ARTIFICIAL INTELLIGENCE IN ACTION IN GXP
Toni Manzano, Chief Scientific Officer and co-founder at Aizon
#AI #Supply Chain #Compliance
Since 1996 I've managed software projects for international pharma industries along all the supply chain process (R+D, clinical phase, manufacturing, quality, equipments, warehousing and logistics), projects to implement the 3 ICH (Q8, Q9 and Q10) and I was also involved in audits and validation tasks . I'm Master in Information and Knowledge Society and Postgraduate in Quality Systems in Industry and Pharmaceutical Research.
Aizon is a cloud company that provides big data and AI SaaS platform for the Biotech and Pharma industry.
END TO END AUTOMATION, DIGITALISATION OF BIOBURDEN ANALYTICS IN A GMP ENVIRONMENT
Miguel Alvariño Gil, Manager Quality OpEX at Lonza Visp
#Automation #QC
My education started off by studying chemistry, followed by a PhD in bioinorganic chemistry. Entered the pharma industry in the Quality Control department at Takeda in Ireland, changed over to Lonza in Switzerland where I started in the Quality Control department. After a year at Paxvax leading the QA Release activities, I re-joined Lonza and I was during three years in charge of the digitalisation of QC activities at Lonza Visp. During the last two years I have worked on automating/robotizing different QC lab activities. I also finished back in 2017 an MBA in general management.
Bioburden Testing is an essential part of the Environmental Testing within different industries and its automation and digitalization is the holy grail of effectiveness increase. Faster time to result, elimination of variable error sources, data integrity optimization and the enhancement of AI readiness are triggering the implementation of cutting-edge technologies and walk-away solutions.
At Lonza, assisted by our innovative MODA TM software, we are implementing some state-of-the-art solutions to fully automate and digitalize the bioburden testing of liquid samples, air sampling and contact plates, dramatically increasing our efficiency.
NEVER TOO SMALL. NEVER TOO HIDDEN FOR A CYBER ATTACK
Carmen López, Global Manager Product Security Information & Training at B. Braun Medical
#Cybersecurity #Cyberattacks Awareness
Carmen López is a computer engineer passionate about people and empowerment with more than 15 years of experience in the healthcare industry. She started her career in Human Resources and Data Protection. She currently focuses on security communication and awareness.
DATA NEEDS A PRODUCT SPECIFICATION
Rik Pepermans, IT evangelist at Unilever ( retired), owner at RP Consulting
#FAIR Principles
Rik Pepermans has a broad experience in the digitalization of laboratories. He worked in labs at Unilever, managed IT for its largest lab, and engaged in the digital transformation of its R&D from the start. Since 2019 he advises companies to address the digitalisation of their R&D as an independent consultant.
The insight that data is the product of labs has led to many improvements like automation, information systems, and recently the awareness of the importance of data reuse as captured in the FAIR principles. Without challenging the benefits of data reuse, it comes with an additional burden on the lab. To balance benefit and cost, I propose to make explicit specifications for the primary use of the data as well as for current secondary uses, and future tertiary uses as in FAIR. Specifications help to ensure that data is adequate for all uses that are considered and fit in the constraints to the lab. The task to identify a data use, quantify its benefits, and propose a data specification for it is put on the customers of the data. The request to the lab for producing the data becomes a negotiation on costs and benefits.
GLOBAL PROGRAM FOR DIGITAL LABORATORIES
Alessio Tremolada, Laboratory Global Process Owner at SGS
#Standardisation #Global Implementation #Scale up
Alessio is an Industrial Chemist, married and with two children. He's Italian and he always practices sports and likes food, better if self cocked. He’s Italian and in his country he studied at Padova university. After the graduation his job experience starts in the laboratories where he liked to execute and innovate the analytical chemistry processes. He spent more than 20 years in SGS moving from lab technician, to manager for the Environmental laboratory business in Italy, to global technical manager for the same division, adding also the responsibility of business IT manager. When SGS started one of the most important IT program for the company, named “Digital Laboratory” Alessio had the role of Global Process Owner for the about 1000 laboratories operating many sectors. In this role he manages the team that is responsible to standardise the digital processes in the lab for achieving the best efficiency, to oversee the IT products development to ensure that they satisfy the user requirements and to collaborate with IT delivery and Rollout managers to reach the company objectives in the program.
