Frontage History and Leadership
With their dedication to the core Frontage values of accountability, continuous improvement and caring, our leadership has driven substantial business growth in the past decade. As you will note below, they have the advanced educational and pharmaceutical industry experience to deliver success for your project too.
Song Li, Ph.D., Founder, Chairman and CEO
Frontage was founded by Dr. Song Li in 2001 with the ambition of becoming one of the best client-oriented, contract research companies in the industry. Dr. Li has beaten many odds to start and grow the company. Born and raised in a village of Henan Province in the People's Republic of China, Dr. Li traveled to Montreal, Canada to earn his Ph.D. in Analytical Chemistry from McGill University in 1992. After two years of post-doctoral research in Pharmacokinetics in the Oncology Department of the Medical School of McGill University, Dr. Li moved to the United States, where he held management positions at Great Valley Pharmaceuticals and Wyeth and led numerous projects related to the development of pharmaceutical products.
View Dr. Li on Doing business in China with Soundview Videos
Dr. Li has more than 20 years of pharmaceutical industry experience and has written numerous scientific publications spanning a wide range of topics, including chiral separations, drug-protein interactions, pharmacokinetics, and analytical chemistry. Dr. Li has been the recipient of numerous awards, most recently the "Realizing the American Dream" award from the Pennsylvania Welcoming Society and the Outstanding 50 Asian Americans in Business Award from the AABDC. In 2001, Dr. Li founded Frontage Laboratories to provide integrated services to pharmaceutical companies around the globe. Since its inception, Frontage has grown from one employee in a single lab to 180 employees in the United States and 120 in China, providing services in bioanalytical, immunoassay, biomarker testing, formulation development, clinical product manufacturing, and clinical studies.
Dr. Li also discussed the challenges of being a global CEO
Zhihe (Zeke) Li, MD, Ph.D., Senior Vice President and General Manager, China Operations
Zhihe (Zeke) Li is responsible for Global Project Management and Corporate Strategy. Dr. Li received his medical degree from Norman Bethune University of Medical Sciences in China and a Ph.D. in Pathology from McGill University. After 4 years post-doctorial training at the National Institutes of Health, he began his career and has been working in the pharmaceutical/biotech industry for more than 10 years. Dr. Li has extensive experience in research and development of small molecules, peptides and protein drugs. He has authored and co-authored more than 30 scientific papers and patents. In the past several years, Dr. Li has been interacting with many companies in the Chinese Pharmaceutical Industry and coordinating numerous ANDA projects overseas.
Ronald Connolly, B.S. ChE, Senior Vice President
Mr. Connolly oversees all business development operations for Frontage US operations, including GMP Consulting, some oversight of API and formulation development projects, and client services. He has been involved in FDA inspections of Frontage Laboratories, and consulted with other worldwide pharmaceutical corporations in the US, South America, Europe, India and China. Mr. Connolly has been involved in more than 25 FDA inspections throughout his career, and has recently been named as an inventor on a pending chemical process patent. Ron earned his B.S. in Chemical Engineering at Drexel University. He has served on the scientific affairs committee of the GPhA and numerous GMP task force groups at Wyeth Pharmaceuticals (now Pfizer) and was involved in an industry initiative to develop a supplier audit template that allowed pharmaceutical companies to provide standard quality and business information necessary for qualifications.
Marita James, CPA, Vice President, Finance
Ms. James is responsible for financial reporting, tax, cash management, and risk management. She brings twenty years of finance expertise in both multi-national corporations and venture-backed life sciences firms. Ms. James started her career with PricewaterhouseCoopers Emerging Business Practice. After PWC, she worked with a number of Investment Banking firms including Fleet Boston Financial and then went on to work with BioAdvance, a Life Science seed fund and several startup Life Science companies. Ms. James has a degree in Business Administration from LaSalle University and is a Certified Public Accountant.
