The Administrative Core Objectives are to oversee and manage the research and preclinical and clinical development activities of the five projects. Dr. Regine Sitruk-Ware, who will direct the U54 Center and oversee the Core, has extensive experience in the management of clinical research and contraceptive research &development. The co-Director Dr Patricia Morris has considerable experience in managing laboratory work and scientific as well as technical staff. The core will support the production of periodical progress reports, will monitor expenditure for each project and contribute to the generation of financial reports. In addition, as several of the projects have a clinical component, work on preparing the Investigational New Drug (IND) Applications to the FDA and annual reports submissions, as well as reporting of the Serious Adverse Events that may occur during the clinical studies is a responsibility of the Population Council as IND holder. Audits of the batch production of study materials in the laboratories will be ensured for Quality Control to allow release of GMP clinical batches for clinical studies. Manuscripts and report writing, organization of meetings of the Advisory Board, will be ensured as well by the core. Decision making Process: The PD/PI and the co-Director will manage together the budgets for each project and make decisions on possible adjustments where needed in communication with the NICHD Program Manager. Cost-effectiveness: The PIs of each of the 5 projects will access the services of the Administrative Core and the Program Manager/ Grant coordinator and Staff Assistant will provide support according to priorities decided by the PD and co-D when needed. Regulatory support will also be provided to each project where a clinical component is included and planning will be organized with the project's PI. Such a small team of people with multiple skills will be cost-effective to support the overall administration of the U54 Center.
Coordination of the administrative aspects of the five projects will be facilitated by the core with a small number of staff involved, each having multiple skills and experience that will make the work effective. This core will give strong support to the PD and co-D and Scientists helping them to achieve the scientific work with less burden.
|Chen, Haiqi; Mruk, Dolores D; Xia, Weiliang et al. (2016) Effective Delivery of Male Contraceptives Behind the Blood-Testis Barrier (BTB) - Lesson from Adjudin. Curr Med Chem 23:701-13|
|Tang, Elizabeth I; Mruk, Dolores D; Cheng, C Yan (2016) Regulation of microtubule (MT)-based cytoskeleton in the seminiferous epithelium during spermatogenesis. Semin Cell Dev Biol 59:35-45|
|Venkatesh, Deepak; Mruk, Dolores; Herter, Jan M et al. (2016) AKAP9, a Regulator of Microtubule Dynamics, Contributes to Blood-Testis Barrier Function. Am J Pathol 186:270-84|
|Li, Nan; Mruk, Dolores D; Lee, Will M et al. (2016) Is toxicant-induced Sertoli cell injury in vitro a useful model to study molecular mechanisms in spermatogenesis? Semin Cell Dev Biol 59:141-156|
|Gao, Ying; Lui, Wing-Yee; Lee, Will M et al. (2016) Polarity protein Crumbs homolog-3 (CRB3) regulates ectoplasmic specialization dynamics through its action on F-actin organization in Sertoli cells. Sci Rep 6:28589|
|Li, Nan; Mruk, Dolores D; Chen, Haiqi et al. (2016) Rescue of perfluorooctanesulfonate (PFOS)-mediated Sertoli cell injury by overexpression of gap junction protein connexin 43. Sci Rep 6:29667|
|Chen, Haiqi; Mruk, Dolores D; Lee, Will M et al. (2016) Planar Cell Polarity (PCP) Protein Vangl2 Regulates Ectoplasmic Specialization Dynamics via Its Effects on Actin Microfilaments in the Testes of Male Rats. Endocrinology 157:2140-59|
|Tang, Elizabeth I; Lee, Will M; Cheng, C Yan (2016) Coordination of Actin- and Microtubule-Based Cytoskeletons Supports Transport of Spermatids and Residual Bodies/Phagosomes During Spermatogenesis in the Rat Testis. Endocrinology 157:1644-59|
|Wen, Qing; Cheng, C Yan; Liu, Yi-Xun (2016) Development, function and fate of fetal Leydig cells. Semin Cell Dev Biol 59:89-98|
|Jesus, Tito T; Oliveira, Pedro F; Silva, Joaquina et al. (2016) Mammalian target of rapamycin controls glucose consumption and redox balance in human Sertoli cells. Fertil Steril 105:825-833.e3|
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