Ronald W. Mink, Ph.D., Chief Executive Officer and President
Dr. Mink became Chief Executive Officer in January 2021 and continued his role as President held since 2009. He is a co-founder of the Company and serves on the Board of Directors. Previously, he also served as Chief Science Officer of Sedia Biosciences. Prior to Sedia, Dr. Mink served as Chief Science Officer (CSO) of Calypte Biosciences from June 2005 until December 2008, Director of R&D at Calypte from 2003 until 2005 and consultant to Calypte from 2001 to 2003. At Calypte, he introduced rapid point of care diagnostic testing technology to the company, oversaw development and launch of the BED HIV-1 Incidence EIA, expanded the company’s Aware™ line of HIV products and launched the creation of its new Life Sciences Division. Prior to Calypte, he was Director of R&D at OraSure Technologies, Inc. (NASDAQ: OSUR). Dr. Mink holds several patents for oral fluid diagnostic tests, including the OraQuick® HIV rapid test, the first U.S. FDA approved rapid oral fluid HIV test. and other tests for oral disease pathogens. He has prior experience successfully developing and commercializing rapid assays in such companies as Eli Lilly and Co.’s diagnostic group and Carter Wallace, culminating in the commercialization of several point-of-care and OTC diagnostic tests, including First Response® One Step Pregnancy Test, First Response® 3 Minute Ovulation Test, CARDS-QS® hCG, CARDS OS® Strep B and others. Dr. Mink received his Ph.D. in Microbiology from the University of Illinois and B.S. and M.S. from Ohio State University.
Nancy Lime, Chief Operating Officer
Ms. Lime joined Sedia in 2019 and was appointed Chief Operating Officer in 2021. Prior to her role at Sedia, she provided operational leadership to Yecuris Corporation from 2015 to 2018, a biotechnology company providing human hepatocytes in a mouse model and research services. Ms. Lime held multiple positions at Oligos Etc. from 2002 – 2016. Her last role was President and CEO, where she provided the mission and vision, operational leadership, and managed the $5 million revenue-generating custom, chemical manufacturing operation. She has had full accountability for product profitability and quality, short and long-range strategic plans, operating plans and budgets, and monthly reporting to the Board of Directors. After the acquisition of Oligos Etc., Ms. Lime remained employed with the acquiring company, Integrated DNA Technologies, until the transfer of all assets and operations to their headquarters in Iowa. From 1990 – 2002, Ms. Lime was at OraSure Technologies Inc. (NASDAQ: OSUR) and promoted to positions of increasing responsibility. Functional areas included: manufacturing, quality control, operations and quality assurance. A few key accomplishments of Ms. Lime’s career is increasing manufacturing output for one product line by more than 300% in one year; developed and implemented a turnaround strategy resulting in strategic buyout; integrating the quality systems of Epitope and STC Technologies post-acquisition, serving on Design Review Boards for new products, playing a key role in the development of oral fluid diagnostics (including FDA approval and ISO certification) and championing efforts to bring manufacturing in-house, leading to $2 million cost saving in the first year alone. In her tenure, Ms. Lime participated in eleven FDA inspections and five CE Marking surveillance audits. Ms. Lime received her B.S. in General Science from the University of Oregon.
Clay Roscoe, M.D., M.Sc. Chief Medical Officer
Dr. Roscoe was appointed to Sedia's Executive Team as Chief Medical Officer of Sedia in January 2021 and has worked for Sedia since Nobember 2018 as Medical Advisor. He is board-certified in Family Medicine and has worked as an HIV clinical specialist for over 15 years. Dr. Roscoe provides general medical advice and guidance on the diagnosis and treatment of persons living with HIV, including in the setting of PEPFAR-supported programs in Africa. He also assists with the identification of new market opportunities, provides sales force support and contributes to ongoing Sedia research projects. He has worked in Namibia, Southern Africa, both for the University of Washington Department of Global Health (ITECH) and the U.S. Centers for Disease Control and Prevention. Dr. Roscoe has extensive clinical and public health research experience in HIV and tuberculosis, as well as more recently in public health preparedness for and diagnosis of SARS-CoV-2. Dr. Roscoe is a faculty physician at the Family Medicine Residency of Idaho and an Assistant Clinical Professor at the University of Washington School of Medicine. Based in Boise, Idaho, he also is the Medical Director for Idaho Southwest District Health, a district level public health department. Dr. Roscoe received his medical degree from the Perelman School of Medicine at the University of Pennsylvania, holds a Master’s in Science in Public Health from the London School of Hygiene and Tropical Medicine, and a B.S. and B.A. from Gonzaga University.