Chemistry, Manufacturing and Controls Services
Dongmei Wang, Ph.D., Senior Vice President and General Manager, CMC Services
With more than 16 years of pharmaceutical industry experience, Dr. Wang leads the Frontage CMC Division in providing analytical method development/validation/transfer and sample stability testing, custom API synthesis and GMP manufacturing, formulation development and manufacturing of clinical trial materials. Prior to joining Frontage in February 2007, Dr. Wang served as the Director of Analytical/QC at NovaDel Pharma Inc. for more than three years, where she built teams to provide support in NDA product development, clinical supplies manufacturing, CMC sections of regulatory filings, and technology transfer to commercial manufacturing sites. Prior to NovaDel, Dr. Wang headed Pharmaceutical Analysis and Control at Therics Inc. in product development for 510(k) and IND filings. Her extensive academic background includes a BS in Chemistry from Peking University (1984), an MS in Chemical Engineering (1987), three years as a lecturer at the Graduate University of Chinese Academy of Science (1987-1990), a Ph.D. in Chemistry with honors from Iowa State University (1994), and subsequent post-doctoral research at the University of Chicago (1995-96).
DMPK and Bioanalytical Services
Abdul Mutlib, Ph.D. – Vice President, DMPK Services
Dr. Mutlib has over twenty years of experience in drug metabolism and analytical chemistry and has published more than sixty papers in peer-reviewed journals. Dr. Mutlib graduated from University of Sydney, Australia in 1987 and did post-doctoral fellowships at the University of Washington (UW) and the University of British Columbia (UBC) before entering the pharmaceutical industry. He was part of the drug metabolism teams at Hoechst-Roussel (Aventis), DuPont-Merck, Pfizer and Wyeth prior to joining Frontage Laboratories in 2010. His research interest includes application of various analytical techniques and stable isotope labeled compounds in elucidating structures of metabolites and metabolic pathways; mass spectrometry; qualitative and quantitative NMR; metabolism-mediated toxicities; reactive metabolites; phase II metabolism; drug-drug interactions; and toxicogenomics.
Harry Zhao, Ph.D. – Senior Vice President, Bioanalytical Services
Dr. Zhao has led the Bioanalytical Services Division of Frontage Laboratories since the start of the company. He established the bioanalytical laboratory, including its SOPs and the setup and maintenance program for LC/MS/MS instruments. Dr. Zhao manages the overall planning, execution, and quality of bioanalytical projects. He leads critical client interactions in the areas of project scope, regulatory requirements, timelines, project proposals, and resolution of critical issues. Dr. Zhao provides guidance to lab directors for review and approval of all technical reports, SOPs, and deviations. In addition, he provides training for all team members. He received his Ph.D. degree in Chemistry from Iowa State University in 1997. Before joining Frontage in 2002, Dr. Zhao spent four years developing mass spectrometers for an analytical instrumentation company.
Zhongping (John) Lin, Ph.D., Vice President, Bioanalytical Services
Dr. Lin is responsible for Bioanalytical R&D and project management. He received his Ph.D. in Analytical Chemistry from Dalhousie University in Halifax, Canada and did his post-doctoral research in Pharmacokinetics and Metabolism at the College of Pharmacy and the Comprehensive Cancer Center of the Ohio State University. Dr. Lin has more than 19 years of bioanalytical chemistry experience and has held both management and scientific positions in Avantix Laboratories, Inc. and AstraZeneca. His expertise includes the drug discovery and development process and pharmaceutical project lifecycle and data management. Dr. Lin's current research focus is in the area of bioanalytical method development and validation, dry blood spot (DBS) sampling with LC-MS/MS analysis, and biomarker quantification using LC-MS/MS. His achievement is evidenced by more than 20 research publications covering the development and validation of LC-MS/MS methods for the determination of small and large molecules (peptide and protein, etc.) in biological matrices. He is the invited reviewer for several international journals including the Journal of Pharmaceutical Biomedical Analysis (JPBA) and Journal of Chromatography B (JCB). Also experienced with regulatory requirements and guidelines, Dr. Lin has hosted more than four FDA inspections.
