Medical & Science Expertise
Bioclinica’s management team comprises industry leaders and experts representing scientific, medical, technology, clinical operations, and business facets supporting successful clinical development.
Michael O’Neal, MD
Chief Medical Officer
Michael O’Neal, MD, is Chief Medical Officer at Bioclinica. As a key member of the senior executive team, Dr. O’Neal is responsible for overseeing all medical affairs efforts within the organization, providing strategic leadership to clinical teams while collaborating with sponsors in all aspects of medical imaging protocol development. Drawing on extensive clinical experience in internal medicine and diagnostic radiology, he oversees physician training, service quality, and process improvements while advising on medical operations, regulatory compliance, and the investment of new technologies across medical imaging.
During his 17 years with Bioclinica, Dr. O’Neal has developed and championed improved standards that enable research sites to produce comparable study data across the globe and has provided oversight of imaging data for more than 75 regulatory approvals. Throughout his tenure, he has played a central role in protocol review, charter development, a reader on multiple trials, and independent oversight of over 400 clinical trials to date. He is a member of professional organizations including the Radiological Society of North America, the American College of Radiology, the American Medical Association, the Drug Information Association, the American Society for Clinical Oncology, and the American Society of Hematology. In 2019, he was recognized by PharmaVOICE magazine as one of the “100 Most Inspiring People in the Life-Sciences Industry”.
Prior to his role at Bioclinica, Dr. O’Neal served as Chairman for the Department of Radiology at the Hospital Center at Orange and the head of Central Medical Imaging MRI center. Dr. O’Neal holds certification in Diagnostic Radiology from the American College of Radiology, in addition to fellowship training in Body Imaging. He is the author of several papers, a speaker at many industry meetings, and was a contributor to the iRECIST Committee prior to publication.
Robert Ford, MD
Senior Advisor, Chief Medical Officer Emeritus
Robert R. Ford, MD, joined Bioclinica in 2020 as a Senior Advisor, Chief Medical Officer Emeritus. In this role, Dr. Ford consults with customers, is responsible for the medical and scientific publication process at Bioclinica, and oversees FDA and regulatory guidance and reader metrics.
Dr. Ford brings more than three decades of clinical experience to Bioclinica after practicing as a radiologist at Princeton Radiology Associates. He also served in various consulting roles and as a clinical instructor throughout the Northeast.
Prior to joining Bioclinica, Dr. Ford founded Clinical Trials Imaging Consulting, LLC, a company specializing in providing consulting services in the area of medical imaging (radiology) in all aspects of drug development. Dr. Ford, was also the founder of RadPharm, an imaging core lab dedicated to the independent review of diagnostic imaging studies for pharmaceutical, biotech and regulatory agencies. During his various consultancies, he helped support the approval of multiple drugs including, but not limited to Herceptin, Eloxatin, Velcade, Sutent, Vectibix, Ixempra, Treanda, Doxil, Avastin and Pegloticase.
Dr. Ford is an author of the Response Evaluation Criteria of Solid Tumors (RECIST 1.1), and the Guidelines for Response Criteria for Use in Trials Testing Immunotherapeutics (iRECIST), both internationally accepted Response Criteria used to standardize patient response to therapy.
He received his B.S. degree from Rutgers University, his MD degree from Robert Wood Johnson Medical School and completed an internship in Internal Medicine and subsequently training in Diagnostic Radiology at Cornell University Medical Center-New York Hospital, Memorial Sloan Kettering Cancer Center, and the Hospital for Special Surgery.
Julie Cole, MD
VP, Medical Imaging, Oncology
Julie Cole (formerly Julie Barudin) received a B.S.E. in Electrical Engineering and Computer Science (cum laude) from Princeton University, and an M.D. from the College of Physicians and Surgeons of Columbia University. She completed a residency in diagnostic radiology at New York University Medical Center, with fellowships in Body Imaging and Women’s Imaging. She is licensed in New Jersey, New York, Pennsylvania and Delaware and board certified by the American Board of Diagnostic Radiology.
Following training, Dr. Cole served as Assistant Professor of Radiology, Ultrasound Division, at NYU Medical Center, and subsequently as Assistant Professor of Radiology, Breast Imaging Division, at the University of Pennsylvania School of Medicine. Before joining BioClinica in 2004, she worked in clinical women’s imaging at Hackensack University Medical Center and at Orange Regional Medical Center where she served as Director of Women’s Imaging.
