Wednesday, December 11, 2019
9:00am PT / 12:00pm ET
CME CREDIT HOURS: 1.0
Cellular Therapy Manufacturing – Clinical Trials and Hopes for the Future
David Courtman, MD (Ottawa Hospital Research Institute, Ottawa, Ontario)
Dr. Courtman is trained in cellular and molecular pathology and biophysics with extensive expertise in the development of novel therapies for cardiovascular disease. He has a long-standing interest in the development of novel cardiovascular biomaterials and the regulation of biological responses within the unique spatially-oriented matricellular environment of blood vessels. He has also participated in the development of a number of cellular based gene therapies for the treatment of cardiopulmonary disorders taking them from initial concept, through appropriate animal disease models, and into first-in-human clinical trials. Dr. Courtman is currently directing the manufacturing of these cell products for trials treating patients suffering from pulmonary arterial hypertension, myocardial infarction, and sepsis. He is a Senior Investigator and Director of Biotherapeutics at the Ottawa Hospital Research Institute, Assistant Professor at the University of Ottawa, and Chief Scientific Officer of Northern Therapeutics.
The translation of cell therapies from basic research to clinical trials requires the development of standard operating processes that are both regulatory compliant and of relatively low risk to the quality if the final product. This often requires the careful external sourcing of ancillary materials and services. An appropriate risk analysis needs to be performed to identify and mitigate the risks involved from external suppliers. In early phase trials this may simply involve document review, development of contractual/reporting arrangements, and implementation of an incoming product qualification strategy. As trials progress to later phases external site visits and complete audits may need to be performed to assure the continuous supply of high quality goods and services. I will draw on examples from past academic trials to highlight our experience in implementing these strategies from first in man safety trials to larger efficacy based studies.
1. To gain an understanding of the regulatory requirements for clinical cell processing for products involving more than minimal manipulation or intended for non-homologous use.
2. Describe the infrastructure commonly used in cGMP manufacturing of experimental cell products.
3. Provide examples of clinical trial designs and outcome measures in advanced cell therapy trials.
This webinar is sponsored by an unrestricted educational grant from: