Dr. Daitch is the Founder of Akonni and has served as the CEO and Board member since its inception in 2003. He has 26 years of product development experience in integrated biosensors encompassing a broad range of disciplines including chemistry, biology, biomaterials, engineering, and chemical/biological defense. He manages and leads multidisciplinary teams of scientists and engineers focused on the development of next-generation in-vitro diagnostic devices. Dr. Daitch has experience in developing a wide variety of sensor system products for remote autonomous or point-of-use detection of complex samples employing miniaturized analyte purification, and specialty biomaterials interfaced with microfabricated detection components coupled to a variety signal transduction modalities. He brings strong product development and R&D experience from the NIH/FDA, USDA, Sandia National Labs and the Intelligence Community. In addition, he has commercial senior management experience (P&L responsibility) from PSR/Veridian, CUBRC, HandyLab, and Akonni. Dr. Daitch was recruited by HandyLab Inc., a microfluidics diagnostic company, to serve on the executive management team as Vice President of R&D. Prior, Dr. Daitch launched a biodefense product development facility and business unit for PSR/Veridian Corp., a premier DOD/IC contractor, and led the growth of the operation to 24 employees and >$5M in annual revenue. As the CEO of Akonni he is responsible for 1) setting and executing strategic direction, 2) product management, 3) leading equity financing rounds (>$30M to date), managing capital, financial audits, 4) corporate governance, shareholder relations, 5) leading business development, strategic partnerships, 6) recruiting, mentoring, listening and learning from our exceptional staff, and 7) setting the company’s culture. He has 5 U.S. patents, 24 publications and served as principle investigator on over $20 million in government grants and contracts.
Dr. Chandler, a founding scientist, joined Akonni Biosystems after 15 years of service at Pacific Northwest and Argonne National Laboratories, where he led and managed multidisciplinary teams of biologists, analytical chemists, engineers, statisticians and computer scientists in the development of integrated nucleic acid-based biodetection systems for environmental and clinical applications. Since receiving his PhD in microbiology, he has authored >60 peer reviewed publications and book chapters and holds 10 issued U.S. patents with several patents pending, and given 34 invited presentations in national and international forums based on investigator-initiated, peer-reviewed research grants from the NIH, DOE, EPA, and DHS. Dr. Chandler has been the PI on >$50M in peer-reviewed grants and contracts. Areas of scientific and technical emphasis include methods and devices for automated sample preparation from large-volume, complex sample matrices and array-based detection technologies. He is a peer reviewer for the Proceedings of the National Academy of Sciences, Nature Biotechnology, Nucleic Acids Research and 12 other journals, and is a regular contributor to NIH study sections and special emphasis panels.
Mr. Davis joined Akonni Biosystems April 2007 and currently manages all aspects of Akonni’s day-to-day operations, to include quality control, human resources, information technologies, IP/legal, facilities, procurement, security and ES&H. Mr. Davis has over 20 years of general management experience with expertise in design, construction, and maintenance of research laboratories to include BSL-2, chemical, optical and class 10,000 clean room facilities. Prior to joining Akonni, Mr. Davis served as Department and Technical Manager for General Dynamics Advanced Information Systems’ Chemical Biological Radionuclide Explosives (CBRNE) business unit. Mr. Davis served in similar roles and as a microbiologist with both Veridian Corporation and Pacific Sierra Research Corporation where he worked with multidisciplinary teams of scientists and engineers developing novel biological detection technologies for US government agencies. In this capacity Mr. Davis also served as a technical lead for field trials of integrated biological collection and detection systems for US defense and homeland security communities.
