CLIA: 39D2085645
New York State has a separate and unique regulatory approval process for laboratory diagnostic testing. PeriRx is currently in the application process with our SaliMark™ OSCC test and is vigorously committed to pursuing this application approval.
PeriRx Executive Bios
Stephen M. Swanick
President, CEO and Founder
Stephen Swanick is President, Chief Executive Officer and Founder of PeriRx, LLC. PeriRx was formed by Stephen Swanick as a premier developer of breakthrough, non-invasive, highly accurate, oral diagnostic technology that will assist clinical professionals in detecting and treating diseases sooner, with improved patient outcomes. In 2010, Stephen Swanick secured the worldwide rights from UCLA after a year-long negotiation for its salivary diagnostic test for oral cancer, the world`s sixth leading cancer. This test, named SaliMark™ OSCC, is the first diagnostic platform in the PeriRx product portfolio. In addition to the oral cancer test, Stephen Swanick successfully secured the worldwide rights to tests for lung cancer and gastric cancer as well as diabetes type II and Sjögren’s Syndrome; an auto immune disease. These tests are currently in clinical development stages. Stephen Swanick also successfully completed a Founders financing round and then a Series A financing. He negotiated a collaborated CLIA license agreement for the PeriRx laboratory to build its assay and perform the oral cancer test. Stephen Swanick is a seasoned executive and accomplished entrepreneur with a proven track record. Throughout the course of his career, he has amassed 30 years of experience in the pharmaceutical and medical device industry through management positions in product development, business development,and CEO/Founder experience. He graduated from St Joseph`s University in Philadelphia, PA in 1985 with a Bachelor of Science and the University of Pennsylvania in Philadelphia, PA in 1994 with a Masters in Science.
Jack Martin, MD
Chief Medical Officer
Jack Martin has been involved in the practice of medicine, medical teaching and medical research for over 30 years. His specialty is cardiology and his interest in oral health has recently been heightened by the growing awareness of the connection between oral and systemic disease, including cardiovascular disease. As president and a board member of various research foundations, Jack Martin has supported investigations in multiple disciplines including oncology. He recognizes that the exploration of saliva as a tool for diagnosing systemic disease has far-reaching potential across many specialties, especially for clinical applications in early cancer detection. Jack Martin brings many years of research experience to PeriRx, LLC and will be invaluable as the company develops salivary diagnostic tests for the surveillance of other systemic disorders including cardiovascular disease and its related medical disorders.
Christopher Asplen
General Counsel
Chris Asplen is the Attorney-in-Charge of the Life Sciences practice at Hill Wallack, LLC. His current and former clients include Applied Biosystems / Life Technologies, Ibis Biosciences (a subsidiary of Abbott Laboratories), OrchidCellmark Labs, Bode Technologies, ARCPoint Labs and Essex Woodlands Health Ventures. He is also the former Director of the Global Alliance for Rapid DNA Technology, a trade association with members including LabCorp, Qiagen, Promega, Safran Morpho, DNA SI and IntegeneX, Inc.
Chris Asplen is also a former Assistant United States Attorney and Executive Director of the Federal Advisory Committee National Commission on the Future of DNA. Upon leaving The United States Department of Justice he established the London office of his previous law firm and advocated on behalf of his Life Science and forensic clients in the international markets.
Richard Chiacchierini, PhD
Statistical Regulatory Adviser
Richard Chiacchierini is the president and CEO of R.P. Chiacchierini & Associates, LLC and has a long list of clients with successful product approvals and other FDA interactions across a broad range of product areas. The experience he brings to PeriRx, LLC spans over 18 years as a very successful consultant and 20 years in FDA senior management. This combination allows him to guide PeriRx clients smoothly through successful FDA interactions. He has an expert understanding of the types of clinical studies that must be conducted, the types of analysis necessary, the proper interpretation of the results, as well as an understanding of how to interpret FDA requirements and requests. He participates in client meetings with the FDA review staff and management on a routine basis. The result is strong regulatory insight. Together with his strong statistical knowledge, his regulatory background gives PeriRx a consulting perspective that is difficult to duplicate.
Jeffrey N. Gibbs, Esq.
Legal Regulatory Adviser
Jeffrey Gibbs has represented healthcare companies on FDA-related matters since 1984. He advises PeriRx, LLC on a wide variety of issues, including product approvals, marketing, clinical studies, and enforcement. Previously, he served in the Chief Counsel’s Office of the U.S. Food and Drug Administration, where he became an Associate Chief Counsel for Enforcement. While at the FDA, Jeffrey Gibbs received the FDA Award of Merit. He also was appointed a Special Assistant United States Attorney for the District of Columbia.
Before joining the FDA, he clerked for a United States District Court Judge in the District of New Jersey. Jeffrey Gibbs has written and lectured extensively on a variety of FDA-related topics. He served as a member of the Editorial Advisory Board for the Food and Drug Law Journal from 1998 to 2004, and was Chair in 2003-2004. Jeffrey Gibbs served as a member of the Human Subjects Research Board for George Mason University from 2003-2011. He is currently on the editorial advisory board of IVD Technology.
Jeffrey Gibbs serves as Secretary and General Counsel of the Board of Directors of the Food and Drug Law Institute. He is a graduate of Princeton University (1975 summa cum laude) and the New York University School of Law (1978 with honors). He is admitted to practice law in the District of Columbia.
Thomas M. Tsakeris
Invitro Diagnostics Regulatory Adviser
Thomas M. Tsakeris is president of Devices and Diagnostics Consulting Group and a member of IVD Technology’s editorial advisory board.
From 1989 to 1993, Thomas Tsakeris was Director, Division of Clinical Laboratory Devices (DCLD), Office of Device Evaluation, CDRH, FDA. He was responsible for the premarket evaluation of clinical laboratory device applications. During his tenure at FDA, he played a key role in developing the implementation strategy for the Clinical Laboratory Improvement Act (CLIA) of 1988.