We are led and inspired by our experts. Together our leaders have accumulated a vast expertise in their therapeutic area. In the past decade alone they each have participated in more than 90 randomized clinical trials and have published more than 130 peer-reviewed research articles. This academic excellence has been translated into success for our clients; Robarts Clinical Trials has been involved in more than 40 full service and more than 100 CIMS multi-center clinical trials since 1986.

Scientific Directors

Brian Feagan
Brian G. Feagan
MD, FRCPC
Senior Scientific Director
Geert D'Haens
Geert D'Haens
MD, PhD, AGAF
Scientific Advisor
William Sandborn
William J. Sandborn
MD
Scientific Advisor

Brian G. Feagan completed a medical degree at the University of Western Ontario in London, Ontario, Canada.

His postdoctoral training included residency in the Department of Medicine and a fellowship in Gastroenterology at the University of Western Ontario. A Fellow of the Royal College of Physicians and Surgeons of Canada, Dr. Feagan holds membership in the Canadian and American Association of Gastroenterology, the American College of Gastroenterology, the College of Physicians and Surgeons of Ontario, Crohn’s and Colitis Canada (CCC) and European Crohn’s and Colitis Organization (ECCO). He has authored over 300 articles and book chapters and has given over 90 invited presentations at national and international scientific meetings. In 1997, Dr. Feagan became Director of Robarts Clinical Trials at the Robarts Research Institute, University of Western Ontario. His research efforts focus on the design and implementation of randomized controlled trials of therapy for inflammatory bowel disease. He has been the principal investigator on numerous large-scale randomized clinical trials.

 

Geert D’Haens graduated from medical school at the Katholieke Universiteirt Leuven, Belgium in 1987.

Professor D’Haens specialized in gastroenterology at the University of Chicago Hospitals, USA and University Hospitals Leuven in 1990-1992. He was board certified in internal medicine in 1992. He defended his Doctoral Thesis in 1996. Currently Professor of Medicine and Gastroenterology at the Academic Medical Centre, University of Amsterdam, Netherlands, Professor D’Haens is a specialist gastroenterologist with a clinical interest in inflammatory bowel disease and gastrointestinal oncology. He has particular expertise in mucosal immunology, gastrointestinal endoscopy and immunosuppression related to IBD.

Professor D’Haens was elected to the International Organization for Inflammatory Bowel Disease (IOIBD) in 2003 and is currently Chairman of the organization. In 1999, D'Haens was co-founder of the European Crohn's and Colitis organization ECCO.

Memberships of other societies includes a Fellowship of the American Gastroenterological Association (2006) and the European Society for Gastrointestinal Endoscopy Research Committee.

Professor D’Haens is the recipient of several awards including the Silver medal for “inflammatory bowel disease" from World Congress on Gastroenterology, Vienna, 1998.

With over 250 peer reviewed scientific articles and 37 chapters in medical textbooks Professor D’Haens has an impressive publication record and is widely recognized as an expert in the area of digestive diseases.

 

William Sandborn completed medical school and an internal medicine residency at Loma Linda University in Loma Linda California.

He completed a gastroenterology fellowship at the Mayo Clinic in Rochester, Minnesota in 1993. From 1993-2010, he was on the faculty of the Mayo Clinic, rising to Professor of Medicine, Vice Chairman of the Division of Gastroenterology and Hepatology, and Associate Dean of Research for Intellectual Property and Industry Relations. In 2011 he became Professor of Clinical Medicine at the University of California San Diego and Director of the IBD Center and Chief of the Division of Gastroenterology for the UC San Diego Health System. In 2016 he also became Vice Chair of Clinical Operations for the Department of Medicine and a member of the Clinical Practice Organization (CPO) Board which oversees all of UC San Diego Health System clinical practice. Dr. Sandborn has published over 599 peer reviewed articles including articles in the New England Journal of Medicine, the Lancet, JAMA, the Annals of Internal Medicine, and Gastroenterology. His research interests are clinical trials and clinical pharmacology related to inflammatory bowel disease. He is currently Chief of the Division of Gastroenterology, Vice Chairman of Medicine for Clinical Operations, a member of the CPO Board, and Director of UCSD IBD Center in the UC San Diego Health System.

 

Collaborators

Brian Feagan
Rish Pai
MD, PhD
Scientific Collaborator
Geert D'Haens
Jordi Rimola
MD, PhD
Scientific Collaborator
William Sandborn
Arjan Bredenoord
MD, PhD
Scientific Collaborator

Dr. Rish Pai received his B.A. from Pomona College in Claremont, California and earned his M.D., Ph.D. from Case Western University School of Medicine in Cleveland, Ohio in the NIH-sponsored Medical Scientist Training Program.

