Frank Langley has over 30 years of Life Sciences experience, and has spent over a decade in executive management in the Transplant Diagnostics industry. Prior to joining TAI Diagnostics as CEO, Mr. Langley was Vice President & General Manager of Immucor Transplant Diagnostics in Stamford, Connecticut. He previously served as President and CEO of Pel-Freez Clinical Systems in Brown Deer, Wisconsin. Under his leadership, the company developed a complete line of Human Leukocyte Antigen Typing (HLA) transplant diagnostic products. Mr. Langley was instrumental in the strategic sale of Pel-Freez to Dynal Biotech (now part of Thermo Fisher) after an extended period of robust growth.
Mr.Langley has deep experience in the functional areas of Product Management, Sales, Marketing, and Business Development. He has worked in startups to Fortune 500 companies and has also served as an advisor, board member, and investor in numerous Life Science industry organizations. This includes his involvement with the Wisconsin Biotechnology Association (now BioForward) where he served as board member and President. He also served on the Research Foundation Board and Technology Innovation Council of the Medical College of Wisconsin. Mr. Langley has a Master’s degree in Business Administration from the University of St. Thomas and an undergraduate degree in Business Administration from the University of Wisconsin.
Dr. Aoy Tomita-Mitchell brings her experience and expertise in rare variant detection to the development of cell free DNA technology for TAI Diagnostics. A co-founder of TAI, Dr. Tomita-Mitchell was also a co-founder of Ariosa Diagnostics, a leading global molecular diagnostics company that was acquired by Roche in 2015.
Dr. Tomita-Mitchell is an investigator at the Children’s Research Institute at the Children’s Hospital of Wisconsin as well as a Professor at the Medical College of Wisconsin. She has conducted pioneering research on circulating donor specific cell free DNA and on fetal cell free DNA, along with an ongoing investigation into the genetic etiology of congenital heart disease. Dr. Tomita-Mitchell’s work at TAI supports a passion for utilizing genetic tests to improve patient outcome.
Prior to postdoctoral work in Pediatric Cardiology at The Children’s Hospital of Philadelphia, Aoy received her BS in Mechanical Engineering, her PhD in Genetic Toxicology and Bioengineering, and a postdoctoral fellowship from the Massachusetts Institute of Technology.
Dr. Michael E. Mitchell MD is a pediatric cardiothoracic surgeon at the Children’s Hospital of Wisconsin and is a Professor of Surgery in the Department of Surgery, Division of Pediatric Cardiothoracic Surgery at MCW. He is a member of the American Surgical Association and has held numerous national leadership positions. Prior to founding TAI Diagnostics, Mike was a co-founder of Ariosa Diagnostics, a leading global molecular diagnostics company (San Jose, CA), and a co-founder of MDinteractive (Framingham, MA), a company that provides a Physician Quality Reporting System.
Dr. Mitchell has a number of medically related patents with several resulting in FDA approved devices. He earned his B.A. in chemistry from Princeton University, and M.D. Magna Cum Laude from Harvard University. He completed his clinical training in surgery at the Brigham and Women’s Hospital, Boston Children’s Hospital, and the Children’s Hospital of Philadelphia.
Dr. Paula North has over 20 years of experience directing clinical diagnostic laboratories and is board-certified by the American Board of Pathology in Anatomic, Clinical, and Pediatric Pathology. She is a Fellow of the College of American Pathologists (CAP) and a member of the United States and Canadian Academy of Pathology, the Society for Pediatric Pathology, and the American Society for Investigational Pathology. Prior to joining TAI Diagnostics as Chief Medical Officer and Laboratory Medical Director, she was Medical Director of the Department of Pathology and Laboratory Medicine at Children’s Hospital of Wisconsin for 10 years, after a decade of experience as Director of Clinical Pathology at Arkansas Children’s Hospital. She has been a pioneer in bringing molecular diagnostics into clinical practice, ranging from PCR assays to whole genome sequencing, founding and directing two academic hospital-based, CAP-accredited Molecular Diagnostic Laboratories, the first in 1996.
Dr. North is Professor of Pathology at the Medical College of Wisconsin and continues to practice pathology at Children’s Hospital of Wisconsin (CHW). She has been placed by her peers on the Best Doctors in America list since 2008, and was named Physician of the Year by the Vascular Birthmarks Foundation in 2015. She has authored over 100 peer-reviewed scientific publications, books, and chapters and is an advisor for several patient-oriented organizations in the field of vascular anomalies. Dr. North received an undergraduate degree from the University of Virginia, an MD from the University of Arkansas and a PhD in Molecular Biology from Vanderbilt University.
John Fowler is Vice Chairman & Executive Vice President of Quad/Graphics, a global provider of print and multichannel solutions with more than 50 print-production facilities on three continents. He oversees global strategic planning and business development with a concentrated focus on overall business strategy and investment opportunities.
