Presenting: Isabel Muñoz-Willery Ph.D. & Roberto Castelnovo, owners & organizers at NL42 Consulting | Paperless Lab Academy
Isabel and Roberto are entrepreneurial persons involved in paperless laboratory processes projects. Coming from international managerial roles with strong domain knowledge in laboratory processes, laboratory automation, laboratory informatics, and project management, they launched their personal project, NL42 consulting, by 2012. Soon their own
customers were asking for better visibility of the industry solutions and learn about the latest technological trends and best-recommended methodologies. Along the time, the Paperless Lab Academy® has become the platform where to find the answers.
Vijay Raju, Global Head of Analytical R&D at Novartis
Master Science in Chemical Engineering from Mississipi State University and MBA from The Ohio State University Fisher College of Business. Vijay started his career as project manager at Boehringer Ingelheim before moving to Novartis. At Novartis, Vijay has pursue then a pathway to Director/Principal Fellow, Technical R&D, becoming Global Head of Analytical R&D (VP) by 2018 based Basel, Switzerland...
Nicolas Argento, ELN/LIMS services manager at École Polytechnique Fédérale de Lausanne, EPFL
For the last 5 years, Nicolas has been transforming an ELN/LIMS project into a core service serving the research laboratories and technology platforms in an academic life sciences research institute. Focused on the added value for scientists and laboratory staff, he coordinated 55 LIMS implementations in a wide variety of laboratories. His team of 4 engineers ensure tailor made deployments, the maintenance and evolution of an in-house infrastructure. IT engineer by training, his previous experience was in IT project management in the banking industries. He decided to embrace an innovative training to specialised in IT for healthcare. Acting as a lead link between laboratories and IT departments, his expertise covers biology R&D, healthcare and telemedicine information systems as well as IT project and services management.
>> see abstract about Institutional ELN and LIMS deployment in Academic research
Sofie van der Meulen, Senior Supervision Officer at the Dutch Data Protection Authority
Sofie works for the Dutch Data Protection Authority. In her position as senior supervision officer she focuses on privacy in the healthcare sector. Before joining the Dutch Data Protection Authority, Sofie has gained broad experience dealing with various kinds of legal issues in both profit and non-profit environments. In her previous position as attorney at law in the field of life sciences, Sofie specialised in legal and regulatory issues related to medicinal products and medical devices, with a special focus on medical software, big data and data protection.
Jernej Grmas, Project Manager at Sandoz Development Center Slovenia, a Novartis Company
Jernej Grmaš is a Project Manager at Sandoz Development Center Ljubljana, a division of Novartis group developing generic pharmaceutical products. After graduation, he joined Sandoz in 2008 as a scientist in Analytical Development, becoming involved in the development of nasal spray products, a topic on which he completed his PhD study at University of Ljubljana in 2019...
Barry Heavey Managing Director at Accenture’s Digital Manufacturing and Quality
Barry is a Managing Director based in Dublin, Ireland and leads Accenture’s Digital Manufacturing and Quality offering for life sciences in Europe. He has over 20 years of experience in the pharmaceutical industry and holds a PhD in Genetics from the University of Vienna.
Mark Fish, Managing Director at Accenture’s Scientific Informatics Services Business
Mark Fish is a Managing Director in Accenture’s Scientific Informatics Services Business. Mark has over 20 years of experience in various leadership roles delivering innovative solutions to the pharmaceutical sector and is passionate about drug discovery and development, translation research and precision medicine, digital transformation, agile software development and analytical quality control automation.
>> see abstract about Accenture live presentation
Sinead Cowman, Global Business Development & Marketing Manager at Lonza Informatics
Experienced Business Development Manager with a demonstrated history as an informatics specialist for the Pharma and biotechnology industry. Skilled in QC Microbiology, Data Integrity, Verification and Validation (V&V), Good Laboratory Practice (GLP), Medical Devices, and Change Control. Graduated from University of Oxford - Said Business School.
