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Delivering Data Driven Value

Resource Tag: Delivering Data Driven Value

CMC Process Validation Walkthrough

The Pistoia Alliance has completed Phase 1 / Proof of Concept to build a pharmaceutical CMC process ontology based on the ISA88/95 framework to standardize laboratory and plant production process recipes, establish standardized definitions, facilitate digital technology transfers and integration with execution systems 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.

In this video, we show how we have imported the developed core CMC process ontology as well as two controlled vocabularies for referring to the different parameter measurements as well as the different recipe steps that make up a manufacturing process to create a knowledge graph to answer our competency and business questions.

Moving from Regulatory Document Submission to Data Collaboration

New Idea ‘Regulatoria’ Round Table Discussion

Problem Statement

CMC Regulatory Specialists spend a lot of time copy-pasting and reformatting information from source documents into regulatory documents. Such Word/PDF processes result in unFAIR data. Besides they are commonly the root causes of slowness, waste/inefficiency, and compliance risk in regulatory dossier preparation, submission, and assessment. Given FDA PQ/CMC and ICMRA PQ KMS projects, Applicants should anticipate the day Authorities enforce pharmaceutical quality CMC information collaboration based on FAIR data in addition to their usual regulatory document submission.

Call for Interest

Pistoia Alliance calls on its members to express their interest in a new project called ‘Regulatoria’. Its scope starts with drug stability data.

The project first goal is to develop a model of drug stability. Its members can use that model to map and structure their drug stability data from their various source systems. The second goal is to study options for data collaboration and exchange with Health Authorities. The project may eventually scale up to other pharmaceutical quality CMC information.

Hosts

Birthe Nielsen and Véronique François, Pistoia Alliance

Presenter

Jean-Pierre Doan, Merck KGaA, Global Regulatory Affairs CMC & Medical Devices Digitalization

The IDMP Ontology

A catalyst to unleash the potential of AI and accelerate data-driven decisions with industry standards

IDMP Ontology Meeting June 2024

Meeting Agenda
  • Recent highlights from IDMP-O
  • Lightning Talks:
    1. Data standards strategy in context of AI – Sridevi Nagarajan
    2. Towards an Overall Control Strategy – Ciby Abraham
    3. IDMP-O bridging to CMC and inclusion to PRISM – Sheila Elz
    4. FDA project PRISM – Vada Perkins
  • Moderated discussion: IDMP-O use cases bridging to CMC
  • Open Discussion

EPR Podcast – FAIR Data in Pharma

In this podcast, Giovanni Nisato, Project Manager at the Pistoia Alliance discusses data integrity and the progress towards implementation of FAIR data principles in the pharmaceutical industry.

Blue and EPR Podcast advert with microphones

FAIR Submission of In Vitro Pharmacololgy Results

Agenda
  • Introduction to In Vitro Pharmacology (IVP) and problematics faced during submission of IVP data for an IND application
  • How to pave the way to the FAIRification of IVP data? Two key steps:
    • Standardised data structure for submission of results – IVP module/GSRS
    • Repository of safety and secondary in vitro pharmacology assays: using a single, centralised protocol repository with an integrated ontology and providing a unique Identifier for each assay
 
  • Q&A session
 
Speakers
  • Kevin Snyder (FDA)
  • Larry Callahan (FDA)
  • Jane Lomax (Scibite)
  • Chris Butler (Abbvie)

Clinical Operations Ontology

Join us for the start of a new Clinical Operations Ontology Project

Stage 1: Proof of Concept

The Pistoia Alliance offers a unique collaborative platform where pharmaceutical companies and R&D service providers can work together in a pre-competitive environment. In this proof of concept phase we focus on improving the efficiency of clinical trial planning by refining the manual site feasibility process. By leveraging linked data and standard methodologies, we aim to effectively model clinical research designs. Through the automation of processes using ontologies and existing databases, we anticipate faster decision-making and a reduction in redundant efforts of site selection.

Hear directly from our Project Manager, and clinical operations expert, Aditya Tyagi about the purpose and intention for this new developing project

FAIR Maturity Matrix

At any given time, different organisations are at different stages of their FAIR implementation journeys (i.e. implementing the FAIR principles of Findability, Accessibility, Interoperability, and Reusability) and benchmarking the level of FAIRness in an organisation is challenging. While there are multiple FAIR data maturity models and metrics, there is no simple, agreed, maturity assessment model of FAIR data principle implementation at the organisational level for life-science organisations. Thus, the Pistoia Alliance FAIR Implementation Best Practice Working Group set out to design a FAIR maturity matrix, which aims to address this gap, in 2023. This document presents the first version of the FAIR maturity matrix, an organisational maturity model of FAIR implementation.

Pharmaceutical CMC Process Ontology Meeting – March 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.

Patient Listening on Social Media for Patient-Focused Drug Development.

Patients, life science industry and regulatory authorities are united in their goal to reduce the disease burden of patients by closing remaining unmet needs. Patients have, however, not always been systematically and consistently involved in the drug development process. Recognizing this gap, regulatory bodies worldwide have initiated patient-focused drug development (PFDD) initiatives to foster a more systematic involvement of patients in the drug development process and to ensure that outcomes measured in clinical trials are truly relevant to patients and represent significant improvements to their quality of life.

Data Quality for LLMs: Building a Reliable Data Foundation

Achieving value with Large Language Models (LLMs) hinges on a reliable data foundation. This is becoming increasingly relevant with the introduction of conversational AI agents that exploit RAG (retrieval augmented generation) techniques to extract information from biomedical data. What isn’t emphasized enough, is the crucial role that well-annotated data and its accessibility to the models plays.

In this webinar, we look at how data quality affects the performance of LLMs. For this, we assess how LLM-powered AI agents query across three versions of the same gene expression corpus, but with varying degrees of quality:

  • Unstructured Data from GEO (Gene expression Omnibus)
  • Structured Data from the CREEDS project
  • ML-ready data, annotated using Elucidata’s Polly
 
Speaker
  • Abhishek Jha, CEO & Co-Founder at Elucidata

Strategic Priorities Update February 2024

Join us for this inaugural update on the newly formed Strategic Priorities of the Pistoia Alliance, followed by a 30 minutes Q&A with our panelists

Agenda

Dr Becky Upton, President of the Pistoia Alliance

  • Introduction

Dr Christian Baber, Chief Portfolio Officer, Pistoia Alliance

  • Strategic Priorities Overview
  • Harnessing AI to Expedite R&D
  • Delivering Data-Driven Value

Thierry Escudier, Portfolio Lead, Pistoia Alliance  

  • Accelerating Use of Real-World Data
  • Sustainability Driven R&D