Clinical Trial Management Thought Leadership

Scientific:



Technology and Data Managment:

 

Joyce Suhy, Ph.D. Vice President 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.

 

Boaz Mendzelevski, M.D., Vice President of Cardiology

Dr. Mendzelevski, Vice President, Cardiology, received his degree in Medicine and Board Certification in Internal Medicine from the Ben-Gurion University Medical School and Hospital in Beer-Sheva, Israel. He then trained in cardiology and received a board certification in Cardiology from the Shaare-Zedek Medical Centre and Hebrew University in Jerusalem, Israel. Dr. Mendzelevski completed further postgraduate training in Interventional Cardiology and Clinical Electrophysiology at the Royal Brompton National Heart and Lung Hospital in London.

Dr. Mendzelevski has authored approximately 250 expert reports, most of which supported NDA regulatory submissions. He has represented pharma clients before the US FDA and the European regulatory authorities on several occasions and has participated in multiple pharmaceutical advisory boards and Data Safety Monitoring Boards (DSMBs). Dr. Mendzelevski was the only CRO expert to be invited by the FDA and ICH to serve on the ICH-E14 expert advisory panel.

 

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.

 

Hui Jing Yu, Ph.D., Medical Affairs Scientist

As a Medical Affairs Scientist at BioClinica, Dr. Yu provides scientific and medical support to sponsors on the utilization of imaging biomarkers in clinical trials across therapeutic areas including Metabolic diseases and Neuroscience. Dr. Yu also manages ongoing research projects and provides scientific support to BioClinica’s Business Development, Marketing, Software Development and Operations teams. She has written and co-authored scientific publications and book chapters with industry and academic experts including her work on quantitative imaging techniques, bone densitometry, phantom design, imaging metrics, and the utilization of imaging endpoints for trial enrichment.

Dr. Yu holds a B.E. degree in Biomedical and Electrical Engineering from Stony Brook University. She completed a MSc degree focusing on physiology and biophysics research and a PhD in Biomedical Engineering from Stony Brook University. Her doctoral thesis focused on the correlation between MRI/MRS biomarkers and cognitive function in Multiple Sclerosis.

Read Hui Jing'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.

 

Jennifer Price, Director of Clinical Solutions

Mrs. Price leads a team that works with potential customers to incorporate BioClinica’s eClinical technical solutions to efficiently collect and integrate data in clinical research programs. Over the past 25 years, she has held positions managing data managers, SAS programmers and validation services within various Pharmaceutical Companies and CROs. Jennifer is a CDISC Registered Service Provider (RSP), a member of the CDISC CDASH core team, a certified clinical data manager (CCDM) and involved with the MCC (Metrics Champion Consortium). Jennifer has presented many eClinical-related presentations at industry conferences and is a frequent blogger on BioClinica's Trial Blazers blog. She can be followed via Twitter at @eClinical_Jen.

Read Jennifer Price's blog posts at BioClinica's Trial Blazers blog.