Quad/Graphics is the parent company of QuadMed, a national provider of employer-sponsored health and wellness solutions. Mr. Fowler has worked closely with QuadMed since inception in 1990 and continued exponential growth from the beginnings of an on-site medical facility for Quad/Graphics’ employees to serving over 90 clients with more than 100 clinics in 22 states. This includes 350,000 lives served by over 700 employees. Mr. Fowler is one of two directors for the QuadMed internal board.
Mr. Fowler has worked with Quad/Graphics since 1980. Prior to joining Quad/Graphics, he worked with the company as an audit and tax manager with Arthur Andersen. John attended Tufts University and Iowa State University, graduating summa cum laude with bachelor’s degrees in both economics and business/accounting. He also serves on the board of directors for Quad/Graphics, Manipal Technologies Ltd. , the Left Bank Wine Company and the University Club Tower and is a past board member of Stat Doctors (prior to its sale to Teledoc) and Creative Forming and Coatings Excellence International (both Mason Wells portfolio companies prior to their sale).
John Neis is the Executive Managing Director at Venture Investors LLC, where he has been a Managing Director since 1997. John brings considerable expertise in biotechnology startups to TAI Diagnostics, including his current directorships at Venture Investors portfolio companies Deltanoid Pharmaceuticals, Cellectar BioSciences, Delphinus Medical Technologies, Virent, and Great Lakes Pharmaceuticals.
John’s experience includes assisting multiple ventures from inception through successful product deployment and exit to public markets. He joined the Board of Third Wave Technologies when they had three employees and served through the initial public offering (they were subsequently acquired by Hologic for $580 million), and also joined the Board of TomoTherapy when they had one employee and served through their public offering, which was the fourth largest healthcare IPO in the first decade of the millennium. Other notable past directorships included NimbleGen Systems, which was acquired by Roche for $272.5 million, and Inviragen, which was acquired by Takeda for up to $250 million.
John is a Chartered Financial Analyst who received his MS in Marketing and Finance from the University of Wisconsin – Madison, and his BS magna cum laude in Finance from the University of Utah.
Mark has over 20 years experience in the healthcare industry, clinical molecular testing and sales. Prior to joining the team at TAI Diagnostics Mark was integral in growing two start-up companies, OralDNA Labs and MyGenetx, driving operations and sales. In earlier years he gained valuable experience being a part of the Molecular Diagnostics Sales Division of Invitrogen. Mr. Mackellar is a graduate of Trent University in Peterborough, Ontario, Canada and also holds a Post-Graduate degree in Medical Laboratory Science from Lakehead University, Ontario, Canada.
Tina Bethhauser has over 25 years of Accounting, Finance and Administrative experience from a variety of industries including non-profit, health care and manufacturing. A significant portion of Ms. Bethhauser’s career was spent at GTI Diagnostics, a manufacturer of invitro medical diagnostics products for antibody testing, in an executive role as CFO. Ms. Bethhauser was instrumental in the strategic sale of GTI Diagnostics to a private-equity group, The Riverside Companies, after a period of continued growth and then again from The Riverside Companies to Gen-Probe, Inc. (now part of Hologic).
Ms. Bethhauser has a Bachelor’s of Business Administration from the University of Wisconsin – Milwaukee and is licensed as a Certified Public Accountant.
Dr. Klass has over 30 years of experience in executive leadership in the development of Molecular Diagnostic Assays for the clinical laboratory most recently in the area of next generation sequencing. He is a subject matter expert in Product Development under QSR regulations for CE Mark, 510K and PMA submissions. Dr. Klass possesses a thorough understanding of and has extensive experience in Product Design, Product Development, Strategic Planning, Intellectual Property, Design Control and GMP Manufacturing in the Molecular Diagnostics area in large corporate and smaller start-up biotechnology applications. He has published 30 research articles in various scientific journals and has 25 issued US patents covering numerous aspects of molecular diagnostics.
Prior to joining TAI Diagnostics, Dr. Klass was Sr. Director for Invivoscribe where, in addition to leading the development and commercialization of numerous NGS assays for leukemia and lymphoma, he led the development and the PMA approval of a companion diagnostic for midostaurin, a drug to treat acute myeloid leukemia. After achieving tenure as a university professor of genetics and molecular biology, Dr. Klass turned toward industry to participate in the application of scientific discovery on platforms that serve to save lives or improve the quality of life of patients in need. For 30 years he’s focused on the development, commercialization and FDA clearance and approval of molecular diagnostic assays for cancer and infectious disease at Abbott Laboratories, Gen-Probe (Hologic), Ventana (Roche) and Caris Life Sciences, where as Vice President of R&D he led the development of Molecular Profiling for cancer screening.