The pharmaceutical industry is currently experiencing a swift transformation, with harmonization and standardization playing crucial roles in its digital journey. It is common for individuals to claim that their processes are distinct and unique. However, upon closer inspection, similarities and patterns can often be identified. By examining these patterns, best practices and blueprints can be established, leading to more robust and efficient processes and systems in approximately 99% of cases.
The focus of today's discussion is centered on a laboratory process pattern that mirrors many of the processes found in pharmaceutical laboratories. Known as the "E2E Request-to-Result Workflow," it is an essential pattern in the pharmaceutical industry that tackles data management challenges through standardized approaches, robust software solutions, and a FAIR data platform. The workflow promises to improve efficiency, productivity, and data integrity.
More or less all laboratory workflows follow similar abstracted process steps: Submitting a Request, Executing a Test, Harvesting Results, Review and Storage, Report and Reuse, usually with some “sub steps” underneath. If we look at this as a pattern, we need to think about a standardized interoperability, standardized data exchange and a concept of a data standard, that can collect all the data along the process steps, the entire workflow and the data life cycle. This is what E2E for us means.
For this purpose the Allotrope foundation created the Allotrope Data Format (ADF) for a holistic representation of the data and the Allotrope Science Model (ASM) for the interoperability and data exchange.
Putting the Design Pattern of the E2E Request to Result Workflow together with the principles of FAIR and Data Centricity by leveraging the ADF and ASM concept, we have a vendor agnostic and fully traceable work- and dataflow across all labs and collaborations, that is the vision and technically reality. This leads to the holy grale, the "Self-Reporting Data Assets", where everyone has access to anything, as far as business wise enabled for automation purposes, process optimizations, simulation, automation, operational performance optimization, compliance, new insights, securing innovation dynamics, making data as an asset and leveraging the full stack of AI. Taking Care of Compliance and IP protection.
Software solutions form the backbone of workflow optimization. FAIR and data-centric platforms like ZONTAL streamline data lifecycle management. Real-world examples can highlight efficiency gains and data quality improvements, affirming the efficacy of these solutions in pharmaceutical operations.
While the Request-to-Result Workflow presents numerous benefits, it's crucial to acknowledge and address associated challenges. Dealing with thousands of instruments, maybe hundreds of vendors and software solutions the concept is easy to understand, but not simple to implement. That’s why it makes a lot of sense to look at the whole spectra of laboratory landscape and look at the low hanging fruits, means, what are the 20% of instruments and software environments, that are representing 80% of the value and which priorities should we take. This is a very simple question, but fruitful to think about in the jungle of the laboratory landscape.
The Request-to-Result Workflow stands as a cornerstone of pharmaceutical operations, promising continued advancements. Embracing standardized approaches, innovative software solutions, and the integration of design patterns and standards fosters efficiency, accuracy, and informed decision-making. By incorporating design patterns and standards into software solutions, companies can ensure interoperability, data consistency, and compliance with industry regulations, ultimately enabling the creation of a self-reporting data asset. As technology evolves, so will the potential for further optimization, ultimately advancing pharmaceutical research and development toward a healthier future.
This pivotal shift in pharmaceutical operations offers unprecedented opportunities for efficiency, collaboration, and innovation.
To ensure longevity, software solutions and digital lab platforms should include data centricity, data standards, and self-reporting data assets as integral parts of their framework.
As we embark on this transformational journey, it is crucial to embrace principles like data centricity, collaboration, and continuous improvement. Doing so will help shape a future where pharmaceutical advancements benefit society as a whole.
For those looking to start or continue their digital lab journey, where do you see the easiest path for implementation and the biggest potential for business value?