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Clinical Trial Management Thought Leadership

Scientific:

 

Joyce Suhy, Ph.D. Vice President and Head of Neuroscience

Dr. Joyce Suhy leads the design and technical oversight of neuroscience clinical trials and provides training to staff involved in these studies. She has been working in the field of MRI and Spectroscopy for over 20 years and has a wealth of experience managing neuroscience clinical trials. Prior to joining Bioclinica, Dr. Suhy worked at Synarc, where she was the VP of Neuroscience, and at SurroMed, Inc. where she was a Clinical Research Specialist responsible for the development, design, and evaluation of a standardized protocol for a multiple sclerosis program.

Dr. Suhy received a PhD in Biochemistry from Loyola University and completed a post-doctoral Research Fellowship in the Department of Radiology at the University of California at San Francisco where her work focused on utilizing MR spectroscopy and imaging to quantify metabolites within the human brain as a method to diagnose and predict the onset of neurodegenerative diseases such as epilepsy, multiple sclerosis, and amyotrophic lateral sclerosis.

Dr. Suhy is a recipient of many honors and grant awards including the Co-principal investigator NIH RO1 Grant, the Principal Investigator NIH National Research Service Award and the Principal Investigator National MS Society Fellowship. She has authored numerous journal articles and book chapters in the neuroscience area and has participated on several expert panels to advance the use of imaging in clinical trials. She is also member of the EU/US Task Force for Alzheimer's Disease, an international group of renowned experts on AD clinical trials.

 

J. Michael O'Neal, M.D.

As the Chief Medical Officer at Bioclinica, Dr. O'Neal provides leadership to all on-staff radiologists and external radiology consultants, manages the organizational planning and operational needs of Bioclinica's Medical Affairs department, and oversees physician training, service quality, and process improvements.

Dr. O'Neal is a graduate of Rutgers University and earned his M.D. at the Universidad Autonoma de Guadalajara. He has over 20 years of experience with extensive clinical training in internal medicine and diagnostic radiology including an imaging fellowship at St. Barnabas Medical Center. In addition to oversight of imaging data in support of regulatory approval for many oncology drugs, Dr. O'Neal has participated in protocol review, charter development, and independent review for nearly 300 clinical trials to date.

Dr. O'Neal holds certifications from the American Board of Radiology and the American College of Radiology and is a member of many professional organizations, including the Radiological Society of North America (RSNA), the American College of Radiology (ACR), the American Medical Association (AMA), the Drug Information Association (DIA), the American Society for Clinical Oncology (ASCO), and the American Society of Hematology (ASH). Prior to joining Bioclinica, he served as the Chairman for the Department of Radiology at the Hospital Center at Orange, as the Vice President of Medical Affairs at RadPharm, and as the Chief Medical Officer at Core Lab Partners.

Read Michael O'Neal's blog posts at Bioclinica's Trial Blazers blog.

 

Jeff Heilbraun, M.S.

Jeffrey Heilbraun attended Tufts University in Boston, Massachusetts where he completed his Bachelor of Science degree in Biology with a focus on physiology. Jeff continued his studies at The American University in Washington D.C., receiving a fellowship and completing his Masters of Science in Health Promotion and Disease Management. He was employed at The American University as an adjunct professor in the Health Promotion program. Jeff joined the Medifacts team in 1993 and has supported activities in Data Management, Operations, and Business Development. Throughout his career at Medifacts, Jeff has maintained his focus on the science and physiology behind cardiac safety within pharmaceutical development, with a special interest in hemodynamics. Jeff has presented posters and session participation at the Drug Information Association (DIA) meeting, American Society of Hypertension (ASH), Canadian Clinical Pharmacology Association and recently at the Cardiac Safety Research Consortium (CSRC).

Read Jeff Heilbraun's blog posts at Bioclinica's Trial Blazers blog.

