Registration is now OPEN for Pistoia Alliance Conference: Collaborative R&D in Action on April 20-21 & 23, 2021.
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Where Life Science
Collaborates
We are a global, not-for-profit members’ organization working to lower barriers to innovation in life science and healthcare R&D through pre-competitive collaboration.
Registration is now OPEN for Pistoia Alliance Conference: Collaborative R&D in Action on April 20-21 & 23, 2021.
Click here to save your seat for this free conference.
Our projects transform R&D innovation through pre-competitive collaboration. We bring together the key constituents to identify the root causes that lead to R&D inefficiencies. We develop best practices and technology pilots to overcome common obstacles.
Technology breeds technology and especially so in the Life Sciences. As such, we have more tools and data in our armory than ever before. However, with this data deluge comes complex challenges in maximizing the value of that data.
Data visualization is the graphical representation of quantitative and qualitative information to reinforce human cognition. The interpretation and understanding emanating from the analysis of scientific data can be optimized by incorporating best practices, strategies, and principles.
R&D life sciences might establish a data-visualization practice to put scientists at the center of the data visualization experience to optimize the cognitive ability of scientists in interpreting data.
The goal of this project will be to create a data visualisation community of interest that will address the needs for visualization among the Pistoia Alliance members and friends. It aims to crystallize a project that will establish best practices for data visualization supporting life science research and identify opportunities for communicating and implementing these best practices.
The project will support organizations to become more aware of the field of data visualization and its benefits to enable scientists to better understand and gain insights from their experimental data.
The Methods Hub project seeks to build a bridge for analytical methods to transition from text-based information to fully digitized, machine-readable instruction sets. In this new paradigm, human interpretation and transcription go away. Data integrity, method reproducibility, and interoperability increase providing value to many in the Pharma industry, including manufacturers, CRO/CMOs, and regulators.
Analytical Methods are often authored and published in free-text formats that lack both structural and semantic consistency.
Given the widespread adoption of software and systems (LIMS, ELNs, LES, etc. systems) that must accurately represent methods in ways that machines can store, export, import, and compare what was specified in the method against executed results, the current paradigm presents problems for Data Entry, Reproducibility and Results Analysis.
Methods that are authored in free text are often entered into electronic systems in 2 ways:
Both of these approaches introduce the possibility for error as well as interpretation of the method, depending on the subject matter expert or even the Natural Language Processing algorithm’s interpretation. This can impact reproducibility as well as introduce unintended errors.
The key objective of the Methods Hub project is to simplify the transferring of method information between two parties. This will involve the creation of a cloud-based database that will allow downloading and sharing of analytical methods in machine-readable formats. This will:
Methods Hub could lead to commercially available repositories of methods where digital as well as text-based method information with appropriate metadata, in a machine-readable format, would be shared and exchanged. The platform would allow for both free and paid downloads of monographs or manuscripts, the interchange between CRO/CMO and Pharma, and also free access of methods that are currently open source.
To date, Pistoia Alliance has, in collaboration with Allotrope Foundation, developed a Methods database based on Zontal Space with a public API specification and human-readable representation of a limited number of chromatography instruction sets. This will provide a good entry point for the Methods Hub Project.
All available sources for Analytical Method information will be evaluated in terms of their information structure from free-text, via semi-structured to fully digital information e.g. based on the Allotrope Foundation Ontology (AFO) and other available ontology providers.
For free-text and semi-structured methods, the extraction of key metadata would be considered.
Natural Language processing tools could be used to pre-populate a standard format for a fully digital representation of the method. Alternatively, well-implemented methods can be exported from a Chromatography Data System (CDS) and just validated by comparison to the text-based description.
The Pistoia Alliance Informed Consent blockchain project will demonstrate the value of blockchain technology in underpinning the clinical trial Informed Consent process.
Obtaining and revoking consent in clinical trials is a complex process involving multiple stakeholders, documents and transactions in which the creation and maintenance of a secure audit is imperative for regulatory purposes. Blockchain is an emerging technology which enables secure transactions between parties by creating an immutable record of these transactions and storing them as part of a decentralised system.
Demonstrate the value of blockchain technology in the Informed Consent process by creating an end-to-end audit trail in a secure and consistent manner, underpinning a higher level of trust between stakeholders participating in a clinical trial.
Get in touch
If you would like to get involved or have further questions or feedback email the project manager, Richard Norman.