Michael Heffernan, Chief Executive Officer
Michael is a seasoned leader within high growth emerging businesses and in transforming new technologies to successful commercialization in a diverse range of business settings. Michael’s direct experience spans several industry sectors including managed care, occupational health, medical device development, insurance and e-commerce, financial services and manufacturing, where he has led commercialization initiatives within entrepreneurial environments.
As CEO and founder of Herberton Group in 1998, he has provided strategic advice to a broad selection of companies and has often assumed a leadership role to advance early stage growth enterprises, providing direction, developing growth strategies, building operations and tactical solutions that meet commercial and stakeholder objectives. Michael has substantial experience in building and motivating high performance management teams.
He has over a decade of pioneering outsourcing experience through the creation of public private partnerships (PPP) with State government and has extensive experience in contracting and managing added value outsourcing solutions. As President and CEO of United Correctional Managed Care, Anaheim, California, he led the transition from a specialty physician network to multi-State expansion to competitively win the first statewide privatized healthcare contracts within departments of corrections, in combined contracts of over $500 million in value. As President of Dexus Technologies, Atlanta, Georgia, he managed the development and commercialization of core technology and led the roll out of the first laptop based life insurance application forms solution within the life insurance industry. He led the transformation of the company to Exchange America to take advantage of emerging web capabilities to create the first B2B exchange to serve the life insurance and annuity industry.
He graduated from the National College of Art and Design, Dublin, Ireland and the University of Central England, Birmingham, England, in industrial design engineering.
Eric Setzer, CPA, Chief Financial Officer
Eric has more than 20 years of hands-on experience with the operational and financial challenges faced by growing technology and life science companies. His background includes general management, mergers and acquisitions, debt and equity financings, initial public offerings, private placements and business strategy.
Eric was most recently Chief Financial Officer of Expression Analysis, Inc. (EA), a genomics service provider located in Research Triangle Park, where he partnered with the CEO to grow revenue and profitability, build the management team, and improve market penetration. EA was sold to Quintiles, a $3.5 billion clinical research organization, in 2012 for 20x invested capital. Earlier, he was CFO of three separate venture capital-funded, start-up companies in the health care technology sector, and the controller of TriPath Imaging, a publicly traded cervical cytology screening company. Eric began his career in public accounting, working for Price Waterhouse in Rochester, New York, and the Entrepreneurial Services Group of Ernst & Young in Raleigh, North Carolina.
Eric received his MBA from the Fuqua School of Business at Duke University, and has an undergraduate degree in accounting & economics from Oswego State University.
Kevin McElfresh, Ph.D., Chief Science Officer
Chairman, Science and Technology Advisory Board
Kevin has operated, managed, and directed forensic DNA laboratories for 25 years and was instrumental in the implementation and court acceptance of restriction fragment length polymorphism (RFLP) DNA testing 25 years ago as well as the initial development, implementation and court acceptance of the use of STRs in forensics over 17 years ago.
Previously Kevin was the Director of Identity Testing at Lifecodes Corporation in Valhalla, NY a company that performed the first forensic DNA tests in the United States, and that is now subsumed into CellMark, a forensic company still in existence. Kevin was also a founder and Executive Director of the Bode Technology Group. He was part of the team with Mr. Tom Bode that grew the company to a $25M volume with a greater than 20% profit margin and a successful corporate acquisition. He has served as an expert witness in over a thousand DNA forensic cases and has extensive experience navigating the justice system in regards to forensics.
Kevin earned his Ph.D. in Molecular and Population Genetics from the University of Georgia and along with Dr. Ronald Sosnowski, was one of the co-inventors on the pending patent that provides the basis for the platform to Genome ID for performing backward compatibility with current forensic DNA databases.
Kevin’s career highlights include:
- Several hundred scientific and research presentations. He is presenting UHD-SNP applications at the American Academy of Forensic Science Meetings in Atlanta in February 2013.
- Participating as part of the team that exhumed and identified the remains in the Tomb of the Unknown at Arlington National Cemetery.
- Consulting on identifying remains in mass graves in Bosnia.
- Consulted on upgrading and implementing DNA identification technology in Saudi Arabia.
- Processing thousands of samples for DNA analysis and analyzing thousands of cases from all over the world.
- He maintains an active Department of Defense Top Secret Clearance.
Sandra L. Close (Kirkwood), Ph.D., Chief Science and Technology Advisor
Sandy has more than 20 years experience integrating biological information, technology, informatics, and statistics and applying that information in clinical and laboratory medicine and health outcomes.
Her experience includes management of large cross functional teams integrating business and science with Eli Lilly and Company, Caremark Inc, and Baxter International. Prior to joining the Center for Advanced Forensic DNA Analysis, she was CEO of GenEngine, a consulting firm specializing in providing comprehensive scientific strategies to biotechnology and pharmaceutical companies. Proficient in solving complex scientific problems through the integration of information, she has successfully shepherded both new drug applications and device approvals through the United States Food and Drug Administration and European Medicines Agency. She brings deep expertise in the application of new technologies to biological problems including the validation of complex assays such as microarrays. She had driven several paradigm shifting activities such as the design and development of an industry leading state of the art anonymization system and fusion engine to protect patientprivacy while permitting query of scientific data and the development and application of the Drug Metabolizing Enzyme and Transporter analysis system.
In addition, she has years of experience in health outcomes utilizing epidemiology and statistical principles to identify the appropriate treatment paradigms for patients including the use of biomarkers in patient care. Her technical expertise is augmented by her experience in public-private partnerships such as the US FDA-Drug Industry Association and the development of processes and guidance documents such as the voluntary data submissions process to the US FDA and EMA. She has given hundreds of presentations and training workshops in translational and personalized medicine, the development and application of biomarkers, medical ethics, patient privacy, statistics, genetics, and assay validation.
