Management and Key Personnel
Chief Executive Officer
Ronald Helm became the CEO and principal owner of Pacific Biomarkers in September of 2011 in the transition that made Pacific Biomarkers a privately held company. Mr. Helm had become chairman and CEO of Pacific Biometrics, Inc. in August of 2002. In 2009, the name of the company was changed to Pacific Biomarkers.
Mr. Helm is a co-founder of Saigene Corporation and served as Chairman and CEO until July of 2002. Prior to forming Saigene in 1996, Mr. Helm was Chairman of the Board and Chief Executive Officer of a biotech company in Southern California and has held senior management positions in the industry since 1992.
For nearly nine years, Mr. Helm served as the Associate Dean for Development and Professor of Law at Pepperdine University School of Law in Malibu, California and following that, was the Senior Vice-President and General Counsel of ComputerLand Corporation, which became Vanstar Corporation (a NYSE company). Mr. Helm went on to found the California law firm of Helm Purcell and Wakeman, where he remained "of counsel" until 2000. He also served as a Managing Director of ComputerLand Europe, an independent private company with 130 retail outlets in 15 countries. Mr. Helm is a member of the Bar of California State and the United States Supreme Court.
Co-founder and Sr. Scientific Advisor
Elizabeth Leary, co-founded Pacific Biometrics, Inc. (Pacific Biomarkers) and Pacific Biometrics Research Foundation (PBRF) in l989. She served as the Vice President of Laboratory Services until the spring of 2000 when she became Chief Scientific Officer. As the Pacific Biomarkers Laboratory’s Chief Science Officer, Dr. Leary lends her expertise within the company and consults actively for the diagnostic and pharmaceutical industries. Her areas of focus are in laboratory support of clinical trials and product research in cardiovascular diseases, osteoporosis, and diabetes.
Dr. Leary served as a director of clinical chemistry and industry consultant for 13 years prior to joining Pacific Biometrics, Inc. Dr. Leary received her degrees in Biochemistry from University of California at Berkeley and Purdue University. She is a diplomate of the American Board of Clinical Chemistry. Dr. Leary is the director of the CDC Cholesterol Reference Network Laboratory at PBRF (one of ten in the world). She is past chair of the Pacific Northwest chapter of American Association for Clinical Chemistry (AACC) and the Lipids and Vascular Diseases Division of AACC, and past president of the North American Chinese Clinical Chemists Association. She has published over 80 articles in peer-reviewed journals and books, and is a recipient of several grants and awards.
Chief Scientific Officer
Amar A. Sethi joined the company in 2009 as V.P of Research and Development and is now Chief Scientific Officer with responsibility for Research & Development, and Business Development. As CSO, Dr. Sethi provides leadership and direction for developing business relationships within the scientific community. He sets research and scientific priorities so that they line up with the overall mission and goals of the organization. Dr. Sethi is responsible for evaluating and setting scientific priorities and coordinating administrative structures that support scientists and for communicating with the scientific and customer communities concerning capabilities and product offerings.
Dr. Sethi earned his M.D. from the University of Copenhagen, School of Medicine, Denmark in 1996 and Ph.D. in 2003. Dr. Sethi is board certified in Chemical Pathology by the National Board of Health, Denmark. He has broad experience in clinical diagnostics laboratories in Europe and USA including molecular diagnostic screening, overseeing chemistry, hematology, coagulation, and immunology. During Dr. Sethi’s research at NHLBI, NIH he acquired extensive experience in basic research of atherosclerotic diseases, focusing on cholesterol metabolism with emphasis on HDL functionality investigating HDL raising therapies, which include synthetic Apo A-I mimetic peptide discoveries. He is Chair-Elect of Lipids and Vascular Disease Division of AACC. He has served as an ad hoc reviewer for multiple international peer-reviewed journals, presented extensively at international scientific meetings, and has published widely in peer-reviewed journals and books. He is Chair-Elect of Lipids and Vascular Disease Division of AACC.
Vice President of Finance and Business Systems
John Jensen joined Pacific Biomarkers in 2005 as Controller and now holds the position of Vice President. As Vice President of Finance, Mr. Jensen is in charge of strategic financial planning, budget preparation and responsible for of all financial reports that summarize the organization‘s financial position. He ensures that sound financial practices are adhered to throughout the organization. Mr. Jensen manages the accounting department, human resources, banking, cash management, risk management, taxation and the annual audit. On the Business Systems side his duties include evaluation of new technologies for proper enterprise return on invested capital, providing financial resources for business development with pricing collaboration on client proposals and partnerships, consultation on technology purchases including their implementation and facility management.