She has contributed to presentations at the RSNA, and has co-authored articles published in Breast Disease and Preventive Medicine journals as well as chapters on breast imaging for multiple radiology textbooks.
Kevin J. Byrne, MD
Dr. Byrne received his BA degree from Tulane University and his MD degree from the Georgetown University School of Medicine. He completed a residency in diagnostic radiology and a fellowship in cross-sectional imaging at Thomas Jefferson University. Dr. Byrne is also a registered vascular technologist.
Prior to joining BioClinica (formerly CoreLab Partners) in 2006, Dr. Byrne has practiced diagnostic radiology for more than 20 years at Chestnut Hill Hospital where he also served as the Quality Assurance Director for the Department of Radiology and as a member of the hospital Cancer Committee. Dr. Byrne also holds a faculty appointment in the Master of Medical Science program at Arcadia University.
Dr. Byrne has been board certified in Diagnostic Radiology since 1983 and is a member of several professional organizations including the American College of Radiology, the Radiological Society of North America, and the Association of Radiologists in Ultrasound.
Michael Cadogan, MD
Dr. Cadogan completed his Pre-medical studies and received his MD degree from the University of the West Indies, Jamaica. He completed his residency in Diagnostic Radiology at the University of Leicester and the University of Birmingham, England. Following an additional year of Residency at Hartford Hospital, CT, he completed a Fellowship in Thoracic Imaging at the University of Maryland and the Armed Forces Institute of Pathology in Washington, DC.
Prior to joining BioClinica (formerly CoreLab Partners) in 2006, Dr. Cadogan held faculty appointments at the University of Melbourne (Australia) and the University of Maryland School of Medicine. His clinical appointments include Head of CT section of the Radiology Department at St. Agnes Hospital, MD, Medical Director of Seton Imaging Center, MD, and Attending Radiologist at North Arundel and Carroll County Hospitals, MD. Prior to that, he was an Attending Radiologist to the Dudley & Stourbridge Hospital Group (UK), during which time he gave numerous lectures and seminars to Radiology Residents and Medical Students from the nearby University of Birmingham.
Dr. Cadogan is a Diplomate of the American Board of Radiology and a Fellow of the Royal College of Radiologists (UK). He is a member of several professional organizations including the American Roentgen Ray Society, the Radiological Society of North America, and the Society of Thoracic Radiology.
Dr. Cadogan’s research interests include pulmonary disease of unknown origin and immunological disorders of the lung.
David DiPaolo, MD
Jeff DiPaolo, MD
Ruth Feldman, MD
Ruth Feldman is a graduate of the City College of New York and Robert Wood Johnson Medical School. She completed her residency in radiology at Columbia University College of Physicians and Surgeons, Overlook Hospital. Prior to joining BioClinica (formerly CoreLab Partners) in 2002, Dr. Feldman was a radiologist in the Department of Medical Imaging at Hunterdon Medical Center where she was also the Associate Director of the Hunterdon Regional Breast Care Program. She also served as the President of the Hunterdon County Medical Society and Chairperson of the Department of Medical Imaging.
At BioClinica Dr. Feldman has participated in over 15 clinical trials. She is a member of several professional organizations, such as ACR, Society of Breast Imaging, RSNA, AAPP, DIA and AOA. She also taught at Robert Wood Johnson Medical School and has written numerous patient information articles, addressed public forums and given Grand Rounds on Women’s Health Issues, particularly Breast Cancer and Osteoporosis.
Elizabeth Greenstein, MD
Nuclear Medicine and PET Radiologist
Beatriz Lega, MD
Dr. Lega received her MD degree from the Medical School of the National University of Cordoba, Argentina. She completed her internship and residency in Internal Medicine at Mountainside Hospital and at UMDNJ-Rutgers Medical School (now Robert Wood Johnson) and completed her fellowships in Oncology and Hematology at Rhode Island Hospital (Brown University) and Rutgers Medical School. She teaches at both the Drexel University College of Medicine and the Robert Wood Johnson Medical School where she is a Clinical Professor of Internal Medicine.
Prior to joining BioClinica (formerly CoreLab Partners) in 2007, Dr. Lega has been in practice in the Hematology-Oncology Department at Saint Peter’s University Hospital and the Garden State Medical Group/HIP of New Jersey where she developed an out-patient chemotherapy treatment and transfusion unit and became chief of the Internal Medicine and Oncology Divisions. Dr. Lega was also on staff at the Oncology unit at Rhode Island Medical Center. For many years she served as a member in the Cancer Committees at Robert Wood Johnson University Hospital and at Saint Peter’s University Hospital, where she was Tumor Board Moderator and Chair of the Cancer Committee.
