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Case Study

Organizational Change Management Assists Biotech to Align on a Model-Based Drug Development Approach

Overview

For businesses to prosper and expand, they must undergo organizational change from time to time. The process of change management drives the successful acceptance and implementation of change, and enables employees to comprehend the shift, commit to it, and operate efficiently during it.

Company transitions may be rough and costly in terms of both time and resources if appropriate organizational change management is not implemented or implemented incorrectly. It can also lead to lower employee morale and improper development of required skills.

There are some critical success factors associated with organizational change management. The key is to ensure a framework that incorporates the essential elements including:

  • Change Strategy Planning
  • Organizational & Process Design
  • Schedule & KPI Tracking & Management
  • Stakeholder Management & Communications
  • Skills & Knowledge Management
  • Document & Training of Employees

This case study presents a successful organizational change management program in which Astrix assisted a biotech company in its mission to:

  • Align the organization to the goals of the leadership team
  • Ensure a framework for governance and organizational structure for sustained change management into the future.

Business Challenge

The discovery medicine organization of a global pharmaceutical company sought to change their current working practices to embrace a model-based drug development (MBDD) paradigm that would encourage quantitative data analysis and use of that analysis to provide support for early go/no-go decisions and future trial design. The organization was functionally siloed both in terms of business process and data integration. In order to achieve the necessary paradigm shift the organization recognized that change would be required across many fronts including changes in mindset and culture, changes to organizational structure and business processes, as well as the development of technical tools and infrastructure to better support access to and analysis of disparate data.

How Astrix Enabled Success

Astrix followed a Diagnosis – Design – Implement methodology with each phase centered around a series of sessions to focus client stakeholders on the deliverables for that specific segment. Executive buy-in was fostered throughout the process.

In the Diagnosis phase of the project Astrix’ senior consultants facilitated the definition of the new vision and the identification of components to address “what needs to change and why.”

In the Design phase Astrix managed several work streams through the design of the change elements including:

  • Organization: design of new matrix team organization and governance models
  • Process: design and agreement of new business processes and business rules (especially in the area of shared data access and changes to who and how data were accessed)
  • Culture: development of stakeholder maps, stakeholder communication, change management plans to facilitate organizational buy-in
  • Technology: identification of technology projects to support data access, data integration, and visualization activities
  • Training: development of a training curriculum and identification of suitable training courses

A comprehensive Implementation plan was developed to manage the rollout of the new MBDD approach first to pilot teams and then to full scale production.

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