Clinical Trial Management Thought Leadership

Scientific:



Technology and Data Managment:

 

Colin G. Miller, Ph.D., F.I.C.R., CSci, Senior Vice President of Medical Affairs

Dr. Colin G. Miller joined BioClinica, formerly Bio-Imaging Technologies in 1999 as Vice President of Business Development. Prior to joining BioClinica, Dr. Miller was Director of Clinical Services at Bona Fide, a company that was acquired by Bio-Imaging in 1999. Dr. Miller started Bona Fide Ltd in 1994 when he moved from the UK to Madison, Wisconsin. Immediately preceding this move, Dr. Miller served as the head of this Physical Measurements Team, Europe, at Procter & Gamble (P&G) Pharmaceuticals. Dr. Miller holds a BSc (Hons) in Physiology and Zoology from the University of Sheffield, UK, and a Ph.D. from the University of Hull, UK. He is also a Fellow of the Institute of Clinical Research, an associate member of the Radiological Society of North America and a member of the American Society of Bone and Mineral Research. Dr. Miller has written and co-authored over 40 scientific publications and is co-editor of the books Clinical Trials in Osteoporosis, Clinical Trials in Osteoarthritis and Rheumatoid Arthritis, and most recently, Medical Imaging in Clinical Trials published by Springer in February 2014.

Read Dr. Miller's blog posts at BioClinica's Trial Blazers blog.

 

Klaus Noever, M.D., Vice President, Business Development and Medical Director

Dr. Klaus Noever has been with BioClinica for more than 15 years and currently serves as VP of Business Development and Medical Director in Europe. His responsibilities include CRO channel management and medical consultation. Dr. Noever obtained his MD from University of Erlangen and worked as a physician at the University hospitals of Bochum (radiology) and Erlangen (cardiology) in Germany. Dr. Klaus Noever has extensive experience with medical imaging having served as a medical imaging consultant for clinical drug development across a range of therapeutic areas including oncology, skeletal diseases, CNS and cardiovascular diseases. Prior to joining BioClinica, Dr. Noever has held positions in clinical R&D at Schwarz Pharma, Boehringer Ingelheim and Siemens Medical Systems.

 

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 therapeutic area and has participated on several expert panels to advance the use of imaging in clinical trials.

 

Chahin Pachai, Ph.D., Vice President and Executive Director, Lyon

Dr. Chahin Pachai joined BioClinica, formerly Bio-Imaging Technologies in April of 2007. After attending business and management courses at Ecole Management de Lyon (2001) and prior to joining BioClinica, Chahin founded Theralys in October 2001, an imaging CRO which was acquired by BioClinica, in February 2007. Dr. Chahin Pachai obtained a degree in Electrical and Electronic Engineering from INSA Lyon in 1995, and a Ph.D., in the field of quantitative MRI, image segmentation and CNS diseases in 2000. He was a research fellow at the Surgical Planning Laboratory, Brigham & Women’s Hospital, Harvard Medical School (1997-98).

Read Chahin Pachai's blog posts at BioClinica's Trial Blazers blog.

 

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.

 

Harris A. Ahmad, M.D., Medical Director of Medical Affairs

Dr. Harris Ahmad joined BioClinica in 2007 as Medical Director in Medical Affairs at BioClinica, Inc. His primary role is as the therapeutic area lead for BioClinica's Autoimmune and Rheumatic Disease Phase 1b though Phase 4 clinical trials which include Crohn's, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis. He has consulted on and designed Clinical Trial Protocols, Imaging Review Charters, and Statistical Analysis Plans for Regulatory Submissions to both the EMA and FDA. His most recent contributions to the industry include the scientific design and development of several key clinical trials using MRI and X-ray as imaging biomarkers for the approvals of Simponi, Actemra, Humira, Cimzia, Orencia, Remicaide, and Enbrel. Prior to Dr. Ahmad's career with BioClinica, he was in residency training in Diagnostic Radiology and Internal Medicine at Hahnemann University Hospital in Philadelphia, PA, USA. Dr. Ahmad received his MD from Drexel University College of Medicine in 2004 with a distinction as a Humanities Scholar.

Read Harris Ahmad's blog posts at BioClinica's Trial Blazers blog.