Dr. Lega is board certified in Internal Medicine, Medical Oncology and Hematology, and a member of the American Society of Clinical Oncology and the American Society of Hematology.
With more than 20 years of clinical practice in Medical Oncology, Dr. Lega main research and clinical interests has been the prevention and treatment of breast cancer. She has been an investigator for many years in NSABP clinical trials and has participated in CALGB, ECOG and multiple industry-sponsored clinical trials and is registered with the National Cancer Institute as an independent investigator. She has presented on prostate cancer and written on bladder involvement in metastatic breast cancer.
Robert Ludwig, MD
Katherine Slazak, MD
Dr. Slazak received her M.D. from New York Medical College. Prior to joining Bioclinica (formerly CoreLab Partners) Dr. Slazak was an assistant attending physician at Imaging Consultants of Essex. She also served as the Director of Medical Education at the Hospital Center at Orange in Orange, NJ. Dr. Slazak completed her residency with the radiology department at Livingston Medical Center and with the pathology department at Rutgers Medical School. She is board certified by the American Board of Radiology.
John Wolodzko, PhD, FACNM, DABSNM
Senior Medical Imaging Physicist
As Senior Medical Imaging Physicist at BioClinica, John Wolodzko provides expertise and support for the analysis and review processes of Molecular Imaging studies, including imaging facility qualification and validation and training of the tools used by technical and radiology staff. John is a Certified Medical Physicist with over 20 years of industry experience in medical physics and nuclear medicine. He is also recognized as a Diplomate in Physics and Instrumentation of the American Board of Science in Nuclear Medicine. John has a BA in Physics from LaSalle University and obtained a MSc degree in Radiation Physics and a PhD in Radiation Physics from Rutgers University.
John is a Fellow of the American College of Nuclear Medicine and a member of several professional organizations including the American Association of Physicists in Medicine (AAPM), the American Association for Cancer Research (AACR), the American College of Nuclear Medicine (ACNM), the Society of Nuclear Medicine (SNM), and the Radiological Society of North America, Quantitative Imaging Biomarkers Alliance (RSNA-QIBA).
Prior to joining BioClinica, he served as the director of Medical Physics and Imaging at Cytogen and Senior Director of Imaging Sciences at Avid Radiopharmaceuticals. He lectures on Nuclear Medicine Physics at Thomas Jefferson University and has presented his work on radiolabeled antibodies and molecular imaging tools at numerous scientific conferences.
Joyce Suhy, PhD
Senior Vice President, Medical Imaging
Dr. Joyce Suhy is responsible for the Neuroscience and Cardiovascular Services at Bioclinica. Dr. Suhy leads the design and scientific oversight of the imaging endpoints for these clinical trials and provides training to staff involved in these studies. Dr. Suhy has authored numerous journal articles and book chapters in imaging of the brain since 1992. 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 multiple sclerosis. Dr. Suhy received her Bachelor’s degree in Chemistry from Northwestern University and her PhD in Biochemistry from Loyola University Chicago. She completed her 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, Alzheimer’s disease and amyotrophic lateral sclerosis. Dr. Suhy is a recipient of many honors and grant awards including a Co-Principal Investigator NIH RO1 Grant, a Principal Investigator NIH National Research Service Award and a Principal Investigator National MS Society Fellowship. She has authored numerous journal articles and book chapters in the neuroscience therapeutic area and has participated on several expert panels to advance the use of imaging in clinical trials.
David Scott, PhD
David Scott, Ph.D., is a Scientific Director at Bioclinica. His aim is to facilitate drug development through standardized measurement of the neural correlates of neurodegenerative and other centrally mediated diseases. As a student at Johns Hopkins University and the University of Michigan, he employed multi-modal imaging approaches including dynamic PET and functional MRI to study the neurobiology of placebo analgesia. At Omneuron, he developed real-time fMRI applications aimed at treating chronic pain, depression and addiction. Since joining Bioclinica in 2012, David’s focus has been to enable MRI and molecular imaging solutions toward safety, eligibility and therapeutic efficacy endpoints. He works with Bioclinica’s staff radiologists, physicists, software engineers, and operational specialists on the design, execution, analysis and interpretation of imaging clinical trials in the neuroscience therapeutic area. His motivation is to effectively translate advanced neuroimaging tools from the lab to the clinic, so that therapeutic benefit can be delivered to patients around the world.
