Leadership
LexaGene has assembled a leadership team, board of directors, and scientific advisory board with rich experience in the management and development of medical technology and life-science innovations.
Dr. Jack Regan
Chief Executive Officer, Founder | DirectorDr. Regan is the inventor of the company’s automated pathogen detection system, MiQLab™. Before founding LexaGene, he led a team of scientists at Bio-Rad Laboratories in developing tests for detecting pathogens, cancer, and neurological disorders using droplet digital PCR. Prior to Bio-Rad, Jack helped QuantaLife, a startup company, bring its product from concept to commercialization where it was subsequently acquired by Bio-Rad. He has also worked at Applied Biosystems/Life Technologies on automated sample preparation and did his post-doctoral training at Lawrence Livermore National Laboratory, where he developed automated instruments to detect respiratory pathogens and bio-threat agents for the US government’s BioWatch program. His doctoral training at the University of California San Francisco focused on influenza viral replication.
Steve Armstrong
Chief Operating OfficerMr. Armstrong has spent his career leading numerous teams in the commercialization of complex medical devices, directly overseeing global operations including design, development, manufacturing, and service operations in eight countries. Throughout his career, he has been responsible for obtaining FDA and global regulatory approvals in over 100 countries for more than 50 devices with hundreds of indications, implementing best-in-class quality management systems, and ensuring worldwide compliance. Mr. Armstrong started his career involved with the development and launch of LASIK technology and has brought new laser and light-based technologies to a variety of medical specialties over the past 25 years for organizations including Palomar Medical Technologies and IPG Medical in both human clinical and veterinary technologies.
Jeffrey Mitchell
Chief Financial OfficerMr. Mitchell has over two decades of financial and SEC experience. Before joining LexaGene, he served in positions of increasing responsibility including Controller and Director of Finance, overseeing areas such as public company financial reporting, audits, and financial planning and analysis for Palomar Medical Technologies, Inc. which was publicly traded on the NASDAQ before Mr. Mitchell helped orchestrate its sale to Cynosure in 2013 for $294 million. In addition to his many years at Palomar, Mr. Mitchell has served in numerous financial and strategic advisory roles for medical device, imaging, and diagnostic companies.
Dr. Nathan Walsh
Vice President of Applications - BioinformaticsDr. Walsh has over 20 years experience interfacing between biology and bioinformatics. His experience with DNA sequence projects includes primer design, next-generation sequencing (NGS), cancer detection, microarrays, and pathway identification. Dr. Walsh most recently served as Head of Informatics at Bio-Rad's Digital Biology Center of Cambridge building a rapid-result next-generation sequencer; prior to that, he served as Senior Director of Informatics and IT to create drug hits from DNA encoded libraries. Dr. Walsh has been a post-doctoral fellow at Harvard Medical School with George Church and Brigham and Women's Hospital Department of Genetics. He has a Biochemistry degree from Brown University and a Ph.D. in Biology from MIT.
Dr. Manoj Nair
Director of ApplicationsDr. Nair has over 7 years of experience developing and leading teams in the development of molecular diagnostic and pathogen typing assays in compliance with FDA IVD regulations for clinical diagnostics and AOAC guidelines for food safety applications. Before joining LexaGene, Dr. Nair served as Staff Scientist at Beckman Coulter Molecular Diagnostics and Senior Scientist at Roche Molecular Systems, where he helped the development of various qualitative and quantitative diagnostic assays for 510(k) clearance, PMA and CLIA waiver. Dr. Nair is also a trained veterinarian and specialized in the diagnosis and treatment of animal diseases in his early career. Dr. Nair conducted his postdoctoral studies at the University of Pennsylvania and Albany Medical College, concentrating on host-pathogen interactions in infections caused by bio-threat agents. His doctoral training at the University of Connecticut focused on the molecular pathogenesis of Cronobacter sakazakii and its detection in contaminated infant formula.
Board of Directors
Tom Slezak
DirectorMr. Slezak recently retired from Lawrence Livermore National Laboratory (LLNL), where he was an Associate Program Leader for Informatics. His career at LLNL spanned 40 years. He was a significant contributor to the Human Genome Program and a developer of the nation-wide BioWatch system. Throughout his career he has chaired many NIH grant review sessions for infectious disease proposals. He is a renowned bio-defense expert and during his career has served on numerous National Academy panels and DoD Standing Committees focused on Biodefense programs. Mr. Slezak also co-chaired a Blue Ribbon Panel on bioinformatics for the CDC that resulted in major new funding for Advanced Molecular Diagnostics and bioinformatics. Mr. Slezak managed a Pathogen Bioinformatics team at LLNL for 19 years, where the team developed a variety of genetic-based assays and analysis software to support a broad range of pathogen detection and forensic programs in biodefense and human/animal health. The software developed by his team is in regular use world-wide.
Dr. Manohar Furtado
DirectorDr. Furtado has worked in the life sciences industry for over 30 years, with experience in discovery research, clinical diagnostic testing, product development and commercialization, M&A activity, fundraising and strategy. He currently serves as President and Founder of Biology for Global Good LLC and Chief Scientific Officer and Chief Regulatory Officer at Apton Biosystems. Additionally, as the former Vice President of R&D at Applied Biosystems, Dr. Furtado helped to build the company’s molecular diagnostics, genomic assays, human identification, food pathogen detection, animal health, pharmaceutical analytics, environmental testing and molecular medicine platforms, which generated over $500 million in revenue. Dr. Furtado has also served as a business development consultant to Bio-Rad, Advanced Cell Diagnostics, DxNow, RxFulcrum, Sample 6, Apton Biosystems and Vibrant Biosciences. He was Senior Director for Regulatory Affairs at Cepheid and appointed to the National Biodefense Science Board by the former Department of Health and Human Services Secretary Kathleen Sebelius.