SGS provides services to clients from more than 1.000 laboratories across the world. It’s a complex and geographically spread network that presents us with several operational challenges. We recognized that without a standardized and Integrated Laboratory Information Management System, we lacked a uniform way of managing the workflows, administration, finances, and operations at our laboratories. This made it harder for us to leverage the complex data we hold, and affected our ability to scale up new technologies, boost productivity and improve efficiency. Aligning, optimizing and digitizing our laboratory processes through our new Digital Labs Transformation program is enabling us to increase efficiency, improve quality, and our test methods. In turn, this will allow us to introduce new data analytics solutions, mobility and analytics, and fully automated labs with AI enabled insights and modelling, and excellent scalability.
LEVERAGING CROSS-BUSINESS SYNERGIES AS A PATHWAY TO DIGITALISATION
Sergio Nasi, Head of Global Laboratory Execution at Boehringer Ingelheim
#Digital Acceleration #MyLIMS #Holistic Approach
DIGITAL LAB - MANAGING A LANDSCAPE OF TECHNOLOGIES: 3 customer cases on People, Architecture and Mastering Continuous Change
Troy Ferguson, Solutions Architect at NNIT
#changemanagement #continuous improvement #blueprint
Troy is Technical IT consultant / Solutions Architect with many years’ experience in various industries from Finance to Telecom.She started her journey in 2013 in Life Science and have built up a solid background in the laboratory area, covering GxP solutions for Pharma Manufacturing, and other, less regulated uses of Laboratory Informatics. She designs solutions and advises about the use of technology in the lab to help ensure that critical data is captured and traced effectively.
she enjoys meeting customers and helping translate business requirements into technical specifications.
she has a wide consultant experience combined with many years in application development and a solid knowledge of Java and Oracle plus experience in .Net, C# and SQL, makes her an all-rounder who thrives on new technical challenges.
she has repeatedly achieved high customer satisfaction due to her enthusiasm for the task in hand, professional approach, well-structured work, and high-quality results.
The Digital (Paperless) Lab is more than implementing one solution. It is about pro-actively managing a landscape of integrated technologies to enabling People to create value in a company through seamless processes.
This requires:
People: The ambition to establish new ways of working to achieve new business benefits – coupled with the skills to translate these into robust TO-BE processes including appropriate technology as an integral part.
Architecture: The definition of an architectural blueprint describing the aspirations and guidelines for the IT-OT architecture, in which the integration strategy between instruments, lab applications and enterprise architectures is detailed
Mastering Continuous Change: Technical investment to manage continuous improvements and optimizations to the current landscape leveraging new or upgraded technology. This also implies mastering technological transition and the associated data migrations and solution retirement.
The presentation will include 3 short cases based on life science customer projects, reflecting each of the points above.
Smart Building Blocks for the Digital Lab
Daniel Juchli, Head of Lab & Research Informatics at wega and Chief Technical Officer (CTO) at the SiLA Consortium.
#Digital Transformation #Standardisation
With over 20 years of professional experience in both chemistry and Informatics, Daniel speaks both the language of scientists and IT experts and can translate between the needs of users and the technical possibilities of IT systems. Daniel is an expert in lab digitalization and leading projects for the selection, deployment or development of laboratory automation and IT solutions in life sciences environments. Joining SiLA in 2014 as a representative of SiLA's Supporting Member for wega Informatik, he has played a major role in the development of the lab connectivity standard SiLA2
A community effort to build simple, standardized and reusable specifications and components that helps labs in their digital transformation and software and hardware vendors to support it better.
PANEL DISCUSSION: DIGITAL REVOLUTION IN THE LABORATORY
A look back at the last 10 years shows how much technology has evolved and been accepted. The cloud is a perfect example. In the early days, discussions about the unknown met with resistance, while today some companies even use multiple cloud systems for data storage. The providers´offering has also adapted to changes, reviewed infrastructure and services proposed, and moved from perpetual licences on premises to annual SAAS fees.
The pandemic definitely took us all by surprise and some were better prepared than others. Some companies had already developed a mature strategy for digital transformation and some have settled on a plan for their lab of the future.
Where do we stand today? Which technology trends will lead us into the year 2030?
PANEL DISCUSSION: CYBERSECURITY ALONG THE DATA LIFE CYCLE
We are aware of the risks of cyber security and accept the numerous control steps involved in accessing our bank account online. We know that there are more or less malicious computer viruses and we become vigilant about attachments.
