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

 描述（由申请人提供）：总体而言，UTMB计划建立一个国家和国际公认的中心，主题是开发用于治疗孕妇和胎儿的药物和生物制剂。该中心的首要目标是加速FDA对治疗怀孕患者和/或胎儿的药物、生物制品和治疗方式的批准。这一目标将通过两个主要目标来实现：（A）通过招聘，教育和培训产科-胎儿药理学领域的初级教师来支持，扩大和多样化研究人员团队;（B）为临床和转化项目增加现有的环境，工具和基础设施。我们的成功是应该的， 在某种程度上，UTMB的临床基础设施，其中包括通过UTMB的地区妇幼保健计划以及Ob/Gyn的围产期研究部门训练有素的研究护士骨干接触广泛，多样化的患者人群。我们的翻译基础设施包括母胎药理学和生物发育实验室，以及最先进的分析中心。临床研究得到了转化项目的支持，这些项目专注于基础科学研究，将改善临床结果。我们的战略是利用和扩大我们现有的资源，以便将基础科学的知识转化为新的治疗方法，并将临床研究的发现转化为临床实践。这一战略将通过以下具体目标来实现：（1）开发智力、程序和物理基础设施，以加速临床试验的实施，以确定药物和其他疗法的有效性和安全性，并支持翻译项目，以确定母体和胎儿暴露于药物和生物制剂的分子机制;（2）通过招聘新的教师，其专业知识将增加现有的多学科团队，并通过增加与UTMB的孕产妇胎儿医学单位网络，转化科学研究所和生物医学工程中心的合作，扩大调查范围;和（3）通过为博士后和临床研究员以及初级教师提供培训选择，通过各种实践培训1对1指导，正式的职业发展计划，教学性多学科课程，以及基础和临床科学研究生学位。我们预计，中心调查团队之间的合作将带来持续的机会，以协同转化新的假设，研究结果和临床研究，以改善母胎结局。

 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.