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Delivering Data Driven Value

Resource Tag: Delivering Data Driven Value

Pharmaceutical CMC Process Ontology – February 2024

This project aims to build a pharmaceutical (CMC) process ontology based on the ISA88/95 framework to standardize laboratory and plant production process recipes to establish standardized definitions, facilitate digital technology transfers, and integration with execution systems in order to capture structured process data for material lot genealogy tracking, streamlined technology transfers, and advanced process analytics, thereby enhancing efficiency and transparency throughout the pharmaceutical production lifecycle.

 

This meeting will cover the background of the project, the scope of work and the MVP in progress.

Informed Consent Blockchain Project

Drug Discovery World : Publication on Pistoia Alliance’s Blockchain Based Informed Consent

This project seeks to demonstrate the value of blockchain technology as part of a decentralized digital identity solution for the Informed Consent process in clinical trials.

IDMP Community of Interest Meeting January 2024

Join us for our upcoming Community of Interest meeting to learn more about our IDMP-O initiative. Our newly launched IDMP-O version 1.0 covers all five ISO IDMP standards, enabling a broad range of use cases around substance identification, regulatory processes integration with manufacturing, supply-chain analytics, therapeutic indications, representation of jurisdiction-agnostic medicinal products and pharmacovigilance.

Our focus for 2024 is on supporting the production implementation of IDMP-O in the pharmaceutical sector. We’re introducing dedicated support and training programs to assist pharma and industry professionals in integrating IDMP-O into their workflows and systems. Parallel to our Phase 3 project activities, governance will be further secured by ISO Technical Specification (TS) 21405 – Methodology and Framework for the Development and representation of IDMP Ontology, co-led by Sheila Elz, Bayer Pharma, and Vada Perkins, Boehringer-Ingelheim. The TS has a timeline of two years, with the target date for final publication July 2025.

Agenda

  • Intro & Highlights from 2023
  • IDMP-O Release 1.0
  • Pharma Implementations
  • IDMP-O Plans 2024
  • Discussion

Liquid Biopsies Enabling a Future of Precision Medicine

Liquid biopsies can be used to detect early cancer recurrence, explore therapeutic resistance, and personalize treatment. In this seminar, we will explore three different perspectives to delve into the potential of ctDNA and rare cells in the context of an ever-increasing drive to personalize medicine:

We will explore the value of rare cells, discuss advances in single-cell techniques, touch upon the value of multi-omic analysis, and examine its relevance to the emerging interest in spatial biology.

AGENDA

CLINICAL PERSPECTIVE – Liquid Biopsy: A new diagnostic concept in oncology

The clinical utility of rare cells, an introduction to the biology and with a focus on patient impact and treatment – Prof Klaus Pantel, Director of the Center of Experimental Medicine, Institute of Tumour Biology, Germany

R&D PERSPECTIVE – Rapid phenotyping of CTC metastatic potential and drug response with TetherChip microfluidics.

Technical innovations in using CTCs for novel assays for anti metastatic drug discovery – Dr Stuart Martin, Professor at University of Maryland School of Medicine – Greenebaum Comprehensive Cancer Center, USA

PHARMA PERSPECTIVE

A biopharma perspective, examining the relevance of these analytes to a therapy development agenda. Paola Marco-Casanova, Associate Director, AstraZeneca, UK

Interactive Q&A session

Unpacking Unstructured Data: Extracting Insights from Neuropathological Reports of Parkinson’s Disease

Linking pathology data with molecular and clinical data allows for a deeper understanding of disease, more accurate diagnosis, and ultimately better patient treatment. Pathology data needs to be structured in order to achieve this.

The aim of this study was to make unstructured neuropathological data, located in the NeuroBioBank (NBB), follow FAIR (Findability, Accessibility, Interoperability, and Reusability) principles, and investigate the potential of Large Language Models (LLMs) in wrangling unstructured neuropathological reports. By making the currently inconsistent and disparate data findable, our overarching goal was to enhance research output and speed.

