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.
C. Warren Olanow, MD, FRCPC, FRCP (hon)
Chief Executive Officer, Co-Founder
C. Warren Olanow, MD, FRCPC, FRCP (hon) – Chief Executive Officer
C. Warren Olanow has been Chief Executive Officer of Clintrex since its founding in 2008. He is 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 currently serves as Professor Emeritus in the
Department of Neurology and in the Department of Neuroscience at this institution. 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 is a 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.
His research has focused on the cause and treatment of PD and other neurodegenerative diseases. He has
led multiple pivotal clinical trials and interacted with regulatory agencies leading to the approval of
Pergolide, DBS for tremor, DBS for PD, Safinamide, levodopa/carbididopa intestinal gel, and the
apomorphine sublingual strip. He also led important experimental clinical trials including the delayed start study (ADAGIO), the STRIDE-PD study, Fetal nigral transplantation, and gene delivery of neurturin. He has 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 is an honorary professor at University College London (Royal Free Hospital), an honorary member of the French Neurological Society, and an honorary fellow of the Royal College of Physicians in the United Kingdom (FRCP). He is 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.
Karl Kieburtz, MD, MPH
President, Co-Founder
Karl Kieburtz, MD, MPH - President/Co-Founder
Karl Kieburtz is a Professor in the Department of Neurology at the University of Rochester School of Medicine and Dentistry. He served as the inaugural Robert J Joynt Professor in Neurology, as the Director of the Clinical & Translational Science Institute and as the Senior Associate Dean for Clinical Research at the University of Rochester. He also was the Director of the Clinical Trial Coordination Center (CTCC) in the Department of Neurology for more than 20 years, Director of the Movement and Inherited Neurologic Disorders Unit, and was Co-Director of the Huntington and Parkinson Disease Centers of Excellence 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 continues to chair multiple DSMBs for 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 of Movement Disorders. He has served as PI of many clinical 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 Foundation and directed the Clinical Core for the Fox Foundation sponsored Parkinson Progression Marker Initiative. He served as the Chair of the FDA Peripheral and Central Nervous System Advisory Committee, as the Chair of the VA’s Cooperative Studies Program Scientific Evaluation Committee and served as a consultant to NIH. He has served on numerous editorial and scientific advisory boards. He has lectured widely on therapeutic development for movement disorders and neurodegenerative diseases.
Cornelia Kamp, MBA
Vice President, Operations
Cornelia Kamp, MBA - Vice President, Operations
Ms. Kamp is the Vice President, Operations of CLINTREX®. She is on the faculty 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 30 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 130 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).
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.
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.
Jordan Dubow, M.D.
Chief Medical Officer
Jordan Dubow, M.D. – Chief Medical Officer
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 15 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 at Paragon Biosciences, Avadel Pharmaceuticals and Marathon Pharmaceuticals, and as Vice President of medical affairs at Cynapsus Pharmaceuticals. Prior to these executive roles, Dr. Dubow was the clinical development lead for Duopa®/Duodopa at Abbvie and supported its approval in the United States. He has extensive experience in clinical development, medical affairs, business development and regulatory affairs and has worked on over 10 new drug applications in the United States, Europe, Australia and Canada. Dr. Dubow will lead the Chief Medical Officer division at Clintrex, where Clintrex Executives provide extensive Chief Medical Officer services for startup biotech and pharmaceutical companies. These services include leadership and support for clinical development, regulatory affairs, investor relations, business development and medical affairs.
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.
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.
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.
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.
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.
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