Jenna Gerber, Quality Control Specialist Supervisor at GSK
Jenna has 10 year experience in the pharmaceutical industry as a scientist to now a quality control specialist supervisor at GSK, Philadelphia. She previously worked at PPD as scientist, project manager and then associate group leader. Jenna got her Bachelor of Science in Pharmaceutical Sciences the University of the Sciences in Philadelphia and master and a Master of Science in Regulatory Affairs and Quality Assurance.
Barbara Pirola, director QA/QC at Esseco
Barbara has about 20 years of experience in the Pharmaceutical field, FDA regulated
10 years in leadership roles: Quality assurance manager, Quality Compliance Manager, Quality Control Manager in the pharma services at Patheon and now at Esseco Srl. Enthusiastic manager who is recognised leader in driving Quality Culture and motivate teams to be best in class. Clear goal vision and persistence in achievement by providing continuous improvement and problem solving attitudes.
Roberto Rollini, Sr Manager Practical Process Improvement, Operational Excellence at Patheon
Roberto considers himself a modern leader able to connect and to everyone at different level of the organisation. Very determined in achieving a mature lean status where Continuous Improvement is part of site’s day life. He is promoting the culture of continuous improvement into the site making the change sustainable and effective. From formulation Development technician at Bracco, he moved to managerial roles in Sandoz, Mipharm, before dedicating his career to operational excellence at Patheon now part of ThermoFisher Scientific.
>> see more about the Lean Lab project at Patheon and Esseco
Daniel Juchli, Head of Lab & Research IT at wega Informatik AG, Switzerland and Chief Technical Officer at the SiLA Consortium
Daniel’s professional background is based on a dual qualification, as a chemist and as an IT professional. He has over 20 years of professional experience in both disciplines.
Daniel speaks both the language of scientists and IT experts and can translate between the participants in project teams. His life science knowledge enables him to bridge the gap between the needs of users and the technical possibilities of IT systems.He is an expert in leading projects for the development of laboratory automation and IT solutions in life sciences environments, such as research and development laboratories or QC laboratories in regulated environments.
Daniel joined SiLA in 2014 as a representative of SiLA’s supporting Member wega Informatik. Since then, he has been instrumental in the development of SiLA 2.
Digital Unified Laboratory Platform: The benefits of a strong UX for R&D and QC processes
During the demo session areas covered are the overview of AgiLab’s powerful UI and how it drives the following processes: QC Product Lots, Stability Protocols, Method Execution, Equipment and Material Management and Booking, R&D Experiments (ELN) and Requests
Practical applications of Data Integrity and Audit Trail Review
The why, what, when, where, who and how of audit trail review. Learnings from this workshop will be: Regulatory requirements around audit trail review, Examples of audit trail review strategies, Roles for audit trail review.
Agile validation in GMP Projects
Onboarding a QA into the validation concept & Interactive live session
Meeting between the Validation Expert, the Vendor SME and the QA of the LIMS project. The QA is new and needs to take over the responsibility from his predecessor who left the company. He knows agile framework from the theory and has only supported classical V-model validation projects.
See how the Validation Expert and the Vendor SME explain him the agile project setup and the validation concept in order to get the commitment of the new QA for the project. A subsequent Q&A session as the new QA has tons of questions and is challenging the new agile approach. This session will be interactive, allowing the audience to also ask questions, express their doubts and share experiences.
A LIMS solution for Lab 4.0
Information technology has transformed the way laboratories operate through ever increasing degrees of automation. We have reached a point, where technology enables us to implement digital solutions that make paper reports completely superfluous for operating a laboratory while being fully compliant with ALCOA+ principles.
Optimize Your Lab Performance by Building the Digital Twin of Your Lab
Are you curious to discover the digital twin of your lab performance? What it looks like? You have probably seen a lot of theoretical models and abstract articles about it. In this workshop, we will make it tangible and build it up together with you.
