CLINILABS - Key Persons

Job Titles:

• ANESTHESIOLOGIST SciMedBE

Job Titles:

• Member of the Leadership Team
• Vice President of Project Solutions

As Vice President of Project Solutions, Chris oversees all Core Laboratory Projects under the Data Services umbrella. She has over three decades of clinical research experience as a clinician and manager in roles at both site and CRO in phase I-IV trials. Chris joined Clinilabs' first central scoring team in 2001 as a Registered Polysomnographic Technologist. During her tenure, Chris has used her unique blend of knowledge and determination to develop, motivate and inspire a diverse team that has contributed to over 260 clinical trials and the development of every major sleep therapeutic marketed since 2001.

Job Titles:

• Psychiatrist
• President of the Sleep Research Society
• PSYCHIATRIST UCSF School of Medicine

Dr. Andrew Krystal is a psychiatrist who cares for adults with all types of sleep disorders, with particular expertise in insomnia. He also treats patients who have mood and anxiety spectrum disorders in addition to sleep disorders. An internationally renowned expert on sleep and mood disorders, he has more than 25 years of experience in patient care and research. Krystal's research focuses on understanding insomnia's causes and how insomnia may be related to psychiatric or other medical conditions. He also studies new treatments for insomnia and other sleep disorders, as well as how sleep maintains and restores normal human functions. After completing a master's degree in biomedical engineering at the Massachusetts Institute of Technology, Krystal earned his medical degree at Duke University School of Medicine. He then completed a residency in psychiatry at Duke, followed by fellowships in sleep medicine and clinical neurophysiology (studying the nervous system through recording the body's electrical activity). In addition to holding various leadership positions, he served as a faculty member and physician at Duke Health for more than two decades before joining UCSF in 2016. Krystal is president of the Sleep Research Society and a member of the American Academy of Sleep Medicine, American Psychiatric Association and American College of Neuropsychopharmacology. He serves on the examination committee of the American Board of Sleep Medicine, which allows medical professionals to pursue certification in sleep medicine.

Dr. Greenblatt has been on the Faculty of Tufts University School of Medicine and the Staff of Tufts Medical Center since 1979. He holds the Louis Lasagna, M. D., Endowed Professorship at Tufts University School of Medicine, in the Department of Immunology (formerly the Department of Pharmacology and Experimental Therapeutics), and is a senior faculty member in the Graduate Program in Pharmacology & Experimental Therapeutics in the Graduate School of Biomedical Sciences at Tufts University. He also holds appointments as Professor of Psychiatry, Medicine, and Anesthesia, Tufts University School of Medicine. He has previously served as Chair of the Department of Pharmacology and Experimental Therapeutics at Tufts University School of Medicine, Program Director and Associate Program Director of the institution's Clinical/Translational Research Center (formerly the General Clinical Research Center), and Chair of the Institutional Review Board. He is Editor-in-Chief of Clinical Pharmacology in Drug Development, operated by the American College of Clinical Pharmacology. He also is Co-Editor-in-Chief, with Dr. Richard I. Shader, of the Journal of Clinical Psychopharmacology, A native of Newton, Massachusetts, Dr. Greenblatt is a Magna Cum Laude graduate of Amherst College (1966). After college he attended Harvard Medical School, graduating in 1970, then trained in internal medicine and clinical pharmacology at Massachusetts General Hospital. Dr. Greenblatt has been an active investigator in the area of molecular and clinical pharmacology going back to the late 1960s. His PubMed listing includes more than 1000 publications; more than 780 of these represent original research reports. His work has been supported by the National Institutes of Health for more than 35 years.

Job Titles:

• Director Northeast Regional Epilepsy Group
• Director of Research at Northeast Regional Epilepsy Group

Dr. Eric Ségal is the Director of Pediatric Epilepsy and Director of Research at Northeast Regional Epilepsy Group based in Hackensack, NJ. He is also the Co-Chief of Epilepsy at Hackensack University Medical Center. He is an assistant professor of pediatrics and neurology at Seton Hall University School of Medicine, Rutgers University, and Mount Sinai School of Medicine. Dr. Ségal received his medical diploma from Albert Einstein School of Medicine, trained in general pediatrics at Montefiore Hospital, neurology at Columbia University Medical Center, and neurophysiology at Children's Hospital Boston. His publications have mainly focused on the diagnosis and treatment of neurogenetic disorders.

