Steven R. Verdooner
CEO & CO-FOUNDER
Steve is a seasoned, results-driven executive with over 30 years of experience in the ophthalmology, neurology and medical device markets, with a proven track record of launching and leading successful startup businesses. He has expertise in a diverse range of business management including sales and marketing, research and development, operations and regulatory management, brand management, business development and strategic planning. Steve has a proven ability to lead and interface with key opinion leaders, advisory boards, customers, scientists, engineers, Company Boards and the financial community.
Steve serves as the CEO of NeuroVision Imaging, a company developing retinal and fluid biomarkers for neurodegenerative disease. Steve was co-founder and CEO of Ophthalmic Imaging Systems (1984-2007). OIS was a company dedicated to research, development, marketing, selling and manufacturing diagnostic medical imaging systems and informatics software for the eye care market. Steve led the initial research, market analysis, product development, commercialization strategy, and product launch for a revolutionary new imaging system that was the first of its kind in ophthalmology. Steve was involved in establishing and building the company infrastructure that took OIS to a public offering in 1992 and eventually being sold to Merge Healthcare in 2011. Steve next joined OPKO Health, Inc. as Executive Vice President. OPKO is a publicly traded specialty healthcare company (that engages in the discovery, development, and commercialization of pharmaceutical products, medical devices, vaccines, and diagnostic technologies.
Alan Czeszynski, MS, MBA
Vice President, Operatons
Mr. Czeszynski is responsible for the realization of NeuroVision’s biomarker portfolio through leadership of Research and Development, Regulatory and Clinical Affairs, and Quality Assurance. He has over 24 years of product marketing and product development experience, the last 15 years in medical devices, with specific expertise in product definition, medical device market access, global product launch, integrated marketing communications, product development, and organizational leadership. Prior to NeuroVision, Mr. Czeszynski served as a Vice President of Marketing, Business Development, and Engineering at Oraya Therapeutics, Inc., developer of a high-precision radiotherapy device for treating wet age-related macular degeneration (now owned by Carl Zeiss Meditec), and before that he led several ophthalmology diagnostics product lines at Carl Zeiss Meditec, including their market-leading optical coherence tomography imaging system. He has successfully developed and launched products in the medical device, industrial CT imaging, consumer electronics, and commercial satellite industries, and started his career as a commissioned officer in the US Navy. He has obtained engineering degrees from the US Naval Academy and University of New Hampshire, and an MBA from Santa Clara University.
Pepe Davis, PhD
VP of Regulatory Affairs
& Quality Assurance
VP of Regulatory Affairs & Quality Assurance
Pepe is an accomplished executive with experience in both startup companies and international medical device businesses. He has a proven track record of building teams and systems that meet business needs and regulatory requirements. He has participated in various industry collaborations with the FDA and served on the UC Santa Cruz Advisory Board for Regulatory Affairs and Medical Device Certificate Programs.
Prior to joining NeuroVision, Pepe spent 14 years at Carl Zeiss Meditec, Inc. During his tenure at Carl Zeiss Meditec, he worked across business functions from R&D to Operations including Vice President of Business Process Excellence and was responsible for Regulatory Affairs, Quality Assurance, Clinical Affairs and Compliance Officer. Previous to joining Carl Zeiss Meditec, Pepe was trained as a Six Sigma Master Black Belt consultant and spent 12 years at startup companies leading research and development of fiber optic technologies for telecommunications, fiber optic sensors and medical devices. He has a BS in Engineering Physics from UC Berkeley and a PhD in Electrical Engineering from UCLA where he specialized in nonlinear optics and plasma physics.
Leyla Anderson, MD, PhD, D(ABMLI)*
VP Biomarker Development
*Diplomate, American Board of Medical Laboratory Immunology (CLIA-approved)
Dr. Anderson has over 20 years of experience in medical research, infectious diseases and immunology, biomarker development, diagnostics, and laboratory medicine. She conducted research on signal transduction, host-pathogen interactions and genomics at Yale University and UC Davis and was a lecturer and graduate student mentor at University of Oxford, England. Prior to joining NeuroVision, Dr. Anderson was the Associate Director of Biomarkers at Q2 Solutions®, a joint venture between Quest Diagnostics and IQVIA™. She earned her medical degree at Ankara University Medical School, and Ph.D. at Rosalind Franklin University of Medicine and Science. She is board certified in Medical Laboratory Immunology (Diplomate, American Board of Medical Laboratory Immunology).
Leyla’s core expertise areas include:
Management and leadership (clinical trials, academic and diagnostic laboratory operations)
Medical Research and Laboratory Immunology (assay design, development, validation and deployment)
Scientific affairs (biomarkers and companion diagnostics)
Regulatory compliance (CAP, CLIA, FDA, IRB, HIPAA, ICH GCP)
Primary Healthcare (Physician)
Hugo Vanderstichele, PhD
Global Head of Biomarker Development
Hugo has proven expertise in the translation of protein biomarkers from concept to clinical value, including but not limited to target identification, selection and evaluation of tools & technologies (single analyte and multiplex immunoassay platforms), protein assay development (from prototyping to qualification, validation, and registration), clinical study design and execution, and market integration of assays or test concepts
He is a founder of Biomarkable and was a co-founder of ADx Neurosciences. He obtained over 21 years IVD experience at Innogenetics (now Fujirebio). His experience covers various domains, including neurodegeneration, endocrinology (steroidogenesis, in-vitro fertilization, embryology), cardiovascular, infectious and autoimmune diseases.
He is a sought-after advisor in world-wide efforts to generate standard operating procedures for sample collection, storage and qualification of biomarker protein assays. He was a scientific advisor in several consortia including the Global Biomarker Standardization Consortium (ADNI), CPAD, and the Michael J Fox Foundation.
He has been the principal investigator in several multi-center projects, has authored or co-authored over 153 publications (H-index 58) and is listed as inventor on several patent applications.