Your scientific partner for drug and in-vitro diagnostic development.
Pacific Biomarkers is a biomarker testing services provider, supporting pharmaceutical, biotech and in-vitro diagnostic (IVD) manufacturing companies through preclinical and Phase I-IV studies of drug and IVD development.
Pacific Biomarkers has an established reputation for expertise, flexibility, protocol consultation, and outstanding client services that has propelled the company to a prominent position in the rapidly growing pharmaceutical outsourcing industry. With over 300 fully CLIA validated assays and an extensive network of scientific, regulatory, and technology expertise, Pacific Biomarkers is the service provider of choice for many leading international drug manufacturers in the race to bring products to market as quickly and cost effectively as possible.
Pacific Biomarkers provides accurate, reliable analyses, and responsive service to sponsors and investigative sites. Pacific Biomarkers collaborates with sponsors to develop, validate, improve analytical methods, and provide technical consultation for protocol design. Our services are customized on a project specific basis which allows Pacific Biomarkers to be more flexible to meet the needs of our clients.
Pacific Biomarkers is a CAP accredited and CLIA certified laboratory. Pacific Biomarkers also provides GLP compliant biomarker laboratory services.
Originally named Pacific Biometrics, Inc., Pacific Biomarkers was founded in 1989 as a spin-off from the University of Washington Lipid Research Center, Dept. of Medicine. Founders Dr. Elizabeth Leary and Russ Warnick had a vision for global standardization of lipid testing. When the CDC initiated the Cholesterol Reference Method Laboratory Network (CRMLN), Pacific Biomarkers became a member of this network: three labs in the U.S. and 11 globally. For 20 years, Pacific Biomarkers provided lipid reference and standardization services for in-vitro diagnostic manufacturers and clinical laboratories.
During this time, Pacific Biomarkers began consulting with pharmaceutical companies to support drug development. This clinical trial support has now become a core business of the company. Traditionally, our therapeutic focus has been cardiovascular and musculoskeletal diseases, diabetes, obesity, metabolic syndrome, and inflammation. Today, we have evolved to meet the needs of our customers, providing biomarker support across a wide range of therapeutic areas.
In 2007, Pacific Biomarkers expanded its capabilities into immunogenicity testing, cell based assay services, and novel biomarker development. Shortly after in 2009, Pacific Biomarkers officially changed its name to Pacific Biomarkers to better reflect our business. In an effort to expand our clinical trial testing to Asia, Pacific Biomarkers partnered with Syngene International Ltd. and Wuxi AppTech in 2011 and 2014, respectively. Through these strategic collaborations, we can offer our 300+ CLIA validated biomarkers across diverse therapeutic areas in Asia with added capabilities within immunogenicity and cell based functional assays in a cost effective business model.
More recently in 2015, we introduced the Pacific Biomarkers Mobile App; an interactive platform that provides access to innovative tools such as the BIOMARKER NAVIGATOR and allows you to create biomarker information reports instantly from our broad biomarker testing menu.
Pacific Biomarkers currently has six Advisory Board members who bring combined experience in academia, pharmacology and central reference labs.
Ronald L. Gingerich, Ph.D., President, Conturix Research, Inc.; formerly founder and CEO of LINCO Research, Inc. Dr. Gingerich earned a PhD degree from Indiana University in 1975 and completed postdoctoral training at Washington University School of Medicine where he served on the faculty for 20 years. During his tenure at Washington University he held positions of Associate Research Professor and Director of the Radioimmunoassay Facility. Dr. Gingerich founded LINCO Research, Inc in 1978, a company focused on providing analytical research tools to the academic, biotech and pharmaceutical diabetes and obesity markets. LINCO Research was an early adopter of the Luminex Multiplexing technology. He later founded LINCO Diagnostic Services, Inc to provide GLP biomarker analytical services support for preclinical and clinical drug development trials for major biotech and pharmaceutical companies. He served as CEO and Chief Scientific Officer for both companies until their acquisition by Millipore Corporation (now part of EMD Merck) in 2006. Dr. Gingerich is an active member of professional societies in the life-sciences industry such as the American Diabetes Association, American Association of Lab Animal Science, American Association for Clinical Chemistry and the American Association of Pharmaceutical Scientists. Dr. Gingerich has authored over 100 publications and holds 2 patents.
Jack C. Bloom, V.M.D., Ph.D., holds a B.S. degree in biology from the University of Pittsburgh and doctorates in veterinary medicine and experimental hematology from the University of Pennsylvania. He completed his postdoctoral training at Jefferson Medical College in hematology/oncology and served on the Faculty of the University of Pennsylvania School of Veterinary Medicine as Chief, Clinical Laboratory Medicine, before joining Smith Kline & French Laboratories as Associate Director of Pathology. He later joined Lilly Research Laboratories as Head, Clinical Pathology, in the Toxicology Division, and subsequently moved to the Medical Division, where he established the departments of Clinical Laboratory Medicine, Experimental Medicine and Clinical Diagnostic Services. As Executive Director and Distinguished Medical Fellow, Diagnostic and Experimental Medicine, he was responsible for routine laboratory, ECG, imaging and specimen banking support for global clinical development; and novel clinical biomarker discovery, validation and application in the Division of Translational Medicine and Pharmacogenomics. Upon his retirement from Lilly in 2009 he established Bloom Consulting Services, LLC and was appointed Special Consultant, Office of the Center Director, FDA. Dr. Bloom serves on several Scientific Advisory Committees for pharmaceutical, diagnostic and pharmaceutical services companies and holds adjunct academic appointments at the University of Pennsylvania and Purdue University.