Mr. Jensen has a strong background in financial management with over twenty five years of experience in a variety of sectors including manufacturing, professional service, and retail medical supplies. He has broadened his skill sets beyond the financial role and held senior management positions including Director of Operations for Seattle Lab and Vice President of Operations for Utility Inc.
Mr. Jensen received his Bachelors of Arts in Business Administration with a Minor in Mathematics at Eastern Washington University in Cheney, Washington. He serves as a board member of the NABFO, the Northwest Association of Bioscience Financial Officers group, a local chapter of APFO, the National Association of Bioscience Financial Officers. Mr. Jensen is also a member of the CFO Roundtable group, a local discussion group of small to mid-size public and private Chief Financial Officers. He formerly served the local community as chair of the Planning Policy Commission for the City of Issaquah and as a member of the King County Metro Transit Advisory Committee.
Vice President of Laboratory Services
Maribeth Raines became Vice President of Laboratory Services in June 2012 and manages the Laboratory Operations, Clinical Biomarkers, and Research and Development Groups at Pacific Biomarkers.
Dr. Raines is biochemist with a broad-based background in a variety of areas but especially in oncology, inflammation, and virology as well as in biomarker discovery, development and commercialization. Prior to joining Pacific Biomarkers, Dr. Raines served as Director of Scientific Affairs for Quest Diagnostics Clinical Trials where she helped establish biomarker, anatomic pathology, and flow cytometry testing for clinical trials and drug development. She was also responsible for building strategic alliances in emerging markets, standardizing processes, and harmonizing test results among multiple laboratories for global biomarker deployment. Dr. Raines also has in vitro diagnostic (GMP) experience having served as Director of Research and Development for Nichols Institute Diagnostics. Prior to joining Quest, she served as Director of Research and Development at Biosource/Invitrogen where she was responsible for new product development and manufacturing of reagents and assays for use in drug discovery, functional proteomics, and biomedical research. Dr. Raines was also an Assistant Professor at the UCLA School of Medicine in the Department of Radiation Oncology where she ran an NIH/NCI funded independent research laboratory involved in cytokine and growth factor receptor signal transduction. She has served as participating faculty for UCLA’s NIH funded Tumor Cell Biology Program and Breast Cancer Training Programs.
Dr. Raines received her PhD in Biochemistry from Michigan State University and completed her postdoctoral training in Hematology Oncology Departments at both UCLA and Memorial Sloan Kettering Cancer Center. Her PhD thesis on the oncogenic activation of c-erbB was instrumental to our current understanding of the EGF receptor and its role in cancer.
Vice President of Project Services
Tonya Aggoune is the Vice President of Project Services which includes responsibility for the Project Management, Data Management, and Information Technology Departments of Pacific Biomarkers. She joined the company in 1997 as the Manager of Information Systems, which included the data management and information technology functions. In 2000, she also became responsible for the Project Management Department (then known as Client Services).
Since joining Pacific Biomarkers as the head of Information Systems, Ms. Aggoune has been responsible for information technology (IT), computer operations, and the Laboratory Information Systems database. She is also the principle liaison between Pacific Biomarkers and client Data Management personnel to develop requirements for reporting, data transfer, and other custom database applications for pharmaceutical and diagnostic studies. Pacific Biomarkers recognizes the benefit of a close relationship between project management and data management in a company whose product is information (laboratory data); thus Ms. Aggoune became responsible for heading the Project Management Department in 2000. This team oversees project management of our pharmaceutical and diagnostic/referral studies. The team is responsible for coordinating the laboratory services needed to meet the sponsor’s study requirements and serves as the principle liaison between the sponsor’s project management and Pacific Biomarkers.
Ms. Aggoune has a BA in Biological Sciences and BS in Electrical Engineering. Her background includes extensive experience as a systems engineer in aerospace research and laboratory information systems in the Health Care industry. As an engineer at Boeing Aerospace, she designed and developed prototypes for computer based training systems, paper-less maintenance systems, and command/control/communication systems. She later joined National Health Laboratories (later became LabCorp) as Assistant Manager of Information Systems where she was able to bring together her experience with computer systems/software and her background in biological sciences.
Senior Director, Laboratory Services and Director of Biomarker Innovation
Timothy Carlson joined Pacific Biomarkers (then, Pacific Biometrics, Inc.) in 1998 as a Senior Scientist. He was promoted to the position of Laboratory Director in May of 2000 and currently serves as Senior Director of Laboratory Services, and Director of Biomarker Innovation.
Dr. Carlson has broad training and experience in basic and clinical sciences. He has received grant research awards from the National Institutes of Health, American Blood Systems Research Foundation, American Association of Blood Banks, and the American Heart Association. Dr. Carlson has published more than 75 research papers, chapters, and abstracts in the areas of nutrition, chronic disease, and homeostasis. He is a registered clinical chemist and dietitian, and holds a PhD in Biochemistry.