Kate Adamczuk, PhD
Kate Adamczuk, Ph.D., is a Senior Scientist at Bioclinica. She oversees Molecular Imaging endpoints across phase I to III of multi-center neuroscience clinical trials. Her main goal is to utilize Molecular Imaging in combination with other biomarkers to facilitate the success of neuroscience clinical trials and accelerate patients’ benefits.
With more than ten years of experience in neuroscience and medical imaging, including positron emission tomography (PET), single-photon emission computerized tomography (SPECT), structural and functional magnetic resonance imaging (MRI), she develops clinical trial design strategies, serves as a scientific expert to Bioclinica clients and staff, plans and executes imaging research, and designs and assists with the implementation of processing pipelines.
Dr. Adamczuk completed her Ph.D. in Biomedical Sciences in the Department of Neurology at the University of Leuven (KU Leuven), where she focused on amyloid PET imaging and its correlation to genetic factors, language networks, cerebrospinal fluid biomarkers, and comparison across amyloid tracers in preclinical Alzheimer’s Disease (AD), Mild Cognitive Impairment and AD patients. During her Post-Doctoral Fellowship in the Department of Neurology at the Harvard Medical School and the Massachusetts General Hospital, she extended her research to Primary Progressive Aphasia and Frontotemporal Dementia patients and added tau and fluorodeoxyglucose (FDG) PET modalities.
Chris Conklin, PhD
Chris Conklin, PhD, is an MRI Scientist at Bioclinica Chris Conklin, PhD, is an MRI Scientist at Bioclinica responsible for the development and optimization of MR imaging endpoints within the drug development space. Chris works with experts in pharma and academic domains to translate these advanced imaging techniques into large, global multi-center trials. To support this endeavor, he designs, validates, and standardizes the acquisition and quantitative analysis of advanced MRI biomarkers. Prior to working at Bioclinica, Chris was an academic researcher interested in the development of higher-order diffusion imaging schemes and analytic tools for pediatric spinal cord and optic nerve functional characterization. He also managed technical operations for motor and language mapping for use in pre-neurosurgical planning. In addition, he has more than ten years of experience deploying task-based and resting state functional MRI designs across a broad spectrum of indications from obesity to intermittent explosive disorders. for the development and optimization of MR imaging endpoints within the drug development space. Chris works with experts in pharma and academic domains to translate these advanced imaging techniques into large, global multi-center trials. To support this endeavor, he designs, validates, and standardizes the acquisition and quantitative analysis of advanced MRI biomarkers. Prior to working at Bioclinica, Chris was an academic researcher interested in the development of higher-order diffusion imaging schemes and analytic tools for pediatric spinal cord and optic nerve functional characterization. He also managed technical operations for motor and language mapping for use in pre-neurosurgical planning. In addition, he has more than ten years of experience deploying task-based and resting state functional MRI designs across a broad spectrum of indications from obesity to intermittent explosive disorders.
Blaine Horvath, B.S.R.T. (R)(MR)(ARRT) CRT
Project Director, Molecular Imaging
Blaine Horvath is a Project Director within the Medical Affairs department. Mr. Horvath’s primary responsibilities include overseeing the design and implementation of various imaging technologies in support of company operations and initiatives. He manages the review of project imaging software as it relates to project endpoints and the execution of those findings as well as interfacing cardiovascular key opinion leaders within the Nuclear Medicine and echo modalities as needed.
Mr. Horvath has been with BioClinica for over 14 years, making significant contributions to imaging protocol design and review methodology for clinical trials across several therapeutic areas including oncology and neuroscience. He brings with him over 20 years of experience as a Radiologic Technologist during which he managed the daily operations of several radiology departments and developed MRI protocols for research purposes. He holds a Bachelor of Science in Radiologic Technology form California State University, Northridge and obtained clinical competency from the Department of Radiologic Sciences at the University of California, Los Angeles Medical Center. Mr. Horvath is certified by the American Registry of Radiologic Technologists (Radiography and Magnetic Resonance), and the California Department of Public Health-Radiologic Health Branch.