But how much do we know about the cyber attackers that have become a real industry today? How well prepared are our own companies?
Data is the be-all and end-all of labs, but how well is it protected?
Data has its own life cycle and follows more and more digitalised processes. What can we do to strengthen their protection?
Data collection is the first step, but do you really use your data?
#datacollection #datainsights #experimentdesign
Many companies have collected or are collecting data in their labs. There is a need to use this data for prediction of experiment outcomes before they are even carried out in the lab by using this collected data. But is the data really usable? What formats is it collected in? Can it all be compared? Is this structured or unstructured data? How can the data be prepared for model building? Would make sense to rethink the whole process and define properly what the data acquisition needs to look like in order to use it later? Can Datamarts and data lakes really help?
In this one hour session we would like to have an open round table discussion with the participants on their experience of the collection and the use of data collected in the lab.
Setting up your lab digitalization project for success: interactive session on common challenge root causes
#digitalizationprojects
This workshop will focus on setting a lab digitalization project for success, and zoom in on two of most common challenge root causes: mismatch in expectations towards software vendors, and underestimation of what a digitalization project requires from Line of Business.
>> see more: NNIT workshop #PLA2023Europe
Successful Digitalization: Focus on the too often neglected aspects
#digitalization #change management
Looking to take your digitalization efforts to the next level? Join Wega Informatik workshop on Successful Digitalization, where they'll delve into the often overlooked aspects of digitalization projects that are essential for success.
see more: Wega Informatik workshop #PLA2023Europe
Simply digitalising your existing processes is not enough.
Lessons from digital implementation projects across 1500+ laboratory teams
#labprocesses #labperformance
In this workshop Binocs will draw on their extensive experience to share some key enablers of optimized laboratory digitalization: examples of how to leverage digitalization to optimize laboratory processes, including enhancing team organization, optimizing decision processes, streamlining communication with lab stakeholders; lessons learned around the impact on analysts and technicians; harnessing data to improve laboratory performance (e.g. service level and throughput)
Connect Everything in the Lab & Beyond - What, Why, & How
#connectedlab #LIMS
A Tomorrow-Ready Lab is built on the foundation of robust integrations. When everything in a lab (and beyond) seamlessly communicate and exchange critical information with each other, labs are better set up to face changes in regulatory, efficiency, and quality needs of today and tomorrow. Join us to discuss what needs to be connected, why lab components must interact, and how to successfully implement integrations.
>> see more: Caliber workshop #PLA2023Europe
Disrupting Drug Discovery with Data Informatics & AI
#DataInformatics #AI #Drug Discovery
Learn how D360 enables you to search across the wealth of data and focus your R&D expertise on science versus time-consuming data wrangling tasks through a maze of applications. This workshop will allow you to gain an understanding of real-world applications for deep learning AI in drug discovery and how AI is used as a tool, rather than a replacement, for the expertise of drug discovery scientists. You’ll receive an overview of pre-trained, public models being used today to fuel property prediction, small molecule generation and unstructured content data extraction.
>> see more: Certara workshop #PLA2023Europe 
Leveraging Dotmatics platform and best-of-breed scientific tools to streamline your small molecule drug discovery projects
#Small Molecule #Drug Discovery #Systems Integration #GraphPad Prism
Integrating data across disparate departments and workflows has been a long-standing challenge in drug discovery. The Dotmatics Solution has been designed to address this challenge by enabling scientists to capture and search all project data, from assay development through screening and hit to lead optimization. The Solution brings together
Dotmatics’ enterprise scientific platform and the specialized applications such as GraphPad Prism to improve collaboration and accelerate the process of using data to inform insights and decisions.
Safeguarding the Future of Labs: A Workshop on Cloud-based Solutions, Security, and Innovation
#LIMS #CloudbasedSolutions
Are you ready to step into the future of business? Join Eusoft and Microsoft for an exciting workshop that explores the cutting-edge technologies transforming the world of work. From AI-powered chatbots like ChatGPT to cloud-based laboratory management systems like LIMS SaaS, we'll dive into the latest trends in digital transformation and discover how they can revolutionize your organization. But with great power comes great responsibility. That's why we'll also explore the crucial role of data security in the digital age. You'll learn how to protect your business from cyber threats and implement best practices to keep your data safe and secure. This workshop isn't just about theory – it's about action.