Mr. Murphy joined Akonni in September of 2015. For the past 7 years, Mr. Murphy served as President and founder of Conatus Consulting LLC, a medical device regulatory consulting firm located in Raleigh, NC. Mr. Murphy is an industry pioneer and thought-leader in the field of Pharmacogenomics, with more than 33 years of scientific and business experience. He is a serial entrepreneur in the personalized medicine space and in 1997 was founder of Intek Labs, the first international Pharmacogenomics company. Following the acquisition of Intek Labs by PPD, Mr. Murphy was the co-founder, President and CEO of Gentris Corporation. Gentris was acquired by Cancer Genetics Inc. in 2015 while Mr. Murphy served on the Board of Directors at Gentris. In 2007, Gentris spun off its diagnostic group and Mr. Murphy served as the President and CEO of ParagonDx, one of the first companies to win FDA clearance of a Rapid Genotyping Kit for patients taking the anticoagulant, Warfarin. He has also held executive vice president management positions with PPGx and Clingenix. Mr. Murphy is a frequent lecturer and author on Pharmacogenomic topics, and currently sits on the editorial review board of the journal, Pharmacogenomics. He has expertise in FDA Regulations and Quality Systems for medical device focused companies, and has been responsible for oversight in over 15 successful 510(k) submissions, FDA audits and inspections. He has established CLIA-regulated laboratories at four start-up companies, and he serves as an Ad Hoc advisor to the CDC (GetRM), EU (EuroGentest), the Clinical and Laboratory Standards Institute (CLSI) and the Association for Molecular Pathology (AMP). Mr. Murphy received his B.S. and M.S. degrees from San Diego State University and was trained in molecular biology at the Salk Institute.
As Director of Engineering at Akonni Biosystems, Dr. Cooney leads an innovative multi-disciplinary team of engineers and scientists in the pursuit of affordable, highly-informative diagnostics. Dr. Cooney draws upon more than 15 years of multi-disciplinary bioengineering experience from both academia and industry – four years in post-graduate academia and more than ten years in industry. His scientific expertise is in microfluidics and biosensors, which began in 1995 as part of his graduate studies at Arizona State University. Prior to serving as Director of Engineering at Akonni Biosystems, Dr. Cooney was an Engineering Manager at Northrop Grumman’s R&D Division and served as a technical liaison with the Manufacturing Division for the deployed Biohazard Detection System. There he also led the R&D of a microfluidic cartridge for isothermal assays for biodefense applications. One of these isothermal assays (Ionian NEAR assay) became the first CLIA-waved molecular diagnostic (Alere-i product line). Prior to his work at Northrop Grumman, Dr. Cooney investigated digital microfluidics applied to isothermal molecular assays, and he co-developed a patented low-cost isothermal fluorescence reader as a scientist at Keck Graduate Institute. Prior to this position, Dr. Cooney served as Research Director for Biomechanics Research and Associates where he was responsible for developing customized analysis instrumentation. As a student, Dr. Cooney was commissioned as an Ensign Officer with the Public Health Service and served at the FDA’s Center for Devices and Radiological Health. Dr. Cooney is named on numerous publications, patents and grants. As principal investigator of projects, funded by the National Science Foundation and the National Institutes of Health, he oversees both the development of high-confidence Lab-on-a-FilmTM diagnostic tests using the same low-cost reel-to-reel manufacturing methodologies as used for pregnancy tests and the development of point-of-care diagnostics to detect drug resistance in low resource settings.
Dr. Foster joined Akonni in September of 2015 as Director of Quality Assurance, and brings a unique blend of scientific knowledge and Quality experience. She began her scientific career as a Medical Technologist (MT, ASCP) working in hospital laboratories. From the clinical lab she transitioned to research before going to graduate school. She earned a Ph.D. in Immunology from the University of Texas Southwestern Medical Center followed by a post-doctoral fellowship at Duke University. Dr. Foster spent 12 years in clinical phase biotechnology companies in roles of increasing responsibility from pre-clinical research and product design and development to directing the manufacture of clinical trial materials and leading Quality Assurance and Regulatory Compliance. She designed ISO 14644-compliant clean room facilities for the manufacture of cellular therapy products for clinical trials, and implemented quality systems to support those activities. During her years in biotechnology, she served on design control teams and has extensive experience in medical and regulatory documentation and compliance. She has designed, written and implemented process validations, operator qualifications, aseptic process simulations, comparability protocols, and has authored multiple CMC sections for INDs. In 2012, Dr. Foster started her own consulting company leveraging her scientific, Quality, and Regulatory skills. As a consultant, client projects included developing Quality Systems, potency assay development, stability studies, cGMP and GLP training, translating R&D projects into cGMP-compliant clinical trial manufacturing, SOP writing, gap analyses, and preparing for pre-approval inspections. In her role as Director of Quality Assurance for Akonni, she is leading design control efforts for product development, managing Device History Files, and preparing Akonni’s first audit for ISO 13485 Certification and FDA submission.
