The UM-CERSI creates new mechanisms for scientific exchange, education and training, as well as regulatory science research. The center brings together diverse thoughts and ideas around emerging technologies and methodologies for regulatory science. The sum of these interwoven activities is a vibrant, cutting edge center that stimulates innovative thought, disseminates understanding of regulatory science and practices, and generates new knowledge in support of the FDA’s fundamental mission -- to promote and protect the public health -- under current priorities and initiatives.
A critical component of center success is establishing, promoting, and facilitating two-way connections between UM and FDA staff. The CERSI will invite visiting scientists from the FDA and from industry to engage with the new Center and to engage in scientific exchange. Also, UM-CERSI will provide continuing education (CE) training for FDA personnel.
Creating New Opportunities for Collaborative Regulatory Scientific Research
Center-Wide Regulatory Science Activities – The UM-CERSI will execute in parallel three regulatory science projects reflecting the collective strengths of UM campuses in College Park and in Baltimore. The Scientific Exchange, Research and Training Activities for each project are managed by project leaders.
UM-CERSI sponsors a small regulatory science research component that is unattached to its projects. Several small Innovation Awards will help build its program in the future.
- Specific Regulatory Science Activities - UM-CERSI focuses on three project areas, each corresponding to an FDA-specified focus. Each major project area includes training and exchange, as well as a research component. Each major project will support at least two graduate students / fellows, who will benefit from FDA advice and guidance. The Executive Committee, comprised of UM and FDA leadership, will solicit proposals from UM faculty and develop a specific plan for each project area. In this way, priorities can be identified and appropriate investments can be made. Additionally, this will provide a mechanism for project renewal and/or new project development as the Center grows and matures.
Project 1 - Improving pre-clinical assessments of safety and efficacy
“Improving pre-clinical assessments of safety and efficacy” focuses on membrane transporters in drug development. Membrane transporters allow nutrients to move throughout the body, and also move drugs throughout the body. However, these doorways can be the basis for drug-to-drug interactions, where a “perpetrator drug” interferes with how a second “victim drug” normally uses a transporter. The University of Maryland is conducting experiments in collaboration with FDA scientists in order to aid FDA to develop decision trees. FDA decision trees will help industry and FDA scientists identify what membrane transporters are most important, in terms of the potential to cause drug-to-drug interactions. FDA decision trees will also provide guidance about how cell culture studies can be used to avoid or require human clinical testing, in order to advise health care professionals and patients about transporter-based drug-to-drug interactions. University of Maryland faculty contributing to the research are Drs. Yan Shu, James Polli, Peter Swaan, and Hongbing Wang.
Project 2 - Ensuring readiness to evaluate innovative and emerging technologies
Ensuring readiness to evaluate innovative and emerging technologies is an important goal for the CERSI, focusing on new technologies that will contribute to the scientific underpinning of two device-related product areas: (1) laser-based therapeutic devices; and (2) tissue engineering constructs.
Regarding the first subproject above, there is a lack of reliable, widely-accepted benchtop techniques for characterizing and assessing the sub-surface laser therapeutic dosage. As a result, the potential for understanding the device- and tissue-dependent effects, as well as laser therapy system performance, are diminished. These complicate the regulatory process and increase the burden on manufacturers to provide clinical studies to demonstrate safety and effectiveness. This project will develop and validate novel test methods that will enable rapid and reliable evaluation of laser therapy system performance and advance the innovation and translation of light-based therapeutic techniques.
The second subproject involves the creation of polymeric scaffolds that function within guided tissue regeneration strategies. These need precise control over the formative processing steps and also detailed and standardized characterization of the resulting properties. Here, we are developing methods to evaluate scaffold properties across manufacturers and between product iterations. By undertaking these studies, we anticipate the basis for standardization of scaffold characterization, in general. University of Maryland faculty contributing to the research are Drs. Yu Chen and John Fisher.
Project 3 - Harnessing diverse data through information sciences to improve health outcomes
“Harnessing diverse data through information sciences to improve health outcomes” focuses on patient prescriber agreements (PPAs) of prescription opioid analgesic drugs. In recent years, FDA has started to employ strategies to reduce misuse and abuse of opioid pain medications. PPAs are contracts between prescribers and their patients to at least list expectations of each the prescriber and the patient. With pain drugs a serious health issue, and opioids having abuse potential, there are several PPAs for various opioid pain medications. These PPAs often outline terms of treatment, patient responsibilities, education issues, addiction treatments, emergency issues, goals, and prescription limitations. University of Maryland faculty are conducting a review of PPAs currently in use, determining which healthcare professionals are using PPAs and the conditions of use. The researchers are also examining different formats and types of PPAs. University of Maryland faculty contributing to the research are Drs. Frank Palumbo, Francoise Pradel, Gail Rattinger, and Ilene Zuckerman.
2012-2013 M-CERSI Awards
The University of Maryland Center of Excellence in Regulatory Science and Innovation (UM-CERSI) has recently awarded two Innovation Awards, and two Innovations in Minority Health Awards.
The aim of M-CERSI Innovation Awards is to promote innovations in FDA training or research that, through well defined outcomes, will foster the development of regulatory science. M-CERSI Innovations in Minority Health Awards are similar to Innovation Awards and additionally aim to address racial and ethnic health disparities.
The four awardees for 2012-2013 are:
- Drs Jeffrey W. Herrmann and Monifa Vaughn-Cooke, Department of Mechanical Engineering
Analyzing Medical Device Recalls and Regulatory Decision Making to Advance Regulatory Science
The proposed research will take a two‐phase approach to identify possible discrepancies between FDA’s regulatory processes and goals and the reliability assessment of state‐of‐the‐art medical devices and innovative emerging technologies.
- Dr Yihua Bruce Yu, Department of Pharmaceutical Sciences
Novel High-Thoughput Quality Control of Pharmaceutical Preparations
The goal is to study the NMR relaxation rates of the solvent molecule (i.e. water) in samples of biotherapeutics and suggest the model linear dependences of the NMR relaxivity on the degree of sample aggregation/degradation.
- Dr Olivia Carter-Pokras, Department of Epidemiology and Biostatistics
Improving Health Literacy and Cultural Competency of FDA Consumer Materials
The goal of this project is to provide evidence and recommendations to improve FDA communication on HIV/AIDS.
- Dr Julie M. Zito, Department of Pharmaceutical Health Services Research
Racial/Ethnic Differences in Pediatric Antipsychotic Use by FDA Labeled Status
The aim to study antipsychotic use in youth in relation to racial/ethnic differences, insurance type, and FDA labeled indication for use.
M-CERSI co-director James Polli indicates “These awards reflect the great depth and scope in research at the University of Maryland that have the potential to impact medical product regulation. Furthermore, the M-CERSI program facilitates even greater scientific interactions between university and FDA staff.” “We are especially glad to be working with the FDA Office of Minority Health on some of these awards” says M-CERSI co-director William Bentley.