The PLA® Conference is planned for offering a balanced mix of keynote presentations, workshops, panel discussions and interactive sessions catered for different learning preferences and levels of expertise.

More specifically, the #PLA2023USA program included speakers from various industries and functions. Both industry experts and end users shared their practical experiences and case studies. This diversity provided a well-rounded perspective on the challenges and opportunities of digital transformation journeys in the laboratories.

In addition, the industry experts centred their presentations around the main theme of the event, “Master your eData Lifecycle” and each session had clear goals of how and where they wanted to steer the discussions.

Embrace an Ecosystem Mindset for Successful Digital Transformation

The ecosystem mindset refers to viewing digital transformation as an interconnected and collaborative effort involving various stakeholders, both within and outside the organization. It recognizes that no single technology or department can drive successful transformation in isolation.  Instead, organizations are encouraged to create a dynamic ecosystem of partners, technologies, and talent that work seamlessly together to achieve common goals.

Pat Pijanowski, John Conway and Lloyd Colegrove drew our attention to what lessons we could learn from the massively successful consumer-led digital transformation and what we could use to shift our own digital transformation strategy in the lab to be more driven by an ‘ecosystem mentality’

To successfully bring digital transformation to the lab, we all need to think a bit differently than we have in the past. We need to adopt an “ecosystem mindset” instead of an “application mindset”

Rely on Fundamental Quality Culture for Quality Production 

In the search for a definition of culture, every anthropologist has a slightly different view of what culture means. However, there are common elements in answering the question of what culture encompasses. Culture is the holistic combination of learned and shared beliefs, values and practises that create cohesion in a group.

The employees of a company thus form a group that works and acts in the way they believe is expected of their company, or better still, in the way expected of everyone role and responsibility.

Mark Newton, Chinmoy Roy and George Bernstein drew our attention to the importance of the human factor for a successful transformation of the digital lab.

They emphasise the responsibility of top management to foster a culture of quality in the organisation from top to bottom and to empower everyone through learning opportunities, mentoring, coaching and the promotion of transparency and ownership at all levels.

They also magnificently cover the delicate topic of balancing business needs with compliance gaps.  Highliging the relevance to consider compliance as a function that is judged on how it supports the business but also recommending business to understand how important quality requirements, and therefore compliance, are to the success of the business itself.

Master your Data Management for easier Innovation and Scaling 

In a data-driven world, companies that succeed in gaining actionable insights through data management will be able to innovate faster, develop better strategies and manage change more efficiently.

Many organisations today, especially global organisations, have hundreds of separate applications and systems where data that crosses departments or divisions can easily become fragmented, duplicated and usually obsolete. When this is the case, answering even the most basic but critical questions about any kind of performance metric or KPI becomes a problem for an organisation.

Fundamentally, the need for accurate, timely information is acute, and with the proliferation of data sources, it is an ongoing challenge to manage them consistently and keep data definitions up to date so that all parts of an organisation are using the same information.

Luke Guerrero and Patrick Courtney explained us that organizations have initiated the conversation about scaling their software usage and mastering data management. Luke talk summarized the current state and suggested pathways for organizations that think differently and want to learn from the successes in biotech and other industries. While Patrick dive into the role of standards and ontologies explaining how SiLA (Standardization in Lab Automation) and AnIML (Analytical Information Markup Language) could drive automation, data management, and machine learning.

Those are few glances to what happen at the PLA® Conference USA this last month. We look forward to welcoming at the next edition in the USA, Europe or India in 2024.

Access here the presentations 

Note: Only presentations the PLA® organisation have got authorisation to share are available

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To meet this challenge, this PLA2023USA session will further explore the topic of mastering your data management with the fol

Transforming biomanufacturing: breaking through today’s digital technology tropes

How communication and data standards enable the automation and data management lifecycle

Presenting Patrick Courtney, Board of Director @SiLA Consortium

Laboratory automation and data management remain challenging tasks, in part because of the diversity of needs, processes and tools. Managing such diversity through modularity and standardization has been a successful approach and is being applied in the laboratory.

However, the role of standards and ontologies is often poorly explained. We will explain how SiLA (Standardization in Lab Automation) and AnIML (Analytical Information Markup Language) are driving automation, data management, and machine learning.

SiLA ensures seamless instrument control and workflow orchestration, while AnIML structures data for consistent analysis and collaboration. Through real-world cases we will present the impact of standards in shaping modern laboratory practices and fostering innovation. Finally, some recently advances in closed loop systems to accelerate research will be presented.

Master data management  is in fact the reincarnation of the problem of how to manage the consistency and integrity of the myriads of data assets that exist across the enterprise.

