Drug Development Case

A biopharmaceutical company focuses on managing its drug development pipeline by using RF Backplanning to define the sequence of FDA submissions and to manage competing resource needs. The result is a disciplined approach to the FDA submission process for achieving 6 submissions in a 12-18 month timeframe.

Company Profile

The company was established in 1987 by a small team of researchers with a vision of building an integrated biopharmaceutical organization with a global presence. To balance the risks associated with drug development they established a dual strategy for achieving their objectives. They combined strong in-house research and development capabilities with acquiring and marketing innovative, high-growth products. They currently manufacture and market drugs in the US, Japan and Europe.

Business Challenge

The organization had grown aggressively by applying the dual strategy. The combination of their own development efforts plus a series of acquisitions (foreign and domestic), placed them in an enviable though challenging position. They needed to go from one NDA filing in the previous 3 years to submitting between six & eight NDA’s in a twelve to eighteen month timeframe. Adding fuel to the fire, for many of the drugs the CEO had committed submission dates to the financial community.

It became clear that the organization faced several major challenges if it was to achieve this goal. Specifically, they needed:

  • A clear strategic focus on product development — which products, in what sequence, and, a coordinated effort to achieve it
  • A new process for electronic based submission of NDAs to the FDA
  • A disciplined and rigorous approach to assessing the resource implications of this effort for the key functions involved (Clinical, Regulatory, Biometrics, QA, Non-Clinical, etc);
  • Excellent coordination and collaboration across multiple functions

Approach

RF Backplanning was first applied to the most critical drugs (the two that were scheduled for submission within the next 10 months). The first RF Backplanning sessions highlighted the lack of alignment on the specifics of each submission, created anxiety in the management team regarding the magnitude of the effort involved and caused assumptions about the submission process of both individuals and functions to be surfaced. This dialogue resulted in a more highly aligned organization, an understanding of the critical components required for success, and a skilled group of managers, scientists and employees capable of applying RF Backplanning to other drugs in the submission pipeline.

Recognizing the value realized from the creation of the initial 2 RF Backplans – in particular the heightened level of cross-functional alignment – management made the decision to create Backplans for all the drugs in the submissions pipeline. These subsequent Backplans were created quickly and with little effort as most of the key resources had participated in the earlier NDA sessions.

To consolidate all the Backplans and provide management with an overview of all the drug submissions, a master schedule was created. Integral to this was the resource requirement plan from each function that defined the functional resources required for each drug by quarter. The consolidated overview and the resource plans highlighted numerous sequencing issues and identified conflicting needs for specific functional resources.

The discussion generated by these insights resulted in decisions to:

  • Immediately employ contractors to fill critical functional gaps
  • Accelerate the hiring process for key functional positions so they would experience the submissions process for the key 2004 drugs and thus be able to replace teh contractors for subsequent submissions
  • Enhance the project management capabilities of the organization
  • Establish a review process for each key drug on a regular basis to track progress and milestone accomplishments as defined in the Backplan

Outcomes

In summary, the RF Backplanning process:

  1. Created a format and reason for a series of critical cross-functional dialogues to occur. It brought all the stakeholders of a drug submission together to create a clear and fact-based dialogue focused on achieving a successful submission.
  2. Created a framework for the management team to fully understand the scope and magnitude of the commitment to the submission schedule by:
    • Providing an overview of the key milestones and events required for each drug submission success.
    • Defining the resources required for success – by function, by quarter.
    • Identifying the infrastructure and organizational issues that had to be resolved immediately to meet the needed timelines.

"Backplanning has resulted in a sea change in the way we approach coordinating a complex set of initiatives. It has brought discipline and focus to our process."

- Senior VP of Clinical and Regulatory Affairs

"Backplanning really got us off the ground. The number of uncovered misalignments between functions got all the key issues on the table. Now we can do the detailed project planning with confidence that the plans stand on a solid foundation."

- Vice President, Project Management

"The Backplanning process was powerful because it got all the key functions to coordinate and collaborate together. We have much more confidence being at the tail end of the process that everything will be in place."

- Vice President, Regulatory Affairs

"Backplanning has made my job easier. I now know what the key company priorities are and our plans for managing all these submissions."

- Regulatory Affairs Associate