Title: Trust Nobody: Establishing End-to-End Traceability and Data Integrity in Medicine Production
Abstract: In the past couple of years, society has become painfully aware of the importance of reliable medicine production.
This talk will discuss the application of state-of-the-art technologies for the pharmaceutical industry for quality control,
specifically modern HPC and data analytics to smartly extract, transform, and control heterogeneous data sources within the
manufacturing processes in order to better improve data-intensive quality and process modeling for a smarter industry. We will
also discuss some blockchain technologies for end-to-end verification of manufacturing data and relevant computationally-intensive
data quality assurance methods for data integrity compliance.
The EU Falsified Medicines Directive “introduces harmonized European measures to fight medicine falsifications and ensure that
medicines are safe and that the trade in medicines is rigorously controlled”. Such obligatory safety features, legal framework,
and record-keeping requirements have arguably imposed stricter controls for manufacturing of medicaments. While the pharmaceutical
industry has consistently improved their manufacturing processes in compliance with good manufacturing practices, it is documented
that deviation from good practices and even falsification of medicines continue.
We will present some concrete results in the context of the EU-funded Smart Pharmaceutical Manufacturing research project (SPuMoNI).
By relying on a pan-European industry-academic Consortium, SPuMoNI has produced an innovative data-intensive approach to systematically
establish and ensure constant proof of the authenticity of pharmaceutical manufacturing data and to develop a software framework for
pharmaceutical officers, following the industry-grade validation standards, both during the IT development and the use of a qualified
computational infrastructure. Being deployed in an industrial (relevant) environment to reach TRL6, SPuMoNI was one of the top three
European industry endeavors shortlisted for the international Artificial Intelligence (AI) Impact Award in 2022.
Bio: With over twenty years of HPC experience in industry and academia, Horacio joined the National College of Ireland to start
the Cloud Competency Centre in 2012, directing NCI’s cloud and data analytics infrastructure, postgraduate programmes, and research &
innovation initiatives. Horacio started his career as a true dot-commer working in HPC systems engineering and product marketing for
innovation-driven companies Silicon Graphics and Sun Microsystems. He later did a PhD and a postdoc in computer science at the
University of Edinburgh.
He has been principal investigator in several large collaborative grants and is a member of grant review panels and evaluation
committees for Cloud, Big Data, HPC, and Parallel Architectures projects at the European Commission, UK's EPSRC, and the Icelandic
Research Fund. He has been a keynote speaker in relevant international conferences and provides media interviews regularly. He
received the EU Dissemination Award in 2006 and serves on the Steering and Organization Committees of major conferences. As a
senior member of the ACM, he is also the academic representative to the Steering Group of Technology Ireland Innovation Forum/ICT
Skillnet. Skillnet is Ireland's is the national agency dedicated to the promotion and facilitation of workforce learning and currently
supports over 15,000 companies nationwide. Further details about his credentials can be found through his LinkedIn and ORCiD records
at: https://linkedin.com/in/horaciogv/ and https://orcid.org/0000-0003-0241-6053 respectively.