Playing FAIR with AI: Supporting Scientific Discovery

Technological advancements exhibit varying degrees of longevity. Some are tried and trusted, enduring longer than others, more often when applied strategically to address tangible business challenges. Conversely, certain technologies succumb to fleeting hype without attaining substantive fruition.

A constant, in this dynamic landscape is the data. To harness the full potential of cutting-edge technologies, it is imperative to have your house, or more specifically, your data, in order. Here, we discuss the importance of foundational data management and the role of FAIR in enabling organisations, specifically within the life sciences, are agile enough to adapt to, and make use of, state-of-the-art technologies.

We will specifically discuss how the SciBite FAIR factory can be used to enable the application of large language models (LLMs) to democratise scientific data, and expedite the extraction of insight.

Speaker: Joe Mullen, Director of Professional Services, SciBite

The Methods Database Project

The Pistoia Alliance Methods Hub is envisioned to be a platform where semantically interoperable analytical methods and supportive tools are available to the Pharmaceutical Industry.

Advancing Data Interoperability: Exploring Ontology Mapping for FAIR Data Initiatives

Achieving data interoperability is fundamental for successful FAIR (Findable, Accessible, Interoperable, and Reusable) data initiatives, and the utilisation of ontology and terminology standards plays a crucial role in this endeavor.

Nevertheless, challenges arise when organisations adopt competing or overlapping standards, necessitating access to mapping solutions to align datasets effectively. This issue is especially prevalent in industries, where internal and private terminology codes must be mapped to public ontology identifiers for integrating public datasets seamlessly.

High-quality mapping between public ontologies exists and standards have emerged that facilitate the publication and sharing of these mappings. Numerous tools and best practices are also available to generate novel ontology mappings. Despite such progress, industries continue to invest significant resources into generating and curating mappings. Consequently, services are in demand to ensure mappings remain updated and accurate as data and ontologies grow and evolve.

In this webinar, we delve into the landscape of ontology mapping, exploring existing mapping sets and innovative approaches to generating and maintaining ontology mappings.

Speakers:

  • Jane Lomax, Head of Ontologies, SciBite
  • Simon Jupp, Head of Semantic Technologies, SciBite

Revolutionizing Laboratory Workflows

The Methods Database Enables Digitization for Faster and More Reproducible Results

During this webinar we will demonstrate how using a common, machine-readable data format will enable a digital transfer of analytical High Performance Liquid Chromatography (HPLC) instructions between chromatography data systems (CDS). We will share results from Merck & Co and GSK, where there has been an effective transfer of HPLC information between different systems and sites. With the Methods Db we can eliminate the manual keying of instructions to reduce risk, steps, and error while improving overall flexibility.

The Final Frontier of LOTF: Digitalizing In Vivo Research

The digitalisation of in vivo research has traditionally lagged behind other areas of the drug discovery pipeline, preventing research institutions from realising their vision for a Lab of the Future. It’s estimated that pre-human research accounts for over 40% of the R&D costs per approved new compound, and in vivo research constitutes a large portion of this expenditure. Pharmaceutical and biotechnology companies can no longer wait to realise the benefits of digitalising such a vital piece of their portfolio.

In this talk, we will discuss the state of digitalisation in in vivo research, explain why this phase of drug discovery is called the “final frontier”, and will examine actual requests from pharmaceutical and biotech companies when tasked with bringing new software into their existing technology stack to meet modernisation initiatives.

Lastly, we will present a use case with a large contract research organisation tasked with replacing homegrown, purpose-built software used in tandem with legacy spreadsheets. We will examine their challenges and wins, including metrics and impact on R&D costs, while implementing a digitalisation initiative.

Speakers:
  • Julie Morrison, President, Rockstep Solutions
  • Amy Huff, Director Of Operations at Charles River Laboratories
  • Jason M. Davis, Product Owner Director at Charles River Laboratories

DataFAIRy to drive AI adoption

The launch of the second phase of its DataFAIRy: Bioassay project, which aims to convert bioassay data into machine-readable formats that adhere to the FAIR guiding principles of Findable, Accessible, Interoperable and Reusable.