Director: Kenneth M. Tramposch, PhD
- Associate Vice President for Research
- Associate Professor of Pharmacology and Toxicology Research
The goal of the Regulatory Knowledge and Support key function is to provide an array of services and educational opportunities to allow researchers to be fully compliant with regulations when conducting studies with human subjects.
Two recent developments will advance clinical research in Buffalo significantly:
1. Implementation of online submission of IRB applications using the web based tool called IRBNet. IRBNet offers several excellent features:
- Ease of use
- Cost effectiveness
- Instantaneous approval notification
- Improved quality of the project documentation
- Interoperability with all SUNY Academic Health Centers
Through the SUNY REACH initiative, a single IRB review will be accepted by all of the SUNY Academic Health centers significantly streamlining the review process and facilitating enrollment of subjects in multicenter trials.
2. Supporting the development of a Consortium to Accelerate Therapeutic Applications of Stem Cells in response to an RFA from the Empire State Stem Cell Board and the NYS Department of Health. This proposal, led by Dr. John Canty, UB Chief of Cardiovascular Medicine uses stem cells to improve cardiac function.
Dr. Ken Tramposch of the Regulatory Core has had pre-IND interactions with the FDA in helping to develop the regulatory path for this translational research project. This project will use an approach to manufacturing of clinical supplies that will be fully compliant with cGMPs. This approach will have a major impact on minimizing the cost of early trials while still meeting approval by the FDA.