Apogenix AG, Im Neuenheimer Feld 584, 69120, Heidelberg, Germany.
Daiichi Sankyo Deutschland GmbH, Munich, Germany.
Pharmaceut Med. 2022 Apr;36(2):71-82. doi: 10.1007/s40290-022-00424-0. Epub 2022 Mar 13.
Innovative medicinal products are required for progress in many therapeutic areas, and in particular, oncology. For these products to succeed, pharmaceutical companies must generate the relevant and robust clinical data required to meet the needs of regulators and healthcare providers. In addition, real-world and health economic evidence is increasingly required to support pricing and reimbursement for innovative medicinal products. To incorporate all of these requirements into the innovative medicinal product strategy early in development, the core principles of how product strategies are developed and applied must be revisited and end-to-end strategic planning implemented. This paper reviews the hurdles faced during development of the integrated strategy for innovative medicinal products, particularly in the oncology field, and examines which functions of a pharmaceutical company should play the greatest role in addressing patient and different stakeholders' needs. It will then illustrate how Medical Affairs activities are evolving to take on this strategic leadership role.
创新药物在许多治疗领域都需要取得进展，尤其是在肿瘤学领域。为了使这些产品取得成功，制药公司必须生成相关且可靠的临床数据，以满足监管机构和医疗保健提供者的需求。此外，越来越需要真实世界和健康经济学证据来支持创新药物的定价和报销。为了在开发早期将所有这些要求纳入创新药物策略，必须重新审视产品策略的开发和应用的核心原则，并实施端到端的战略规划。本文回顾了在创新药物综合策略开发过程中遇到的障碍，特别是在肿瘤学领域，并探讨了制药公司的哪些职能应在满足患者和不同利益相关者的需求方面发挥最大作用。然后，本文将说明医学事务活动如何发展以承担这一战略领导角色。