Through hands-on activities and interactive discussions, you'll gain practical insights into how to leverage cloud-based tools to improve efficiency and streamline operations. You'll discover how to unlock new possibilities for growth and innovation, all while staying ahead of the competition. Join Eusoft and Microsoft for a dynamic and informative workshop that will take your business to the next level.
The future is here – are you ready to embrace it?
AI DigiBots - A Vital Artificial Intelligence Complement to drive Efficiency and Compliance whilst Saving Costs for Pharma Operations
#Automation Technologies #cost of operations
New age Intelligent Automation Technologies such as Digital Robots (DigiBots), Machine Learning (ML) and Artificial Intelligence (AI) are ushering in Automation in core Pharma operational functions complementing / augmenting human efforts. These boost efficiencies as well as compliance in several ways; Thus, bringing down the cost of operations across Pharma Enterprises.
Continuing from our GVW’s past successes in promoting the need and executing innovative data services towards a patient-centric value chain, we shall present during its workshop, our successes and challenges when using and implementing AI based DigiBots.
Do you still print and sign instrument reports? We have an alternative to manage them all digitally
#loi #DataIntegrity
Paper records are still in use in labs.A possible solution could be to upgrade the system to a new compliant version and/or import the reports into the ELN or LIMS system, usually as PDF attachments. The results would still have to be manually transcribed into the ELN or LIMS system, with a double check to be recorded, because implementing an automatic interface with each instrument is expensive and time-consuming. Also, this could be complicated with systems that cannot be connected to the network (e. g.instruments that only save reports to a USB stick) or that cannot be updated. Ioi can help in these cases!
Any type of report can be captured by Ioi, even simulating a USB stick, and can be stored in a secure DB for review and approval, or can be uploaded to an ELN or LIMS. In this case,advanced parsing capabilities are also available that could avoid manual transcription of results.
>> see more: Inpharmatic workshop #PLA2023Europe
Internet of Lab Things: A comprehensive perspective on device connectivity in the lab
#IoLT #Integration #LES
This session will provide a comprehensive overview about connected devices in the lab. We will touch technical aspects and integration approaches, look into use cases and discuss overall goals and application areas. The session will also include a short live demonstration of state of the art LES-Software and show use cases for R&D as well as (GMP regulated) QC areas.
Why are scientific data lakes so important in the context of today’s digital transformation?
#Data lakes #optimisation #use cases
In this session, we will show why our clients are building scientific data lakes, what they are helping optimise, and how they are being built. We will also cover a wide range of case studies and use cases including product, production and laboratory optimisation, followed by lessons learned. So we look forward to seeing you at our Workshop to show you how Scientific Data Lakes can bring you better product quality, speed of research, data prediction.
>> see more: Labvantage workshop #PLA2023Europe
Digitalization, The Lab of the Future and Lab 4.0: a LabWare Perspective
#Digitalization #labofthefuture #LIMS
The workshop will address the Trends affecting the Lab of the Future, how Technology will transform Labs, what are the Challenges and Strategies to meet the requirements for Lab of the Future.The workshop will present technologies that will enable digitisation and the move towards the Lab of the Future, or a Less Paper laboratory environment.
Integrating devices and systems in QC and Production to enable data driven decisions
# interfaces #dataintegrity #validation
Implement, integrate, validate seamlessly. How to connect devices and systems to derive value from the data they generate and error proof your workflows and processes. Lab instruments and enterprise systems reside in silos to solve a specific needs. Connecting these devices a d systems provide the ability to capture data to make better, more efficient decisions and will error proof the workflow by removing data transcription.
The session will discuss the value of interfacing, the technical aspects of having systems exchange data, validation of the interfaces, how data integrity concerns are managed within this process and what process improvements will ultimately be realized.
Integration into the Lab Ecosystem and the LabX-Agilent Integration Experience
# Integration #Labecosystem #dataintegrity
In this workshop, you will discover the recommended approach to fully integrate your lab and witness a demo of a LabX integrated solution with Agilent.
We will address:
- Integration into the Lab Ecosystem
- Increase efficiency, data quality, security and ensure Data Integrity
- Facilitate the integration to Lab Informatics System
- The differences between GAMP5 software categories and what it means to your business
- We will see what Meta Data is, and discuss the best way to ensure Complete Data
- How LabX monitors all critical resources and reduces all validation costs and efforts.
>> see more: MettlerToledo workshop #PLA2023Europe