Job Titles:

• Clinical Professor of Neurology at the University of Minnesota Medical School
• FAAN FAHS

Dr. Frederick R. Taylor is a Clinical Professor of Neurology at the University of Minnesota Medical School. He is United Council of Neurological Specialties certified in headache medicine and a board-certified neurologist. He has spent his career directing an integrated Headache Center and teaching medical and inter-professional persons the science and art of medicine and headache medicine. He served a six-year term (2004-2010) as Associate Editor for the Headache Subsection of the Pain, Palliative and Supportive Care subsection of the Cochrane Library of Systematic Reviews. He consults from time to time on evidence-based grading guidelines, especially for SEMPI. He is currently serving in his fourteenth year as Co-Editor for the Abstracts and Citations Section of the journal Headache: The Journal of Head and Face Pain. He is also Content Author for Tension-Type Headache in Adults for UpToDate, Inc.(2005-present) for which he receives Royalties, Contributing Editor for Headache Currents and Past Migraine Subsection Editor for Current Pain & Headache Reports (2007-2012). He served previously as a primary funding reviewer for the National Institutes of Health. He has been active in the International Headache Society (IHS) having served on the Ethics Committee and Classification Sub-committee (ICHD 7.7 Chiari I malformation) of the IHS for 2004 and 2015 editions. He is a fellow and active member of both the American Academy of Neurology (AAN) and American Headache Society (AHS). As a Palatucci Fellow of the AAN he has worked with insurance providers on quality measures in headache care delivery. He has served on the AHS Education Committee and subcommittee on medical student education and Past Editor for the On-Line publications for the public of the American Committee for Headache Education for the AHS. He is extensively published in headache with peer-reviewed publications, book chapters, invited editorials and has lectured worldwide (Irish Pain Society,Dublin; International Primary Care Headache Symposium, Nice, France and Turkish CME programs) including invited talks at both the American Academy of Neurology and American Headache Society and numerous Continuing Medical Education programs. Dr. Taylor has special interests in patient-empowered care, integrative medicine, the role of the patient as self-care healer and inter-professional evidence-based practice and education. He has received multiple local, regional, national and international outstanding physician awards; including a Minnesota "Super-Docs" award and an Albert Nelson Marquis Lifetime Achievement Award.

Job Titles:

• Clinical ( Cardiovascular ) Consultant
• Clinical Professor of Medicine at Rutgers University

Dr. Ihor Gussak is clinical (cardiovascular) consultant for pharmaceutical and medical devices industries specializing in the early stages of clinical research and cardiac safety, including cardiac safety pharmacology of cardiac and non-cardiac investigational drugs, licensing opportunities, pre-clinical research, translational medicine, cardiac telemonitoring, and clinical trials. His major scientific interests are in clinical and experimental cardiac electrophysiology and electrocardiology, hereditary and acquired cardiac channelopathies, including Brugada, early repolarization, long and short QT syndromes, cardiac iatrogenicity, and acute and chronic heart failures. Dr. I. Gussak holds an academic appointment as Clinical Professor of Medicine at Rutgers University, New Brunswick, NJ. His contributions to the scientific literature include 7 books, 19 book chapters, and over 80 original peer-review manuscripts. He is a member of American College of Cardiology (Fellow), American Heart Association (Clinical Cardiology Council), American Academy of Pharmaceutical Physicians, Mayo Medical Alumni Association, Drug Information Association, International Cardiac Electrophysiology Society, International Society for Holter and Noninvasive Electrocardiology, Strazhesko Institute of Cardiology, Kyiv, Ukraine (Honorary Professor), and Journal of Electrocardiology (Executive Editor).

Job Titles:

