About Us
CLINTREX team members are internationally renowned leaders in the global scientific and neurological communities and have extensive experience in all aspects of the development process for new drugs, devices, and biologics. Clintrex members have held important leadership and consulting positions in academic, pharmaceutical, and regulatory communities. These include:
- Director of the FDA Division of Neurology Products (formerly the Division of Neuropharmacologic Drug Products
- Chairman of the FDA Peripheral and Central Nervous System Drugs Advisory Committee
- Consulting relationships with multiple divisions of the FDA, EMA, Health Canada, and Japanese FDA
- Senior associate dean of a medical school
- Chairman of a major neurology department at a medical school
- Director of a research institute at a medical school
- President and officer of multiple neurological societies, including the International Parkinson and Movement Disorder Society, International Medical Society for Motor Disturbances, and the American Neurological Association
- Editor and associate editor of major neurological journals including Movement Disorders and Neurology
- Chairs of multiple foundations and pharmaceutical advisory boards.
- Formation and operation of major multi-center clinical research groups, including the Parkinson Study Group (PSG), the Huntington Study Group (HSG), the Alzheimer’s Disease Cooperative Study (ADCS), and the NIH Exploratory Trials in Parkinson Disease (NET-PD) program
- Clintrex members have led more than 100 pivotal clinical trials that have resulted in the approval in the US, Europe, and Japan of multiple medical and surgical treatments for CNS disorders.
Managing Principals
Karl Kieburtz, MD, MPH
Managing Principal, Co-Founder
Karl Kieburtz, MD, MPH - Managing Principal, Co-Founder
Karl Kieburtz was the founder and President of Clintrex Research Corporation. Following its acquisition, Dr Kieburtz now serves as Managing Principal of Clintrex Research LLC, a division of Tox Strategies. He is a Professor of Neurology at the University of Rochester School of Medicine and also served as the inaugural Robert J Joynt Professor in Neurology, the Director of the Clinical & Translational Science Institute, and Senior Associate Dean for Clinical Research at the University of Rochester. Dr. Kieburtz is the past chair of the Parkinson Study Group Executive Committee, past member of the Huntington Study Group Executive Committee, and Scientific Advisor to the Alzheimer Disease Cooperative Study (ADCS) and chaired the ADCS Data Safety Monitoring Board for over a decade and chaired multiple DSMBs for industry-led AD clinical trials. He has served as an officer of the American Neurological Association, a member of the International Executive Committee of the Movement Disorder Society, and as Associate Editor of Neurology and Movement Disorders. He has served as PI of over 50 trials sponsored by the NIH, the FDA, and industry, and was Chair of the large NIH-sponsored NET-PD study. Dr. Kieburtz is an advisor to the Michael J Fox and Silverstein Foundations. He served as the Chair of the FDA Peripheral and Central Nervous System Advisory Committee, as the Chair of the Veteran’s Administration Cooperative Studies Program Scientific Evaluation Committee, and as a consultant to NIH. He has served on numerous editorial and scientific advisory boards and lectured widely on therapeutic development for neurodegenerative diseases.
Jordan Dubow, M.D.
Managing Principal
Jordan Dubow, M.D. – Managing Principal
Jordan Dubow was previously the Chief Medical Officer and President of Clintrex. Following its acquisition, Dr. Dubow now serves as a Managing Principal of Clintrex Research, LLC, a division of Tox Strategies. Dr. Dubow attended medical school and completed training in Neurology at the Northwestern University Feinberg School of Medicine in Chicago. He then completed fellowship training in movement disorders and vascular neurology at Evanston Northwestern Healthcare in Chicago and Weil Cornell Medical College/New York Presbyterian Hospital in New York. He has more than 20 years of clinical trial experience as an Investigator and in the pharmaceutical industry, mainly as a biotech Chief Medical Officer. He has served as the chief medical officer and a member of the executive management committee for over a dozen companies in either a full-time or acting role. He has extensive experience in clinical development, medical affairs, business development and regulatory affairs and has worked on over 20 new drug applications in the United States, Europe, Australia, and Canada. Dr. Dubow has been involved in dozens of regulatory interactions with the FDA and ex-US regulatory agencies. Through investor relations work, he has helped companies raise over 1 billion dollars
Vice Presidents/ Senior Advisors
Russell “Rusty” Katz, MD
Senior Regulatory Advisor
Russell “Rusty” Katz, MD – Senior Regulatory Advisor
Dr. Katz joined CLINTREX® in December 2014 as Senior Regulatory Advisor. He attended medical school and trained in Neurology at the Albert Einstein College of Medicine in New York City. He joined the Food and Drug Administration (FDA) in March 1983 as a medical officer in the Division of Neuropharmacological Drug Products (DNDP).
