Applying a Launch Excellence Framework in Patient Safety

• Published in: Drug safety Vol. 45; no. 10; p. 1279
• Main Authors: Beauchamp, S, Anstatt, K, Haag, A, Lalchandani, V, Talati, B, Kim, J, Strother, R, Shah, A
• Format: Journal Article
• Language: English
• Published: Auckland Springer Nature B.V 01-10-2022
• Subjects: Alignment; Best practice; Collaboration; Commercialization; Communications; Patient safety; Patients; Pharmacovigilance; Product development; Safety; Safety management; Scientific papers; Teams
• ISSN: 0114-5916; 1179-1942

Introduction: Following BMS acquisition of several late-stage development assets, the need to enhance pharmacovigilance (PV) product launch preparation and support to enable improved safety communications with HCPs post-approval became more apparent. Communications between Safety and other functions, primarily Medical Affairs, was inconsistent and, often, reactive. Objective: To develop and test a conceptual launch framework that will enhance the creation and exchange of safety information to better inform clinicians healthcare decisions. Methods: A current state assessment of launch activities in the preand peri-launch settings revealed several best practices, gaps, and opportunities that were used to guide the development of a new framework. This new framework, including new roles, processes, and tools, creates a dedicated launch capability for PV: * Establish a single point of contact for coordinating and connecting safety launch activities. * Assign clear launch accountabilities to existing roles on the asset safety management team. * Build a Medical Collaboration Model to formalize engagement opportunities between the Safety and Medical Affairs functions. * Development of a simple 10-step process to direct asset teams in value-driven safety activities surrounding launch. * Creation of Complex Medical Query Rapid Response Model to streamline the communication and safety response for complex medical queries. * Identification of new sources and new uses for existing data sources to further inform launch teams of safety topics. Once the framework was created, the concepts were piloted at varying stages of asset launch for refinement before broad scale up and implementation. Results: The new framework has been applied to 2 assets to date, resulting in improved stakeholder engagement and collaboration with (a) greater transparency on safety data gaps from the perspective of HCPs and patients, (b) opportunity to share information and expertise regarding the safety profile based on safety surveillance activities (c) alignment on medical and scientific communication opportunities including publications. Both teams identified opportunities to enhance safety communications and exchange insights for the asset. Conclusion: Ensuring patient safety is critical in the development, approval, and commercialization of new medicines. By forming a launch capability framework, the team created structure that will trigger cross functional connectivity based on the unique safety needs of each new product preparing for market. Alignment on unmet data needs, data generation and scientific and medical communications surrounding the safety profile are key drivers of success. This new capability will ensure valuable safety data and insights are effectively and efficiently shared across functions at BMS.