LumiThera
Debra Roark Macrae has a strong background in quality management and auditing. Debra has extensive experience in creating and implementing quality management systems, ensuring compliance with regulatory requirements. Debra has held leadership roles in various companies, including LumiThera, MarqMetrix Inc., HealthFirst, Physio-Control, Atossa Genetics, Flextronics Medical, Miraca Life Sciences, and Abbott Laboratories - Diagnostic Division. Throughout their career, they have successfully obtained ISO certifications and managed external regulatory agency inspections. Debra has also played key roles in cross-functional project teams, overseeing quality activities for medical device development and ensuring compliance with FDA and ISO standards. Debra'sexpertise includes managing quality activities for diagnostic equipment, software, and hardware design control.
Debra Roark Macrae pursued their education in a chronological manner, starting with a Bachelor of Science (BS) degree in Laboratory Technology from the University of Oklahoma, which they obtained between 1983 and 1986. Debra later attended the University of North Texas from 1993 to 1996, where they obtained a Master of Science (MS) degree in Biology, specializing in Immunology.
In addition to their formal education, Debra has also acquired several certifications to enhance their professional skills. Debra obtained a Quality Auditor certification from the American Society for Quality in December 2006. In October 2010, they obtained an FDA QSR and Industry Practice certification from the American Association for Medical Instrumentation. In November 2011, Debra earned the Six Sigma Black Belt certification from the American Society for Quality.
Although no specific information is provided regarding their Medical Technologist certification, it is mentioned that Debra is certified as a Medical Technologist by the American Society for Clinical Pathologists.
LumiThera
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At LumiThera, they are committed to developing solutions to prevent vision loss and blindness, improve visual function and stop or slow the progression of blinding diseases of the eye. They will continue to innovate non-invasive approaches to address unmet medical needs. LumiThera, Inc. is a commercial-stage medical device company initially focused on treating patients affected by dry age-related macular degeneration. The Company’s expertise is in the application of photobiomodulation (“PBM”), using non-invasive light emitting diodes (“LED”) for acute and chronic ocular diseases and disorders. The Company is developing an ophthalmic LED office-based instrument to be used in multiple ocular conditions or disorders as non-invasive medical treatments. Three clinical studies have demonstrated clinical and pathological benefits of PBM in treating subjects with dry AMD. The recent TORPA II clinical trial results demonstrating improvements in clinical outcomes of vision and reduction of pathological “drusen” following imaging analysis were published in December 2016 in ACTA Ophthalmologica, a top peer-reviewed Ophthalmology journal. The company recently completed the LIGHTSITE I clinical trial,a thirty subject dry AMD study partially supported by the National Eye Institute. The Valeda LIght Delivery System is now available for sale in the European Economic Area.