Luc Bracoud, MSc
Luc Bracoud graduated from Ecole Centrale Lyon in 2001. He joined Theralys in 2002, which was later acquired by BioClinica (formerly known as Bio-Imaging Technologies) as a software developer and medical image processing engineer. He also served as a project manager, and has been involved in various large multi-center clinical trials mainly in Stroke, MS and AD, as well as Gaucher Disease. His main image processing activities are related to spatial registration, segmentation, atrophy quantification, perfusion imaging, diffusion and diffusion tensor imaging.
Olivier Rousset, PhD
PET Scientist, Neuroscience
Olivier Rousset, PhD, is a PET Scientist at Bioclinica. He works closely with Bioclinica’s neuroradiologists, scientists, software engineers, and operation specialists on medical imaging endpoints for Neuroscience clinical trials. He also notably participates in the evaluation, training, and support of heterogeneous imaging facilities worldwide, and the deployment of advanced imaging protocols.
Prior to joining Bioclinica, Dr. Rousset was a researcher at Johns Hopkins Medical School in the department of radiology, where he pursued his work on improving PET accuracy through process automation and the development of study-specific analysis pipelines.
Dr. Rousset has many years of experience in Emission Tomography techniques with an emphasis on PET, as well as experience with structural MRI for multimodality correlation (registration, segmentation, atlasing). He formalized an entirely new method to address partial volume effects, the major source of quantification inaccuracies in PET. He extensively validated with original phantom experiments and computer simulations. He notably reported its accuracy and sensitivity to statistical noise and proposed a method to compute maximum expected inherent data variance increase -with experimental data closely following his theoretical predictions. Also, he developed methods to assess true image resolution of PET scanners as well as head movement correction solutions.
His partial volume correction method (usually referred to as the GTM, RSF, or Rousset method) has been adopted by groups such as Columbia University, University of Berkeley, Karolinska Institute (Sweden), and UCLA, as well as being supported by both open-source (e.g., SPM, PETpvc) and commercial (e.g., PMOD) software.
He has specific Neuroscience experience in Alzheimer’s Disease, Rett syndrome, Tourette syndrome, cocaine addiction, and Parkinson’s Disease.
His academic career includes holding a PhD in Biomedical Engineering at Claude Bernard University, Lyon 1 (France), where he also obtained his BS in Physics -Science and Structure of Matter, followed by post-doctoral fellowships at both the National Institute of Health and Johns Hopkins, which he joined as faculty as Research Associate in 2004.
Madhura Ingalhalikar, PhD
MRI Scientist, Bioclinica
Madhura Ingalhalikar, PhD, is an MRI Scientist at Bioclinica. In this role, Dr. Ingalhalikar is responsible for optimizing and developing quantitative endpoints for neuroscience clinical trials. She is an expert in MR neuroimage analysis with a focus on diffusion MR analysis. She has developed novel techniques in diffusion connectomics, neuro-radiomics, and AI-based analysis applied to Parkinson’s disease, multi-system atrophy, Duchene’s muscular dystrophy, autism, and brain tumors.
Prior to joining Bioclinica, Dr. Ingalhalikar was an Associate Professor and the founding member of Symbiosis Center for Medical Image Analysis (SCMIA), Symbiosis International University, where she led the research in medical image analysis. With a well-articulated vision, perseverance, and teamwork under her leadership, she brought SCMIA to an international repute.
Dr. Ingalhalikar earned her medical degree in Biomedical Engineering from the University of Iowa, where she focused on developing methods for deformable registration of diffusion tensor images. During her Post-Doctoral Fellowship followed by a full-time research scientist position in the Department of Radiology at the University of Pennsylvania, she extended her research in diffusion MRI to connectomics and machine-learning for neuro-image analysis.
Her work has been published in high impact journals such as Proceedings of the National Academy of Sciences (PNAS), Movement Disorders, Neuroimage, Human Brain Mapping (HBM), and more. She is part of the editorial board for the Journal of Neuroradiology and worked as an editor for invited topics in Frontiers in Neuroscience.
Thomas Fuerst, PhD
Chief Science Officer
Dr. Thomas Fuerst leads the design and scientific oversight of musculoskeletal clinical trials for Bioclinica. Dr. Fuerst received his Ph.D. in medical physics from the University of Wisconsin at Madison and has more than 13 years of research experience in bone densitometry, vertebral fracture methods and body composition assessment with a focus on multicenter clinical trials. Prior to joining Bioclinica, he 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, he 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 is also the co-founder of 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 routinely consults with industry and government agencies on the use of DXA to evaluate bone mineral density and body composition.
