Center for Development of Medications and Biologics for Treatment of the Pregnant Patient and Fetus

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 DESCRIPTION (provided by applicant): Overall UTMB plans to establish a nationally and internationally recognized center with the theme of Development of Medications and Biologics for Treatment of the Pregnant Patient and the Fetus. The overarching Center goal is to accelerate FDA approval of medications, biologics, and therapeutic modalities for treatment of the pregnant patient and/or her fetus. This goal will be achieved by 2 major objectives: (A) support, expand, and diversify the teams of investigators by recruitment, education, and training of junior faculty in the field of obstetric-fetal pharmacology and (B) augment the existing environment, tools, and infrastructure for clinical and translational projects. Our success is due, in part, to the clinical infrastructure present at UTMB, which includes access to a wide, diverse patient population via UTMB's Regional Maternal and Child Health Program as well as the cadre of trained research nurses in Ob/Gyn's Perinatal Research Division. Our translational infrastructure includes the Maternal-Fetal Pharmacology and Biodevelopment Laboratories, with a state-of-the-art analytical center. Clinical studies are supported by translational projects whic are focused on basic science investigations that will improve clinical outcomes. Our strategy is to leverage and expand our existing resources in order to translate knowledge from basic sciences to new treatments and to translate findings from clinical studies into clinical practice. This strategy will be accomplished by the following specific aims: (1) develop an intellectual, procedural, and physical infrastructure that will accelerate the conduct of clinical trials to determine the efficacy and safety of medications and other therapies as well as support translational projects to determine molecular mechanisms underlying maternal and fetal exposure to medications and biologics; (2) expand the scope of investigation by recruiting new faculty whose expertise will augment the existing multidisciplinary team and by increasing collaboration with UTMB's Maternal Fetal Medicine Units network, Institute for Translational Sciences, and Center for Biomedical Engineering; and (3) increase the number and quality of researchers in the field of maternal-fetal pharmacology by providing training options for postdoctoral and clinical fellows as well as junior faculty via various tracks of hands-on training 1-on-1 mentoring, formal career development programs, didactic multidisciplinary courses, and postgraduate degrees in basic and clinical sciences. We anticipate that collaborations among and beyond the Center's investigative teams will lead to continued opportunities to synergistically translate new hypotheses, research findings, and clinical studies to improve maternal-fetal outcomes.