Miraculins Inc., a medical diagnostic company focused on developing and commercializing diagnostic tests and risk assessment tools for unmet clinical needs has announced that it has appointed key consultants in the areas of scientific, manufacturing, technical development and clinical and regulatory affairs. Key consultants include Dr. Michael J. Evelegh, Dr. Peter Horsewood, Mr. James Overbeck, and Mr. Jan-Ake Westin.
"Miraculins is undergoing important changes to its operations in order to prepare for the launch of the PREVU(i) Skin Cholesterol test," commented Christopher Moreau, President and CEO of Miraculins. "In addition to building up our infrastructure, we are also supplementing our human resources in key strategic areas."
Dr. Michael J. Evelegh provides Miraculins with an important strategic planning resource, possessing both a continuity of knowledge regarding the technical aspects of the PREVU technology and an established track record of high level regulatory guidance.
Dr. Evelegh is the former Executive Vice President, Clinical and Regulatory Affairs at PreMD Inc. and he has over 20 years of experience in researching and developing human diagnostics, including product development, clinical trials, regulatory submissions and manufacturing. Of considerable note, Dr. Evelegh was the Director of Research and Development for Biomira Diagnostics Inc., a medical technology company, where he managed the regulatory approval process for the Truquant BR Radioimmunoassay (RIA) test kit, the first blood test ever cleared for detecting breast cancer.
Dr. Peter Horsewood adds considerable scientific knowledge and capacity to Miraculins in bringing contract manufacturing online for production of the reagent testing kits, one of two components of the PREVU test. He was a key member of the research team responsible for moving the PREVU technology from the lab bench towards the market place and is an inventor on a number of patents supporting the technology in his former role with PreMD Inc. as Director of Scientific Affairs. Dr. Horsewood is also a part time Associate Professor in the Department of Pathology and Molecular Medicine at McMaster University.
Mr. James Overbeck is the technical lead and project manager responsible for leading the contract manufacturing process for the handheld reader (spectrophotometer) on Miraculins behalf. Mr. Overbeck provides services to the company through Q Product Management LLC, and has provided comparable services to PreMD Inc. including playing a leading role in the redesign of the handheld reader from a tethered (wired to laptop) format, to a self contained wireless unit.
His 20 plus years of experience in technology driven markets include a number of leadership roles with X-Rite Incorporated, a NASDAQ listed global leader in color science and technology, where Mr. Overbeck was the key customer contact on major OEM accounts including Kodak, Xerox, Heidelberg, Komori, Ford, Sun Chemical, Sullivan Schein and Dentsply.
Additionally, to Miraculins has retained GVI Clinical Development Solutions (CDS) for clinical development services including quality assurance, regulatory affairs and clinical trial support such as facilitating new clinical trial opportunities and clinical economic support of the PREVU technology.
CDS is lead by Mr. Jan-Ake Westin who has been appointed Vice-President, Clinical Operations for Miraculins. In this role, Mr. Westin's department is responsible for the establishment of an ISO 13485 certified quality system and coordinating the regulatory notifications required for medical device product marketing in Canada, the United States and Europe.