Founder, President & CTO
Founder and CEO Maxwell Sensors, Inc., Director of Sensor Systems at Intelligent Optical Systems, Inc., Director of Biomedical Optics at Physical Optics Corp. 52 published papers and 15 issued patents. Winston Ho served as an SPIE program committee and NIH grant review committee. MS Biochemistry and Ph.D. Biophysics from Arizona State University, and then worked as a postdoctoral fellow at Columbia University in New York and a Research Scientist at University of Arizona (Optical Science Center).
Vice President of Molecular Products
Prior to joining Applied BioCode, Dr. Aye was the Technical Director, Assay Development at Focus Diagnostics (subsidiary of Quest Diagnostics). He developed and commercialized IVD products, including SimplexaTM Mycoplasma pneumoniae assay, Influenza A H1N1, and Flu A/B & RSV assay, as well as Simplexa Direct chemistry and Sample-to-Answer molecular detection system. He has developed and launched over 40 molecular products, including ASR, GPR, RUO, CE IVD and FDA 510(k) cleared products. Dr. Aye obtained his doctoral degree in Biology from the University of California, Irvine.
Andy Chao has served start-up to fortune 100 Companies as an auditor, consultant, and management role. He has extensive healthcare experience with an accredited hospital holding company, medical device manufacture, pharmaceutical, and diagnostic companies. He co-leads SEC S-1 audit and filing with Big Five accounting firm. He drafts accounting pronouncements under US GAAP and IFRS for multi-billion dollar consumer products, diagnostic, and technology clients. Consulting financial controls and reviews for medical device manufacture and pharmaceutical, he has helped the clients streamline the process and save $1.2 million and $3 million, respectively. As a management for the accredited hospital and consumer product companies, he manages quarterly SEC reporting, internal controls, financial planning, and periodic financial audits.
Director of Technical Services
Michael Ho, Ph.D. joined Applied BioCode, Inc. in 2015 as Director of Technical Services that leads and directs the Technical Services group for Applied BioCode products globally. Michael has extensive knowledge in molecular diagnostic products for clinical, foodborne, veterinary, and biodefense applications. He excelled in development and support of PCR based chemistry and instrument platforms since 1996. He also specialized in nucleic acid extraction methodology and received a patent on the subject. He majored in Medical Microbiology & Immunology at San Jose State University, California, and received his Ph.D. in Microbiology from University of California at Davis. Prior to joining Applied BioCode, Michael led Technical Service and Product Development operations at Applied Biosystems (Thermo Fisher), Cepheid, EraGen Biosciences, Luminex, and Focus Diagnostics (Quest Diagnostics).
Director of Software and Compliance
As Director of Software and Compliance, Mr. Kowalski is responsible for directing software development for products requiring FDA clearance. Prior to Joining Applied BioCode, Mr. Kowalski was Director of Software Engineering at Applied Medical where he was instrumental in completing UL, CE, and FDA submissions and obtaining clearance. As Software Manager at Beckman Coulter he led product development and commercialization of multiple products at several California development sites. Major platforms included DNA Sequencing, Protein Analysis, and Centrifugation systems. With 15 years at Beckman Coulter, he served as a core program team member in the development, commercialization and support of multiple platforms serving life-science, biomedical and molecular diagnostic markets. Mr. Kowalski earned his degree in Electrical Engineering Technology from Michigan Technological University.
Director of Quality Assurance
Steve is responsible for managing the continued development, implementation and maintenance of quality systems and activities within an FDA and ISO 13485 regulated medical device environment, and facilitating interdepartmental cooperation required to achieve corporate objectives. Prior to joining Applied BioCode, he worked at Teco Diagnostics where he was responsible for quality assurance and regulatory affairs for IVD products. He also spent time at Nesher Technologies where he was a co-inventor of a patented method for multiplexed and ultrasensitive microRNA detection using alternating laser excitation technology. He was also involved in academic research at the Scripps Research Institute and the University of Florida. He received his doctoral degree in Biochemistry from Indiana University.
Vice President of Productions
Experienced manufacturing and operations manager in the in vitro diagnostics and pharmaceutical industries. Director of Manufacturing ProteoGenix, Inc., Director of Manufacturing and QC BioCentrex, LLC, Director of QC and Calibration CareSide, Inc., Manager R&D SmithKline Beecham Clinical Laboratories. BA in Biology and Six Sigma Black Belt certificate from UCLA.
Regulatory, Quality and Clinical Affairs
Mr. Robert Di Tullio has 40 years of experience in the in vitro diagnostics industry, the last 28 of which is in regulatory, clinical and quality management. Previously, he was Vice President, Global Regulatory and Clinical Affairs for Alere and held similar positions at ProteoGenix, Sequenom, Siemens Medical Solutions Diagnostics and Diagnostic Products Corporation. Robert is currently the industry liaison to the Clinical Laboratory Improvement Advisory Committee (CLIAC) and a long-time member of the Regulatory Affairs Professionals Society (RAPS). Robert was the co-chair of the AdvaMed Diagnostics Task Force from 2007 to 2013, and was an advisory board member for the Medical Device graduate degree curriculum at the University of Southern California. He received a B.S. in Biology from Saint Joseph's University in Philadelphia.
Business Relations & Commercialization
Mr. Mooney has served as an executive in a variety of Fortune 500 healthcare companies including Johnson & Johnson and Bausch and Lomb. As a Division level President, he has extensive worldwide executive sales, marketing and commercial operations experience in the Medical Products and Diagnostics industry. Don has an extraordinary track record in full line functional responsibility, strategy innovation, integrating organizations, identifying and negotiating business alliances, and changing organization culture to meet changing market dynamics.
Marketing & Strategic Planning
Mr. Wessel has over 30 years of global experience in the Clinical In-vitro Diagnostics markets. He was the Vice President of Sales, Marketing and Corporate Development for BioCentrix (Culver City, CA) as well as Director, Global Strategic Marketing and Planning for Beckman Coulter Inc. (Brea, CA). During his 25 years at Beckman Coulter, Bob was responsible for strategic planning, strategic marketing, product management, and new product commercialization for Beckman Coulter's Clinical Diagnostic Division. Mr. Wessel received a Bachelor's Degree in Bacteriology from UCLA.