The State of MLR Review Efficiency: Trends & Best Practices

In the pharmaceutical industry, the efficiency of Medical, Legal, and Regulatory (MLR) reviews is pivotal. Companies that have optimized their MLR workflows have achieved a 57% reduction in review cycle times and a 55% decrease in time spent in review meetings. This report examines the integration of technology, human capital, and processes designed to enhance MLR efficiency, drawing insights from industry leaders and authoritative sources.
MLR Strategy

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Strategic Trends in MLR Review Efficiency 

  1. Technological Advancements

a. Artificial Intelligence (AI) and Automation 

AI technologies, such as machine learning and natural language processing, are transforming MLR processes by automating tasks like claims management and content comparison, leading to increased precision and scalability. This automation not only accelerates the MLR process but also ensures compliance by detecting deviations from approved messages. 

b. Predictive Analytics 

Predictive analytics tools analyze historical MLR data to forecast potential compliance issues, enabling proactive risk management and more efficient resource allocation.  

  1. Human Capital Development

a. AI Literacy and Training 

Pharmaceutical companies are investing in AI literacy programs to upskill their workforce. For instance, Johnson & Johnson has implemented mandatory generative AI training for over 56,000 employees, while Merck has developed a proprietary platform to facilitate AI usage among more than 50,000 employees. 

b. Cross-Functional Collaboration 

Enhancing collaboration among medical, legal, regulatory, and marketing teams is crucial. Companies leveraging collaborative platforms have reported increased review speed and reduced compliance errors. 

  1. Process Optimization

a. Risk-Based Review Models 

Implementing risk-based review strategies allows for differentiated scrutiny based on the compliance risk of promotional materials, expediting approvals for low-risk content while maintaining rigorous oversight where necessary. 

b. Standardization and Centralization 

Standardizing workflows and centralizing compliance frameworks ensure alignment across global operations, reducing variability and enhancing efficiency. 

Key Challenges and Leadership Considerations 

  1. The High Cost of Inefficiency

Inefficient MLR workflows can lead to significant financial and reputational risks, including delays in product launches and potential regulatory fines.  

  1. Evolving Regulatory Scrutiny

Increasing regulatory oversight necessitates continuous adaptation of MLR processes to comply with evolving standards.  

  1. Organizational Resistance to Change

Implementing new technologies and processes requires a cultural shift. Leaders must champion change management to align cross-functional teams and foster a culture of continuous improvement. 

Best Practices for Pharma Leaders 

  1. Invest in Scalable, Intelligent MLR Technologies

Adopting AI-driven MLR platforms enhances scalability and compliance. For example, AI-assisted MLR reviews have been shown to reduce approval times significantly.  

  1. Redefine Governance with Risk-Based Review Models

Implementing tiered review frameworks allows for more effective resource allocation, ensuring critical materials receive appropriate oversight without delaying lower-risk content. 

  1. Build a Data-Driven MLR Operating Model

Utilizing real-time analytics to monitor review performance enables informed, strategic adjustments to processes. 

  1. Strengthen Cross-Functional Collaboration

Enhancing collaboration between teams is crucial for improving MLR efficiency.  

  1. Embrace a Change-Ready Culture

Fostering a culture that values agility and continuous improvement is essential for successful MLR transformation.  

Conclusion: The Leadership Mandate 

The future of MLR efficiency depends on strategic, forward-thinking leadership that embraces technological advancements, invests in human capital, and optimizes processes. By integrating AI and automation, fostering cross-functional collaboration, and implementing risk-based review models, leaders can transform MLR efficiency into a competitive advantage, ensuring compliance while accelerating speed-to-market. 

Recommended Reading & Resources: 

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