Senior Director, Functional Area Lead, Marketed Products, Patient Safety and Pharmacovigilance, Takeda Pharmaceuticals International AG, Cambridge, Massachusetts.
Senior Director, Head of Business Development, Alliance Management and Vendor Oversight, Patient Safety and Pharmacovigilance, Takeda Pharmaceuticals International AG, Cambridge, Massachusetts.
Clin Ther. 2024 May;46(5):424-428. doi: 10.1016/j.clinthera.2024.03.007. Epub 2024 Apr 26.
Pharmaceutical development is a highly regulated industry through numerous worldwide guidance, laws, and regulations. Issues related to the safety of pharmaceutical products have been the most common cause of withdrawals from the market, as well as restrictions on distribution and limitations on labeling. Collaboration (hereafter referred to as partnership) between pharmaceutical companies in drug development has been recognized as critically significant to maximize the efficiency of drug development. In general, pharmaceutical companies might benefit from partnering in conducting pharmacovigilance (PV) activities, resulting in enhanced safety monitoring, improved clinical outcomes, and support of optimal benefit-risk assessment. However, some challenges exist. Differences between partners in strategy, culture, and processes can impact the harmonization of safety practices and decision-making processes, necessitating open communications and consensus-building to effectively address safety concerns. Both successful and unsuccessful partnership attempts within the pharmaceutical industry provide valuable business cases and lessons for the future. This paper sheds light on some of the critical aspects of PV in partnerships within the pharmaceutical industry. It addresses issues of the benefits and risks of partnerships, regulatory/legal expectations, and best practices for safety teams' integration.
制药行业是一个高度受监管的行业，受到众多全球指导原则、法律和法规的约束。与药品安全相关的问题是导致药品从市场撤回、限制分销和标签限制的最常见原因。在药物开发方面，制药公司之间的合作（以下简称合作关系）已被认为对最大限度地提高药物开发效率至关重要。一般来说，制药公司在开展药物警戒（PV）活动方面可能受益于合作关系，从而加强安全性监测、改善临床结果，并支持最佳的获益-风险评估。然而，也存在一些挑战。合作伙伴在战略、文化和流程方面的差异可能会影响安全实践和决策过程的协调一致，需要进行开放的沟通和共识建设，以有效地解决安全性问题。制药行业中成功和失败的合作尝试都为未来提供了有价值的商业案例和经验教训。本文探讨了制药行业合作关系中药物警戒的一些关键方面。它涉及合作关系的收益和风险、监管/法律期望以及安全团队整合的最佳实践等问题。
