DSCSA compliance

Top Takeaways from Berlin CMO Summit

More than 100 pharma organizations attended the CMO Summit in Berlin December 12, and the emphatic refrain throughout this one-day conference was “serialization readiness.” With 2017 DSCSA deadlines in the U.S. and 2019 FMU deadlines in the EU, serialization preparedness is top of mind for CMOs struggling to make progress fast enough to hit key compliance timelines.

Here are our three main takeaways from the event.

1. Lack of CMO serialization readiness is concerning

During the first presentation of the day, conference organizers Supply Chain Wizard and Medicines for Europe shared their research that showed the troubling state of serialization readiness. In 2016, more than 65 percent of CMOs still don’t have sufficient resources for serialization and more than 55 percent have not yet initiated their first line project. While this was a slight improvement over 2015, the numbers still aren’t ticking up fast enough. That’s likely because according to the same report, more than 40 percent of CMOs don’t have approved capital budgets and more than 40 percent lack the regulatory and technical knowledge to fully engage serialization solution providers.

CMOs face unique serialization and traceability challenges and requirements compared to brand owner manufacturers. The biggest challenge for CMOs is added complexity. Brand owners have to implement serialization into one supply chain—their own. CMOs have to support serialization in the supply chains of their entire customer base. CMOs behind the “readiness curve” will need an experienced serialization partner that can get them up to speed quickly and efficiently using proven, flexible software that communicates in both standard and non-standard messaging formats with all trading partners.

2. Supply chain visibility and analytics are a ‘must have’

Gartner surveyed chief supply chain officers of pharma organizations, and outlined the main issues they currently face. The top five concerns are:

  • Leveraging supply chain analytics
  • Supply chain visibility
  • Building talent training programs
  • Designing a supply chain strategy for cost to serve
  • Building a resilient supply chain

We think CMOs can meet regulations faster, and better understand their business processes, through valuable insights when their serialization partner offers easy-to-understand supply chain reports and analytics. For example, on rare occasions, brand owners will generate a wrong set of numbers. Moreover, some brand owners have told us they will require “full reconciliation” to know what happened with each and every number, like which have been sampled, are on hold, or have been damaged/destroyed. CMOs need software that allows them to not only gain visibility into supply chains, but also provide reports and alerts that show duplicates, destroyed codes and malformed serializations.

3. Industry benchmarks are critical

One speaker posed these important questions: “What does good look like? How do we benchmark? What are leaders doing?” Different customers have different requirements; some will sell product in different markets with different serialization regulations. That’s why the industry needs a set of universally understood building blocks for supply chain serialization capabilities, such as:

  • Segmentation across deliverables to assign metrics and KPIs
  • Common/shared end-to-end supply chain principles
  • The ability to work cross-functionally to collate and collect information across execution and post-compliance methods
  • Communication protocols and dashboards that fully capture value-based events enabled through serialization
  • Embedded IT serialization expertise within the supply chain organization

Verify Brand sees our role as providing support to CMOs to make serialization a revenue and profit opportunity and to better serve pharma manufacturers. It’s part of our commitment to ensure that CMOs are future-proofed as their customer requirements continue to evolve. While everyone is evaluating tools for compliance, CMOs that can leverage data and advanced processes to improve pharma brand operations will rise to the top of the list as the most in-demand partners.

We think seeing is believing; let us walk you through a demo of our software so you can see for yourself how you can easily implement your serialization projects with a seamless, flexible solution while improving operations, increasing responsiveness and delivering real business value to pharma brands.

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