Clinical Services
Jason Wu, MD, MS, MBA – Senior Vice President and General Manager, Clinical Services
Dr. Wu has more than 20 years of experience in clinical medicine, life science research and pharmaceutical development. He has conducted or managed over 30 different clinical trials in North America and contributed to the regulatory filings and approvals of seven marketed products. Dr. Wu has published more than 10 scientific papers in leading international journals covering both clinical and scientific research. Dr. Wu was Executive Director of Product Clinical Development at Graceway Pharmaceuticals, where he was responsible for product development of several product pipelines acquired from 3M. Prior to Graceway, he was Sr. Clinical Project Director at Auxilium Pharmaceuticals and led the full development team to BLA filing. From 2001 to 2005, Dr. Wu held a senior management position at Sanofi-Aventis Worldwide Dermatology Division, where he led a development program for a new anti-fungal topical product and provided medical affairs support for company marketing needs. Dr. Wu also worked for Pharmacia & Upjohn (Pfizer) as Head of South China and Head of the Peptide Hormones Business Unit in China, as well as Clinical Research Manager and Team Leader for a global Phase IIIb program in the US.
David Reiner, MD, CPI, Medical Director, Principal Investigator
Dr. Reiner has 15+ years of professional experience in clinical medicine practicing Cardiology and Internal Medicine. He served for 10+ years on the Medical Quality Assurance/Process Improvement Committee of Englewood Hospital and Medical Center, as well as the Biomedical Ethics Committee. Dr. Reiner has a diverse research background that started in medical school where he participated in basic science animal lab investigations utilizing a septic shock model. During his fellowship in Cardiology at Montefiore Medical Center he was a sub-investigator in 2 noteworthy trials with TIMI (an Academic Research Organization affiliated with Harvard Medical School), evaluating different treatment strategies in acute coronary syndromes. More recently he was a sub-investigator in clinical research studies sponsored by Bracco Diagnostics and Gilead Sciences at the Institute for Clinical Research at Holy Name Medical Center. Dr. Reiner is a Certified Physician Investigator by the accrediting boards of the Academy of Physicians in Clinical Research and the Academy of Clinical Research Professionals. Dr. Reiner’s clinical expertise and leadership further enhances the highest quality of services that Frontage seeks to provide both current and future clients.
Lisa Diamond, Ph.D. – Vice President, Clinical Affairs
Dr. Diamond is a senior scientist with clinical, pre-clinical, GLP, R&D and basic research experience. She has over 20 years experience in the industry as a bench scientist, a manager/director in research and development, and a director/VP in clinical research. Prior to joining Frontage, Lisa spent 3 years at a small biopharmaceutical company as the Associate Director of Clinical Development, and 13 years at a biotechnology company, most recently as Associate Director of Research and Development working in the field of xenotransplantation. Lisa received an MS and Ph.D. from New York University, and completed a post-doctoral position at Princeton University (Princeton, NJ). She is an adjunct professor at Rider University (Lawrenceville, NJ), has 3 issued patents and has authored/coauthored over 30 publications in peer-reviewed journals.
Drug Development and Regulatory Consulting
Yuanchao (Derek) Zhang, Ph.D. – Vice President, Drug Development and Regulatory Consulting
Dr. Zhang joined Frontage from the FDA in December 2008. He has 14 years of experience in drug research, development and regulatory approval, including 4 years of industrial experience at Pfizer and over 6 years of regulatory experience at the FDA. Dr. Zhang was Senior Clinical Pharmacology Reviewer in the Office of Clinical Pharmacology, the Center for Drug Evaluation and Research, the Food and Drug Administration. He successfully reviewed numerous NDAs (including several NME NDAs and BLAs), NDA supplements, and IND submissions. He also contributed to several guidance document development and revision.
Prior to working with the FDA, Derek was Senior Research Scientist of Pharmacokinetics, Dynamics & Drug Metabolism at Pfizer's laboratories in Groton, MA. Dr. Zhang received his Ph.D. from the University of California, San Francisco (UCSF) under Professor Leslie Z. Benet.