He completed his anatomic pathology residency at the University of Chicago Medical Center (as chief resident), followed by a gastrointestinal and hepatic pathology fellowship at the same institution. Dr. Pai is currently an Associate Professor of Laboratory Medicine and Pathology at Mayo Clinic in Arizona. He is on the editorial board of the American Journal of Surgical Pathology, serves as chair of the education committee of the Rodger C. Haggitt Gastrointestinal Pathology Society, and is on the education committee of the United States and Canadian Academy of Pathology. Dr. Pai works extensively with Robarts executive and scientific leaders in developing and validating histologic indices for clinical trials in inflammatory bowel disease and other diseases of the gastrointestinal tract. Dr. Pai also participates in protocol development and development of histologic endpoints.



Jordi Rimola MD, PhD. Department of Radiology, Hospital Clinic de Barcelona, University of Barcelona Barcelona, Spain

Dr J Rimola is a Radiologist subspecialized in abdominal and gastrointestinal imaging and member of the Inflammatory Bowel Disease unit directed by Dr. Julian Panés in Barcelona. He has had a leading role in the application of cross-sectional imaging techniques to the study of Crohn’s disease, development and validation of activity indices, and implementation of MRE in multicentric clinical studies. He participated in the ECCO-ESGAR guidelines elaboration and in different other expert consensus and recommendations documents.



Albert J (Arjan) Bredenoord studied Medicine in Antwerp, Belgium. He subsequently worked on several clinical research projects on GI motility at the Mayo Clinic, Rochester, USA and at the University of Utrecht, the Netherlands which resulted in a PhD thesis on gastroesophageal reflux disease in 2006.

His clinical training was performed in Nieuwegein, the Netherlands and at the Royal London Hospital in London, UK. He currently works as a consultant Gastroenterologist at the Amsterdam Medical Center where he is dedicated to patients care, scientific research and education in the field of benign esophageal diseases. His main focus is on achalasia, reflux disease and eosinophilic esophagitis. He is one of the pioneers of high-resolution manometry and impedance monitoring of the esophagus. The esophageal clinic in the AMC Amsterdam hosts the largest population of benign esophageal diseases in the Netherlands. Dr Bredenoord is an author of over 200 papers, books and book chapters on esophageal diseases and organizes regular courses in Europe, North America and Asia. Dr Bredenoord is president-elect of the European Society of Eosinophilic Esophagitis EUREOS, Editor of the journal Neurogastroenterology and Motility and co-founder of the International HRM working group. Dr Bredenoord collaborates with Robarts Clinical Trials on studies on endpoint development for clinical trials in eosinophilic esophagitis and advises on all stages of trial design in drug development for eosinophilic esophagitis.



Our experts are multidisciplinary and cross-functional. Our Medical R & D team is composed of clinicians, scientists, biostatisticians, and methodologists whose combined expertise and contributions to clinical and outcomes research have been pivotal to the evolution of clinical trial design and the development of effective therapies. Access to and collaboration with our content experts differentiates Robarts Clinical Trials from traditional Contract Research Organizations.

Medical Research & Development Leadership

Vipul Jairath
Vipul Jairath
MD, PhD
Director, Medical R & D
Reena Khanna
Reena Khanna
MD, MSc, FRCPC
Director, Medical and Imaging Research
GY Zou
GY Zou
PhD
Biostatistician Director

Dr Jairath trained in the UK holds degrees in pharmacology and medicine from Leeds University, a PhD from Oxford University and a post-graduate diploma in clinical trials from the London School of Hygiene and Tropical Medicine.

His specialist clinical training in Gastroenterology and IBD was completed in London and Oxford, UK. Prior to moving to Western, he was a Consultant Gastroenterologist at Oxford University hospitals and a National Institute for Health Research Clinical Trials Fellow at the Oxford Clinical Trials Research Unit/Center for Statistics in Medicine.

Dr Jairath is Associate Professor of Medicine, Epidemiology and Biostatistics at Western University. His research interests are in the design, conduct and implementation of randomized controlled trials and clinical trial methodology. At Robarts his research focuses on trial design, endpoint development and validation as well as larger scale effectiveness research and strategy trials. He oversees the academic research and development program and the Robarts IBD clinical research fellowship.

He holds professional memberships with the College of Physicians and Surgeons of Ontario, Royal College of Physicians (UK), British Society of Gastroenterology, American Gastroenterology Association and Canadian Association of Gastroenterology. He was past scientific officer of the European Crohn’s and Colitis Organization clinical trials committee (ClinCom) and is vice-president of the newly formed Canadian IBD Consortium. He is a practising gastroenterologist and his IBD clinic is based at University hospital, London, Ontario.

