CNYBAC presents: The Transition from GLP to GCP - The Benefits of Designing Pivotal Large Animal Studies to Better Reflect the Design of Future Clinical Trials in Humans
Presenter: Michael Jamieson, DRSc, Advisor, Research & Innovation Partnerships, Queen’s Partnerships and Innovation, Queen’s University, Kingston, Ontario
Good Laboratory Practices (GLP)/ Pivotal Large Animal Studies can be more than just one of the boxes you need to check off in order to receive regulatory approval to do a human clinical trial with your companies’ new medical technology. Large animal studies are mainly used to support the filing of IDE/IND, but they can be designed to provide additional valuable information that can increase the chances of the human trial being successful. GLP studies are traditionally designed to provide safety and efficacy, with an emphasis on safety, on the use of a medical technology, but these studies can also be designed to collect information for areas such as reimbursement, clinical adoption, human factors, risk evaluation and mitigation and transportation and storage logistics, all important factors in the successful development of any new medical technology. It is all about making sure that you maximize every opportunity that you have to collect information related to your company’s new medical technology.
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Speaker Bio: Dr. Jamieson has spent his entire career working in the research and development of healthcare products in both industry and academia having spent over twenty-five years in industry before joining the University of Southern California(USC) in 2008. Dr. Jamieson is currently an Advisor with the Queen’s Partnerships and Innovation (QPI) group at Queen’s University where he is responsible for strategic input with regards to the regulatory and quality issues related to areas such as the clinical translation of healthcare technologies developed at Queen’s and the development of new technology/partnership opportunities for Queen’s. He is also currently a Co-I and a member of the Internal Leadership Council for an NIH Center Grant called C-Doctor funded through NIDCR (http://c-doctor.org/ ). C-Doctor represents a public-private partnership with the primary mission of providing comprehensive clinical, scientific, technical, regulatory, financial, and management resources to academic researchers to develop a model for the cost-effective transition and timely development of academic based research projects.
Before joining Queen’s, Dr. Jamieson was the Director of Clinical Translation and Core Investigator at the Ottawa Hospital Research Institute (OHRI) and the Associate Director of the International Center for Regulatory Sciences (ICRS) and an Assistant Professor in the Department of Regulatory and Quality Sciences at the University of Southern California. Dr. Jamieson's research interests include the regulatory/translational/quality training and support of university-based researchers and the development of a new model for maximizing the efficiency of translating academic research and for conducting joint research projects between industry, not for profits and universities.
The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program will provide 1 hours of continuing education hours. *When registering, note Certificate of Attendance Need (General or SOCRA).