VIATECHMD - Key Persons
Job Titles:
- Company Member & FDA Advisor
Dr. Fisher began his toxicology career in 1978 working with the Bureau of Radiological Health (now the Center for Devices and Radiological Health; CDRH) of the Food and Drug Administration where his research focused on the assessment of ultrasound-induced developmental and behavioral toxicology. He received his PhD in developmental genetics from the George Washington University where his research utilized mammalian whole embryo culture to evaluate alterations in embryonic gene expression as biomarkers of exposure and toxicity, and their utility in predicting skeletal anomalies. Dr. Fisher joined Covance Laboratories in 1998 where, as a Principal Scientist and Study Director Manager, he was responsible for the design, conduct, and interpretation of preclinical developmental and reproductive toxicology (DART) and juvenile toxicology studies. Dr. Fisher returned to the FDA in 2010, as the Deputy Director of the Division of Biology, providing oversight to the toxicology research programs within the Office of Science and Engineering Laboratories, CDRH. In 2012, he became the Director of the Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD) within the Office of Device Evaluation, CDRH, providing oversight on device submission reviews and regulatory policy. In 2017, Dr. Fisher served as one of the Acting Office Directors during the Total Product Life Cycle reorganization pilot within CDRH, and in 2019 assumed the official role as Director of the Office of Health Technologies (OHT3) within the Office of Product Evaluation and Quality (OPEQ). He is a member of the Society of Toxicology, the Teratology Society, and past President of the Mid-Atlantic Reproduction and Teratology Association (MARTA).
Ben is the inventor of our device and brings over 45 years of experience in design, engineering and development of technologies and products, including during his tenure at Chrysler. His experience includes F500 c-suite business and licensing negotiations, and patent and IP development. Ben and his wife first faced challenges surrounding Preterm Birth during the time of their youngest son's birth in 1987 (and again with the birth of their youngest daughter in 1999). Since that time, Ben has engaged in research that is now supported by the latest scientific discovery uncovering the significance of biomechanical forces, acting upon the lower uterine segment and cervix, in exciting the progression of birth. Ben designed, built, and lab tested our initial device prototypes, including those prepared and utilized in our first and very successful human fitment studies from 2016 - 2017. Ben is responsible for the development of our highly efficient and effective business model and building the empowering relationships with our affiliates.
Job Titles:
- Assistant Professor, Surgery, Wake Forest University School of Medicine Program Director, Obstetrics & Gynecology, Maternal and Fetal Medicine / High Risk
Job Titles:
- Chief Scientific Officer & Medical Director for Capital City Technical Consulting, Inc
- Clinical & Regulatory Advisor / CSD Study & Trial Monitor
Dr. Gannon serves as Chief Scientific Officer & Medical Director for Capital City Technical Consulting, Inc. (CCTC) in Washington, D.C.. He received his medical and clinical training at Ross University, Case Western Reserve and George Washington University. He btained an M.B.A. at George Washington University in 1988 and has since built a wealth of experience in the management of clinical trials including designing the trials and building operational teams to ensure their successful completion. Dr. Gannon has held positions in multinational Clinical Research Organizations, medical device, biotech and pharmaceutical firms. Dr. Gannon has managed clinical trials and operations, regulatory strategies and submissions, and execution of Phase I through Phase IV clinical trials in the U.S., Europe and Asia. Additionally, Dr. Gannon is involved in philanthropy in the Washington, D.C. area and currently serves on the Board of Directors for the Engineering World Health Organization and The Foundation for Sickle Cell Research.
Job Titles:
- Chairman Emeritus of Western Bank
- Company Member & Business Advisor
Julie Causey is Chairman emeritus of Western Bank and on the Board of Directors of Fairview Health Services and the Board of Trustees of Minnesota Public Radio. Through 2015, Julie served as Executive Chairman of the $550MM Western Bank with accountability for profitability, strategy, asset quality, capital adequacy, and risk management. She led the successful sale of the 100-year-old bank in 2012 and then continued to lead the bank for 2+ years including serving on the Board of Directors of the $3B acquiring bank. Julie served on the Board of Directors of the $30B Federal Reserve Bank of Minneapolis, the Board of Trustees of Colby College, and the Board of Directors and as Audit and Finance Committee Chair for the HealthEast Care System. She holds a B.A. in Economics from Colby and an M.B.A. in Finance from Wharton. By way of her deep understanding of M&A, growth and innovation in the banking and healthcare industries, Julie brings unique experience, insight and strategic focus to ViaTechMD.
Job Titles:
- President of DuVal & Associates
- Regulatory Counsel & Advisor
Mark is President of DuVal & Associates, P.A.. Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems working both domestically and internationally. He was on assignment for 3M Health Care Systems, Ltd. In Europe based out of the United Kingdom. He then worked at Medtronic in Corporate Compliance for FDA, Anti-kickback, False Claims Act, HIPAA & HITECH, and other advice related to the FDA-regulated industry. Mark earned his Juris Doctor from the William Mitchell College of Law where he served as executive editor on the law review, and his Bachelor of Arts in Public Administration from St. Cloud State University. Mark has served on various boards including the Minnesota BioBusiness Alliance, Minnesota Biosciences Council, The Food and Drug Law Institute and has been a former Chairman of the Minnesota State Food, Drug, and Medical Device Section of the Minnesota State Bar Association. He is also on the Board of Advisors of the Masters in Regulatory Affairs Services program at St. Cloud State University.
Job Titles:
- Company Member & Business Advisor
Max is the Principal at The Fiore Group and Chief Product Development and Operations Officer at NxThera, Inc. where he was key in transforming the company from an R&D startup into a highly successful commercial entity, mass producing a complex medical system. NxThera recently sold its technology to Boston Scientific for a reported $408M. Max drove innovation, internal R&D and M&A activities at American Medical Systems leading to the sale of AMS to Endo Pharmaceuticals in 2011 for $2.9B (a 45% premium to the previous year's average share price and the largest medical device deal of 2011). Max holds BSEE and BS degrees in Biomedical Engineering from Northwestern University; MSEE from The University of Wisconsin-Madison, Stanford University School of Business, Palo Alto, California, summer 1998, Schwab Executive Program, Product Development and Manufacturing Technology; Max is currently on the advisory board of the Biomedical Engineering Department at the University of Minnesota.
Job Titles:
- Executive Vice President, Medical Affairs and Chief Medical Officer, UnitedHealth Group
Job Titles:
- Clinical Research Director & Advisor
- Founder, President and CEO of Stiris Research
Shantal is the founder, President and CEO of Stiris Research and Stiris Research USA. Before starting Stiris, Shantal was a Director at a mid-sized CRO where she led teams in global and North American clinical trials. Prior to that, Shantal held positions at both Hoffmann-La Roche and Janssen Ortho Inc. (Johnson & Johnson group of families). Shantal received a B.A. from Western University and her business training through the Tuck Executive Education Program at Dartmouth and the Ivey School of Business at Western University.
Job Titles:
- Company Member & Scientific Advisor
Dr. Murray received her PhD in Bioengineering from Arizona State University, to then become a Postdoctoral Associate at Yale University, and now holds the position of Edmondson/Crump Endowed Associate Professor for Biomedical Research and Rehabilitation Science, at Louisiana Tech University. Dr. Murray was a recipient of the highly competitive National Science Foundation "NSF" Graduate Research Fellowship and two NSF IGERT Fellowships. Dr. Murray has 19 years of research experience and biomedical engineering design. One of the driving forces behind her decision to enter the bioengineering profession was her prior experience managing a health clinic serving an at-risk population. She shares our intense desire to improve the health of women.