The new Drug Substance Strategic Value Framework – addressing industry pain points

9 February 2024
Drug Substance
Catherine Wyatt
Phorum Director

At the beginning of 2022, BioPhorum Drug Substance leadership initiated a strategic review. It recognized that while the drug substance environment had evolved since the pandemic, the current program of workstreams had remained largely static and pre-dated many leadership team members. From this review, it identified a shared vision, common goals, and the key trends to address over the next five to ten years.

The result is The Drug Substance 2.0 Strategic Value Framework.

In defining the Framework, the team has articulated the main opportunities for realizing benefits in a BioPhorum collaboration. It will enable the Phorum to evaluate the current program and future ideas using a common language within a consistent Framework that will support decision-making.

It includes three ‘true north’ goals:

  1. To make Pharma 4.0 a reality for biomanufacturing commercial operations
  2. To halve the time to implement post-approval changes globally
  3. To reduce major health authority inspection findings to zero.

However, this is just the starting point, as the real value to BioPhorum and its members will come from the insights gained from having this Framework in place. Its design facilitates the assessment of progress against agreed objectives at different levels, from the true north goals down to detailed impacts. It enables interpretation by workstreams, the Phorum, and the broader membership.

The main benefits of the Framework are to:

  • Advance the biopharmaceutical industry by having a common view of improvement priorities for the next five to ten years
  • Build a common purpose and language for the Phorum, enabling better decision-making about the BioPhorum Drug Substance program
  • Enable members to consistently measure and quantify the tangible and intangible impact of the work in the Drug Substance workstreams
  • Develop a balanced program of work, ensuring the Drug Substance program encompasses the pain points across the industry
  • Build an industry-aligned pipeline of ideas for future consideration
  • Help Phorum leadership identify gaps in the current work program and prioritize potential new workstream activity.

“The Drug Substance 2.0 Strategic Value Framework is helping us to prepare the Drug Substance Phorum for the future,” said Albin Simoni, Head of Global MSAT DS, Merck. “Building from the Framework to the ongoing activities for prioritization and maturity model, I believe we are going in the right direction to bring even more value to the industry.”

It is important to recognize that the Framework will not be static and, although it lays out a plan for the next five years and more, it will be reviewed regularly as part of Phorum governance. There is a commitment to watch for any changes in trends, including emerging issues and linkages with other phorums, and make adjustments as insights come from the current Drug Substance program. As a result, it will be an evolving, flexible Framework that remains current to the issues faced by the biopharmaceutical industry today and in the years ahead.

The development of the Drug Substance 2.0 Strategic Value Framework puts the Phorum in a very strong position to ensure it is focusing on the key pain points for technical operations in the biopharmaceutical industry. This is where BioPhorum is uniquely placed to excel – helping member companies resolve their combined, highest-priority issues and driving appropriate, synchronized change to create value across the industry.

For more information, download the paper here and contact Catherine Wyatt, Phorum Director, at

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