P54: Patient Safety Integration Framework Between Two Major Biopharmaceutical Organizations
Strategic Planning and Integration Lead
Bristol-Myers Squibb Company United States
To integrate two patient safety organizations and establish a premier global patient safety capability while keeping a focus on business continuity, quality, compliance, value capture, talent engagement, and process/technology optimization.
The following framework has been established to enable successful and timely integration: Day 1 Planning and Inspection Readiness; Integration Planning and Governance; Initiative Execution; and Change Management.
Application of this new framework within our organization has helped us reach the targeted end state within a period of 2 years.
Day 1 Planning and Inspection Readiness: Interim processes were established in advance of acquisition close, including establishment of a company safety governance body to ensure all patient benefit/risk decisions were effectively and urgently addressed. This has been instrumental in supporting discussions with regulatory authorities while operating in 2 separate pharmacovigilance (PV) systems, with 9 inspections successfully completed as of Q1 2021.
Integration Planning and Governance: A Patient Safety Integration Management Office was established to define and govern the integration roadmap of 28 initiatives across 8 functions, based on aligned guiding principles and a clear target end state definition. Strategic oversight and monthly program reviews have enabled proactive issue identification and mitigation. Connection with cross-functional IMOs has ensured enterprise-wide alignment.
Initiative Execution: A consistent approach to chartering, project and resource planning, status reporting, dependency/risk management, escalation, and endorsement has been adopted. To date, 6 initiatives have been successfully completed (including alignment of roles/responsibilities and integration of processes and systems) with minimal business disruption.
Change Management: A set of change management and communication standards have been adopted across the organization to enable a consistent employee experience as changes are being implemented. Additionally, global, regional, and local change champion networks are ensuring employees are being engaged at all levels through a variety of channels to promote awareness, cultural alignment, change impact mitigation, training, and adoption of new ways of working.
The growing challenges in the regulatory landscape, as well as clinical trial complexity and cost, are leading to more biopharmaceutical divestitures and acquisitions. Historically, large companies would acquire small organizations or product portfolios to diversify and launch new products; however, 2019 showed us that large companies are starting to merge as well at very high costs: Danaher Corporation/GE Biopharma at $21.4 Billion; Takeda/ Shire at $58.6 Billion; AbbVie/ Allergan at $63 Billion, and the largest acquisition, BMS/Celgene at $74 Billion. Such large mergers and acquisitions not only draw attention from financial analysts, but also health authorities, who closely monitor such integrations to ensure medicines are developed, marketed, and distributed as per regulations and are safe and effective for patients.
Based on our previous experience, full integration of established PV systems may take a minimum of 18 months and, to our knowledge, a standard framework for executing on large PV integrations is not available. Development and application of this integration framework has been critical to ensuring that our large organization of 8 patient safety sub-functions and over 700 employees worldwide maintains business continuity, quality, compliance, and inspection readiness, and that we remain on track to reach the target end state, in keeping with our guiding principles:
• Focus on the priority of achieving a single PV system;
• Select best practices between the two heritage organizations;
• Identify sources for value capture/synergies;
• Minimize impact on day-to-day business operations.
This framework may be applied to support another company integration and can be used in the future to create efficiency and reduce operational costs associated with integration planning and execution.
Co-authors: Eileen Leonard, Anjali Shah