MLR in pharma: what does the future hold?

Anthill

/@helloanthill

Published: December 7, 2022

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This video provides an in-depth exploration of the future of Medical, Legal, and Regulatory (MLR) review processes in the pharmaceutical industry, emphasizing that true efficiency gains stem from fundamental operational restructuring centered around a "Content Creation Hub" and the adoption of modular content strategies. The speakers, drawing on experience from major pharmaceutical companies, stress that simply implementing new technology is insufficient; success requires standardizing processes and establishing centralized governance to manage the content supply chain effectively. The core challenge addressed is the difficulty of training hundreds of people on complex systems and ensuring consistency, which often leads to variations and poor quality inputs ("crap in, crap out").

A critical theme is the necessity of standardization and templates for modular content to function efficiently. Modular content requires a significantly different way of working and necessitates new organizational roles, such as "librarians," to manage and catalog content modules. Without standardization, the ability to plug modules into various downstream channels is severely hampered. The goal is to establish a baseline of consistent, high-quality content that allows regions and local affiliates to slowly build something more relevant and easily "pre-approved." This approach minimizes the need for full re-approval cycles and greatly assists in operationalizing the entire content supply chain.

The experts advocate for an agile and adaptive approach, urging pharmaceutical companies not to "reinvent the wheel" but rather to look at existing industry solutions and best practices. A key structural recommendation is the establishment of a centralized "Content Factory" supported by dedicated content librarians. This centralized structure ensures consistency, facilitates easier tracing of content history, and allows MLR colleagues to focus their attention on high-risk or novel content, rather than redundant reviews. This operational shift is positioned as the solution to the widespread pain point of slow, inconsistent MLR processes.

Ultimately, the discussion highlights that while MLR is often viewed as a necessary but tedious topic, optimizing it through modular content and a centralized Content Factory is essential for enabling rapid, compliant omnichannel engagement. The experts emphasize that flexibility is crucial, acknowledging that there is "no one-size-fits-all approach," but stressing that foundational elements like centralized governance and standardization are non-negotiable for achieving scalable operational efficiency and speeding up time-to-market for promotional and medical information materials.

Key Takeaways:

  • Operationalizing the Content Supply Chain: Optimizing MLR requires viewing content creation as a supply chain, demanding a centralized "Content Creation Hub" to ensure consistency and manage the flow from creation to deployment.
  • Standardization is Non-Negotiable: Modular content cannot be truly efficient without rigorous standardization and the use of approved templates, which allows content modules to be consistently plugged into various downstream materials and channels.
  • The "Crap In, Crap Out" Principle: Variation in how 800+ people upload and work within content systems leads to inconsistent quality; centralizing training and standardizing input processes are essential to maintain high quality and compliance.
  • New Roles Required: The shift to modular content necessitates the creation of new roles, specifically "content librarians," who are responsible for managing, cataloging, and maintaining the library of approved content modules.
  • Focus on Pre-Approval: The strategic goal is to establish a baseline of content that is centrally "pre-approved," allowing local regions and affiliates to adapt and build upon it without triggering extensive, full MLR reviews for every minor variation.
  • Agility in Decision Making: Companies should be agile in adopting solutions and avoid the tendency to "reinvent the wheel," instead looking around the industry to see what proven solutions and processes others are successfully utilizing.
  • Content Factory Model: The recommended organizational structure is a centralized "Content Factory," which provides the necessary governance and infrastructure to support modular content and streamline the review process.
  • MLR Focus Shift: By implementing modular content and centralized governance, MLR teams can shift their focus from reviewing redundant or standardized content to concentrating their expertise on novel, high-risk, or complex materials, thereby removing unnecessary duplication of work.
  • Support for Omnichannel Strategy: Speeding up MLR and the content supply chain is crucial for supporting modern omnichannel engagement, enabling affiliates to respond faster and more relevantly to the needs of Healthcare Professionals (HCPs).
  • Flexibility vs. Foundation: While recognizing that "there is no one-size-fits-all approach" for every company, the foundational elements—centralized governance, standardization, and a Content Factory—are universal requirements for efficiency.

Key Concepts:

  • MLR (Medical, Legal, Regulatory Review): The mandatory process in pharmaceutical and life sciences companies where all promotional and medical materials are reviewed and approved by medical, legal, and regulatory teams to ensure compliance.
  • Modular Content: An approach where content is broken down into small, reusable, approved blocks (modules) that can be assembled quickly into various communications (e.g., emails, presentations, websites) while maintaining compliance.
  • Content Creation Hub / Content Factory: A centralized organizational structure or platform responsible for the governance, creation, standardization, and management of all core content modules and templates.
  • Content Supply Chain: The end-to-end process flow of content, from initial creation and sourcing through MLR review, localization, distribution, and final delivery to the target audience.

Tools/Resources Mentioned:

  • Activator: Mentioned in the description as a technology solution that enables content history tracing, makes approval status clearly visible, and helps streamline MLR reviews.