Neugut Alfred I, George Vinu, Jacobson Judith S, Parkinson Michael D, Segall Leslie E, Lebo Michelle, Branas Charles C, Freedberg Daniel E, Rahman Mirza I
Department of Medicine, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, Columbia University, 722 West 168th Street, Room 725, New York, NY, 10032, USA.
Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.
Pharmaceut Med. 2025 May;39(3):151-156. doi: 10.1007/s40290-025-00567-w. Epub 2025 May 23.
Collaborations between academia and the pharmaceutical industry are common for drug development and clinical trials, but rare for pharmacovigilance. Here we describe a novel model for collaboration between academia and the pharmaceutical industry, focused on post-marketing pharmacovigilance, that others may wish to emulate. For the past 5 years, Otsuka Pharmaceutical, a global Japan-based pharmaceutical company, has collaborated with faculty at Columbia University, a major university, for epidemiology support. The primary aim of this collaboration is to provide expert research guidance for Otsuka's pharmacovigilance group on questions involving pharmacoepidemiology. University epidemiologists are also consulted by other industry divisions, such as the clinical trials group. University epidemiologists help to determine the incidence, prevalence, and outcomes of diseases; draft the epidemiology components of risk management plans for drugs; and plan retrospective database analyses. A second major aim of this collaboration is to provide educational services to the company by conducting workshops on basic epidemiology and biostatistics; leading a monthly lecture/journal club series; hosting seminars on medical topics; and providing a writing workshop to assist in preparing abstracts and papers for presentation and publication. University epidemiologists provide oversight/evaluation through quarterly presentations and updates to the industry partner's external advisory committee as well as to university leadership. This type of epidemiologic collaboration has key advantages for industry over the alternatives of building an in-house epidemiology department or hiring outside consulting firms: lower cost; rapid access to university experts for potentially esoteric medical topics; and, for education, deep university experience in terms of assembling didactic programming and recruiting speakers. We offer this model for collaboration for others performing mandatory regulatory post-marketing pharmacovigilance activities.
学术界与制药行业之间的合作在药物研发和临床试验中很常见，但在药物警戒方面却很少见。在此，我们描述一种学术界与制药行业之间的新型合作模式，该模式专注于上市后药物警戒，其他机构可能希望效仿。在过去5年里，总部位于日本的全球制药公司大冢制药与一所主要大学哥伦比亚大学的教员开展了合作，以获得流行病学支持。这种合作的主要目的是就涉及药物流行病学的问题为大冢制药的药物警戒团队提供专业研究指导。其他行业部门，如临床试验组，也会向大学流行病学家咨询。大学流行病学家帮助确定疾病的发病率、患病率和转归；起草药物风险管理计划的流行病学部分；并规划回顾性数据库分析。这种合作的第二个主要目的是通过举办基础流行病学和生物统计学讲习班、开展每月一次的讲座/期刊俱乐部系列活动、举办医学主题研讨会以及提供写作讲习班以协助撰写用于展示和发表的摘要及论文，为公司提供教育服务。大学流行病学家通过每季度向行业合作伙伴的外部咨询委员会以及大学领导层进行汇报和更新来提供监督/评估。与建立内部流行病学部门或聘请外部咨询公司的替代方案相比，这种流行病学合作模式对行业具有关键优势：成本更低；能够快速接触到大学专家，以解决潜在的深奥医学问题；在教育方面，在组织教学计划和招募演讲者方面拥有丰富的大学经验。我们为其他从事强制性监管上市后药物警戒活动的机构提供这种合作模式。