Klaus Engelke, PhD
Director of Special Imaging Techniques
Professor Klaus Engelke received a Ph.D. in Physics from the University of Hamburg, Germany for his pioneering work on µCT using Synchrotron Radiation. Afterwards he joined the Osteoporosis Research Group at UCSF (University of California at San Francisco) to develop advanced radiographic methods for the diagnosis of osteoporosis. At UCSF he also developed the first workstation for vertebral fracture analysis using digitized x-rays. He then joined the newly formed Institute of Medical Physics (IMP) at the University of Erlangen, Germany to develop desktop µCT Scanners and advanced image processing methods. Prof. Engelke joined Synarc, now Bioclinica, as a Director of Special Imaging Techniques in 2005. At the University of Erlangen he continues to develop novel in vivo and in vitro image acquisition and analysis techniques for the musculoskeletal field. He has authored more than 250 peer reviewed publications and more than 350 conference contributions.
In 2007, 2013 and 2015 Prof. Engelke chaired or was member of the QCT Task Forces that developed the official positions of the International Society of Clinical Densitometry (ISCD). He is member of the committee for the development of the German guidelines for the diagnosis and treatment of osteoporosis under the auspices of the DVO ‘Dachverband Osteologie’. He is also a member of the scientific advisory committee of the International Osteoporosis Foundation (IOF) and co-chaired the Committee on Bone Densitometry of the International Commission on Radiation Units (ICRU). He was co-president of the German 2011 Osteology meeting and co-president of the 21st International Bone Densitometry Workshop and 7th European Symposium on Ultrasonic Characterization of Bone in 2017 in Banz, Germany
In 2017 he was awarded the Dr. John P. Bilezikian Global Leadership Award from the International Society for Clinical Densitometry, which recognizes Klaus for his contributions to the advancement of osteoporosis and bone imaging research. In 2019 he was awarded the ‘Excellence in Research Award’ from the European Calcified Tissue Society (ECTS) for his pioneering research in musculoskeletal imaging.
Kenneth Gaither, PhD
VP, Medical Imaging
Dr. Kenneth W. Gaither has global responsibility leading the implementation and oversight of clinical trials for Bioclinica. With more than 25 years of experience, Dr. Gaither has expertise in the musculoskeletal, gastroenterology and respiratory therapeutic areas utilizing bone densitometry, endoscopy, MR enterography, body composition assessments, vertebral fracture and morphology methods, and structural geometry 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, the International Society for Clinical Densitometry, and the European Crohn’s and Colitis Organisation. 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.
Marcela Vieira, MD
Medical Director, Gastroenterology
Marcela Vieira, MD, is the Medical Director of Gastroenterology at Bioclinica. In this role, Dr. Vieira is responsible for Gastroenterology Services where she leads the design and medical and scientific oversight of the imaging endpoints for clinical trials and provides training to staff involved in these studies. Her focus is on innovation and collaboration, bringing cutting edge technology to the care of patients with gastrointestinal disorders.
Dr. Vieira is a physician-scientist and gastrointestinal endoscopist. She brings experience from early and late phase trials, having worked on Drug Safety and Clinical Development teams across various programs, including small molecules and biologics. She has also participated on the pre-clinical development of an oral polymer-based Duodenal Exclusion Therapy, inspired by the efficacy of gastric bypass surgery in improving metabolic abnormalities associated with Type 2 Diabetes. Her main interests lay in translating basic science discoveries into patient benefits across multiple therapeutic areas, including inflammatory diseases and immunology.
Prior to joining Bioclinica, she most recently worked in the pharmaceutical industry as a Clinical Research Physician at AstraZeneca and in academia as a Gastroenterology Researcher at Johns Hopkins University.
She has authored publications in high-impact journals such as GIE (Gastrointestinal Endoscopy Journal) and won the “Best Video Award” at Digestive Disease Week (DDW) 2016 sponsored by the American Society of Gastrointestinal Endoscopy.
Dr. Vieira earned her medical degree from Universidade José do Rosário Vellano (UNIFENAS) in Brazil and she is a board-certified gastrointestinal endoscopist by the Brazilian Society of Gastrointestinal Endoscopy (SOBED).
