Our Management
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James R. McCullough
Chief Executive Officer
Mr. McCullough is one of our founders and has been Chief Executive Officer since inception in May of 2008. From March of 2001 to October of 2006, Mr. McCullough was the Chief Executive Officer of AusAm Biotechnologies, Inc. a biotechnology company developing diagnostics to identify kidney and cardiovascular diseases. At AusAm, Mr. McCullough oversaw commercial development, FDA clearance, and marketing and distribution for Accumin, a diagnostic for detection of patients at risk for early-stage kidney and cardiovascular disease. He received his BA from Boston University in 1990, and his MBA from the Columbia Graduate School of Business in 1995.
David Okrongly, PhD
Chief Operating Officer
Dr. Okrongly joined Exosome Diagnostics as Chief Operating Officer in September 2011. Dr. Okrongly was President and CEO of Quanterix from August 2009 to May 2011, leading the company in development of the first fully automated, single-molecule diagnostic platform with 1,000x better sensitivity than ELISA. From May 1997 to December 2006, Dr. Okrongly was with Bayer Diagnostics, where he was the leader of the global R&D organization, launching industry-leading platforms in immunoassay, hematology, clinical chemistry and molecular diagnostics. After the Siemens acquisition of Bayer Diagnostics in 2006, he was appointed Senior Vice President in charge of the Molecular Diagnostics Business Unit from January 2007 to August 2009. Prior experience includes VP of R&D Xytronyx, a San Diego-based POC company from 1994–1997 and Applied Immune Sciences, a Santa Clara, CA stem cell therapy company, where he led product development from 1987 to 1994. During Dr. Okrongly's tenure, the company completed an IPO and was eventually acquired by Rhone Poulenc-Rorer (now Sanofi). He received his Bachelors degree from the University of Wisconsin-Madison and his PhD from Columbia University, both in Chemistry.
Sara Barrington, ACA
Senior Vice President of Finance and Administration
For the past 20 years, Ms. Barrington has acted on corporate financial matters, including capital sourcing, merger and restructuring transactions in the biotechnology, e-commerce, and venture capital fields. Prior to Exosome, Ms. Barrington served as Chief Financial Officer of Creative Technology U.S., a leading provider of audio/visual solutions, and Chief Financial Officer of AusAm Biotechnologies, a developer of kidney and cardiovascular disease diagnostics. She has held various positions at British Telecom in finance and marketing in the New Business Development group. Ms. Barrington trained with BDO Stoy Hayward, London, in their audit practice and qualified as a chartered accountant with the Institute of Chartered Accountants of England and Wales (ICEAW).
Susan W. Belzer
Director of Development and Services
Ms. Belzer has more than 20 years of experience in biomedical research and development. She has developed more than 60 infectious disease LDT's for use in clinical diagnostics, donor, pharmaceutical and medical device testing. Previously, Ms. Belzer held positions as Research and Development Manager at ViroMed/LabCorp and Manager/Supervisor of ViroMed Molecular Diagnostic Lab. She received her undergraduate degree in biology from the University of Minnesota, College of Biological Sciences in 1980 and her MBA from Augsburg College in 2009.
Sally Bowden
Director of Regulatory Affairs
Sally Bowden has over 20 years of experience in the quality and regulatory field in medical devices, companion diagnostics, education and health care systems. She has served in executive positions as vice president of Quality Systems and Process Improvement at Ventana Medical Systems and as vice president of Quality and Regulatory Compliance at Roche Diagnostics Corporation. She was an associate professor for Purdue University School of Engineering and Technology where she developed the Quality Management Curriculum within the Mechanical Engineering Technology department. Ms. Bowden founded Samco & Associates, Inc. in 2009 to provide consulting for companies interested in developing quality systems that meet FDA and global requirements and re-engineer them for efficient, effective compliance in the medical device field for all classes. In addition, she is helping to pioneer the Companion Diagnostic process in collaboration with pharmaceutical and diagnostic firms while building strong relationships with the applicable regulatory agencies. Ms. Bowden is a graduate of Purdue University School of Engineering.