Dr. Holmberg joined Akonni Biosystems in 2008 and currently leads the commercialization effort for Akonni’s sample preparation product line including the TruTip Automated Workstation, on track to be a FDA Class I device, and Purification Kits covering a wide range of clinical applications. As a certified, experienced Project Management Professional, she manages multidisciplinary teams, comprised of both internal and external stakeholders, towards the development, verification and validation of our products following Design Control. In addition, Dr. Holmberg made significant assay and method development contributions to Akonni’s test-menu pipeline. Prior to Akonni, Dr. Holmberg was a Senior Scientist at Ionian Technologies where she developed molecular assays for rapid detection of biowarfare agents and genetically modified foods. She is a co-inventor of NEAR, Ionian’s patented isothermal amplification technology which became the first CLIA-waived molecular test in 2015 under the Alere-i product name. Over the course of her career in industry she has served as PI, Co-investigator, or Key Personnel to lead assay development projects on grants, contracts, and programs under federal agencies including NIH, NIJ, DARPA and DTRA. She received her Ph.D. in Inorganic Chemistry from the University of North Carolina, Chapel Hill researching metal-mediated redox detection of DNA, after which she studied polymerase evolution and recognition of unnatural nucleobases as an NIH Postdoctoral Fellow at The Scripps Research Institute in La Jolla, CA. Dr. Holmberg is author on a number of peer-reviewed scientific publications, and co-inventor on multiple issued or pending US and worldwide patents.
Mr. Reinemann has an exceptional track record of developing and implementing strategic, data-driven marketing and sales initiatives for diagnostic products, resulting in strong double-digit growth and increased market share. His international business experience is positioning Akonni for success as the organization navigates late-stage product development, registration, and commercialization of its novel diagnostic platform for global health applications. Mr. Reinemann brings a diverse background, with experience in both technical and business roles and expertise in biology, global healthcare systems, and public health. In 2008, while living in the small island nation of Micronesia, he led a regional team under the World Health Organization (WHO) Global Programme to Eliminate Lymphatic Filariasis (GPELF). Working with local officials and tribal leaders, the program led to the screening and treatment of thousands of indigenous people, contributing to the WHO’s goal to eliminate Lymphatic Filariasis by 2020. While earning his Master’s in Public Health at Columbia University in New York, and working at the Mailman School of Public Health’s Center for Infection and Immunity, Mr. Reinemann worked on pioneering research projects in immunotherapy and pathogen discovery, and implemented cutting-edge technologies for highly multiplexed analysis and next-generation sequencing. Prior to joining Akonni in June of 2016, Mr. Reinemann served in various Commercial Operations roles at Qiagen. Over the course of 5 years at Qiagen, Mr. Reinemann led marketing and sales efforts that accelerated the growth of what has become the company’s single biggest revenue-contributing product – QuantiFERON-TB Gold, an immunological test for Tuberculosis infection. As Regional Marketing Manager of North America, Mr. Reinemann’s achievements included year-over- year growth of 55%, and the introduction of innovative co-marketing initiatives with strategic accounts, resulting in customer-specific growth upwards of 75%. As Senior Global Product Manager, Mr. Reinemann managed a $150M product line with an annual growth rate of >25%, leading cross-functional project teams on commercial efforts as well as product development and product launches.
TruDiagnosis Systems, TruDx Readers, TruArray Tests, TruTip Kits, Primers, Lysis and Binding Buffers, Wash Buffers and Elution Buffers: For Research Use Only. Not for use in diagnostic procedures. No claim or representation is intended to provide information for the diagnosis, prevention or treatment of a disease.