The PeriRx, LLC Executive Team

Transcription

1 The PeriRx, LLC Executive Team Stephen M. Swanick / President, CEO and Founder Mr. Swanick is the President, Chief Executive Officer and Founder of PeriRx, LLC. PeriRx was formed by Mr. 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, Mr. Swanick secured the worldwide rights from UCLA after a yearlong negotiation for its salivary diagnostic test for oral cancer, the world`s 6th leading cancer. This test is the first diagnostic platform in the PeriRx product portfolio. In addition to the oral cancer test, Mr. 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. Mr. Swanick also successfully completed a Founders financing round and then a Series A financing. He also successfully negotiated a collaborated CLIA license agreement for the PeriRx laboratory to build its assay and perform the oral cancer test. Mr. 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 in management positions in product development, business development and CEO and 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.

2 Jack Martin MD Chief Medical Officer Dr. 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, Dr. 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. Dr. 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.

3 Neil G. Gottehrer, DDS Chief Dental Officer Dr. Gottehrer is a board-certified, practicing periodontist and has been in practice in suburban Philadelphia for more than 30 years. His practice is focused on cosmetics, implant dentistry and periodontics. He is a graduate of the University of Maryland Dental School and received his postgraduate periodontal training at the University of Pennsylvania. In addition, Dr. Gottherer is a diplomate, of the American Board of Periodontology and the International Congress of Oral Implantology. Dr. Gottehrer teaches the senior elective course in periodontics at the University of Maryland Dental School and is a guest faculty member of the University of Maryland Dental School and SUNY Stony Brook School of Dental Medicine. Internationally known as a dental industry author and lecturer, he has been recognized as a clinical opinion leader in continuing education by Dentistry Today and serves as a peer-review editorial board member for that publication.

4 Michael Ventriello / Public Relations & Marketing Adviser Michael Ventriello has more than 30 years of integrated public relations and marketing experience and has been successful in the fields of health care, consumer packaged goods and technology. His functional specialty is launching innovative companies and products quickly and effectively. Mr. Ventriello has approximately 10 years of concentrated experience in agency-side dental industry public relations and marketing communications. During this time he developed highly successful go-tomarket PR and marcom campaigns for some of the dental industry s most innovative products. Sirona s CEREC 3D and later, CEREC AC Powered by BlueCam LED Medical s VELscope Oral Cancer Screening Device Hu-Friedy s DownPak Endodontic Obturation Device Sunstar s GUM PerioShield Oral Health Rinse Heureaus-Kulzer s InnoEndo Resilon Obturation System OralDNA Labs Salivary Diagnostic Tests Provia Labs Store-a-Tooth Dental Stem Cell Storage System In addition to possessing award-winning writing skills, Mr. Ventriello has strong contacts with the editors of all the major dental publications, as well as most of the top key opinion leaders. He leverages these relationships to gain his clients increased and valuable industry exposure by influencing the influencers. He formed his own public relations and marketing communications company in 2013 and is currently applying his experience and relationships to introduce PeriRx and its SaliMark line of salivary diagnostic tests to the healthcare marketplace.

5 Richard Chiacchierini, PhD Statistical Regulatory Adviser Dr. 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 analyses 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.

6 Jeffrey N. Gibbs, Esq. Legal Regulatory Adviser Mr. Gibbs has represented health care companies on FDA-related matters since 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, Mr. 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. Mr. Gibbs has written and lectured extensively on a variety of FDA-related topics. Mr. Gibbs served as a member of the Editorial Advisory Board for the Food and Drug Law Journal from 1998 to 2004, and was Chair in Mr. Gibbs served as a member of the Human Subjects Research Board for George Mason University from He is currently on the editorial advisory board of IVD Technology. Mr. 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.

7 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, Mr. 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.

8 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.