Shortly after starting at the FDA, Dr. Katz was named as the Deputy Director of the Division. In November 1999, he was appointed Director of the Division (now known as the Division of Neurological Products) and maintained this position until his retirement in June 2013.
Dr. Katz has focused his academic interest on scientific and regulatory issues related to drug development. He has published numerous chapters and articles pertaining to all aspects of the development of drugs and biological products for the treatment of a wide array of neurologic diseases and has lectured extensively on these topics.
He is the recipient of numerous awards and honors including the Ronald and Nancy Reagan Research Award from the Alzheimer’s Association, the Lifetime Achievement Award for Alzheimer’s Disease Therapeutic Research presented by the Sixth Congress of Clinical Trials on Alzheimer’s Disease, the Extraordinary Contributions Award from the American Epilepsy Society; and the FDA Distinguished Career Service Award.
Dr. Katz is widely recognized as one of the leading authorities in clinical trial issues and regulatory affairs related to neurological drug development.
Nick Kozauer, MD
Vice President, Regulatory Strategy
Nick Kozauer, MD – Vice President, Regulatory Strategy
Nick Kozauer spent over 13 years at the Food and Drug Administration (FDA), holding multiple leadership positions within the neurology drug review divisions. Most recently, Dr. Kozauer served as the director of the Division of Neurology 2 (DN2) in the Office of Neuroscience (ON) from 2019-2023, overseeing the regulation of drugs being developed for the treatment of stroke, migraine, epilepsies, and multiple sclerosis and other neuroinflammatory disorders. Following his time at FDA, Dr. Kozauer was Senior Vice President for Clinical Development and Regulatory Strategy at Biohaven Pharmaceuticals. In this role, Dr. Kozauer provided regulatory and clinical development guidance across the company’s pipeline comprising over 20 development programs for neurological, psychiatric, immunologic, and oncologic indications. Additionally, he led the clinical development of a TYK2/JAK1 inhibitor being studied for the treatment of early Parkinson’s disease and other neurodegenerative and neuroinflammatory disorders.
Dr. Kozauer earned his MD at Rutgers New Jersey Medical School and completed a psychiatry residency at Georgetown University Hospital and a combined geriatric and neuropsychiatry fellowship at the Johns Hopkins Medical Center. Following his training, Dr. Kozauer was appointed as the Director of Neuropsychiatry at the Johns Hopkins Memory Center at the Copper Ridge Institute.
Andrew McGarry, M.D.
Vice President, Clinical Development
Andrew McGarry, M.D. – Vice President, Clinical Development
Andrew McGarry, MD obtained a neuroscience degree at the University of Rochester, is a graduate of the University of Medicine and Dentistry of New Jersey Robert Wood Johnson Medical School and completed
neurological training at the University of Rochester Medical Center, including a fellowship in Experimental Therapeutics and Movement Disorders.
At Clintrex he oversees the Clinical Development Division. Dr. McGarry has extensive experience analyzing and interpreting preclinical and clinical data, designing Phase 1, Phase 2, and Phase 3 clinical trials, oversight of study enrollment authorization, safety oversight for numerous studies including as Safety Monitoring Committee Chair, anomalous data review, and ongoing partnership with a variety of client personnel (preclinical, statistical, clinical, regulatory) to optimize the overall development plan.
He is also currently an Associate Professor of Neurology at Cooper University Healthcare at Rowan University, where he helps oversee the movement disorder clinic and treats a variety of neurodegenerative diseases. Dr. McGarry is a member of the Huntington’s and Parkinson’s Study Groups and has interest in genetic modifiers and metabolomics in Huntington’s Disease, non-motor features of Parkinson’s Disease, and rational repurposing of existing medications for unmet needs in movement disorders. He has served as site investigator or co-investigator for numerous clinical studies, particularly in Huntington’s and Parkinson’s Disease, and has developed and initiated several investigator-initiated clinical studies. His experience also includes leadership and authorship for numerous manuscripts and book chapters over the last 15 years in neurodegenerative diseases.