Gordon F. Kapke, Ph.D., DABCC, FACB, has more than 40 years of clinical lab experience. Dr. Kapke has generated research data in the university setting, community hospital setting, and the global clinical laboratory setting. He has been a key figure in implementing regulated laboratories in Europe, Africa, Australia, and Asia. With 20 years of experience supporting clinical trials, Dr. Kapke’s most recent interest is in Bayesian analysis of clinical trial biomarker data.
Jay Heinecke, M.D., is Professor, Department of Medicine, Karasinski Charin Metabloic Research, University of Washington. The major focus of research in the Heinecke laboratory is to understand the role of HDL and macrophages in the pathogenesis of atherosclerosis, diabetes and other inflammatory diseases. Current studies center on the investigation of the pathways that promote cholesterol efflux from macrophages, which is of central importance in the cardioprotective effects of. The Heinecke research group also has a major interest in translational studies to determine if altered HDL protein composition, macrophage sterol efflux, and inhibition of macrophage inflammation associate with CAD and diabetic status.
Deborah Phippard, Ph.D., is the Senior Vice President of Research at Precision for Medicine. Dr. Phippard received her PhD in Molecular & Cell Biology, Developmental Biology & Genetics from the University of London and she has over 25 years of experience in leading biomarker and drug development programs for pharmaceutical and diagnostics companies, as well as the National Institutes of Health. Dr. Phippard runs the 65,000 sq.ft. state of the art Precision biorepository and laboratories located in Frederick, MD and oversees the global Precision Laboratory Network. Precision provides fully integrated and global clinical trial capabilities, including design, implementation and execution of clinical trials (Phase 0 to IV) and translational medicine/biomarker programs. She has extensive experience in antigen specific cell-based assays and immunophenotyping using techniques such as 18+ color flow and how to design biomarker studies to work robustly for multi-site global clinical studies including set up and management of the required logistics such as kitting and sample collection, preservation and transportation.
Prior to joining Precision for Medicine in 2014, Dr. Phippard served for 5 years as the Executive Director of Biomarker & Discovery Research at the Immune Tolerance Network (ITN), where she managed a global network of scientists, biostatisticians, data managers, and operations experts engaged in cutting edge translational research in the autoimmune, transplantation and inflammatory space. Prior to joining the ITN, she spent close to 20 years working in the pharmaceutical industry.
Additionally, Dr.Phippard currently serves as the principle investigator for two NIH biorepository programs and is the College of American Pathologist accredited Biorepository Director for Precision.
Built in 2012 from a cold shell, we have completely customized over 21,000 sq. ft. of expandable space including a CAP/CLIA certified laboratory.
In an effort to expand clinical trial testing to Asia, Pacific Biomarkers partnered with Syngene International Ltd. and Wuxi AppTech in 2011 and 2014, respectively.
Syngene International Ltd., a Biocon company, is a leading custom research and manufacturing organization supporting drug development from lead generation to clinical supplies. Syngene offers bioanalytical services (for small molecules and biologics) in addition to specialty tests such as immunogenicity screening assays, neutralizing antibody assays, cell based assays and ligand binding characterization assays. Clinical laboratory services provided by Syngene range from moderate to high complexity assays such as customized flow cytometry and immunohistochemistry assays.The Pacific Biomarkers-Syngene partnership combines biomarker support for clinical trial research of the former with development capabilities of ligandbinding assays of the latter in a cost-effective business model situated in India. Both laboratories are CAP and GLP certified with strong emphasis on regulatory compliance and quality assurance providing reliable analytical data that stands up to the most rigorous regulatory and scientific scrutiny.
WuXi AppTech is a leading pharmaceutical, biotechnology and medical device R&D outsourcing company, with operations in China and the United States. As a research-driven and customer-focused company, WuXi AppTech provides a broad and integrated portfolio of laboratory and manufacturing services throughout the drug and medical device R&D process. WuXi AppTech’s services are designed to help its global partners in shortening the cycle and lowering the cost of drug and medical device R&D. The Pacific Biomarkers-WuXi partnership allows us to support a broader spectrum of companies developing medicines in Asia with special emphasis on clinical trials performed in China.
Through our strategic collaborations, Pacific Biomarkers can offer its 300+ CLIA validated biomarkers across diverse therapeutic areas in Asia with added capabilities within immunogenicity and cell based functional assays in a cost-effective business model.