Redesign of Medical Legal Regulatory (MLR) for a maturing company
"Mary was a key driver in assessing gaps and seeking solutions to build a more structured and efficient MLR review process for our growing company. She sought out and was willing to listen to cross-functional views and ideas to identify potential solutions. Through her collaborative leadership, we were able to identify multiple problems, implement improvements, and establish a more effective process to meet our expanding product needs."
Leah P, Former Executive Director, Regulatory Promotion at Amgen
Challenge
When a startup outgrows its early infrastructure, processes often need to catch up. For one biotech, this process was MLR, which had developed three primary flaws: (1) long lead times; (2) team tension and churn; and (3) inadequate support from medical.
With a growing product portfolio, this critical control system was not scalable to meet the company’s projected needs. That’s when I was asked to lead the redesign.
Solutions
The primary compliance fix was to put doctors on the review teams.
We also identified several sticking points that were impeding scalability. A primary culprit was review redundancy; all team members needed to sign off on every piece. Another was involving reviewers too late; they would raise show-stopper issues after significant commitments had been made and deadlines were looming. Finally, ill-defined escalation processes allowed stakeholders to work around reviewers, leading to a breakdown in team dynamics and loss of respect.
We solved these issues by:
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Streamlining workflows. We identified 50 types of materials and developed a matrix to specify which reviewers needed to sign off on each category. We also defined roles to clarify responsibilities and foster collaboration across the disciplines. The reviewers’ burdens decreased significantly.
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Encouraging engagement at the concept stage. We taught brand teams to engage with reviewers up front, so they could identify issues early and manage risk much more effectively. The result? Better pieces, more throughput and quicker turnaround times.
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Defining a clear – and fair – escalation process. We established a formal escalation process that included both the reviewers and the next level. It enabled better communication and got people cooperating with one another.
Results
We revolutionized the process, enabling the business to automate MLR shortly afterward, and shored up controls to help the company better manage promotional risk.