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Delivering High-Quality Assays for Rapid Therapeutic Drug Monitoring

Real-Time Insights that Empower Healthcare Providers

Healthcare providers often make dosing decisions without critical blood level information. Saladax Assays ensure rapid, accurate results, preventing the risks of suboptimal drug levels or toxicities.

At Saladax, we strongly advocate that every patient receive treatment designed to secure optimal therapeutic outcomes.

Headquartered in Bethlehem, PA, Saladax Biomedical, Inc. is a privately held company that develops, manufactures, and markets assays that provide rapid therapeutic drug levels for essential and life-saving medicines prescribed by psychiatrists and oncologists. Since 2007, Saladax’s proprietary technology has been used in clinical laboratories or point-of-care settings to assist clinicians monitor and optimize patient care. Additionally, the company collaborates with leading pharmaceutical companies to develop tests for clinical trials and companion diagnostics. For more information, visit MyCareTests.com

Salvatore J. Salamone, PhD

President & CEO

Dr. Salamone has more than 30 years’ experience in the health care and medical device industries. Prior to founding Saladax in 2004, Dr. Salamone was Vice President of Research and Development at Roche Diagnostics where he was responsible for North American research and development efforts for the Laboratory Systems Division. During his 17-year tenure at Roche, Dr. Salamone’s efforts resulted in the launch of seven major reagent product lines, comprised of more than 70 FDA-approved products and more than 200 instrument applications. At Saladax Dr. Salamone’s group has developed proprietary positions in the field of oncology and psychiatry drug management. These assays address unmet medical needs in providing precision treatment. Dr. Salamone is recognized globally in the field of drug monitoring, having authored more than 100 publications, including articles, textbook chapters, books, and is also the holder of 41 issued US patents and the corresponding international patents. He has received numerous awards including the 2021 C.E. Pippenger Award for Outstanding Contributions to Therapeutic Drug Monitoring. In 2016 he was inducted into the prestige’s New Jersey Inventors Hall of Fame. Dr. Salamone earned two bachelor’s degrees from Villanova University, a master’s and a Ph.D degree from Rutgers University and was a Science Engineering Research Council (SERC) Post-Doctoral Fellow at Oxford University.

Maria Serieno-Foster

Chief Commercial Officer

Ms. Foster has over 30 years of experience in the diagnostics and medical devices industries. Her extensive experience spans chemistry/immunoassay to molecular diagnostics/biotechnology within organizations ranging from blue-chip corporations (i.e., Johnson & Johnson) to entrepreneur start-ups. She has developed and led dynamic; high-performance teams focused on commercialization and business development strategies and execution. She has been instrumental in market development and successful product launches that include random access immunoassay, molecular analyzers, and diagnostic tests in cardiology, infectious disease, and psychiatry. Ms. Foster has her BBA from St Mary's College, Notre Dame, and MBA from Kellogg School of Management, Northwestern University.

Jeff Wisnoski

Director of Operations and Product Support

Jeff Wisnoski has over 20 years of experience in the scientific industry with 10+ years focused in IVD operations and assay manufacturing. His knowledge and expertise have been instrumental in launching many Saladax products globally and contract manufacturing with international pharmaceutical companies. In addition, he has led product transfers from R&D to manufacturing, process validation, and scaling manufacturing. Jeff received his BS degree in chemistry from Eckerd College.

Mary Rose Hilaire, PhD

Senior Director, Research & Development

Dr. Hilaire joined Saladax in 2017. Dr. Hilaire provides leadership and cross-functional team oversight to ensure that Saladax develops and produces world-class assays on clinical chemistry analyzers and point-of-care devices. These assays provide rapid therapeutic levels for essential and lifesaving medicine prescribed by psychiatrists and oncologists. In addition, she guides the team from product concept through product development, validation, and clinical trials, so that the assays are ready to be sold globally. Dr. Hilaire earned a bachelor’s degree in chemistry from Temple University and her Ph.D. in physical chemistry from the University of Pennsylvania.

Amy Orcutt, RAC

Director, Regulatory and Quality

Amy Orcutt has more than 10 years of experience in the health care and medical device industries. Prior to joining Saladax, Amy worked as a quality and regulatory consultant for Fortune 500 companies. Amy has extensive experience in the development and implementation of global regulatory strategies, and quality systems management. Amy received her BS degree in chemistry from Stonehill College, and her MBA from the University of Memphis.