Wayne D. Comper, PhD, DSc
Chief Science Officer
Dr. Comper is a founder of the company and has been Chief Science Officer since its inception. Previously, Dr. Comper was Founder and Chief Science Officer of AusAm Biotechnologies, Inc., where he was able to guide the discoveries of urine biomarkers of kidney disease to FDA clearance. In addition to his entrepreneurial activities, he has been active in basic research and is a world leading authority on renal physiology and mechanisms of albuminuria/proteinuria with over 170 peer-reviewed publications. He has held academic research positions at Monash University (Clayton, Victoria, Australia) and been a visiting professor to the Nephrology Section, Rush Medical School (Chicago, Illinois) and School of Medicine, Indiana University.
Michael Donovan, PhD, MD
Chief Medical Officer
Dr. Donovan is board certified in anatomic and clinical pathology and pediatric pathology. Prior to joining Exosome Diagnostics, he held positions as Chief Scientific Officer for Aureon Biosciences, Assistant Professor at Harvard Medical School, Senior Director of Molecular Pathology at Millennium Pharmaceuticals, and Senior Vice President at Incyte Genomics. Dr. Donovan received his medical degree from the University of Medicine and Dentistry of New Jersey, and his PhD in cell and developmental biology from Rutgers University. Dr. Donovan recently joined the faculty at Mt. Sinai School of Medicine as a Professor in the Department of Pathology and Genetics and will also serve as Director of Experimental Pathology.
Hannah Mamuszka, MS
Vice-President of Business Development
Ms. Mamuszka has more than 15 years of experience in pharmaceutical research and development, primarily focused in oncology. Prior to joining Exosome Diagnostics, Ms. Mamuszka was Global Director for Pharmaceutical Services for Oncotech, then by acquisition, Exiqon, where she designed preclinical studies and biomarker-focused clinical trials for pharma to validate new biomarkers. Earlier in her career, Ms. Mamuszka held laboratory positions at the NCI, ArQule, and Millennium Pharmaceuticals, where she was part of the VELCADETM development team. She received her BS from the University of Maryland and her MS from Harvard University.
Mikkel Noerholm, PhD
Director of European Operations
Dr. Noerholm heads the European operations of Exosome Diagnostics from the company's site in Munich, Germany. He joins the company from a position as Research Scholar at Massachusetts General Hospital and Harvard Medical School, where he helped develop the exosome technology. Prior to that, Dr. Noerholm was the Director of Technical Support at Exiqon, Inc., which he helped establish in 2006. Before moving to the U.S.A., he held a position as R&D Project Manager at Exiqon in Denmark, where he led the development of what is now that company's miRCURY LNA Arrays. Dr. Noerholm has a PhD in micro- and biotechnology from the Technical University of Denmark and an MBA from Babson College.
Leileata M. Russo, PhD
Director of Research
Dr. Russo became the Director of Research at Exosome Diagnostics in May 2010. In 2007 she was appointed to the junior faculty position of Assistant in Biology at Massachusetts General Hospital and Instructor in Medicine at Harvard Medical School. Her research has focused on the mechanism of diabetic nephropathy and renal diseases and she has over 27 peer reviewed articles and reviews in this area. She has received numerous awards from the Juvenile Diabetes Research Foundation including Postdoctoral Award in 2004, an Advanced Postdoctoral and Transition Award in 2006 and a JDRF Innovator Award in 2008. She is a co-inventor on the provisional patent "Use of membrane vesicles (exosomes) in diagnosis and prognosis of cancer" and the lead researcher on nucleic acid analysis in urine based exosomes. She received her PhD in Biochemistry from Monash University (Clayton, Victoria, Australia) in 2003.
Johan Skog, PhD
Director of Research
Dr. Johan Skog has served since July 2010 as the Director of Research at Exosome Diagnostics and has been a consultant for the company since 2008. He was an instructor (Junior Faculty) at Harvard Medical School and an assistant in Neurology at Massachusetts General Hospital, where he was the first to show that tumor derived mutations can be detected in the microvesicle RNA from serum and other biofluids. His research background includes virology, gene therapy, brain tumors, RNA and biomarker discovery and he is an inventor on several patents. Dr. Skog was a lecturer at Umeå University (Umeå, Sweden) in Medicine, Biomedicine, Tumor Biology, Technical Biology and Dentistry on the topics of gene therapy, viral vaccines, prion diseases, the life cycle of DNA viruses and viral infections of the central nervous system. He earned his Master of Biomedical Sciences and PhD at Umeå University, Sweden.