Cooperative Agreement to Support Regulatory Research Related to the 2022 Prescription Drug User Fee Act and Biosimilar User Fee Act (U19)

项目摘要 美国食品药品监督管理局（FDA）的药物评价和研究中心（CDER） 寻求合作研究的建议，并召集活动，以推进和促进监管科学 在FDA，制药行业和国会在2022年的处方中优先考虑的几个关键领域， 药物使用者付费法案VII（PDUFA VII）和生物类似药使用者付费法案（BsUFA III）。在14个以上的建筑上 Duke-Robert J. Margolis，MD，在优先主题方面与FDA合作多年的工作经验， 卫生政策中心（Duke-Margolis）建议继续与FDA合作，以解决一系列 PDUFA VII和BsUFA III中确定的政策、科学和业务挑战。 Duke-Margolis将根据其过去的经验与FDA合作，确定优先主题， 制定和交付多达9项合作研究和召集活动，其中包括年度 完成多达四次大型公开会议、两次非公开专家讲习班和三次其他会议， 活动（例如，智囊团、网络研讨会）。取决于 预期的召集目的或需要，召集可以是虚拟的，混合的或亲自的。通过这一新 合作协议，并与PDUFA VII和BsUFA III的目标保持一致， 值得信赖的科学，杜克-马戈利斯建议扩大我们现有的基础设施，广泛的利益相关者， 关系，召集经验和专业知识，以及与众多FDA合作的良好记录 各中心和办事处实现以下目标： 具体目标1：开展多学科、多利益攸关方和协作研究， 支持FDA及其利益相关者解决复杂药物开发和监管审查问题的计划 PDUFA VII和BsUFA III中概述的挑战。 具体目标2：综合和提炼核心背景研究、利益相关者投入和研讨会或会议 在目标1中开展讨论，以促进和制定具体、可操作的后续步骤和建议 所有利益相关者群体。 具体目标3：以公开方式向公众传播根据目标2提出的调查结果和建议， 透明和及时的方法，着眼于不断吸引利益相关者，以进一步完善和 在可行和适当的情况下实施关键概念和建议。 Duke-Margolis非常适合与FDA合作，推进在以下关键领域的研究： PDUFA VII和BsUFA III。我们寻求建立在我们的高级团队的十四年工作经验， 通过其他此类合作协议与FDA合作，让利益相关者参与到高水平的 优先关注的问题，制定取得进展的建议和模式， 科学监管，更高效地为有需要的患者开发安全有效的药物。

PROJECT Summary The Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) is seeking proposals for collaborative research and convening activities to advance and promote regulatory science in several key areas prioritized by the FDA, the pharmaceutical industry, and Congress in 2022’s Prescription Drug User Fee Act VII (PDUFA VII) and Biosimilar User Fee Act (BsUFA III). Building on more than fourteen years of collaborative working experience with the FDA on priority topics, the Duke-Robert J. Margolis, MD, Center for Health Policy (Duke-Margolis) proposes to continue collaborating with the FDA to tackle the range of policy, scientific, and operational challenges identified in PDUFA VII and BsUFA III. Duke-Margolis will build on its past experience to work collaboratively with FDA to identify priority topics for development and delivery of up to nine collaborative research and convening activities that include the annual completion of up to four large public conferences, two private expert workshops, and three other convening activities (e.g., think tanks, webinars) as needed and achievable under the annual budget. Depending on the intended convening purpose or need, convenings may be virtual, hybrid, or in-person. Through this new cooperative agreement, and in keeping with goals in PDUFA VII and BsUFA III to expedite development through trusted science, Duke-Margolis proposes to expand on our existing infrastructure, extensive stakeholder relationships, convening experience and expertise, and positive track record of collaboration with numerous FDA Centers and Offices to achieve the following aims: Specific Aim 1: Implement a multidisciplinary, multi-stakeholder, and collaborative research and convening program to support FDA and its stakeholders in addressing complex drug development and regulatory review challenges as outlined in PDUFA VII and BsUFA III. Specific Aim 2: Synthesize and distill the core background research, stakeholder input, and workshop or meeting discussions pursued in Aim 1 to promote and establish concrete, actionable next steps and recommendations for all stakeholder groups. Specific Aim 3: Disseminate the findings and recommendations developed under Aim 2 to the public in a transparent and timely method, with an eye toward continually engaging stakeholders to further refine and implement key concepts and recommendations where feasible and appropriate. Duke-Margolis is uniquely suited to collaborate with the FDA to advance research in the key areas identified in PDUFA VII and BsUFA III. We seek to build on our senior team’s fourteen years of experience working collaboratively with the FDA through other such cooperative agreements to engage stakeholders on high- priority questions of interest, develop recommendations and models for making progress, and advance regulatory science and more efficient development of safe and effective drugs for patients in need.