He has completed his post doctorates in Protein Chemistry and in Clinical Chemistry. He was a Fogherty International Scholar at the University of Lund in Malmö, Sweden. Dr. Carlson served on the American Association for Clinical Chemistry Abstract Review Committee, as the Editor of The Nutrition Forum, on the newsletter of the Nutrition Division of the American Association for Clinical Chemistry Nutrition, and as Secretary for the Lipoproteins and Vascular Disease Division of the American Association for Clinical Chemistry.
Director of Research and Development
Andrew Macintyre joined Pacific Biomarkers as Director of Research and Development in September 2013. He is responsible for the strategic planning for the evaluation and validation of new assays and platforms. He ensures that sound scientific principles form the foundation of our laboratory testing, and provides leadership in quality goals and regulatory standards for the R&D group. He works as a resource to the Business Development group in developing new client relationships and new business opportunities. He also helps strengthening the relationship with current clients, working with R&D staff and other scientists to present new innovations through both educational and business orientated presentations.
Dr. Macintyre is an Oncologist and Laboratory Medicine Specialist, who has worked in the National Health Service in UK and at the Universities of Liverpool and Manchester. Dr. Macintyre has a PhD in Veterinary Pathology from the University of Liverpool. He has over two decades of preclinical and clinical development experience in a wide variety of international environments, including developing and validating assays for pharmacokinetics, immunogenicity and biomarkers. He has worked in a number of global Contract Research Organizations, as well as pharmaceutical companies; he has submitted numerous IND, BLA, and 510(k) applications in a variety of therapeutic areas.
Dr. Macintyre has worked on a variety of therapeutics, successfully taking them from early development stage to late clinical phases and developed translational development strategies. He also brings a wealth of regulatory experience, having worked with the competent authorities in the United States, Europe, and Asia.
Director of Strategic Planning
Ken Waters became the Director of Strategic Planning for Pacific Biomarkers in September 2002. His primary focus is to assist the Company with corporate and strategic partnering activities.
Mr. Waters has also established his own business and legal consulting practice associating with several well-known firms. His clients have included AT&T, Williams-Sonoma, Commodore International, CMS Enhancements Inc., ComputerLand, Power Up Software, Peerless Systems Corporation, and CelluLand. Mr. Waters has specialized in the computer industry, corporate turnarounds, restructuring, and providing advice in the franchise field. He has had experience in manufacturing, retail, and distribution in companies of varying sizes. He has associated himself in the past with Frank Lynn & Associates in Chicago, and with Grisanti, Gaileff, and Goldreff.
Mr. Waters is the former CEO of ComputerLand Corporation, President of Power-Up Software, and President of Microage Corporation. During his tenure at ComputerLand, the company became the world’s largest retail computer company with over 800 stores worldwide. At the time he was President, Microage Corporation was the largest public company headquartered in Arizona. Mr. Waters has a BA in Political Science/History and is a member of the California Bar Association. He was rated one of the Top 25 most influential executives in the computer industry by the Computer Reseller News for 1987 and 1988.
Director of Laboratory Operations
Dave Swezey became the Director of Laboratory Operations in 2009. In this role, he oversees all of the analytical testing services in the main laboratory at Pacific Biomarkers. His position works closely with both the Science & Technology and Quality Assurance departments. A key component of his responsibilities includes employing engineering principles to improve laboratory processes and procedures at the pre-analytical, analytical, and post-analytical phases of testing. His 15 years of experience in working with laboratory robotics is applied in streamlining complex testing in the Laboratory. He is also responsible for the training program for new Laboratory employees.
Mr. Swezey joined the company in 1997 as the Technical Supervisor in the Laboratory and moved into the position of Quality Assurance Manager in 2000. Mr. Swezey received his Bachelor of Arts degree in Biology from Humboldt State University in Arcata, California. He then earned his license as a Registered Medical Technologist through an internship at Cottage Hospital in Santa Barbara, California in 1979. After his internship he served as Chemistry Supervisor at Medical Group Pathology Laboratory until 1990, when he moved to the Seattle area and served as the Night Laboratory Manager for Laboratory Corporation of America in Kent, Washington until 1997.
Quality Assurance Manager and Safety Officer
Jason Ray became the Quality Assurance Manager for Pacific Biomarkers Inc in 2009 after working in the department and as the Quality Assurance Supervisor for several years. As the Quality Assurance Manager, Mr. Ray leads the Quality Assurance department’s efforts to ensure the company’s quality objectives and regulatory requirements are met, as well as manage the document control system, internal audits, and regulatory and client audits. Additionally, Mr. Ray functions as the Safety Officer for Pacific Biomarkers Inc. and is responsible for ensuring safety compliance, injury investigation, and training.
