In 2012, we established the University of Maryland, Center of Excellence in Regulatory Science (UM-CERSI) that involves the University of Maryland in Baltimore (UMB), the University of Maryland College Park (UMCP), and the FDA, with scientific exchange, research, academic, and outreach components. The Center's mission is to foster the development of regulatory science ? the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products. The UM-CERSI has focused on three of the original FDA Regulatory Science Initiatives: 1) Improving pre-clinical assessments of safety and efficacy; 2) Ensuring readiness to evaluate innovative and emerging technologies; and 3) Harnessing diverse data through information sciences to improve health outcomes. In addition, we have established strong collaborations with the Office of Minority Health, spanning a variety of research thrusts. In the figure below, we highlight what has emerged as our most successful and visible initiatives: (1) our cutting edge research areas; (2) our monthly lectures; (3) our science exchange workshops; (4) our innovation awards, (5) our MS/MEng education programs; and (6) our America's Got Regulatory Science Talent competition. The sum of these activities represents a vibrant Center with a variety of activities. Our vision for the future wrests on these strengths while adding programs in support of one of the newest FDA priority areas: Supporting new approaches to improving product manufacturing and quality. The UM-CERSI enhances FDA efforts to advance regulatory science by providing: 1) direct scientific and training linkages to two leading UM campus; and 2) providing cutting edge regulatory science research experiences for teams of FDA and UM personnel in three collaborative projects. The UM-CERSI has Center-wide activities that promote regulatory science within the broader scientific community. It also links individual projects, each of which have education & training, and research activities.

Public Health Relevance

We propose continuation of M-CERSI that fosters scientific exchange, education and training, as well as FDA-oriented research, all focused on regulatory science. The Center is organized into Center-wide activities that cut across projects bringing diverse thoughts and ideas to all Center participants, and five Center foci, each of which advances scientific exchange and regulatory science research based on area-specific projects.

National Institute of Health (NIH)
Food and Drug Administration (FDA)
Research Project--Cooperative Agreements (U01)
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University of Maryland College Park
Biomedical Engineering
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College Park
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Zhu, Peng; Ye, Zhi; Guo, Dong et al. (2018) Irinotecan Alters the Disposition of Morphine Via Inhibition of Organic Cation Transporter 1 (OCT1) and 2 (OCT2). Pharm Res 35:243
Guo, Dong; Yang, Hong; Li, Qing et al. (2018) Selective Inhibition on Organic Cation Transporters by Carvedilol Protects Mice from Cisplatin-Induced Nephrotoxicity. Pharm Res 35:204
Burcu, Mehmet; Zito, Julie M; Safer, Daniel J et al. (2017) Association of Antidepressant Medications With Incident Type 2 Diabetes Among Medicaid-Insured Youths. JAMA Pediatr 171:1200-1207
Yang, Hong; Guo, Dong; Obianom, Obinna N et al. (2017) Multidrug and toxin extrusion proteins mediate cellular transport of cadmium. Toxicol Appl Pharmacol 314:55-62
Pennap, Dinci; Burcu, Mehmet; Safer, Daniel J et al. (2017) Hispanic Residential Isolation, ADHD Diagnosis and Stimulant Treatment among Medicaid-Insured Youth. Ethn Dis 27:85-94
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Li, Qing; Yang, Hong; Guo, Dong et al. (2016) Effect of Ondansetron on Metformin Pharmacokinetics and Response in Healthy Subjects. Drug Metab Dispos 44:489-94
Burcu, Mehmet; Safer, Daniel J; Zito, Julie M (2016) Antipsychotic prescribing for behavioral disorders in US youth: physician specialty, insurance coverage, and complex regimens. Pharmacoepidemiol Drug Saf 25:26-34
Dong, Zhongqi; Li, Qing; Guo, Dong et al. (2015) Synthesis and Evaluation of Bile Acid-Ribavirin Conjugates as Prodrugs to Target the Liver. J Pharm Sci 104:2864-76
Dong, Zhongqi; Ekins, Sean; Polli, James E (2015) A substrate pharmacophore for the human sodium taurocholate co-transporting polypeptide. Int J Pharm 478:88-95

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