Company | Management Team and Founders
Mr. Samulski brings to AskBio experience in all aspects of business start-up and implementation. He is a program management professional with over fifteen years of experience in consumer products, manufacturing, and engineering. Mr. Samulski's experience includes project management and control methodologies of $30M fast-tracked projects for Procter and Gamble and Fluor Daniel. He possesses strong leadership and strategic planning abilities, with a keen aptitude for project management methodologies, quality systems, and project controls. Mr. Samulski holds a Masters of Project Management degree, graduating with highest honors from Western Carolina University.
Dr McPhee has worked in translational research utilizing recombinant AAV for gene transfer since 1996. This work has included the preclinical and clinical development of gene therapies for Canavan disease, Parkinson disease, Amyotrophic Lateral Sclerosis, Duchenne Muscular Dystrophy, Hemophilia A&B, Epilepsy, Conjestive Heart Failure and various Ocular Disorders. Dr McPhee is also experienced in rAAV manufacturing and regulatory activities, as well as intellectual property portfolio management. Dr. McPhee received his Ph.D. in Molecular Medicine from the University of Auckland in New Zealand, and obtained his M.P.H. (concentration in quantitative methods) from Harvard University.
Dr. Samulski received his PhD in Medical Microbiology and Immunology from the University of Florida. Dr. Samulski's graduate work (1978-82) demonstrated the first use of AAV as a viral vector and culminated in the first US patent involving non-AAV genes inserted into AAV. After completing post-doctoral training at Princeton, Dr. Samulski was hired to provide his expertise in AAV biology as a member of the scientific advisory board of Avigen, a new AAV research company. Later, in 1993, Dr. Samulski co-founded an AAV-based gene therapy company called Merlin. This research group was headed by Dr. Xiao and was the first group to demonstrate AAV-mediated long-term gene transduction in muscle (J. Virology, 1996). This finding precipitated a merger of Merlin with Somatix, Inc., which then merged in 1995 with Cell Genesys. In total, Dr. Samulski has worked with AAV for 25 years, and for the past eight years, has been director of the University of North Carolina Gene Therapy Center. Dr. Samulski has over 20 patents filed or issued in the area of AAV vectors. Dr. Samulski former member of the Recombinant DNA Advisory Committee (RAC), a committee tasked with assisting the FDA with approving or disapproving gene tbherapy clinical trials in the United States. He also frequently serves as a gene therapy consultant to the FDA. Through the UNC gene therapy center, Dr. Samulski has produced within an academic setting an FDA approved AAV clinical vector used to treat children with the neurological disorder of Canavan's disease.
Dr. Xiao is a faculty member at the University of Pittsburgh Gene Therapy Center and has worked with AAV for 15 years. Dr. Xiao trained under Dr. Samulski, and together they have published seminal studies demonstrating long-term AAV gene expression in brain, muscle, and production of AAV in the absence of helper Adenovirus. Dr. Xiao was the first program research scientist at Avigen, a company based on AAV type 2 mediated gene therapy. Dr. Xiao also served as chief scientific officer for Merlin, Inc., also an AAV-based company. Dr. Xiao is particularly interested in the treatment of muscular dystrophy, and to that end, he has designed and patented a series of mini and micro dystrophin genes that have shown efficacy in alleviating dystrophic pathology in mice. Dr. Xiao is co-inventor on 12 patents, 6 of which have issued.
Over the past two decades, Ms. Mikhail has founded and successfully operated several companies. Ms. Mikhail has been a co-founder of three biotech companies which have spun out of universities located in North Carolina, and has continued active involvement in each of these companies. In addition, Ms. Mikhail is on the business advisory board for BioResource International, an agra-bio company spun-out of North Carolina State University. She is an attorney by training, with a law degree from Northwestern University. Ms. Mikhail worked for Ropes & Gray in Boston and Sullivan & Cromwell in New York City, before starting her own law firm, Life Sciences Law, PLLC in Research Triangle Park, NC. The firm advises some of the world's largest biotech and pharmaceutical companies such as Bayer HealthCare LLC and Aventis SA, as well as earlier stage companies such as BioStratum, InnerOptic Technology, Nobex, Invitrox, and Karyogen on a variety of intellectual property and corporate matters. She has an MBA (concentration in finance) from the University of Chicago, and has worked as a management consultant for A.T. Kearney and Arthur Andersen, where she advised several of the Fortune 100 on operational and strategic matters. Ms. Mikhail has been an executive-in-residence for the TEC program at NC State and has been a lecturer for the Launching the Company course at UNC.