Mr. Ray’s background includes 16 years of progressive responsibility and leadership roles throughout the industry including medical device, pharmaceutical, and diagnostic companies. Mr. Ray received his Bachelors of Science in Biology at Colorado State University in Fort Collins, Colorado. Prior to joining Pacific Biomarkers in 2003, Mr. Ray developed a strong assay development background starting out as a QC technician at a medical device company, and continued to advanced to a position of Research Associate IV at a molecular diagnostic company where he designed and developed custom assays for clients ranging from the health, veterinary, and environmental fields. Mr. Ray owned and operated a small manufacturing business for 10 years supporting molecular research at university, governmental agencies, and non-profit organizations, and additionally has consulted for the diagnostic industry in the capacity of technical assay development, product development and launch, as well as manufacturing.
Consulting Sr. Scientist
Edwin Merrifield joined Pacific Biomarkers in January 2007 as a Senior Scientist. He was promoted to the position of Director, Biomarker Technical Operations in November of 2007 and was responsible for the technical direction and provision of client support for Clinical Biomarker Services. In April 2012 Dr. Merrifield assumed a new role as a Consulting Senior Scientist responsible for the development and validation of novel biomarker assays, technical training of personnel and oversight of assay continuity studies.
Dr. Merrifield has more than 25 years experience in the biotechnology industry, with a particular focus on GMP process development, GLP laboratory operations, technical transfer of processes and analytical methods, and assay development for biologic drugs. Dr. Merrifield has published more than 25 research papers, chapters and abstracts in the areas of polysaccharide, glyco-conjugate and biosimilar analysis. He holds PhD in Carbohydrate Chemistry and completed two years of post doctoral study at the University of British Columbia in Vancouver, BC where he was awarded a Killam Fellowship for the study period.
Organ Injury Biomarker Scientist
Candace Adamo joined Pacific Biomarkers as an Organ Injury Biomarker Scientist in March, 2014 and has now assumed oversight of the Safety Biomarker Program. This program explores the use of novel biomarkers to assess organ injury due to toxic effects of drugs in development or other circumstances such as transplantation, contrast-induced injury, sepsis or trauma.
Dr. Adamo is evaluating combinations of the most promising biomarkers to identify acute kidney injury (AKI) and injury to other organs for use in clinical and preclinical safety studies, including qualifying markers clinically significant through work with the FDA. Her work is currently focused on optimizing the pre-analytical phase of testing in regards to biomarker preservation and stability; evaluating analytical cross reactivity and interference; and developing interpretive strategies for use of multiple biomarkers of injuries to specific organs. She also contributes to the development of business strategies and marketing of the Safety Biomarker Program at Pacific Biomarkers.
Dr. Adamo earned her PhD in 2011 from the University of Washington, Pharmacology Department where she characterized the cardioprotective effect of sildenafil citrate (Viagra®) on the mdx mouse model of Duchenne muscular dystrophy (DMD) using echocardiographic assessment of cardiac structure and function. She continued her training in vascular biology while completing her post doctorate at Emory University, School of Medicine. Her background includes immunoassays, cell-based assays, advanced microscopy and both protein and gene expression analysis.
Associate Scientist, Business
Jeff Chamberlain joined the business development team at Pacific Biomarkers in 2014, bringing with him a background in bioengineering and technology commercialization. He is accountable for advancing and maximizing sales by identifying growth opportunities and applying a technical and scientific sales approach.
Prior to coming to Pacific Biomarkers, Dr. Chamberlain worked for Zwitter Technology, a startup company that was founded to commercialize a polymeric coating technology with applications in many fields including medicine, medical devices, and marine coatings. As the Project Lead and Manager of Business Development, he oversaw a collaborative project with a large pharmaceutical company and was the Principal Investigator on a Phase II SBIR grant. He also represented the company in fundraising efforts and pitches to potential industrial collaborators. Dr. Chamberlain worked as a contractor for Peyvan Systems, an engineering consulting and product development company based in Seattle.
Dr. Chamberlain earned his Ph.D. in Bioengineering at the University of Washington, Seattle, where he leveraged multiple biosensing modalities to study bacterial binding and biomolecular interaction analysis. He also obtained the Technology Entrepreneurship Certificate from the UW Foster School of Business and served as president of the UW Science & Engineering Business Association (SEBA). He is a frequent volunteer in the Seattle life sciences business community, primarily through his involvement with the Washington Biomedical and Biotechnology Association (WBBA).