Chopra Pravin
The Academy of Global Medicines Development Professionals (GMDP Academy), New York, NY, USA.
Faculty of Life Sciences and Medicine, King's College London, London, UK.
Pharmaceut Med. 2025 Mar 13. doi: 10.1007/s40290-025-00556-z.
Medicines development has dramatically transformed in the preceding decades. It has evolved from a task undertaken by a small team to a complex series of activities, involving several functions and qualified professionals, across multiple, interrelated, scientific disciplines, worldwide. Conceptualized as a medical specialty, concerned with the research, development, and monitoring of medicines, and spearheaded largely by pharmaceutical physicians, the discipline has extended to embrace non-medically qualified scientists progressively taking on traditional roles within the medicines development ambit. There is expanded engagement of professional backgrounds. Each individual function contributes unique expertise and skills, but they all share a sense of identity, a collective commitment, and a common goal of improving human health and well-being, through innovative treatments. At the same time, milestone advancements in the research and development environment, in healthcare delivery, the regulatory ethos, data sharing with greater transparency, the exponential digitalization, and the emphasis on patient outcomes have imposed greater accountability in systems and processes, and across all global stakeholders. Increasingly, this demands a joint purpose, fostering continuous learning, and engendering a professional identity within the medicines development community, a coinage gaining incremental affirmation as equivalent to pharmaceutical medicine. The aligned set of related competencies and capabilities across the multi-professional teams involved, the sense of identifying concurrently across different, albeit complementary, communities of practice, the obligation of ongoing specialized knowledge training, the mandated enterprise-wide codes of ethics and moral conduct, and the intertwined career paths within the larger business organizational construct of academic institutions, regulatory agencies, and the biopharmaceutical industry-all profess to meet the criteria, and merit medicines development/pharmaceutical medicine be acknowledged, regarded, and recognized as a distinct profession of stature, in its own standing. The concept of pharmaceutical medicine has been floated since 1957, and has received considerable attention in scientific literature over the years. Yet, the discipline struggles to be universally understood and appreciated. This perspective scrutinizes related engendering influences and hindering elements, while advocating the furtherance of medicines development from a traditional occupation, emerging as a vocation, and transforming into a mature profession, with the vision and purpose of advancing better medicines for improved health outcomes for people, globally.
在过去几十年里，药物研发发生了巨大变革。它已从一个由小团队承担的任务，演变成一系列复杂的活动，涉及多个相互关联的科学学科中的多种职能和专业人才，遍布全球。该学科最初被概念化为一个医学专业领域，专注于药物的研究、开发和监测，主要由制药医师引领，如今已逐渐扩展，接纳了非医学专业背景的科学家，他们在药物研发领域承担起传统角色。专业背景的参与范围不断扩大。每个职能部门都贡献独特的专业知识和技能，但他们都有共同的身份认同、集体责任感以及通过创新治疗改善人类健康和福祉的共同目标。与此同时，研发环境、医疗服务、监管理念、数据共享透明度的提高、指数级数字化以及对患者结果的重视等方面的里程碑式进展，给系统和流程以及所有全球利益相关者带来了更大的问责压力。这越来越需要一个共同目标，促进持续学习，并在药物研发界形成一种职业身份认同，这个术语越来越被认可为等同于药物医学。参与其中的多专业团队所具备的一系列相关能力和资质、在不同但互补的实践社区中同时产生的认同感、持续进行专业知识培训的义务、全企业范围内强制遵守的道德和行为准则，以及学术机构、监管机构和生物制药行业等更大商业组织架构中相互交织的职业发展路径——所有这些都表明符合标准，药物研发/药物医学理应被认可、视为并确认为一个具有独特地位的专业领域。药物医学的概念自1957年提出以来，多年来在科学文献中受到了相当多的关注。然而，这一学科仍难以得到普遍理解和认可。本文审视了相关的促成因素和阻碍因素，同时倡导推动药物研发从传统职业发展成为一种使命，并转变为一个成熟的专业领域，其愿景和目标是开发出更好的药物，为全球人民改善健康状况。
