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.
The Methods on Demand 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 on Demand 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 on Demand 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 on Demand 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.
Bringing the industry together to define quality in study design and reporting for digital medicine by establishing consistency in the evidentiary base used to support clinical applications of digital medicine tools.
To achieve broad adoption and positively impact health, digital medicine products require evidence to demonstrate that they are trustworthy. The quality and quantity of evidence required to deem a product fit-for-purpose are not agreed upon by industry, patient, or government stakeholders. Currently, there is no consensus on what constitutes “evidence” or what metrics should be used to distinguish high-quality evidence from low-quality evidence.
Defining quality in study design and reporting will drive the field of digital medicine towards maturity by establishing consistency in the evidentiary base used to support clinical applications of digital medicine tools. This will in turn allow trials to be run in a distributed fashion, collecting more critical data which will help produce better outcomes and more precision medicines.
The project will combine inputs from the key areas of digital medicine – patients, CROs, sponsors and technology companies to ensure that each stakeholders requirements are considered.