• Professor of Neurology
• PROFESSOR of NEUROLOGY NYU Langone School of Medicine

Dr. Jacqueline French is a professor of Neurology in the Comprehensive Epilepsy Center at NYU Langone School of Medicine and Founder/Director of the Epilepsy Study Consortium, an academic group that has performed a number of early-phase clinical trials in epilepsy, and has developed new methodologies for epilepsy trials. Dr. French trained in Neurology at Mount Sinai Hospital in New York and did her fellowship training in EEG and epilepsy at Mount Sinai Hospital and Yale University. Dr. French has focused her research efforts on the development of new therapeutics for epilepsy, and new methodologies for clinical trials. Over the past 20 years, she has served as the Principal investigator on a number of trials for new epilepsy drugs. She is responsible for the creation of a number of new trial designs that have been accepted by regulatory authorities for new drug approval. Dr. French has been active in creating guidelines for the American Academy of Neurology and the International League Against Epilepsy. She chaired an AAN/AES committee that produced two widely quoted guidelines on the use of new antiepileptic drugs. She has served as chair of the International League Against Epilepsy North American Regional Commission, and Commission on Therapeutic strategies. Dr. French serves as the Chief Medical/Innovation Officer of the Epilepsy Foundation. She is the past president of the American Epilepsy Society. She is the past Secretary of the American Society of Experimental Neurotherapeutics. She and is the recipient of the American Epilepsy Society Lennox Award (2017) and Service Award (2005), the Epilepsy Foundation Hero award (2013), and is an ILAE Ambassador for Epilepsy. She has authored over 300 articles and chapters, is the editor of three books, and lectures internationally on clinical trials and the use of antiepileptic drugs.

Dr. Kevin Steel is a board-certified cardiologist who completed a dedicated fellowship in cardiac imaging at Brigham and Women's Hospital in Boston, Massachusetts. Upon his return to San Antonio, Dr. Steel went on to develop the Department of Defense's largest advanced cardiac imaging service at the San Antonio Military Medical Center and build a busy cardiac MRI program for the community of San Antonio. After 20 years as an active-duty military officer, Dr. Steel retired from the Air Force and has brought his expertise to Washington State. Dr. Steel is internationally recognized as an expert in cardiac MRI, specifically MRI stress tests. He has numerous publications in medical journals and is often invited to speak at conferences on this topic. He is an active member of the Society of Cardiovascular Magnetic Resonance, an international organization of cardiologists, radiologists, physicists, and scientists that promote cardiac MRI world-wide. He works with multiple hospitals and clinics to develop state of the art cardiac MRI programs as well as software developers to create accurate and user-friendly MRI reading products. Dr. Steel and his family are originally from Tacoma, Washington. He attended Central Washington University before moving to the island of Guam as he awaited entrance to medical school. He attended Kirksville College of Osteopathic Medicine, now known at A.T. Still University, located in Kirksville, Missouri before further residency and fellowship training in Ohio, Texas, and Massachusetts. He currently practices cardiovascular medicine in Bellingham, Washington.

Job Titles:

• CHIEF EXECUTIVE OFFICER Instat Consulting, Inc
• Co - Founder of Instat

Dr. Mark McBride is co-founder of Instat and has more than 30 years of experience in leadership and management of biostatistics and data management services in the pharmaceutical and biotechnology industry. He specializes in combining strong technical knowledge with customer-focused results. Dr. McBride's experience includes statistical analysis and reporting for Phase I-IV studies in various therapeutic areas, including metabolic diseases, oncology, HIV/infectious diseases, pain management, dermatology, and respiratory, with extensive expertise in statistical analyses of Phase I-III studies in the CNS therapeutic area. His CNS experience includes the analysis and management of studies for indications such as Schizophrenia, Parkinson's Disease, Depression, Alzheimer's, and other psychiatric and neurological disorders. In addition, he has had responsibility for a variety of statistical activities for key clinical development programs, with experience supporting regulatory components for drug approval. He has represented several pharmaceutical companies in meetings with the FDA and has served as a member of several Data Monitoring Committees (DMCs). Prior to co-founding Instat, Dr. McBride enjoyed a successful career with a leading CRO where he held a variety of senior management positions, including Senior Vice President, Global Biostatistics and Data Management, with responsibility for managing the global data services business unit. He also led the integration of data groups after the acquisition of various companies to create the Global Biostatistics and Data Management group with common SOPs and systems. He received his Ph.D. in Biostatistics from the University of North Carolina and a BS and MS in Statistics from Brigham Young University.