Vahan Sharoyan, PhD
Senior Scientist, Engineering
Dr. Sharoyan is an expert in the field of medical imaging and its applications for detection, monitoring and quantifying disease pathology. Specializing in MRI, he contributes to numerous clinical trials for pharmaceutical, and medical device industries. Dr. Sharoyan’s core expertise is in imaging endpoints, imaging protocol development and standardization, study startup, site qualification, image quality control and analysis. His experience spans across several therapeutic areas including Musculoskeletal diseases (MRI assessments in rheumatoid arthritis, osteoarthritis and ankylosing spondylitis), Neuroscience (MRI and PET of Alzheimer’s decease), Oncology (DCE MRI), Orthopedics as well as muscle and adipose tissue imaging in aesthetic medicine and muscle wasting. Dr. Sharoyan holds a PhD degree in Solid State Physics from the Institute for Physics Research of the Armenian National Academy of Sciences.
Mark W. Tengowski, DVM, MS, PhD
Director, Medical & Scientific Affairs
Dr. Tengowski brings a large breadth of applied medical knowledge, critical thinking ability, and drug development experience from compound nomination through post-marketing investigations to Bioclinica. In the industry since 1999, his imaging experience spans ultrastructural- and light-level microscopic evaluations to non-invasive imaging methods, applying imaging endpoints to nominate and advance compounds, manage safety findings, and achieve regulatory approval. Mark served as a medical advisor to the Business Development team, supporting new requests for clinical trials and consultation while being a scientific expert for projects with an inflammation or musculoskeletal focus (e.g., osteoarthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, NAFLD/NASH and cholangitis, Crohn’s disease, ulcerative colitis, deep vein thrombosis, women’s health [breast volume/density, vaginal dryness, uterine fibroids, and endometrial thickness], medical devices, and orphan diseases [hyperoxaluria, acid sphingomyelinase deficiency, Pompe disease, Gaucher disease, Niemann-Pick disease]). With a veterinary background in inflammation and pharmacology, Mark approaches protocols from a mechanistic point of view – devising an imaging strategy that will achieve the study’s objective and end points. In the external environment, Mark has been an invited speaker to the FDA and been the author of draft guidance issuances, given posters and podium presentations at national and international meetings, participated in several disease workshops, and published numerous abstracts, articles, and book chapters. Dr. Tengowski is a graduate of the University of Wisconsin-Madison and is licensed to practice veterinary medicine in WI and NY states, with USDA-accreditation, and a member of the American College of Rheumatology.
VP, Medical and Scientific Affairs Cardiac Safety Service
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. Throughout his career, Jeff has maintained his focus on the science, technology, trial design and regulatory considerations surrounding cardiac safety (ECG and blood pressure endpoints) 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), and at the Cardiac Safety Research Consortium (CSRC). He has supported publications in cardiac safety considerations in Oncology drug development and the regulatory considerations for “off-target” blood pressure response in compound development.
Bruce Lloyd, MD
Associate Medical Director and Director of Clinical Cardiology Services
Bruce K. Lloyd, MD is BioClinica’s Associate Medical Director and Director of Clinical Cardiology Services. Dr. Lloyd is responsible for the day to day operation of Bioclinica’s cardiovascular services. This involves answering clinical questions, supervising the cardiovascular technicians, and coordinating ECG interpretation services. He also provides clinical review and oversight for Quality Control processes.
Dr. Lloyd received a Doctor of Medicine degree from the Cornell University Medical College in 1972 and his initial training in Internal Medicine was completed at the Johns Hopkins Hospital. He completed his training in both Internal Medicine and Cardiovascular Diseases at the National Naval Medical Center in Bethesda, Maryland. Following completion of his training, Dr. Lloyd remained on the staff at the National Naval Medical Center. In 1984 he became the Chief of Cardiology at the National Naval Medical Center and was appointed as the Senior Cardiovascular Advisor to the Surgeon General. In 1985, Dr. Lloyd was selected as the Consulting Cardiologist for the White House serving under both President Ronald Reagan and President George H.W. Bush and was a consultant for the US Congress.
During his work at the National Naval Medical Center, Dr. Lloyd was the attending physician for one of the landmark cases involving drug interactions and its effect on the QT interval. He is one of the authors of the article ‘Toursade de Pointes Occurring in Association with Terfenadine Use’ reporting this significant drug interaction.
Since moving to Georgetown University, Dr. Lloyd has held multiple positions within the hospital. He has continued to teach and provide clinical care to a wide variety of patients. He has been a visiting professor at numerous locations including four different hospitals in the Russian Federation. He has received multiple awards for his teaching excellence.