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.

 

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.

 

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.

 

Jonathan Andrus, Senior Vice President, Operations

Mr. Andrus manages study and project operations for the eClinical Division of BioClinica. Mr. Andrus joined BioClinica (formerly Phoenix Data Systems, Inc.) in 2003 as V.P., QA and Corporate Compliance. Prior to joining the Company, Mr. Andrus managed clinical system validations and Part 11 & HIPAA assessments, and conducted computer system audits with Taratec Development Corporation. He also served in a number of roles at Premier Research. Mr. Andrus is chair of the Drug Information Association (DIA) North American Special Interest Area Communities (SIAC). His professional affiliations include the Drug Information Association, the Society for Clinical Data Management (where he serves on the board of trustees), the American Society for Quality and the Clinical Data Interchange Standards Consortium (CDISC), where he serves on CDISC's customer advisory board. Mr. Andrus received his Bachelor’s degree from Temple University and his Masters 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.