President and Chief Executive Officerr
Betsy Hanna is a healthcare and biotech leader with a proven track record in the global diagnostics market. Her extensive experience includes leadership positions with major healthcare organizations, as well as start-ups, with responsibility for strategic marketing, U.S. and international sales management, and product launch. Most recently, she was Clinical Genomics’ Chief Commercial Officer with responsibility for developing and executing go-to-market strategies. She joined Clinical Genomics from Origin, Inc., a clinical-stage biotech company where she was the President and Chief Operating Officer. Prior to Origin, Ms. Hanna had increasing responsibility during eight years at Johnson & Johnson. At J&J Diagnostics, she was Vice President, Strategic Marketing, and led the global launch of two instrument platforms. Ms. Hanna also served as Vice President Europe, Mideast and Africa at J&J Diagnostics, and she was Vice President of Strategic Marketing and a member of the Global Management Board for J&J Vision Care. Ms. Hanna has a BS in Chemical Engineering from the University of Illinois and an MBA from Harvard Business School.
Chief Operating Officer
Michael Paris is an accomplished product development and operations executive with extensive experience in lifecycle management of innovative medical devices. He brings expertise in building and leading technology development and operations in early-stage ventures, as well as mature companies. Additionally, he has led and contributed to the successful regulatory authorizations (PMA and 510(k)) and commercial launch of numerous products. Most recently, Mr. Paris served as Chief Operating Officer and Senior Vice President, Operations and Technology Development, at Origin Inc., a biotechnology company. Prior to that, he held positions of increasing responsibility at Bioconnect Systems, a medical device company; Orthovita, Inc., which was acquired by Stryker Corporation in 2011; and Rex Medical, a medical device company specializing in the development, manufacturing, and marketing of innovative, minimally invasive medical devices. Mr. Paris received his BS degree in Mechanical Engineering Technology from Temple University, and an Executive MBA from Lebow College of Business, Drexel University, where he is a Board Member.
Lawrence LaPointe, PhD
Chief Innovation Officer
Larry LaPointe, PhD, has more than two decades building healthcare companies to transform cancer testing, including most recently as co-founder of Clinical Genomics. He previously served as CTO and general manager of Enterix Inc, a cancer screening company he also co-founded. Dr. LaPointe is a well-published research scientist and holds numerous patents in biomarker discovery, cancer detection and molecular diagnostics. He has a BS in Biology from Florida State University and a PhD in Bioinformatics from Flinders University, Australia.
Chief Strategy and Commercial Officer
Ed Rosen is an experienced global life sciences and oncology business leader with a proven track record in strategic planning, commercialization and P&L optimization. He has successfully led companies through periods of transformational growth, overseeing commercialization, innovation and product development across pharmaceutical, device and diagnostic businesses in key markets. He also brings a wealth of knowledge around health economics and reimbursement, having initiated and navigated several national coverage determinations. Most recently, he was an Executive in Residence at Columbia University, where he worked with entrepreneurs and inventors to facilitate the transfer of research innovations from the lab to the market, and to support start-up efforts across therapeutic, diagnostic and device applications. Prior to that, Mr. Rosen held positions of increasing responsibility at Johnson & Johnson, where he focused on oncologic immune cell therapy and circulating tumor cells for research and clinical use. Mr. Rosen holds a BA in Business Studies, from the University of Lincoln, Hull, United Kingdom.
Zivjena Vucetic, MD, PhD
Senior Vice President, Medical
Zivjena Vucetic is an experienced global medical, clinical and scientific affairs leader with success in developing medical value for novel diagnostic solutions across different disease areas (oncology, neurodegenerative, cardiovascular and infectious diseases). She brings a depth of expertise in clinical development and post-market evidence generation for novel biomarker tests, including development and execution of clinical trial strategy, collaborations with thought leaders and academic investigators and developing medical education programs. Most recently, she served as a Medical Director at Ortho-Clinical Diagnostics, a global in-vitro diagnostics company, where she led clinical trial strategy for a broad portfolio of novel and routine laboratory tests. Prior to that, Dr. Vucetic was at Fujirebio Diagnostics, where she held several roles of increasing responsibility within scientific and medical affairs, focusing on value development of novel biomarkers, expanding and improving clinical utility of new or underutilized laboratory tests and identifying potential new technologies through external collaborations. Zivjena holds an MD from the University of Zagreb School of Medicine in Croatia, a PhD in Biochemistry from Temple University and completed her Post-Doctoral Fellowship at the University of Pennsylvania School of Medicine.
Vice President, Reimbursement
Mr. Bruce has over 25 years of experience advising and serving in senior management roles (CFO, COO, CEO, Director) for a range of private and public companies operating in highly-regulated industries, including healthcare, energy production, telecommunications and gaming. Prior to joining Clinical Genomics, he founded and led Oakmont Advisory Group, a financial and management consulting group serving a wide range of investors, lenders and shareholders in their efforts to improve operational and financial execution at client companies. Among his previous positions, he served as COO and VP of Reimbursement at Enterix and led the company’s efforts to secure regulatory approvals and reimbursement for the InSure® FIT test. He holds a BA in East Asian Studies from Princeton University (phi beta kappa; summa cum laude) and an MBA from the Yale University School of Management.
Vice President, Regulatory Affairs
Michele Houldsworth has deep experience in Quality Assurance specializing in system design and development for compliance in small to medium enterprises. She is a certified lead auditor of quality systems and medical devices and has hands on experience in all phases of product development from research to commercialization of medical devices and IVDs (Class II, III). Her experience includes successful achievement of ARTG listing and CE-marking, experience in technical file, design dossier and 510k file preparation for AU, EU, US and Chinese markets. Ms. Houldsworth is expert in process validation including sterilization and biocompatibility. BE MBiomedE (Mech; Honours Class I; University of New South Wales; 2007).
Vice President - Compliance, Legal Affairs & Corporate Secretary
Perri Pomper is an attorney and compliance professional with extensive experience in legal management and building sustainable compliance programs. Prior to joining Clinical Genomics in 2018, Perri was a Director for Ethics and Compliance at Novo Nordisk Inc. where she was responsible for building the short and long-term strategy for the ethics and compliance program, oversaw all training and communication and served as the Secretary for board sub-committees. Previously Perri was a Legal Consultant with Polaris Management Partners.
Perri is licensed to practice law in New York and New Jersey and received a Juris Doctorate from Touro Law School and a B.A. in Psychology from the State University of New York at Albany.
Susanne K. Pedersen, PhD
Vice President, Science and Innovation (CSO) and Co-Founder
Susanne Pedersen has deep commercial experience focused on biomarker discovery and validation including product concept to successful commercial launch. IVD assay expertise includes molecular diagnostics, proteomics, and immunoassays in esoteric pathology labs as well as point of care testing. Since 2010, her concentrated expertise has been in epigenetics and cell free DNA measurements for cancer detection. Dr. Pedersen is the Inventor of biomarker discovery patents and has a successful track record building cross-functional teams that meet commercial milestones including scale up. B.Sc. (Cell Biology; Southern University of Denmark, 1996); Ph.D. (Molecular Biology; Southern University of Denmark; 2000).