Salvatore J. Salamone, PhD

President & CEO

Dr. Salamone has more than 30 years’ experience in the health care and medical device industries. Prior to founding Saladax in 2004, Dr. Salamone was Vice President of Research and Development at Roche Diagnostics where he was responsible for North American research and development efforts for the Laboratory Systems Division. During his 17-year tenure at Roche, Dr. Salamone’s efforts resulted in the launch of seven major reagent product lines, comprised of more than 70 FDA-approved products and more than 200 instrument applications. At Saladax Dr. Salamone’s group has developed proprietary positions in the field of oncology and psychiatry drug management. These assays address unmet medical needs in providing precision treatment. Dr. Salamone is recognized globally in the field of drug monitoring, having authored more than 100 publications, including articles, textbook chapters, books, and is also the holder of 41 issued US patents and the corresponding international patents. He has received numerous awards and in 2016 he was inducted into the prestige’s New Jersey Inventors Hall of Fame. Dr. Salamone earned two bachelor’s degrees from Villanova University, a master’s and a Ph.D degree from Rutgers University and was a Science Engineering Research Council (SERC) Post-Doctoral Fellow at Oxford University.

David M. Brewer, Chairman

Columbia Ventures Corporation

Dave spent over 35 years in the aluminum industry in management positions with three different companies. He has served in management and senior management positions in manufacturing, planning, marketing, sales and general management. He held various management positions with ARCO Aluminum, a division of Atlantic Richfield, including president of one of their largest divisions. He also represented Norsk Hydro of Norway in their efforts to expand into North America through acquisitions and green field projects in the aluminum industry. He has been with Columbia Aluminum and is successor company Columbia Ventures (CVC) for over 25 years. He has held various management positions including President of trading operations, President of Columbia Aluminum Extrusions and Fabrication, and President & COO of Columbia Aluminum. Since 2006 he has served as Vice Chairman of Columbia Ventures and assisted in its expansion into telecommunications. He currently or previously serves on the boards of CVC; Magnet, I.E in Ireland; Mid Park Manufacturing; One Communications; CTC Communications and non-profits The Home of the Innocents and Kentucky Chapter of the American Diabetes Association.

Jenny Jiang, Director

Fosun Pharmaceutical Group

Ms. Pei (Jenny) Jiang graduated with Master degree of Immunology from Fudan University in 2012. She joined Shanghai Fosun Long March Medical Science Co., Ltd since July 2012. During the period, she had served as Technical Support, Product Manager, Product Director during Jul 2012 to Dec 2016; Business Development Director, Assistant General Manager since Jan 2017.

Rick Blume, Director

Managing Director, Excel Venture Management

Rick Blume is Managing Director of Excel Venture Management, and he has been financing companies in healthcare for over three decades. Rick co-founded CB Health Ventures in 1998. In addition to Saladax, Rick has served as a director or active investor in many companies including Lantos Technologies, Cytyc (acquired by Hologic - HOLX), AbT (now OSI - OSIP), Somatogen (acquired by Baxter - BAX), EdenTec (acquired by Nellcor), Exact Sciences (EXAS), IPC The Hospitalist Company (IPCM), GeneOhm (acquired by Becton Dickinson - BDX), Zonare, TransMedics, US Servis (acquired by McKesson); and the former public health insurance company Washington National. Rick has been active in initiating and teaching courses in venture capital and entrepreneurship at both Boston College Carroll School of Management and Simmons College School of Management, and serving on the Boards of the Chicago Biomedical Consortium and the National Regenerative Medicine Foundation. Rick did his undergraduate studies at University of the Pacific and Stanford. His MBA is from Stanford University.

Michael Esposito, Director

Norbridge, Inc.

Michael Esposito is the President of Norbridge, Inc., a management consulting firm based in Boston. He undertakes functional and corporate planning assignments for pharmaceutical, biotechnology, medical equipment/supply/device and diagnostics companies around the world. Mr. Esposito received his MBA from the Amos Tuck School at Dartmouth College (1981) and his BS in Pharmacy from the Massachusetts College of Pharmacy (1978). Prior to joining Norbridge in 1998, Mr. Esposito was a Vice President at Arthur D. Little and a Marketing Manager at Pfizer, Inc.

