Michael Jamieson, DRSc
Regulatory and Quality Sciences
Associate Director, International Center for Regulatory Sciences
1. Regulatory/translational support of university based researchers 2. Development of a new model for conducting joint research projects between industry/not for profits and universities 3. Development of Good Research Practice guidelines specifically for academic researchers 4. Data Integrity and Reproducibility in Academic Research
- 1540 Alcazar Street, CHP 140
Los Angeles, CA 90089
Dr. Jamieson's research interests include the regulatory/translational support of university based researchers and the development of a new model for conducting joint research projects between industry/not for profits and universities. The title of his doctoral dissertation was "The Role of Universities in the Development of Medical Products: A Survey of Industry Views" which looked at what the medical products industry in the US industry sees as the impediments to working with universities on joint research projects and the development of new products and how best to improve the current model.
The following are the current funded research projects that I am involved in:
1/ Data Reproducibility Initiative for Translational Research (DRIFTR)
Phase 1: University of Minnesota/ Smithsonian
Phase 2: NIH/NCATS UO1 (pending)
I am one of the founding members of the Data Reproducibility Initiative (DRI), a collaboration between six different universities with the goal of developing an open access set of tools to be used by scientists to demonstrate and maintain the quality of their research data. The mission of the Data Reproducibility Initiative for Translational Research (DRIFTR) project is to provide a set of tools and training modules for improving data quality and data reproducibility that AHC can incorporate into their research training processes. This project is more than online training, it is providing the tools and hands-on items needed for a lab to increase data quality. Research quality assurance (QA) practices are rarely taught, and therefore, rarely utilized to demonstrate data reliability in academic research environments. Our goal is to address the prominent training gap that exists throughout research institutions: QA principles for basic and translational research are not utilized. Principles of research QA can be readily applied to all research processes – from early basic research through preclinical efficacy studies. They directly address data traceability, and when applied, they result in data that can be reproduced. Our mission, to provide research QA training and implementation resources, will be achieved through the (1) targeted development of training materials providing multimedia, QA-content specifically designed to support basic and translational science, and (2) provision of a sustainable hosting location that will feature a sharing platform whereby the resources can be utilized by research programs at each AHC. The DRI project was just recently highlighted in an article in Nature (http://www.nature.com/news/how-quality-control-could-save-your-science-1.19223); there is a quote from me about 2/3 of the way through the article.
2/ Establishment of Resource Centers for Dental, Oral and Craniofacial Tissue Regeneration Consortium (C-DOCTOR)
Phase 1: NIH/NIDCR
Phase 2: NIH/NIDCR U24 Center Grant (pending)
Our vision is for C-DOCTOR to be a national center (USC, UCLA, Stanford and UCSF) for the clinical translation of innovative regenerative medicine to replace dental and craniofacial tissues and organs lost to congenital disorders, trauma, and disease. C-DOCTOR will represent a public-private consortium with the primary mission of providing comprehensive clinical, scientific, technical, regulatory, financial, and management resources to promote cost-effective transition and timely development of DOC tissue regeneration products. C-DOCTOR is optimally positioned to critically identify and prioritize unmet clinical needs; recruit, select, and train technology teams with promising therapies; and de-risk these therapeutic approaches through a structured Stage II program. By the end of this Stage II funding period, C-DOCTOR will have established a balanced portfolio of refined ITP teams that are ideally positioned for aggressive pre-clinical development in Stage III, and strategic alliances with industry partners that are motivated and able to support eventual clinical trials.
3/ The First Step Towards Ensuring the Quality and Reproducibility of the Preclinical Research Data Generated by the School of Pharmacy
Bensussen Grant (ongoing)
The first part of the study is looking at the feasibility of developing a centralized calibration, validation and/or qualification system whereby it would be the responsibility of the School to provide the resources to address the calibration, validation and qualification of essential equipment that is used by researchers in the School thereby ensuring the quality of the data generated. We are currently putting together a list (make and model) of all of the equipment in each active lab in the School of Pharmacy that should be calibrated and its current calibration status. Once we have that information then we will be able to go out to outside vendors (in some cases the manufacturers of the equipment) to get a quote to see how much it would cost to have all of that one type of equipment calibrated on a yearly basis.
The second part of the study will be to develop standardized templates for documents such as Writing of Standard Operating Procedures, Document Control, Equipment Validation/Qualification Protocols, Personnel Training and Process Validation, Control of reagents and Solutions, etc. Issues such as choice of animal strains, different lab environments or subtle changes in protocol, can be controlled by the proper use of SOPs, change control procedures, properly calibrated/validated equipment, validated animal and/or cell lines and validated methodologies; all of which will be addressed in the research project.
4/ Allopregnanolone a Regenerative Therapy for Alzheimer's
Toxicology: National Institute on Aging (NIA) U01
Phase 1 Clinical Trial: National Institute on Aging (NIA) UF1
The first clinical trial to evaluate the safety and tolerability of allopregnanolone (Allo), a naturally occurring brain steroid, in mild cognitive impairment and Alzheimers disease participants. Allo is an investigational drug molecule shown in animal studies to stimulate the birth of new neurons, rescue cognition and lower indicators of Alzheimers disease. Objectives: 1) The first group of participants in the trial will be given one dose of Allo once per week for 12 weeks, only increasing the dose for the next group of participants when the lower dose has been shown to be safe. The primary goal is to determine the highest dose that is safe and tolerated by participants. 2) Analysis will also be done on blood samples taken from participants at the beginning and end of the trial to determine how the body responds to the drug molecule. 3) As per FDA requirements, the trial will investigate potential safety concerns including blood vessel changes via brain imaging. Secondary goals are to assess the short-term effects of Allo treatment on learning and memory as well as detect changes via MRI brain imaging to help researchers prepare for a larger-scale clinical trial
Dr. Jamieson joined the faculty of the University of Southern California (USC) School of Pharmacy in 2008 after spending twenty five years in the pharmaceutical, biologics and medical device industry. He has been teaching in the Regulatory Science Program at USC since its inception in 2000, first as a guest lecturer from 2000 to 2007 and then as the Associate Director of the Regulatory Sciences Programs from 2008-2010. He is currently the Associate Director of the International Center for Regulatory Sciences and an Assistant Professor in the Titus Family Department of Clinical Pharmacy and Pharmaceutical Economics and Policy.
Dr. Jamieson received his Master's from the University of Southern California in 2008 and was in the first graduating class of the Doctorate of Regulatory Sciences in 2011.
Dr. Jamieson is also the Co-Founder/ Director of Clinical and Regulatory Affairs for Artenga Inc., a university spin off that has developed a drug delivery system which improves the efficacy of chemotherapy drugs and provides a platform to deliver larger sized molecules across the blood brain barrier.
Michael W. Jamieson DRSc, Frances J. Richmond PhD. The Role of Universities in the Commercialization of Medical Products: A Survey of Industry Views. Therapeutic Innovation and Regulatory Science, 2014;48(3): 347-356