Robert A. Hauser, M.D., MBA, FAAN
Senior Advisor
Robert A. Hauser, M.D., MBA, FAAN, Senior Advisor
Professor of Neurology, University of South Florida College of Medicine
Dr. Robert Hauser is a Professor of Neurology at the University of South Florida College of Medicine in Tampa, Florida. He serves as Director of the USF Parkinson’s Disease and Movement Disorders Center, a Parkinson Foundation Center of Excellence. Dr. Hauser earned his medical degree from Temple University School of Medicine in Philadelphia, Pennsylvania, and completed neurology training at the Eastern Virginia Graduate School of Medicine, in Norfolk, Virginia.
Dr. Hauser completed a fellowship in Movement Disorders at the University of South Florida and became Center Director in 1994. He has authored or co-authored more than 350 peer-reviewed publications and is one of the world’s most cited Parkinson’s Disease investigators. He is Past Chairman of the Interventional Neurology Section of the American Academy of Neurology, has served on the executive committee of the Parkinson Study Group, and was a member of the steering committee for the NIH-sponsored Neuroprotective Exploratory Trials in Parkinson’s Disease program (NET-PD). Dr. Hauser lectures frequently at scientific meetings around the world.
Dr. Hauser’s primary research interest is the development of new medical and surgical treatments for Parkinson’s disease and other movement disorders. He has extensive expertise in clinical trial design and execution. The outcome measures he developed have become the gold standard for use in clinical trials. Dr. Hauser maintains an active clinical practice and he has been voted a Top Doctor by his peers every year since 1993.
Cornelia Kamp, MBA
Vice President, Operations, Co-Founder
Cornelia Kamp, MBA – Co-Founder, Vice President, Operations
Ms. Kamp is the Vice President, Operations of CLINTREX®. She is a Research Associate Professor of the University of Rochester and serves as Executive Director of the Clinical Materials Services Unit (CMSU) in the Center for Human Experimental Therapeutics. She received a Master’s Degree in Business Administration (Operations Management and Finance) from William E. Simon School of Business Administration, at the University of Rochester.
She has had nearly 35 years’ experience in pharmaceutical-based research including project management, clinical drug/device supply services, data
management, operations, budgets, contracts, site management, site activation, and regulatory. Ms. Kamp has overseen the operations of more than 150 multi-center international clinical trials and managed nearly 30 INDs from initial submission through annual reporting and creation of the final Clinical Summary Reports (CSRs).
She served as the Director of Clinical Research Operations at the Clinical Trials Coordination Center (CTCC) at the University of Rochester for more than 8 years and was formerly Vice President of Site Operations for SCIREX (now the Premier Research Group).
Directors
Margherita Torti, M.D.
Medical Director
Margherita Torti, M.D. – Medical Director
Margherita Torti, MD obtained her medical degree from the University of Rome and trained in Neurology at the Neurological Department of the University “La Sapienza.” During her residency, she joined the Center for Movements Disorders of the University, researching non-motor symptoms of Parkinson’s disease.
She performed a fellowship at the Center for Movement Disorders in Markam, Canada, where she had the opportunity to further specialized in Movement Disorders. After returning to Italy, Dr. Torti worked at the Clinical Trial Center for Parkinson’s disease and Movement Disorders of the IRCCS San Raffaele Pisana, Rome, Italy where she served as sub-investigator and project coordinator in many clinical trials.
She participated also in many investigator-initiated projects aimed to investigate the epidemiology, risk factors, and clinical aspects of Parkinson’s disease.
Beverly Moore, M.S.
Director, Business Development
Beverly Moore, M.S. – Director, Business Development
Beverly Moore has been the Director, Business Development, since 2016 working closely with new clients on CDAs, providing proposals, and contracts. She is a retired nurse who received her Master’s degree in Health Services and is also a paralegal from the University of Florida.
Previously, she was a Director for a maximum-security facility where she managed services for the incarcerated population, as well as, maintained fiscal management of county, state, and federal funds. She also was a highly successful grant writer, trainer, and public speaker providing education in national seminars for correctional program development.
She served on multiple county advisory boards and was the recipient of the award for outstanding public service and several national achievement awards for program development.
Utilizing her blend of legal and business experience, she later became General Manager for a prominent Longboat Key Association, managing the affairs of the association including financials, accounting and budgeting procedures, personnel practices, regulations of the state and standards of the association, inventory and procurement, contract relations and negotiations, and activities for capital improvements.
Julie Kennedy, RN, CCRP
Director, Project Management
Julie Kennedy, RN, CCRP – Director, Project Management
As the Director, Project Management of Clintrex, Ms. Kennedy is responsible for the oversight of projects, ensuring compliance with timelines, milestones, and budgets; as well as the administration of Clintrex independent enrollment adjudication committees. She also supports the VP, Operations, and contributes to Business Development activities.
Ms. Kennedy is a registered nurse with 20 years of experience in pharmaceutical CNS research, including project management, site operations, protocol development, and training. She has been a Certified Clinical Research Professional (CCRP®) through SoCRA since 2009 and was a Certified Clinical Research Coordinator (CCRC®) through ACRP from 2002 to 2009.
Biostatistics
Mika Leinonen M.Sc
Biostatistical Advisor – Clinical Trials
Mika Leinonen M.Sc. - Biostatistical Advisor – Clinical Trials
Mika Leinonen is a biostatistical advisor to CLINTREX® who focuses on the development of clinical study protocols, statistical analysis plans, and data analysis. He has an M.Sc. degree in statistics and has worked in the pharmaceutical industry for more than 25 years. He worked with Orion Pharmaceuticals from 1995-2003. He subsequently established a statistical consulting firm called 4Pharma AB with operations in Sweden and Switzerland.
He has extensive experience in statistical and regulatory issues related to clinical trials including traditional and novel statistical analytic methodology. He has served as the primary statistician for more than 50 clinical studies in the areas of movement disorders and neurodegenerative diseases and has been responsible for statistical work leading to the approval of several drugs.
He also has statistical experience in various other therapeutic areas including oncology, respiratory diseases, cardiology, and rare diseases. He has had numerous face-to-face meetings with the FDA, EMA, and the PMDA in Japan, both as an employee of pharma companies and as an external consultant.
In Memoriam
C. Warren Olanow, MD, FRCPC, FRCP (hon)
C. Warren Olanow, MD, FRCPC, FRCP (hon)
C. Warren Olanow M.D. An exceptional colleague, mentor, and friend who dedicated his life to
improving the lives of people afflicted with movement disorders, through both clinical practice
and pioneering research and a world renowned author for his publications in Parkinson’s
disease.
He had been Chief Executive Officer of CLINTREX since its founding in 2008. He was the
former Henry P. and Georgette Goldschmidt Professor and Chairman of the Department of
Neurology, at the Mount Sinai School of Medicine in New York City, and served as Professor
Emeritus in the Department of Neurology and in the Department of Neuroscience. He received
his medical degree from the University of Toronto and performed his neurology training at the
New York Neurological Institute at Columbia University. He was Past President of the
Movement Disorder Society, Past President of the International Society of Motor Disturbances,
Past Treasurer of the American Neurological Association, and past Editor-in Chief of the journal
Movement Disorders. He was a founding member and served on the initial Executive
Committee of the Parkinson Study Group. He had led multiple pivotal clinical trials including the
Pergolide study, ADAGIO study, STRIDE-PD, DBS for tremor, DBS for PD, Fetal nigral
transplantation, gene delivery of neurturin, the recently approved trial of levodopa/carbididopa
intestinal gel (Duopa®) treatment and the pivotal study testing the apomorphine sublingual strip.
He had served on dozens of Scientific Advisory Committees for pharmaceutical and biotech
companies, including the Michael J Fox Foundation, and the National Space Board Research
Institute. He was an honorary professor at University College London (Royal Free Hospital), an
honorary member of the French Neurological Society, an honorary fellow of the Royal College
of Physicians in the United Kingdom (FRCP). He was the recipient of the 2013 movement
disorder research award from the American Academy of Neurology and the lifetime
achievement award from the International Parkinson and Movement Disorder Society. Warren
had an unwavering commitment to helping others through his research, support, and his
friendships. His legacy will live on through the countless lives he has touched, and we are
forever grateful. He will be missed.
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