Mr. Esposito was a member of the Board of Directors at Angioblast Systems, Inc. and at Aspect Medical Systems, Inc. prior to their acquisitions. He is a former Trustee and is now Chairman of the Annual Appeal for the Rotch-Jones-Duff House & Garden Museum. He is a member of the Board of Trustees of the New Bedford Symphony Orchestra and a member of the Corporation of MCPHS University (formerly The Massachusetts College of Pharmacy and Health Sciences).

Joanne Spadoro, Director

First Light Diagnostics

Joanne has been in the in vitro diagnostics / medical device field since 1990. During the course of her career and prior to the founding of her consulting company, First Light Diagnostics, Joanne has held various executive roles and has been responsible for the development and commercialization of many novel, clinically important products. As Senior Vice President of Product Development and Operations, Joanne was a member of the executive team at Roche Molecular Systems that launched the first commercial PCR based products worldwide for infectious disease diagnostics, viral load monitoring, and blood screening applications. Subsequently, at Immucor, as CSO and Worldwide Vice President of Operations, Joanne guided the organization through the development and FDA approval of the first molecular immunohematology test for the detection of extended blood antigens. Joanne’s broad understanding of diagnostics includes product development, operations, quality systems, clinical affairs, regulatory affairs, and business development. Joanne has a B.A. degree in biological sciences from Douglass College and a Ph.D. in cell biology from the University of Connecticut.

Ivy Sun, Director

Fosun Pharmaceutical Group

Ms. Xiaoting (Ivy) Sun is currently the CFO of Fosun Diagnostics. Prior to joining Fosun, Ms. Sun worked at Deloitte Touche Tohmatsu and served as a senior auditor from October 2008 to September 2010 and an audit manager from October 2010 to January 2014. From January 2014 to November 2017, she worked at Demag Cranes & Components (Shanghai) Co., Ltd. with her last position as business controller. From November 2017 to February 2018, she served as a senior manager of finance at National Silicon Industry Group Co., Ltd. (a company listed on the Shanghai Stock Exchange, stock code: 688126). During June 2018 to June 2021, she has been the vice president of finance of an integrated pharmaceutical company ”Edding Group Company Limited”, who has submitted A1 in HKEX in end March 2021. Ms. Sun obtained her Bachelor’s degree in economics from Xiamen University in July 2004. She has been a non-practicing member of the Chinese Institute of Certified Public Accountant since March 2014.

Edward Chu, MD

Chair, Professor of Medicine, Pharmacology & Chemical Biology at the University of Pittsburgh School of Medicine; Chief of the Division of Hematology-Oncology in the Department of Medicine at the University of Pittsburgh School of Medicine; Deputy Director of the University of Pittsburgh Cancer Institute (UPCI); and Leader of the UPCI Molecular Therapeutics and Drug Discovery Program. Prior to his position at the University of Pittsburgh, Dr. Chu served as Deputy Director of the Yale Cancer Center and the Yale University School of Medicine.

Alec Goldenberg, MD

Director, Hematology Clinic and Hepatoma Tumor Study Group, Bellevue Hospital, New York University Medical Center; Clinical Associate Professor of Medicine, New York University School of Medicine; and clinical practitioner. Dr. Goldenberg has 20 years combined experience in clinical oncology practice with Memorial Sloan-Kettering and New York University.

John M. Kane, MD

John M. Kane, MD. is the Senior Vice President for Behavioral Health Services at Northwell Health in New Hyde Park, New York. He is Chairman of the Department of Psychiatry at The Zucker Hillside Hospital in Glen Oaks, New York. Additionally, he is Professor and Chairman of Psychiatry at The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell and Director of the Institute of Behavioral Science at the Feinstein Institute for Medical Research. Dr. Kane earned his medical degree from New York University in New York, New York, and completed his internship and residency in Psychiatry at The Zucker Hillside Hospital. He is a Diplomate of the American Board of Psychiatry and Neurology. Dr. Kane is the recipient of many awards, including the Lieber Prize, The APA’s Kempf Award and Foundations Prize, the New York State Office of Mental Health Lifetime Achievement Award, The Dean Award from the American College of Psychiatrists. He has served as President of the American Society of Clinical Psychopharmacology, the Psychiatry Research Society and the Schizophrenia International Research Society.Dr. Kane has been the principal investigator for research projects focusing on schizophrenia, psychobiology and treatment, recovery, and improving the quality and cost of care. He is the author of over 800 peer-reviewed papers and serves on the editorial boards of numerous journals.