 

Ronald L. Van Heertum, M.D., Vice President of Oncologic and Molecular Imaging

Ronald L. Van Heertum, MD is Vice President of Oncologic and Molecular Imaging at Bioclinica. He is responsible for the management and implementation of all aspects of Molecular Imaging. Prior to coming to Bioclinica, Dr. Van Heertum was Professor and Executive Vice Chairman/CAO, Department of Radiology at Columbia University College of Physicians & Surgeons as well as Director of Nuclear Medicine and PET. In this position he participated in many clinical trials in oncology, neurology and psychiatry and established an international reputation in SPECT and PET imaging. He has authored or co-authored over 250 publications and is the editor of a book on Brain Imaging that is now in its 4th Edition. He has been an active member of the RSNA, American College of Radiology where he is an FACR, a life member and former Chairman of the American Board of Nuclear Medicine and the Society of Nuclear Medicine and is listed in Who's Who in America, Who's Who in Medicine and Healthcare and The Best Doctors in America.

Read Ronald Van Heertum's blog posts at Bioclinica's Trial Blazers blog.

 

Thomas Fuerst, Ph.D., Chief Science Officer and Head of Musculoskeletal

Dr. Thomas Fuerst leads the design and technical oversight of musculoskeletal clinical trials for Bioclinica. As Chief Science Officer, he provides training to scientific and operational staff involved in musculoskeletal studies. Dr. Fuerst is a trained medical physicist with more than 13 years of research experience in bone densitometry, vertebral fracture methods and body composition assessment with a focus on multicenter clinical trials. Dr. Fuerst received his Ph.D. in medical physics from the University of Wisconsin at Madison for work investigating dual-energy imaging techniques for quantitative measurements in cardiology.

Prior to joining Bioclinica, Dr. Fuerst was a faculty member of the University of California, San Francisco, where he served as Director of the Quality Assurance Center and as Associate Director of the Osteoporosis and Arthritis Research Group (OARG). While at UCSF, Dr. Fuerst conducted groundbreaking research in the use of dual x-ray absorptiometry (DXA) and quantitative ultrasound to assess bone strength and fracture risk. He also successfully coordinated the collection, quality control and centralized analysis of densitometry scans and imaging data for international, multi-center Phase II and Phase III clinical trials. Dr. Fuerst went on to co-found the imaging core lab Synarc, where he served as Scientific Director.

As an active member of the International Committee for Standards in Bone Measurement, Dr. Fuerst has worked to improve, standardize and advance bone density technologies. He consults with industry and government agencies including the NIH, NIA, NCHS, and the State of California on the use of DXA to evaluate bone mineral density and body composition.

 

Tim Crowe, Director, Cardiovascular Imaging

As Director, Cardiovascular Imaging, Tim provides technical and operations imaging support and input to the CV therapeutic areas. His background suits him well to ensure quality and scientific integrity is maintained for all project deliverables. Prior to joining Bioclinica, Tim supported a renowned academic research group at the Cleveland Clinic leading their new business activities with a focus on the cardiovascular imaging sector of clinical trials. His experience in cardiovascular imaging stretches over the last 25 years and has included directing a prominent atherosclerosis imaging core laboratory which supported research in dyslipidemia, coronary intervention, intravascular ultrasound, cardiac transplantation, valve disease, hypertension and AAA devices to name a few. He has co-authored over 60 publications, numerous abstracts, presented at major scientific sessions and provided imaging and clinical research training for clinical trial meetings internationally.

 

Kenneth W Gaither, PhD., Head of Musculoskeletal

Dr. Kenneth W Gaither has global responsibility leading the implementation and oversight of clinical trials for Bioclinica and has more than 20 years of experience in bone densitometry, body composition assessment, vertebral fracture and morphology methods, and structural geometry of bone within international multicenter clinical trials. He has published on these areas in peer-reviewed journals, and is a member of the American Society for Bone and Mineral Research and the International Society for Clinical Densitometry. Dr. Gaither received his Ph.D. in systems science with a focus on the utilization of simulation modeling for risk based systems. He has held director and vice president level positions within project management, data management, site selection and operations in a variety of healthcare industries including clinical research organizations, centralized imaging laboratories, and medical device manufacturers. Prior to Dr. Gaither's career in healthcare, he served in the US Marine Corps as a signals intelligence officer and is a decorated veteran of foreign wars.

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