Jason Boone, Ph.D., Vice President, Sales and Marketing
Dr. Boone has been serving as Vice President of Sales and Marketing at Sedia since the merger of Sedia and Floragenex in October 2016. Additionally, he is serving as the President of Floragenex overseeing company development, licensing, operations, and finance. He previously served as Vice President of Floragenex beginning in 2012. Dr. Boone has also served in various other roles at Floragenex, including Director of Sales from January 2010 until September 2012 and as Director of R&D from 2009 until 2010. At Floragenex, Dr. Boone spearheaded new sales modeling techniques and business development efforts with academic and commercial life sciences groups. He has held full sales and business development responsibility from 2012 onward and engaged with high value markets and customers to direct appropriate outcomes while negotiating, establishing, and conducting market research on new product lines and services. Dr. Boone received his Ph.D. in Developmental Neuroscience from the University of Oregon and B.A. from Alfred Unitersity.
Joeciey Valero-Hansen, Director, Quality Systems
Ms. Valero-Hansen is Director of Quality Systems and has served Sedia Biosciences since 2014 with her experience developing and managing Quality System functions. Prior to joining Sedia Biosciences, Ms. Valero–Hansen functioned as the Change Configuration Manager and CAPA Coordinator for RS Medical from 2010 to 2014 where she performed stop gap analysis and overhauled the document and change control systems to bring them into compliance. She assisted in ISO and FDA audits and strove to improve and strengthen the company’s Quality System. Previous to her time with RS Medical, Ms. Valero-Hansen served in various roles with HemCon Medical Technologies from 2004-2010. As Quality System Data Coordinator, she improved and maintained the Quality System by leading the Material Review Board, CAPA, non-conformance and process deviation meetings to track and trend quality system activities. In this role, she helped to implement an FDA recommended risk based approach to non-conformances and CAPA as well as significantly decreased the use of planned deviations. Previous to that, Ms. Valero-Hansen served as an Auditor, in addition to being a Quality Control Technician. In this dual role, she monitored the company’s critical suppliers and internal manufacturing processes for continued compliance and assisted in ISO and FDA audits. Additionally, she served on the quality system compliance committee to rewrite and implement Standard Operating Procedures for compliance to and to achieve ISO 13485 certification. Ms. Valero-Hansen received her B.S. in Molecular and Cellular Biology from California State University, Fresno.
Leslie North, PMP, CCRP, Director, Regulatory and Clinical Affairs
Ms. North joined Sedia Biosciences in September 2020 as Director, Regulatory and Clinical Affairs, and is responsible for leading the Regulatory and Clinical Trials operations for the company. Ms. North’s experience includes program and project management at ICON Plc (2019-2020), IQVIA MedTech (2017-2019), and Biotronik, Inc. (2009-2017) where she managed the project teams and clinical trial operations of global clinical research studies for companion diagnostics, in-vitro diagnostics, blood safety therapies, breast implant products and cardiology indications. Prior, Ms. North was at Hemcon Medical Technologies as Vice President, Clinical Trials (2006-2008), where she was responsible for the development of the clinical strategies and operationalization of the company’s clinical research programs. As Director of Clinical Affairs for Calypte Biomedical (2004-2006), Ms. North coordinated the conduct of international product evaluations within industry and NGO programs within key African and Asian countries and was responsible for the regulatory submissions that led to product approvals within the strategic countries of interest. Her early career was at OraSure Technologies (1991 – 2004) in various roles within R&D and Clinical Research, where she was a key leader during the clinical development programs for the company’s oral fluid diagnostics, and acted as primary company liaison to the Centers for Disease Control and Prevention during the product launch of the company’s HIV rapid test technologies and implementation within US Public Health Laboratories. Ms. North holds a B.S. degree from Humboldt State University in Molecular and Cellular Biology. She has achieved PMP certification (Project Management Institute) and CCRP certification through Society of Clinical Research Professionals (SOCRA).