Reengineering of Work Processes Cuts Drug Development Timeline in Half

PROJECT BACKGROUND

To be more competitive, a mid-sized pharmaceutical company needed to shorten its development timeline. To that end, it hired a globally recognized management consulting firm to help reengineer its work processes. After expending significant financial and human resources, the consulting firm produced a model that, although generally applicable to any pharmaceutical company, was not defined in sufficient enough detail to be readily implemented, nor did it include adequate consideration of this particular company’s culture or corporate structure. The original objective remained unsatisfied, and the company needed a means to translate the generic model into a specific strategy and road map that could be implemented effectively.

IPM’S SOLUTION

The company employed Integrated Project Management Company, Inc. (IPM) to first customize the generic plan to fit the pharmaceutical company’s unique needs, and second ensure the integration and implementation of new work processes. The overall objective was to create a well- documented, seamless network of interactions across the company that would streamline the pathway of investigational compounds through the development pipeline.

When IPM joined the initiative, the company had already defined a basic work-process structure that included required technology-development competencies in R&D, manufacturing, quality assurance, strategic sourcing, and regulatory affairs. Each component work process, however, did not adequately define activities and responsibilities, provide a consistent level of detail, or identify interdependencies among other activities and work processes, thereby making integration impossible.

Consequently, IPM’s initial task was to work with the various teams responsible for creating each work process and ensure they 1) applied a disciplined, consistent approach, 2) thoroughly documented their process, 3) developed a plan to roll out a new workflow and 4) created a governance structure to clearly delineate roles, responsibilities, and authority for final decision-making.

As teams completed their process designs, IPM initiated a parallel effort to capture interdependencies across all processes. Analyzing the inputs (the elements each process requires to function) and outputs (what each process delivers upon completion) revealed disconnects in the overall design related to deliverables, timing, or both. Through a unique method developed by IPM, each disconnect was identified and then resolved until the entire network of drug development activities was fully integrated and documented.

PROJECT RESULTS

The company cut drug-development time in half. Even before the initiative was completed, the company put a new product through the process, saving valuable development time on what became a significant blockbuster.

IPM successfully led the reengineering of 20 different drug-development work processes that spanned multiple functional organizations and governance hierarchies. By mapping the integration of these processes, IPM was able to close gaps and rectify disconnects that had been causing missed commitments, timeline delays and mounting frustration.

Process mapping ultimately enabled IPM and the company to define the critical pathway, allowing management to apply the right resources to the right activities, minimizing delays and shortening the overall development timeline.

So that the company could apply best practices to future projects, IPM developed several tools tailored to the company’s needs to help them plan and allocate resources, determine decision-making criteria, and protect proprietary data while sharing them during the development process. By the initiative’s conclusion, the company was able to:

  • Cut development timeline by more than 50 percent
  • Anticipate an additional $100 million per month in revenues from the speedier launches of several late-stage, high potential new products
  • Reduce cost of goods sold, due to more-robust technology and efficient manufacturing processes
  • Eliminate the need for costly contingency-development efforts
  • Increase efficiency in transferring technology to manufacturing sites
  • Increase its flexibility in responding to changes in commercial volume forecasts
  • Improve resource utilization
  • Significantly increase management confidence in plans and commitments
  • Increase employee collaboration, accountability, ownership, and buy-in
  • Enhance its ability to capture in-house knowledge and accumulate intellectual property