History / 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, PhD, 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 was known to always provide technical help to his friends and colleagues who were faced with complex analytical issues.
With the passion to aide others in troubleshooting development issues and frustration with the level of expertise available to perform outsourced analytical projects that he was running at Wyeth Pharmaceuticals’ esiLederle division, Dr. Li felt compelled to start Frontage.
Dr. Li has beaten many odds to start and grow the company. Growing up as a farmer’s son in a remote village in the People’s Republic of China, Dr. Li was the first person to receive a B.S. degree in the history of his hometown district with a population of more than 100,000. He made the most of his studies and had the opportunity to receive his doctorate education at McGill University in Montreal, Canada. Based on his post-doctorate studies in analytical chemistry and chiral compound analysis, Dr. Li was hired by Great Valley Pharmaceuticals and was brought to the US to start his career in the pharmaceutical industry. He has since been recognized as a leader in analytical and bioanalytical research, and the insights gained in these areas have helped Dr. Li to build the successful venture Frontage is today.
Zhihe (Zeke) Li, MD, PhD, Senior Vice President and General Manager, China Operations
Zhihe (Zeke) Li is responsible for Global Project Management and Corporate Strategies. Dr. Li has received his medical degree from Norman Bethune University of Medical Sciences in China and a PhD 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 molecule, peptides and protein drugs. He has been authored and co-authored more than 30 scientific papers and patents. In the past several years, Dr. Li has been interacting with Chinese Pharmaceutical Industry and coordinating numerous ANDA projects overseas.
Ronald Connolly, BS, 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 (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, PhD, Senior Vice President and General Manager, CMC Services
Dr. Wang's responsibilities include custom API synthesis and GMP manufacturing, formulation development, analytical services and GMP manufacturing of clinical trial materials. She has more than 16 years of pharmaceutical industry experience and three years of lecturer at the Graduate School of Chinese Academy of Science. Prior to joining Frontage in February 2007, Dr. Wang served NovaDel Pharma Inc. as the Director of Analytical/QC for more than three years where she built teams to provide supports in NDA product development, clinical supplies manufacturing, CMC section of regulatory filings, and technology transfer to commercial manufacturing sites. Prior to NovaDel, Dr. Wang headed the Department of Pharmaceutical Analysis and Control at Therics Inc in product development for 510(k) and ANDA filings. Her extensive academic training includes a BS in Chemistry from Peking University (1984), an MS in Chemical Engineering (1987), a PhD in Chemistry with honors from Iowa State University (1994), and subsequent post-doctoral research at the University of Chicago (1995-96).
Other CMC Services Personnel
Preclinical/DMPK and Bioanalytical Services
Abdul Mutlib, PhD – Vice President, DMPK Services
Dr. Mutlib has over twenty years of experience in drug metabolism and analytical chemistry, having 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 Universities of Washington (UW) and 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, PhD – 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 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, PhD, 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. Hi 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 experiences 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.
Lisa Diamond, PhD – 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 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 PhD from New York University (New York, NY), 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.
Jakey Patwari, MD – Vice President Clinical Research
Dr. Patwari maintains 22 years of experience in the management of clinical trials at both the national and international levels. During this time, Dr. Patwari has made substantial contributions to the conduct and management of more than 100 clinical trials in multiple therapeutic areas, including Neurology, Cardiovascular, Endocrinology, Women’s Health, Pulmonary, GI, GU, ENT, Ophthalmology, Psychiatry, and others. He has conducted and managed many Phase II-IV clinical trials for various sponsors, including; the NIH, Novartis, BMS, GSK, Merck, Pfizer/Pharmacia, Sankyo, Osiris, Salix, Wyeth, Progenics, and Eli Lilly. Dr. Patwari has also worked on many clinical device trials for companies such as; J&J, Medtronic, Boston Scientific, Biomet, Lantheus, Siemens, eV3, and others. Before joining Frontage, Dr. Patwari worked as Director of the Institute for Clinical Research at Holy Name Hospital in New Jersey. Dr. Patwari was responsible for the operation of 20 multi-specialty clinical research sites for more than 7 years. Dr. Patwari maintains dual certifications for both a Certified Clinical Trials Investigator (CCTI) by the Drug Information Association (DIA) and also as a Certified Clinical Research Coordinator (CCRC) by the Association of Clinical Research Professionals (ACRP).
Greg Zhou, PhD – Vice President and Global Head of Biometrics, Clinical Data Management and IT
Dr. Zhou is responsible for managing and building technical capacity to provide quality services to our clients for their outsourcing and in-sourcing needs in clinical data management, biostatistics and statistical programming. Internally, he is also responsible for company-wide enterprize information infrastructure. Before joining Frontage, Dr. Zhou was a Global Head of Statistical Reporting and Programming at Wyeth Research, managing a large organization to support all therapeutic areas. Overall, he has 20 years of experience working in global pharmaceutical companies in various functional areas. Dr. Zhou earned his PhD in Business Administration in Computer Information Systems from Touro University.
Drug Development and Regulatory Consulting
Yuanchao (Derek) Zhang, PhD – 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 the working with the FDA, Derek was Senior Research Scientist at Pharmacokinetics, Dynamics & Drug Metabolism, Groton Laboratories, Pfizer Global Research & Development, Pfizer Inc. Dr. Zhang received his PhD from the University of California, San Francisco (UCSF) under Professor Leslie Z. Benet.
