As a first step toward defining an industry-accepted ontology, the BioPhorum Technology Strategy Big Data to Smart Data workstream has reviewed best practices for ontology development across industries, adapted them to the biomanufacturing
space and then carried out an initial proof-of-concept (PoC) implementation of ontology-enabled analysis. The results demonstrate how implementing better data management as part of a digital transformation can create compounding value over time.
Digital Technologies
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Biomanufacturing digitalization readiness model: Best practice and guidance
Aug 2023 | Deliverable, Deliverables Report, Digital Technology Roadmap, POI - Technology Strategy, Publication, Technology Strategy
The purpose of this paper is to share best practice and guidance for using the ‘Biomanufacturing digitalization readiness model’ (BDRM) published in Part 1: BioPhorum Digital Technology Roadmap (DTR)1. Visualizing the characteristics of a successful digital transformation, the BDRM is used to assess the organizational status of important attributes and identify gaps in need of attention.
Data governance needs in biomanufacturing position paper and critical personas
Aug 2023 | Deliverable, Deliverables Report, Digital Technology Roadmap, POI - Technology Strategy, Publication, Technology Strategy
This position paper and supporting personas from the BioPhorum Technology Adoption team address the issue of where to start our industry’s digital transformation journey. Part of the answer is data governance and the pressing need to collaborate and agree on a standard set of taxonomies and ontologies for the biopharmaceutical industry, recognizing that these standards will need sufficient flexibility to allow innovation. As a first step, we propose that the industry adopt The FAIR Guiding Principles for scientific data management and stewardship.
Digital Technology Roadmap
Jul 2022 | Deliverable, Deliverables Report, Digital Technology Roadmap, POI - Technology Strategy, Publication, Technology Strategy
This paper outlines the foundational element that chart the course for pharmaceutical manufacturers who decide to take this journey and provides a vision of what that destination could look like in 10 years’ time. It outlines the current state of the industry, key challenges and barriers to adoption, and hints at the value that taking this journey will bring to patients, organizations and industry. This paper (which forms Part 1 of the Digital Technology Roadmap) looks at the problem statement and the work that has gone before.
The benefits of progressively more sophisticated lab instrument integration in the quality control labs
Mar 2022 | Deliverable, Deliverables Report, Information Technology, Lab of the Future, POI - Information Technology, Publication
QC labs play a key role across biopharmaceutical organizations to ensure product quality and patient safety. However, they have yet to achieve full digital maturity. Poor digitalization and integration have led to many non-optimal solutions for labs, such as workarounds and tailored solutions that are too expensive to upgrade. Often teams cannot take advantage of the latest innovations. With the help of this document, advocates for change can persuade other stakeholders to raise their game by showing the opportunity for significant benefits. The origins of this analysis in cross-industry collaboration and alignment represent a weight of common intent that should not be ignored.
MES of the future manifesto
Jan 2022 | Deliverable, Deliverables Report, Information Technology, MES of the Future, POI - Information Technology, Publication
The purpose of the MES of the future manifesto is a call to action from the biomanufacturing industry to vendors of MES solutions. The manifesto articulates: the gap between the current generation of MES solutions and the needs of the biomanufacturing industry and a realistic and achievable vision for the MES of the future that will meet the needs of the biomanufacturing plants of the future. It is intended to stimulate collaboration between biomanufacturers and vendors of MES solutions that will outline roadmaps for future development.
Regulatory: Feedback to DMKA questions to critical GXP augmented intelligence
Sep 2021 | Feedback to agency, Information Technology, POI - Regulatory, Regulatory
BioPhorum response to work being conducted by The Danish Medicines Agency (DKMA) to define criteria for the application of artificial intelligence (AI) and machine learning (ML) across GxP-regulated areas. The questions asked by the agency considered the requirements and quality of data used to build, test and validate an algorithm, and how it would respond to biases and deviations in results.