Automated lab scheduling enables your team to move away from firefighting and allows it to work more efficiently and optimally.
How the cloud is revolutionizing the lab
Scientific organizations need to optimize operations by improving efficiency while maximizing quality and adhering to regulations, while driving innovation. Across product development and quality control domains, they are increasingly turning to cloud-enabled solutions to increase deployment flexibility, lower total cost of ownership, and maintain data security.
Inquiro from Dexstr: How the combination of Search and AI eases the digitalization process of life science companie
The amount of data available internally and externally is increasing at an unprecedented rate. Structured data (about 20% of all data) is historically well managed with solutions such as LIMS, ELN, SAR (Structure-Activity-Relationship) database, and many others. But how to effectively manage the remaining 80% of unstructured data (report, document, literature, patent, ...) and access and extract valuable information for the decision-making process [in life science companies]?
Your Sample Goes Digital
Who’s not familiar with being lost in samples and processes? Clear labeling is recommended to make sample identification as easy as possible. Though all labs strive for this standard, you often find vessels in your freezer with illegible labels or without any labelling at all. One of the main reasons is that reliably cataloging samples is usually a painstaking and time-consuming task.
Automation without the Robot
Manual pipetting is a fundamental lab skill. Even in labs where automation is present, pipettes are still critical for certain tasks — often ones that are either too routine or too dynamic to automate. See how Gilson’s TRACKMAN® Connected pipetting platform addresses this gap, providing the reliability, traceability, and reproducibility expected of automation — all in a simple, fast platform that fits in a backpack.
Collect your instruments in a unique platform and review data digitally
Discover an innovative platform able to:
Collect instrument measurement details, enriching them with all essential metadata: Date&Time, attributability, measurement context, sample ID…
Connect all your laboratory instruments to a unique repository, solving data integrity issues.
Drive the measurements through an approval workflow and review with Electronic Signature.
Reduce human errors, improving data reliability.
Increase efficiency, gaining time for quality.
Create a safe data flow between the lab and the business.
Generate reports based on data acquired, according to your needs.
Be smart, use Ioi wherever you are through Tablet, Smartphone, PC
Smart labs: How to solve the connectivity puzzle
Laboratories are going smart, and the current pandemic accelerated that process. But what does smart really mean? For sure connectivity is important, but how to distinguish true connectivity from fake connectivity? And how to not only transform digitally on paper but also truly transform your lab and last but not least your people in the lab. To help you build a truly connected lab we created the ABC of smart labs: a checklist of what you should Avoid, Buy and Consider.
How the Internet of Lab Things, #IoLT, is changing the Laboratory World
More and more devices are including connectivity technology, allowing them to be part of a persistent network. This includes laboratory instruments such as balances. These instruments can become a seamless part of a laboratory’s Internet of Things (IoT) environment, allowing quick interfacing and simple usage. During this session, we will discuss the practical ways of creating an Internet of Lab Things (IoLT) environment, and the technical and regulatory challenges to be expected.
How FAIR Data Can Accelerate AI-Driven Drug Discovery
Unstructured scientific data is one of the biggest drains on productivity in the pharmaceutical industry today, at an estimated impact of €10 billion per year. In this talk we will explore the hidden costs that data silos and proprietary file formats have—from manual data-cleansing to compliance to enterprise-wide digital transformation.
Digital Transformation in R&D: the Signals Research Ecosystem
Research Scientists daily face the challenge that the science they are doing is complex and often generates a high volume and variety of data. In addition, they are spending too much time preparing this data and learning the tools to explore it vs the time they can spend on ideation and innovation. In this workshop we will present the PerkinElmer Signals Research Platform which is designed from the ground up to consider these challenges.
