Dr. Winn-Deen is an experienced life sciences and diagnostics business professional with a proven track record for successful leadership, much if it focused on novel biomarker and product development for emerging markets. She has a history of identifying, establishing, and supervising successful IVD and CLIA assay product development programs, key corporate partnerships, and cooperative research agreements. Dr. Winn-Deen has extensive experience in negotiation and execution of patent in/out licensing contracts, and the ability to perform both the business and technical due diligence for evaluation of potential new business acquisitions. She served as a Federal-level advisor to HHS through work on the Genetics, Health, and Society Advisory Committee and the Clinical Laboratory Improvement Act Committee (CLIAC), and is a member of the Clinical and Laboratory Standards Institute’s Consensus Committee for Molecular Methods. She has clear and persuasive writing skills, with a proven track record for receiving federal grant funding, and authorship of numerous scientific papers/book chapters. She excels at creative problem solving, and is the inventor on 38 issued US patents. As a skilled presenter of a company’s technologies, and strategic vision, she can help you optimize your company’s profile for both public and business-to-business meetings.
Mr. Deen is an experienced GMP manufacturing executive, with a focus on biological drugs and in vitro diagnostics. He has designed, built, and validated new GMP production facilities, managed existing manufacturing operations, and worked as both a client and a provider of GMP contract manufacturing services. In these roles, he has written the manufacturing section of FDA submissions for both diagnostics and drugs, and has led his organizations through successful FDA inspection and certification. Based on this history, Mr. Deen is well placed to advise your company through build vs. buy decisions, ‘design for manufacturability’ choices to ensure a smooth hand-off from R&D, validation of new manufacturing operations/processes, and scale-up/optimization of existing regulated manufacturing operations.
Mr. Smith holds a B.S. in Molecular, Cellular, and Development Biology from the University of California, Santa Cruz (UCSC), a M.A. in Biophysics from Boston University, and a J.D. from Golden Gate University School of Law. Mr. Smith has biotech work experience at Santa Cruz Biotechnology and Applied Biosystems/Thermo Fisher, as well as university-based research experience at UCSC and Boston University. He has focused on intellectual property law since 2009, is a fully licensed patent agent, and a member of the California bar. As both a scientist and an attorney Mr. Smith can help you through the process of writing and prosecuting patents. He is also available to advise you on related licensing and contract matters such as non-disclosure agreements, material transfer agreements, cooperative research agreements, and patent licenses. Mr. Smith has also committed himself to public service by volunteering free legal services to those in need through the Alameda County Bar Association, working on local and international projects through Rotary in an effort to build community and eradicate disease, and judging competitions for First Lego League where future scientists and engineers participate in robotics competitions that teach children how to coordinate their efforts in the same way industrial research teams would.