Reena Khanna is Director, Medical and Imaging Research with Robarts Clinical Trials and provides a vast array of clinical research services including clinical trial designs, protocol development, statistical analyses, and medical monitoring.

Reena completed her BSc Honours with high distinction at the University of Toronto. She then studied medicine and internal medicine at UWO before moving to McMaster for training in gastroenterology. While Reena was at McMaster and UWO she served as chief resident during both of her residencies. Following graduation from gastroenterology, she completed an IBD fellowship at the Cleveland Clinic. In 2012 Reena was chosen as the inaugural Research Fellow in international IBD clinical trials at Robarts Clinical Trials.

Reena is also an Assistant Professor at the Western University and as of November 2016, completed her MSc in clinical epidemiology at McMaster University. Before becoming Director at Robarts, she was a Senior Medical Director. Her clinical and research interests are in outcome measures, efficient trial design, and randomized controlled trials in inflammatory bowel disease.

Guangyong (GY) Zou completed a PhD in Plant Sciences at the University of Connecticut (USA) followed by a PhD in Biostatistics at Western University (Canada). He was a staff Biostatistician in Dana-Farber Cancer Institute at Harvard Medical School in Boston and is now a Full Professor of Biostatistics with tenure in Schulich School of Medicine & Dentistry and Scientist, in Robarts Research Institute at Western University. GY’s research focuses on development and evaluation of statistical methods that are useful in medical and epidemiologic research.

He has published over 120 peer-reviewed articles, many of which have made high impact in medical and epidemiologic research. For example, a single-authored 2004 article on regression models for estimating risk ratios has already received close to 3000 citations.

GY has over 19 years of experience in the design and analysis of clinical trials, including cluster randomization trials. At Robarts Clinical Trials Inc., GY’s research focuses on statistical methods for the design and analysis of clinical trials, endpoint development and validation, as well as, larger scale effectiveness research and strategy trials. As Director of Biostatistics, GY oversees statistical support for academic research and development programs and the Robarts IBD clinical research.

MAJOR CONTRIBUTIONS



Pioneers in an Evolving Clinical Trial Landscape

Efficient outcomes result in efficient trials. The need for standardized outcome definitions has long been recognized in IBD, both for clinical trials and practice. We have taken this problem on directly and are developing solutions. Robarts Clinical Trials is a pioneer in the development and validation of both the outcome indices and the technology that are shaping the evolving clinical trial landscape.

Our research translates into important benefits for our clients. Together with our international expert collaborators, we are helping to develop more objective and relevant measurement of disease activity. We operationalize our findings into superior clinical trial methodology that is in-line with emerging regulatory standards. Our collaborative research includes significant contributions to standardize the assessment of disease activity based on symptomatic, endoscopic, histopathologic, and magnetic resonance image findings, as well as the validation of the instruments used for assessment.

Outcome Measure Development

We are on the cutting-edge of outcomes research. We recognize disease-related factors that are relevant to patients, clients, and regulatory bodies, and are working towards harmonizing those needs into outcomes that will provide meaningful long-term consequences for patients and for the treatment of IBD.

Evidence-Based Medicine

We have our finger on the pulse of academic research. We recognize the contributions of the greater academic research community to refine and improve the treatment of inflammatory bowel and gastrointestinal disease, as well as the value of synthesizing the best available evidence to identify new or unmet needs and to provide the best recommendations to our clients.

Translational Research

We are moving the bench closer to the bedside. The pace of drug discovery and development is frequently limited by a lack of necessary resources to translate important findings into large scale studies. Technical inconsistencies and a lack of standardized processes often preclude collaboration and synthesis of data, even among laboratories with similar research interests. We believe basic science should be at the forefront of drug discovery and are developing methods to overcome current constraints to the application of translational research in a multi-center clinical trial setting.

EDUCATION



Robarts Clinical Trials demonstrates its ongoing commitment to continuing education through:

  • Investigator Meeting Training
  • Invited Speaking Engagements
  • Patient Community Support
  • Attendance at all major IBD/GI conferences (DDW, AIBD, ACG, UEG, ECCO)
  • Support to Advisory Boards
  • Clinical Trials Fellowships

Clinical Trials Fellowship

Each year we fund clinical research fellowships. These are predominantly aimed at advanced trainees in gastroenterology with a higher degree who have completed subspecialty training. These fellowships are hosted in Canada, Netherlands and our US locations with the opportunity to obtain advanced IBD clinical research. Interested applicants should contact Vipul.Jairath@robartsinc.com.

 

 

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