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Life Sciences Case

A life sciences company gains control of its pharmaceutical product development process by using Backplanning to build organizational discipline, alignment, and cross-functional coordination.

Company Profile

CIRON grew quickly due to the unique approach it had taken to drug delivery. Potential applications of their technology were numerous. As a result, new applications were constantly being considered while serious work was being pursued on a key set of major medical indications

Business Challenge

The organization’s cultural heritage was a university research environment. Employees were intelligent, curious and willing and eager to explore the unusual. Everyone was committed to the companies unique process of drug delivery and enthusiastic about the difference it could make to individuals impacted by serious diseases. The challenge was translating the commitment and enthusiasm into results. The top management team was getting tired of having to get into the details of each project to get them back on track, there were too many conflicts being brought up to the management team, and everyone’s solution to just add resources only seemed to make the problem worse.

It became clear that the organization faced several major organizational challenges:

• A clear strategic focus on product development – which products and in what sequence
• A standard process for investigating potential applications of their drug delivery technology
• A disciplined and rigorous approach to the NDA submission process
• Coordination and collaboration across the organization and its product development process to leverage critical resource limitations

Approach

To begin the change, Backplanning was applied to one key drug project. This project was behind schedule, had detailed project plans but a lack of clarity on priorities, and low moral. The Backplanning process had a significant impact:

1. The project went from being 9 months behind to being on track. Key assumptions that the team held turned out not to be valid and changed the overall approach of the effort. None of these assumptions were uncovered before since the team had gone from a high level plan to detailed project plans and had no means for seeing the bigger picture.
2. A realization that the overall strategy of the company had changed and that clarity on priorities was needed to address tradeoffs between this and other key projects.
3. The team now knew the 20% of activities that would generate 80% of their results and updated detailed workplans accordingly.
4. The Backplan created coordination, buy-in and accountability across the whole organization as everyone was now able to see the interdependencies between functions for key results that needed to be achieved in the next 3 months.

Given the experience of this pilot, the CEO and Executive Committee used the Backplanning process at the Corporate level to clarify the 20% of Strategic results needed for success. Key dates for Phase I, II, III trial completions, NDA Approval, sales, and related activities were clarified. When this high level Backplan was completed, the top 45 people were asked to develop Backplans for the key drug projects. Coordination, staffing, equipment and sequencing issues were identified. During the next 30 days these issues were resolved and used to revise the initial Backplans.

Final Backplans were presented to all employees in a company-wide meeting. Implementation plans were created for the key activities identified in the Backplans for the next three months. Since then, Backplanning has becoming a standard practice for all aspects of the organizations critical results.

Outcomes

Today, the organization is now in control of its strategic focus and NDA process. Backplanning has spread throughout the organization to align project management, new product ideas, and strategic human resource planning. It is too early to present results in medical or financial terms, but the following sample of employee comments highlight the difference Backplanning is making:

"It has highlighted all the potential pitfalls and forced us to deal with them now. It has also clearly defined roles and project responsibilities, and focused us in a very productive way. It is a great step forward in making this organization more effective."

Director of Pre-Clinical

"As a result of Backplanning I now fully realize the complexity of commercializing our products."

Director of Research

"I like the way Backplanning allows us to track our projects simply and effectively."

Executive Committee Member

"It sure works for us. Our meetings are focused, disciplined and much shorter."

Chief Financial Officer

"Wished we had instituted Backplanning earlier. It would have defined the challenges and hurdles in a more timely fashion. At least we now know what we face."

Operations