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Delivering Data Driven Value

Resource Tag: Delivering Data Driven Value

Quantum Computing: Where Are We Now?

Join the Pistoia Alliance for a 3-Part Webinar Series on Quantum Computing in the Pharmaceutical Industry

The Pistoia Alliance Quantum Computing Community of Interest is dedicated to exploring the rapidly evolving field of Quantum Computing and its transformative potential for the pharmaceutical industry. While Quantum Computing is still in its developmental stages, the promise it holds for revolutionizing pharma is immense. As stability in Quantum Computing technology is achieved, the opportunities for significant advancements in pharmaceutical research and development will soar.

In the current landscape, AI, ML, and generative AI dominate the spotlight, often overshadowing the advancements in Quantum Computing. This raises several pertinent questions: Does the rise of LLMs diminish the potential benefits of Quantum Computing for pharma? Can some tasks previously envisioned for Quantum Computing be handled by LLMs? How can the pharmaceutical industry integrate Quantum Computing into its problem-solving approaches? Moreover, does the industry possess the necessary skills to embrace this quantum revolution?

To address these crucial questions and more, the Pistoia Alliance is hosting a series of three webinars under the theme “Quantum Computing in Life Science R&D: Where Are We, Where Are We Going, When Will We Get There?”

Webinar #1: “Where Are We Going?”

How Ontologies Can Enhance Clinical Operations

Speakers
  • Aditya Tyagi, Pistoia Alliance
  • Melissa Weller, Crownpoint Technologies
 
Agenda
  • Overview of the Clinops Ontology Project
  • Proof of Concept Demonstration and Behind-the-Scenes Look at the Ontology
  • Development Challenges and Solutions
  • Discussion of Next Steps and Future Plans
  • Questions and Answers

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.