 

Margaret Ziola, MD, Medical Director, Cardiology and Neurovascular

In her position as Medical Director, Cardiology and Neurovascular at Synarc, she is responsible for the scientific oversight of all cardiovascular projects including coordination and collaboration with key opinion leaders and expert readers as well as our Sponsor's scientific counterparts. Dr. Ziola participates in clinical trial protocol design and data interpretation and regulatory strategy planning. She oversees the quality of Synarc's cardiology and neurovascular reading services and explores new applications of imaging to clinical trial research.

Dr. Ziola has more than twenty years of cardiovascular experience in support of pharmaceutical research and development programs. Her expertise includes clinical analysis, interpretation, and reporting of cardiac safety data for over 100 clinical trials in various therapeutic indications, including cardiovascular, infectious disease, oncology, CNS, gastroenterology, and endocrinology.

Dr. Ziola holds her medical degree from the Nicolaus Copernicus Jagiellonian University Medical School in Krakow, Poland. She has participated in expert meetings, given invited lectures and co-authored several scientific articles.

Prior to joining Synarc, Dr. Ziola worked at ARYx Therapeutics leading global cardiovascular clinical trials design, conduct and monitoring. Earlier in her career, she served as Director of Cardiovascular Clinical Services position at Gentiae Clinical Research, a cardiovascular core lab she helped establish, supporting central reading of cardiac imaging and electrocardiography. Prior to that she was affiliated with the groundbreaking Ischemia Research and Education Foundation.

 

J. Michael O'Neal, M.D.

Dr. O'Neal provides leadership and oversight to BioClinica's staff radiologists and external radiology consultants. He holds responsibility for managing the organizational planning and operational needs of the Medical Affairs department, overseeing service quality, physician training, and process improvement. Dr. O'Neal joined CoreLab Partners in 2004 as a diagnostic radiologist with more than 20 years of practice experience and has continued to provide key leadership through the 2013 BioClinica/CoreLab Partners merger. Before joining the company, Dr. O'Neal served as Chairman for the Department of Radiology at the Hospital Center at Orange from 1996-2004. Dr. O'Neal is certified by the American Board of Radiology and has been published in the Journal of Bone and Joint Surgery. He is a member of several professional organizations, including the RSNA and the American College of Radiology. Dr. O'Neal is a graduate of Rutgers University and the Universidad Autonoma de Guadalajara in Mexico, where he earned his M.D (1981).

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.

 

Jonathan Andrus, Vice President, Strategic Accounts & eClinical Solutions

Mr. Andrus has a strategic role with BioClinica, building strong relationships across the pharmaceutical industry, including Sponsors, CROs, AROs, regulatory bodies, technology developers, and clinical research professionals.  Having successfully established many of BioClinica's current service offerings, Mr. Andrus oversees the eClinical Solutions group, which works closely with customers to help them apply technologies that vastly improve the way they run clinical trials.  Mr. Andrus has over 17 years of experience focused on data management, operations, quality, regulatory compliance, and eClinical technologies. Throughout his career, Mr. Andrus has shown a strong commitment to advancing research and education in the clinical research field both on a national and international level. He is 2014 Chair of the Society for Clinical Data Management (SCDM) − a position he held in 2008 as well – with the international organization leading the global conversation on data management in clinical trials. Mr. Andrus joined BioClinica in 2003, by way of Phoenix Data Systems as V.P., QA and Corporate Compliance.  During various roles, he has been responsible for staff development, study operations oversight, system testing and validation, and development of SOPs, guidelines, validation protocols, and other documentation. Prior to BioClinica, Mr. Andrus managed data, oversaw and conducted clinical system validations and Part 11 & HIPAA assessments, and conducted computer system audits.  Mr. Andrus has been a frequent presenter, lecturer and facilitator on a host of clinical research related topics.

Mr. Andrus is the former Chair of the Drug Information Association (DIA) eClinical Special Interest Area Community (SIAC), is a member of the DIA Advisory Council for North America (ACNA), as well as the American Society for Quality (ASQ). Mr. Andrus received a Bachelor's degree from Temple University and a Master's of Science in Quality Assurance and Regulatory Affairs from Temple University's Graduate School of Pharmacy. He is a certified quality auditor (CQA) and certified clinical data manager (CCDM).

Read Jonathan Andrus's blog posts at BioClinica's Trial Blazers blog.

 

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.