Administrative Core

行政核心

• 批准号: 10747154
• 负责人: LONNY R LEVIN
• 金额: $ 25.12万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-10 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10747154
• 关键词: Adenylate Cyclase; Advisory Committees; Affect; Animal Model; Biochemistry; Biological Availability; Biotechnology; Characteristics; Chemicals; Communication; Computer Models; Contraceptive Agents; Contraceptive methods; Crystallography; Data; Drug Kinetics; Elements; Ensure; Enzymatic Biochemistry; Evaluation; Fertilization; Fostering; Funding; Goals; Human; Human Resources; Infertility; Institution; Institutional Review Boards; Investigational New Drug Application; Lead; Link; Maintenance; Male Contraceptive Agents; Marketing; Medicine; Mus; National Institute of Child Health and Human Development; Oral; Oral Contraceptives; Partner in relationship; Pharmaceutical Chemistry; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacology; Physiology; Positioning Attribute; Principal Investigator; Property; Quality Control; Reproductive Biology; Research; Research Activity; Research Personnel; Resources; Series; Sperm Motility; Structure; Therapeutic; Time; Work; contraceptive efficacy; design; drug development; drug discovery; drug quality; early phase clinical trial; improved; in vivo; inhibitor; male; mating behavior; member; men; outreach; pharmacodynamic biomarker; pharmacologic; pill; preclinical development; preference; prevent; programs; recruit; scaffold; sperm cell; structural biology; tool

Administrative Core The objective of the Administrative Core is to link together the various elements of the Weill Cornell Medicine Contraception Research Center (WCM-CRC). This center, titled “On-demand nonhormonal male contraception via ADCY10 inhibition,” has a singular scientific theme; to identify the safest and most efficacious means for blocking soluble adenylyl cyclase (sAC; ADCY10) in vivo to achieve an on-demand contraceptive pill for men. To achieve this goal, the WCM-CRC leverages the established inter-disciplinary team comprised of expertise in sAC physiology, pharmacology, biochemistry, reproductive biology, structural biology, enzymology, computational modeling, medicinal chemistry, and drug development. This team, which has been effectively and efficiently working together for the past 4 years, successfully advanced sAC inhibitors into potent, specific, drug-like leads that demonstrated proof-of-concept for on- demand male contraception in vivo in mice. This administrative core mirrors the successful administrative core from the previously funded WCM-CRC; all personnel and operational resources are maintained. Due to the advancements made over the past four years, the WCM-CRC investigative team joined forces with an expert in reproductive biology and an expert in contraceptive marketing and end-user preferences to form Sacyl Pharmaceuticals, Inc. (SACYL), a biotech company established to further develop and market sAC inhibitors as nonhormonal, on-demand birth control pills for men. SACYL will provide `Pharma-quality' drug development expertise to augment the work proposed in this application. In addition to ensuring that the established group of collaborators comprising the WCM-CRC functions as a single entity, the WCM- CRC Administrative Core will be responsible for maintaining complementarity between the WCM-CRC and SACYL as well as fostering interactions between the WCM-CRC and NICHD program personnel, investigators in other CRCs, and regulatory agencies. The Core's administrative responsibilities include planning, flow of information, developing resources, outreach, and overall administration for the WCM- CRC. In practice, the WCM-CRC Administrative Core will provide structure and oversight for the already existing relationships between the two co-Principal Investigators, the other project leaders, SACYL, and the Center's advisory committees.

行政核心 行政核心的目标是将威尔康奈尔大学的各种元素联系在一起 医学避孕研究中心（WCM-CRC）。这个名为“非荷尔蒙男性按需”的中心 通过ADCY 10抑制避孕，“有一个单一的科学主题;以确定最安全，最 用于在体内阻断可溶性腺苷酸环化酶（sAC; ADCY 10）以实现按需治疗的有效手段 男性避孕药为了实现这一目标，WCM-CRC利用现有的跨学科 由sAC生理学、药理学、生物化学、生殖生物学 结构生物学、酶学、计算建模、药物化学和药物开发。这 在过去的4年里，我们的团队一直在有效地合作， 先进的sAC抑制剂成为有效的，特异性的，药物样的线索，证明了概念验证， 需要雄性小鼠体内避孕。此管理核心反映了成功的管理 从以前供资的WCM-CRC核心;所有人员和业务资源保持不变。由于 在过去四年取得的进步，WCM-CRC调查小组与 一位生殖生物学专家和一位避孕药具营销和最终用户偏好专家， 来自Sacyl Pharmaceuticals，Inc.（SACYL），一家生物技术公司，旨在进一步开发和营销 sAC抑制剂作为男性非激素、按需避孕药。SACYL将提供“医药质量” 药物开发专业知识，以加强本申请中提出的工作。除了确保 已建立的包括WCM-CRC在内的合作者小组作为一个单一实体运作， CRC行政核心将负责保持WCM-CRC与 SACYL以及促进WCM-CRC和NICHD方案人员之间的互动， 其他CRC和监管机构的研究者。核心的行政职责包括： WCM的规划、信息流、资源开发、推广和整体管理- 《儿童权利公约》。在实践中，世界基督教运动-儿童权利委员会行政核心将为已经建立的 两位共同主要研究者、其他项目负责人、SACYL之间的现有关系，以及 中心的咨询委员会。