Job Titles:

• Professor of Neurobiology Columbia University Irving Medical Center and NYSPI

Dr. Sandra Comer is Professor of Neurobiology in the Department of Psychiatry at Columbia University and Research Scientist VI at the New York State Psychiatric Institute. Following Ph.D. studies at the University of Michigan and post-doctoral research at the University of Minnesota, Dr. Comer joined Columbia University in 1993, where her research focus has been on the development and testing of novel approaches to the treatment of opioid use disorders. She is Director of the Opioid Laboratories in the Division on Substance Use Disorders and runs a very active research program devoted to examining various aspects of the abuse liability of opioids. Dr. Comer served on the Institutional Review Board at NYSPI for 10 years, so she is familiar with the regulatory requirements of research with human volunteers. In addition, she is an active member of the College on Problems of Drug Dependence, the longest standing group in the United States addressing problems of drug dependence and abuse. She served as Chair of the Program Committee, was elected President in 2015-2016, and currently serves as the Public Policy Officer of CPDD. She currently is a member of the World Health Organization Expert Advisory Panel on Drug Dependence, gives lectures and presentations to the U.S. Food and Drug Administration, reviews grant applications for the National Institutes of Health, and mentors both pre- and post-doctoral students. She has published over 150 papers, chapters, and books on issues related to substance use disorders.

Job Titles:

• Clinical Operations Executive Resolute Consulting, LLC
• Resolute Consulting, LLC

Ed Kim has over 20 years of clinical research experience with areas of expertise in Early Phase/Phase 1, Phase 2-3, clinical operational management, as well as project management. Prior to joining Clinilabs as a consultant, Ed served as the Vice President of Early Phase at WCCT Global managing the clinical operations of their four sites in Cypress, Costa Mesa, Orange, and Long Beach. He was responsible for the day to day management of both the Phase 1 and Phase 2-3 operations which included oversight for CRCs, Nursing Staff, Project Managers, Regulatory, Enrollment/Recruitment, Quality Management, Pharmacy, and Facilities. Previous to his tenure at WCCT Global, Ed spent almost 15 years at legacy California Clinical Trials/Parexel, Los Angeles. At Parexel, he served as the Director of Clinical Operations overseeing all clinical operations for their three Phase 1 units in Glendale (hospital-based and non-hospital based units) and Culver City. In addition to Ed's daily clinical operational responsibilities, he was responsible for all financial forecasting, projections, and budgets for Parexel Corporate. Also, as part of the executive team, he also served as part of the Steering Committees for maintaining several strategic partnerships and business relationships with designated Pharmaceutical companies. Ed Kim's clinical trial experience ranges from CNS therapeutic areas (ie: Schizophrenia, Depression, Anxiety, Alzheimer's Disease, Multiple Sclerosis, Parkinson's Disease, MCI), Medical Devices, Ophthalmology, Cardiac/QTc, Asian-Bridging (1 st generation Japanese, Korean, Chinese), Healthy Normal Volunteer, Sleep, and Dyna-bridging (serial CSF collection and LP). Ed received his Bachelor's of Science in Psycho-Biology from the University of California, Riverside.

Job Titles:

• Chief Operating Officer
• Member of the Leadership Team

Eileen McAuley has more than 25 years of clinical research experience, having occupied positions in operational and strategic leadership roles. She currently oversees Clinilabs Drug Development Corporation's operations, and is responsible for the oversight of project management, monitoring services, data management, biostatistics, medical writing and our Phase 1 clinics. Most recently, Eileen served as Senior Vice President, Clinical Services, at Frontage Labs, a provider of Phase 1 clinical research and bioanalytic services. Prior to that, she was the COO at Integrium, a full service CRO for cardiovascular, metabolic, and dermatology trials. Eileen began her career as a critical care nurse and progressed to serve in clinical operations roles of increasing responsibility, including roles as Director of Project Management and head of operations for specialty clinical organizations. She earned a master's degree in public administration from Seton Hall University, with a focus on health policy and management. She received a Bachelor's of science degree from Montclair State College in New Jersey.

Job Titles:

• Chief Executive Officer
• Member of the Leadership Team
• President

Gary Zammit, is the President & CEO of Clinilabs Drug Development Corporation, a full-service CRO that provides clinical drug development to industry, focusing on CNS therapeutics. Gary Zammit is a scientist and former academician who founded Clinilabs Drug Development Corporation in 2001, having the belief that there was an industry need for a specialty CNS CRO that could improve the way new drugs and medical devices are developed. Dr. Zammit is widely sought for his expertise in neuropsychiatric drug development. Gary has authored more than 230 original publications and 2 books, and has served as a reviewer and editor for well-known medical journals. He is committed to ensuring that Clinilabs Drug Development Corporation's senior management remains involved in every project that we accept, so that clients have easy and immediate access to the leadership of a high-performance development team.

