Innovative Clinical Study Design for Medical Devices, June 12th 2013
Speakers and Panel
Dr. Gregory Campbell


Dr. Campbell is the Director of the Division of Biostatistics in the Office of Surveillance and Biometrics (OSB) of Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) since he came to FDA in 1995. He received a Ph.D. in Mathematical Statistics from Florida State University. 


His current research interests include statistical evaluation of diagnostic tests using ROC methodology, statistical issues in device clinical studies and the evaluation of diagnostic tests from microarrays. He serves as Associate Editor for Statistics in Pharmaceutical Research and Journal of Biopharmaceutical Statistics. He has been the recipient of the FDA's Commendable Service Award, Award of Merit and Outstanding Service Award as well as the CDRH Outstanding Scientific Award for Excellence in Analytical Science. He is a Fellow of the American Statistical Association. He has been a member for ten years in the Senior Biomedical Research Service in the Department of Health and Human Services.   He has served in leadership positions for the Eastern North American Region of the International Biometric Society and the Society for Clinical Trials. 




Mr. John O'Dea, Crospon


With 22 years experience in the medical device industry, he has overseen the successful launch of eight electronic medical device products in the past fourteen years. He co-founded Caradyne, an Irish respiratory medical device company in 1998, which was selling products in 30 countries prior to its acquisition by Respironics Inc. in 2004. He holds Bachelor and Masters Degrees in Mechanical Engineering and a PhD in Electronics Engineering all from University College Dublin, and an MSc in Clinical Research from NUI Galway. Prior to founding Crospon, he served as General Manager of Respironics Ireland. In the past 20 years he has held R&D management positions in Nellcor Puritan Bennett and engineering positions in Digital Equipment Inc. and in Dataproducts Inc. He is a named author on six issued U.S. patent families. He is currently a Vice President of Engineers Ireland and Adjunct Professor at the School of Engineering and Informatics at NUI Galway where he is Chairman of the External Advisory Board for the Irish Regenerative Medicine Institute (REMEDI). He is Chairman of the Irish Medical Devices Association.





Prof. Martin O'Donnell, NUI Galway


Martin O'Donnell is Professor of Translational Medicine at NUI Galway and Associate Director of the HRB Clinical Research Facility Galway. Graduated from University College Cork, he trained in Geriatric and Stroke medicine in Ireland, McMaster University (Canada) and Stanford University (US). He holds a PhD from the Department of Clinical Epidemiology and Biostatistics, McMaster University. He is Director of an MSc in Clinical Research at NUIG, being run in collaboration with McMaster University His main areas of research interests are clinical trials in Vascular medicine and Stroke Epidemiology.



Gary Brogan, Vice-President, Regulatory and Clinical Affairs, Cappella Medical Devices Ltd.

Gary is an experienced professional in the Medical Device industry who currently leads the Quality, Regulatory and Clinical functions in Cappella Medical Devices, an innovative designer of products in both coronary and peripheral indications. During his tenure, he has led numerous clinical trials ranging from a First in Man to a post-market registry. Gary joined Cappella with a successful track record in both multi-national and start-up environments, having held a succession of quality, regulatory, and clinical roles at Boston Scientific and Labcoat Limited. He also has many years of experience as a consultant to the medical device industry on clinical and regulatory strategies. He hold an Honours degree in Quality Management from Sligo IT and a Masters Degree in Bioengineering from Trinity College Dublin.



Fionnuala Gibbons, Clinical Trial Liaison Officer, Molecular Medicine Ireland Ltd.

Fionnuala Gibbons took up the Enterprise Ireland funded position of Clinical Trial Liaison Officer in April 2009, with responsibility for the development of clinical research process knowledge and awareness among the researchers, indigenous and multi-national medical devices, diagnostic, pharmaceutical and biotechnology companies. Fionnuala brings to the position a wealth of experience and knowledge across the pharmaceutical industry. She initially began her career as a nurse (working as a Theatre and Anaesthetic Sister, Charing Cross Hospital, London), and then transitioned to clinical research working as a Research Coordinator in the Thrombosis Research Centre in Kings College Hospital, Clinical Research Associate in PPD Contract Research Organisation in Cambridge and Bristol-Myers Squibb (BMS), Dublin. Fionnuala has worked across a variety of therapeutic areas including cardiology, oncology, rheumatology, endocrinology, psychiatry, HIV and haematology, supervising mentoring and advising research personnel. Prior to joining MMI, Fionnuala held the position of Oncology Scientific Advisor for sanofi-aventis. Fionnuala has developed a strong insight and understanding of medical device, diagnostic and pharmaceutical development from concept phase through to commercialisation.