher College of Business at The Ohio State University.
With over 20 years international experience in the biotechnology and pharmaceutical industries, specializing in quality assurance, compliance auditing and business development, Claire Kwan became part of the Pharma-GPS team in 2011. Her background includes basic laboratory research, manufacturing, quality assurance, regulatory affairs, and business development in entrepreneurial, biopharmaceutical settings in US, China, Taiwan, Canada and Europe. In previous positions at Carcinex Inc, Ms. Kwan established and managed cGMP compliant quality assurance systems for the production of in vitro diagnostics, and prepared 510(k) submissions. As Manager of Quality Assurance and Business Development at the USA and Asia divisions of Genelabs, Inc., Ms. Kwan designed and implemented quality systems. Her QA responsibilities also included performing internal and contract manufacturer compliance audits, conducting training programs, and participating in the design and construction of a GMP facility for manufacturing of parenterals. Ms. Kwan led successful joint venture evaluations/due diligence activities between Genelabs and Chinese/Taiwanese companies, including negotiating/developing contracts in the Chinese language and securing available government funding. Most recently, as Director of Quality Assurance and Regulatory Affairs at Centaur Pharmaceuticals, she was responsible for overseeing preclinical, manufacturing, and clinical QA, GLP/GMP/GCP compliance, regulatory affairs, and the submission of several successful INDs. She received her B.S. in Microbiology and MPH in Epidemiology and Laboratory Practice from the University of Michigan, and her MBA from Golden Gate University.