Job Titles:

• Vice President of Marketing and Communications
• Vice President, Strategy and Corporate Development

Ms. Jeanine Falinski, Vice President of Marketing and Communications, has more than 15 years of experience in the pharmaceutical industry. Jeanine graduated from Emerson College with a degree in New Media and Marketing. She, later on, received her MBA in Pharmaceutical Management from the LeBow College of Business at Drexel University. Jeanine joined Clinilabs in 2004 as a Manager of Subject Recruitment and continued on through positions of progressive responsibility including Senior Director of Marketing and Communications and Senior Director of Business Development. In 2014, she joined Evolution Research Group as Senior Director of Business Development. Later on, she joined Artcraft Health, a marketing agency devoted to patient engagement and recruitment in clinical trials. In January of 2019, Jeanine returned to Clinilabs having gained valuable experience in other organizations and is excited to bring a new level of strategy and design to our team and our clients.

Job Titles:

• Chief Information Officer
• Member of the Leadership Team

Jerry Deptuch is a seasoned Information Technology professional having achieved positions with increasing responsibility throughout his career. Jerry is committed to help set and lead the technology strategies of our organization in collaboration with the executive management team. With his hands-on approach, Jerry serves as an effective liaison between the technology department and the other business units within Clinilabs. Jerry is innovative in his approach to identify new technologies that can assist the organization in achieving its goals and objectives. Having a master's degree in Mathematics, Jerry has a cost-effective approach in his methodologies to identify the resources needed to meet or exceed these goals and objectives. As the Chief Information Officer, Jerry guides his team to create business value through technology, planning of business growth opportunities, and ensuring tech systems and procedures are in place to meet objectives while maintaining business efficiency and productivity at Clinilabs.

Job Titles:

• Chief Medical & Scientific Officer of DUCK FLATS Pharma

Luana Pesco Koplowitz received her M.D. from Rutgers Medical School and her Ph.D. from Rutgers College of Pharmacy and Columbia Pacific University. She is a fellow of the American College of Clinical Pharmacology and also a member and fellow of the Faculty of Pharmaceutical Medicine of the United Kingdom. Dr. Pesco Koplowitz is Chief Medical & Scientific Officer of DUCK FLATS Pharma, (Flemington, New Jersey), which specializes in adult and pediatric translational medicine, clinical pharmacokinetics, and nonclinical development in all therapeutic areas, including oncology. Dr. Pesco Koplowitz has received numerous awards in clinical research throughout her career. She has served on the FDA/PhRMA QT Working Group Committee. Since 2007, she has been a member of the Advisory Committee of the FDA Cardiac Safety Research Consortium (CSRC). Since 2015, she is also an invited member of the International Neonatal Consortium of the Critical Path Institute for FDA/EMA/PMDA. She is a frequently invited speaker and lecturer in overall drug development and regulatory strategy in adult and pediatric patients, translational medicine, neonatal medicine, clinical pharmacology, and cardiovascular safety. Dr. Pesco Koplowitz has been responsible for numerous successful INDs and NDAs/CTDs in multiple therapeutic areas during her 30-plus year career and holds several use patents in the treatment of various diseases. She is author or co-author of over 30 publications and is a reviewer for several clinical pharmacology, cardiology, and pediatric medical journals.

Job Titles:

• Member of the Leadership Team
• Vice President of Clinical Operations

Ms. Nancy Cameron has worked in the clinical research industry for over 25 years. She obtained her BS degree in Radiologic Science from the University of North Carolina at Chapel Hill and has a MA in Educational Administration. Nancy has proven abilities in the monitoring and management of Phase I to Phase IV Clinical Trials across a broad range of therapeutic areas, with an emphasis in central nervous system (CNS) drug development. Her CNS experience has spanned from small, complex Phase 1 and II studies to Phase 3 global trials in Alzheimer's disease, mild cognitive impairment, Parkinson's disease, Multiple System Atrophy, Multiple Sclerosis, Attention Deficit Disorder, sleep, analgesia, and CNS rare diseases within adult, geriatric, and pediatric populations. Nancy began her clinical research career as a Clinical Research Associate. After five years of clinical monitoring, she moved to project management and has progressed to increasing roles of responsibilities. At Clinilabs as Vice President of Clinical Operations, Nancy oversees and supports a specialty CNS group of project managers, monitors, and other study team members to ensure timely delivery and quality