Joseph Caruso
DirectorMr. Caruso has thirty years of broad executive management experience as a CEO and board member, contributing operational, financial, administrative, and general management leadership to public and private companies. He was one of the founding members of the management team of Palomar Medical Technologies, which developed many first-of-its-kind technologies including the first FDA OTC cleared laser for home use. As its CEO and Chairman of the Board of Directors, Mr. Caruso was instrumental in taking Palomar public in 1992, growing the company from a start up to its sale in 2013 for approximately $300M. Mr. Caruso was actively involved in the design and development of a number of the medical devices launched by Palomar and worked closely with many world-renowned research institutions such as Massachusetts General Hospital. Mr. Caruso has negotiated dozens of acquisitions, license agreements and joint development agreements in his career including with companies such as Johnson and Johnson and Gillette (now part of Proctor and Gamble Company).
Stephen J. Mastrocola
DirectorMr. Mastrocola brings almost 40 years of accounting and auditing experience working with public and private companies. Mr. Mastrocola recently retired from Ernst & Young LLP (EY) after 19 years, where he was a senior assurance partner and led EY’s New England Assurance Practice for several years. Prior to EY, Mr. Mastrocola was an assurance partner at Arthur Andersen LLP. Through his 40-year career at leading auditing firms, he served primarily emerging and growth-oriented companies in the life science sector with products in medical devices and diagnostics. Mr. Mastrocola is a Certified Public Accountant with extensive experience in various financial transactions including IPOs, debt financings, mergers and acquisitions, revenue recognition, internal controls and corporate governance, including compliance matters. Mr. Mastrocola is also a member of LaunchPad Venture Group and serves on the Boards of Partners for Youth with Disabilities and the New England Aquarium.
Scientific Advisory Board
Dr. Kimothy Smith
SAB MemberDr. Smith served as the first Chief Veterinarian for the United States Department of Homeland Security (DHS) and Chief Scientist for the Office of Health Affairs, where he advised the Secretary of Homeland Security on strategies and emergency response plans for food and agricultural security. He went on to serve as the Acting Director of the National Bio-Surveillance Integration Center. Prior to working for DHS, Dr. Smith was the Deputy Division Leader for Operations in the Counter-Terrorism and Incident Response Division of the Non-Proliferation, Arms Control and International Security Directorate at Lawrence Livermore National Laboratory (LLNL). During his tenure at LLNL, he also served as the Deputy Associate Program Leader for the Chemical and Biological National Security Program, where he led field deployments of the government’s biological agent monitoring system (BioWatch). He was also the Chief Science Officer for ExcitePCR and a Professor of Microbiology and Epidemiology for the University of Nevada School of Community Health Sciences. Dr. Smith was a practicing veterinarian for 10 years and also earned his PhD in molecular epidemiology.
Dr. James Marsden
SAB MemberDr. Marsden, as a world-renowned food safety expert, served as an advisor to the White House on food safety and nutrition and has testified on numerous occasions to the United States Congress, the US Food and Drug Administration (FDA), and the US Department of Agriculture (USDA). He recently served as the executive director of food safety at Chipotle where he was responsible for directing the food safety programs at Chipotle Mexican Grills, ShopHouse restaurants, and Pizzeria Locale. He was recruited into the position to bring best practices in food safety to Chipotle and push suppliers to adopt stricter policies for food safety testing. To Chipotle, he brought over forty years’ experience in the food industry working with government officials, regulators, food companies, trade associations, and academics. He previously worked for several food companies and technology providers and served as Vice President for Scientific Affairs at the American Meat Institute (AMI) and President of the AMI Foundation. Earlier in his career, he was a Professor at Kansas State University and provided expert testimony in cases involving foodborne disease outbreaks from E. coli, Salmonella, Campylobacter, Listeria monocytogenes, and Norovirus.
Dr. Shelley Rankin
SAB MemberDr. Rankin is a Professor of Microbiology at the University of Pennsylvania’s School of Veterinary Medicine (Penn Vet). She is the Chief of Clinical Microbiology and Head of Diagnostic Services at Penn Vet’s Ryan Hospital. She is a member of many scientific societies, a past Chair of the American Society for Microbiology, Animal Health Division (2011) and is currently Co-Chair of the Subcommittee on Salmonella for the United States Animal Health Association. She is an author of the International Society for Companion Animal Infectious Diseases (ISCAID) Guidelines for Antimicrobial Use to treat infections of the skin, urinary tract, and respiratory tract. She has published 100 peer reviewed papers and regularly speaks at international conferences. She has been recognized as an Association of American Veterinary Medical Colleges One Health Scholar and a Wharton Mack Institute Technology Fellow.
Shawn Stevens
SAB MemberMr. Stevens is a nationally recognized food industry attorney and the founder of Food Industry Counsel LLC, the only law firm in North America that exclusively represents food industry clients. Mr. Stevens works with some of the world’s largest growers, food processors, national restaurant chains, food distributors, and grocery chains, helping them protect their brand by reducing food safety risk, complying with FDA and USDA food safety regulations, managing recalls, and defending high-profile foodborne illness claims. Mr. Stevens regularly speaks to international audiences on a wide variety of food safety topics, authors dedicated columns in major food safety publications such as Food Safety and Quality Magazine and Meatingplace, and has been quoted in national media publications such as TIME Magazine, the New York Post, and Corporate Counsel Magazine.