Sandy earned her Ph.D. in Medical and Molecular Genetics from Indiana University School of Medicine, Indianapolis, IN under the direction of Dr. P. Michael Conneally where she also completed a post-doctoral fellowship. She also has a Master of Science degree from Columbia University, New York, NY and a Bachelor of Science degree from Indiana University, Bloomington, Indiana. Currently holds an adjunct faculty position at Indiana University School of Medicine in the Division of Pharmacology.
Randy Nagy, Executive Director, Business Development
Randy is a visionary executive with more than twenty three years of senior management experience and has successfully facilitated the development and introduction of many of the technologies in use today in the global DNA identification market. Randy’s experience working with crime labs started when he helped them convert from radioactive to chemiluminescent DNA probes and from cotton swatches to medical grade filter paper collection and storage devices over twenty years ago and he continues to help advance the technologies used in crime laboratories today
As a senior manager or executive at Life Technologies, Promega, Whatman, Bode Technology and LGC Forensics, he has managed the introduction and success of many products and services into the forensic and human identification markets world-wide including DNA Typing Grade products and ACES chemiluminescent detection products for RFLP, PowerPlex STR Systems, the C.E.P swab, FTA DNA collection and storage devices, the Buccal DNA Collector, the SecurSwab and many DNA testing services.
He has also served on a number of committees focused on DNA forensics including the Human Identification Trade Association (HITA), the International Association of Chiefs of Police Forensic Committee and the National Institute of Standards and Technology Technical Working Group on Biological Evidence Preservation.
He graduated from the University of Western Ontario, London, Ontario, Canada with degrees in chemistry and biology.
Lucy A. Davis, Director, Forensic Programs
Ms. Davis was a qualified forensic serologist and DNA analyst, DNA Technical Leader, DNA Section Supervisor, State CODIS Administrator and Quality Assurance Supervisor at the Kentucky State Police. While at KSP she was responsible for the implementation of RFLP and STR analysis procedures and helped draft the Kentucky Convicted Offender Legislation.Upon retirementshe became an independent DNA consultant, where she conducted training for numerous organizations including National Forensic Science Technology Center, Northeast Regional Forensic Institute, and Southern Police Institute. She helped develop the Applied Biosystems Validation Program and Forensic Quality Services (FQS) ISO 15189 accreditation policies. She is a certified FBI Quality Assurance Standards and ISO/IEC 17025 Lead assessor and has participated in over 100 forensic laboratory inspections. She has conducted a 16 week intensive training course to over 120 new forensic analysts specific to their laboratory protocols.
Lucy has Diplomat certification by the American Board of Criminalistics and is a certified Medical Technologist by the American Society of Clinical Pathologists. She has served on numerous boards including the Technical/Scientific Working Group on DNA Analytical Methods, the Midwest Association of Forensic Sciences (MAFS) Board of Directors, the American Academy of Forensic Sciences (AAFS) Board of Directors and Executive Committee, the College of American Pathologist (CAP) Proficiency Test Review Committeeand Forensic Quality Services – International Accreditation Board.
Lucy has a Bachelor’s of Health Sciences from the University of Kentucky, specializing in Medical Technology and is presently completing her Masters in Molecular Biology at the State University of New York, University of Albany.
Mary Louise Clair, Director, Quality Assurance
Mary Louise Clair is a quality assurance professional committed to improving forensic DNA testing services and assisting laboratories in adhering to laboratory standards and regulations. She graduated cum laude from George Mason University with a BS in Biology in 2003. In 2004, she began her work in the quality assurance field as a Quality Assurance Coordinator at The Bode Technology Group in Springfield, Virginia. There, she assisted during external audits and site visits to demonstrate compliance with American Society of Crime Lab Directors Laboratory Accreditation Board (ASCLD/LAB), FBI Quality Assurance Standards (QAS) and The New York State Department of Health (NYSDOH) standards, provided administrative review for entries into the CODIS eligible data banking system and aided in the application of the laboratory’s quality program.
Prior to joining the Center for Advanced Forensic DNA Analysis, Ms. Clair was Quality Manager at Casework Genetics in Woodbridge, Virginia where she was instrumental in developing and documenting the quality assurance and control programs. She has participated in reviewing thousands of STR profiles and participated in numerous laboratory inspections by ASCLD/LAB, FQS, and NYSDOH as a staff member of the laboratory being reviewed.
Brittin L McMahon, Laboratory Manager
Brittin is a highly dedicated DNA Laboratory Manager with extensive experience as a Senior Forensic DNA Analyst in casework, validations, research, the writing of standard operating procedures and training.
Her forensic casework experience includes tenure with the Federal Bureau of Investigation, the Kansas Bureau of Investigation, the Texas Department of Public Safety and the Joint Expeditionary Forensic Facilities in Bagram Airfield and Camp Leatherneck, Afghanistan. Beyond the demand of casework analysis, she acted as an advisor to US military and coalition forces in regards to battlefield forensics.
In addition, Brittin managed the DNA Laboratory of the Afghan Criminal Techniques Academy in Bagram, Afghanistan and provided the initial DNA training for Afghan Scientists from the Ministry of the Interior. Her expertise helped to design the layout, budget, training, quality control and assurance documentation for the implementation of this laboratory.
Brittin has a Master of Forensic Science degree from the George Washington University specializing in Forensic Molecular Biology and a Bachelor of Science degree from the California State University, Hayward.