From strategy to action: How to accelerate digital transformation
Scientific organizations are continuing the discussion around digital transformation, but the narrative is shifting from strategy to execution. Organizations are looking at how they can leverage scientific developments, technological advancements, and digital solutions to create an enhanced laboratory and increase productivity. Join our talk as we discuss the focus of Thermo Fisher Scientific’s digital solutions in driving industry evolution and helping our customer’s to prepare for the next set of digital transformation goals.
Andreas Steinle, Manager Digital Solution at Roche Diagnostics GmbH
#Case Study #Data Transfer #FAIR principles #SCRUM #Cloud #GXP
Andreas Steinle is accountable for digital transformation in the analytic department of Roche Pharmaceuticals Technical Development Europa since early 2018.
Between 2005 to 2017, Andreas was head of the group “Analytical Systems” with the responsibility for support of validation of analytical systems and laboratory equipment (pH Meter, HPLC, LIMS, Archiving, etc.) in Roche Pharma Biotech Production in Penzberg.
In addition in this role he he was also responsible for the integration of laboratory equipments into enterprise systems and the representation to health authorities.
>> see the abstract about Unlock your analytical instrument data for data science
Presenter: Bob McDowall, director at R D McDowall Limited
#Chromatography #CDS #LIMS #ELN
An analytical chemist with over 45 years’ experience including 15 years working in the pharmaceutical industry and over 25 years working for the industry as a consultant. Bob has been involved with automating analytical laboratories since 1980 and was an early implementer of a Laboratory Information Management System (LIMS).
Bob is an auditor and he has been involved with the validation of computerized systems for over 30 years and is the author of books on the Validation of Chromatography Data Systems (two editions 2005 and 2017) and in 2019 published his book on Data Integrity and Data Governance - Practical Implementation in Regulated Laboratories.
>> see abstract about if spreadsheets are a fast track to regulatory non compliance
Presenter: Mark Newton, Principal at Heartland QA
#Data Integrity #Metadata #Chromatography
Mark is an independent consultant who specialises in data integrity, laboratory informatics, computer systems validation, and Quality. He has 35 years of experience in the pharmaceutical industry in QC Labs, computer systems validation and lab informatics at Eli Lilly. Mark co-lead Eli Lilly’s data integrity remediation program for QC Labs worldwide in 2012, consulted and audited several Lilly sites preparing for data-integrity focused inspections.
Mark is a co-leader for the GAMP Data Integrity Special Interest Group and Chair of ISPE Global Documents Committee.
Co-author of "Harmonizing USP <1058> and GAMP for Analytical Instrument Qualification" Schuessler, Newton, Smith, Burgess, McDowall. Pharm. Engineering, Jan/Feb 2014
Co-editor of the GAMP Good Practice Guide "A Risk-Based Approach to Compliant Computerized Laboratory Systems" Nov. 2012.
Presenter: Sergio Nasi, Head of IT Operations Laboratory Execution at Boehringer-Ingelheim
#LabInformatics #Paperless Processes #Systems Interface #Pandemic Situation
Presenter: Dr. Lloyd F. Colegrove, Director of Data Services at Dow Chemical
#Industry4.0 #Artificial Intelligence #Digital Transformation Strategy #Change Management
Lloyd F. Colegrove recently retired as the Director of Data Services and the Director of Fundamental Problem Solving within Manufacturing and Engineering. He was also the Analytics Platform Director for Dow’s Manufacturing and Engineering’s Industry 4.0 program. Lloyd’s background is in Chemical Physics where he obtained a B.S. and Ph.D. from Texas A&M University. He spent 7 years in Polymer Research in Dow (R&D and TS&D) before moving into Manufacturing in an Analytical Improvement role and then a Quality Leader for five Dow businesses before moving to help establish a new capability called Fundamental Problem Solving, where top chemists and engineers work on complex, often multi-effect, plant problems. With this established, he refocused his efforts working to establish the data initiatives that support this work. Lloyd is married with two daughters and is an avid cyclist, hiker and landscaper.
>> see more about Digital Transformation in the Chemical Industry. The Devil's in the Details.