Li Zhang, MD

Professor of Medical Oncology and Deputy Director of Lung Cancer Research Centre at Sun Yat-Sen University; Chief of the Department of Medical Oncology and Associate Director of the National Anti-Cancer Drug Clinical Research Centre at the Sun Yat-Sen University Cancer Centre in Guangzhou, China. Dr. Zhang also serves on the Board of the International Association for the Study of Lung Cancer, vice chairman of the Association of Rehabilitation and Palliative Care and vice chairman of both the Cancer Chemotherapy Association and Lung Cancer Association of the Guangdong Province, China.

Howard McLeod, PharmD

Dr. Howard McLeod is the Medical Director of the DeBartolo Family Personalized Medicine Institute at the Moffitt Cancer Center. He is also a Senior Member of the Division of Population Sciences. He is a Professor at the University of South Florida College of Medicine and Pharmacy. Most recently, he was the Fred Eshelman Distinguished Professor and Founding Director of the UNC Institute for Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill. Dr. McLeod is chair of the NHGRI eMERGE network external scientific panel and a recent member of the FDA committee on Clinical Pharmacology. He is a member of the NIH NHGRI Advisory Council. Since 2002, Dr. McLeod has been vice chair for Pharmacogenomics for the NCI clinical trials cooperative group CALGB/ALLIANCE, overseeing the largest oncology pharmacogenomics portfolio in the world. Dr. McLeod is also a 1000 talent scholar of China and a Professor at Central South University in Changsha, China. He also directs the Pharmacogenetics for Every Nation Initiative, which aims to help developing countries use local clinical pharmacology information to improve National Drug Formulary decisions. Howard has published over 470 peer reviewed papers on pharmacogenomics, applied therapeutics, or clinical pharmacology and continues to work to integrate individualized therapy principles into clinical practice to advance personalized medicine.

Ralph Aquila, MD

Dr. Aquila is the Medical Director, Fountain Hous, Sidney R. Baer Jr. Center. For over a quarter century, Dr. Aquila has been running a service that treats person with serious mental illness, predominately, schizophrenia. He is the Medical Director of Fountain House. He has conducted numerous clinical trials. His team has been looking at other medical co-morbidities since the early nineties as a for the cause of premature death in persons with schizophrenia. Together with Fountain House is pushing forward the agenda about excess mortality in serious mental illness with the World Health Organization. He is an assistant professor of psychiatry at the Ichan school of medicine, Mt. Sinai.

David Taylor, BSc MSc PhD

David Taylor is Director of Pharmacy and Pathology at the Maudsley Hospital and Professor of Psychopharmacology at King’s College, London, UK. In 2014, David was ranked in the top 100 clinical leaders in the NHS by the Health Service Journal.

David was a member of the UK Department of Transport expert panel that introduced drug-driving regulation. He is currently a member of the UK government’s Advisory Council on Misuse of Drugs.
Professor Taylor is the Editor-in-Chief of the journal Therapeutic Advances in Psychopharmacology.

Professor Taylor has been the lead author of the Maudsley Prescribing Guidelines since their inception in 1993. The Maudsley Prescribing Guidelines have sold over 300,000 copies in fourteen editions and twelve languages. David has also authored over 350 clinical papers in journals such as the Lancet, BMJ, British Journal of Psychiatry and Journal of Clinical Psychiatry. These papers have been cited over 15,000 times. Professor Taylor has written or edited seven other books and written over twenty book chapters.

William Clarke, PhD MBA DABCC

Dr. Clarke received his Ph.D. in Analytical Chemistry from the University of Nebraska in Lincoln in 2000, followed by a post-doctoral fellowship in Clinical Chemistry at the Johns Hopkins School of Medicine, ending in 2002. In addition, he received an MBA focused on medical services management from the Carey School of Business at Johns Hopkins in 2007. Following his post-doctoral fellowship, he remained at Johns Hopkins, where he is a Professor in the Department of Pathology, as well as the director of both Point-of-Care Testing and Clinical Toxicology for the hospital. His research interests include clinical mass spectrometry, method development and evaluation for therapeutic drug monitoring, clinical toxicology, point-of-care testing, and development/validation of biomarkers for use in drug management. Dr. Clarke has published as author or co-author over 150 peer-reviewed manuscripts or book chapters, and is the Co-Editor of the textbook Contemporary Practice in Clinical Chemistry.

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