This session will be held at the Paperless Lab Academy® USA Chapter on Day 2, November 16th from 15:00 to 16:30.

Join the discussions at the Paperless Lab Academy® 2023 USA!

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In this particular session we will go through real-word cases and discover from one hand the approaches of Boehringer Ingelheim and Catalent Pharma going global with their LIMS, where standardisation and  harmonisation are key factors for the success.

Leveraging cross-business synergies as pathway to digitalisation

The case of the MyLIMS program currently under way at Boehringer Ingelheim will be presented as a pragmatic approach to address the digitalisation of two apparently diverse businesses such as Animal Health and Biopharma with one holistic template-driven solution which brings significant benefits in terms of simplification of the application landscape, and is the foundation for ongoing and future integration with ERP, MES, LES , CDS and paperless mobile-based sample handling.

Managing Change in Multiple Laboratories: LIMS Deployments and the Benefits of Standardization

Presenting Geoffrey Trullinger , IT Global Lab Automation Software Operations Manager @ Catalent Pharma Solutions

Geoffrey is the Software Operations Manager for Catalent’s Global Laboratory Automation team and has a background in laboratory informatics, laboratory operations, and IT quality/validation.  He has experience implementing laboratory systems, ranging from specialized benchtop instrumentation to multi-site LIMS and chromatography systems, working with a variety of different laboratories and systems.  His approach focuses on the way that software can improve workflows, standardize processes, and reduce risk.

Effective change management is crucial when deploying a Laboratory Information Management System (LIMS) to multiple laboratories.  This presentation will explore key strategies and best practices for navigating the complex process of LIMS deployments, including determining lab readiness, identifying opportunities for standardization, and maximizing user adoption.  Join us as we delve into the essentials of change management to drive your successful LIMS deployment journey.

On the other hand, completing this session a special use case from Regenxbio where strategic integration is here key.

Advanced digitalization of QC-Micro Processes

Presenting Caitlin Harrison, Sr. Manager, QC Microbiology @ REGENXBIO, Inc.

Caitlin is an experienced Quality professional with over 12 years’ experience, specialized in Quality Control Microbiology in the pharma industry. Experience with implementation and validation of several different computer systems, focusing on development of MODA-EM for the QC lab and integration with processing equipment and external monitoring systems for automatic data migration.

Utilizing real-world examples, Caitlin Harrison will showcase the transformative impact achieve through strategic digital integration at a Cell & Gene Therapy organization. Attendees will gain a comprehensive understanding of the critical role of a robust digital strategy, elevated capabilities achieved through the innovative & proactive application of the MODA® platform. How digital transformation can enable companies to maintain a competitive edge.

This session will be held at the Paperless Lab Academy® USA Chapter on Day 1, November 15th from 14:00 to 15:30.

Join the discussions at the Paperless Lab Academy® 2023 USA!

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One of the critical aspects of this transformation is the digitization of laboratory processes in the manufacturing industry. Laboratories play a pivotal role in ensuring product quality, innovation, and compliance.

Digitalizing laboratory processes is not without its challenges. Laboratories generate vast amounts of data that need to be managed, analysed, and stored securely. Moreover, laboratory operations involve complex workflows, stringent regulatory compliance, and interdisciplinary collaboration between scientists, engineers, and data analysts. Overcoming these challenges requires more than just implementing digital tools; it necessitates a holistic approach, which is where the ecosystem mindset comes into play.

The ecosystem mindset refers to viewing digital transformation as an interconnected and collaborative effort involving various stakeholders, both within and outside the organization. It recognizes that no single technology or department can drive successful transformation in isolation. Instead, organizations are encouraged ­­­­­­to create a dynamic ecosystem of partners, technologies, and talent that work seamlessly together to achieve common goals.

This article anticipates the discussions that will take place at the Paperless Lab Academy® USA on November 15-16 in Raleigh, NC. The opening session in particular, led by Pat Pijanowski, John Conway, and Lloyd Colegrove, will set the stage by challenging the current paradigm of application-centric approach.

They will introduce the concept of ecosystem mindset. The digital ecosystem has much more to offer today than it did when labs started adopting LIMS, LES, and ELN. The ecosystem mindset approach is too powerful to simply be overlooked.

Key Elements of the Ecosystem Mindset

• Collaboration: An ecosystem mindset encourages collaboration between different departments, functions, and even external partners. In the context of laboratory digitalization, this means breaking down silos between R&D, quality control, and IT to create a unified approach to data management and analysis.

• Openness to Innovation: An ecosystem mindset means being open to innovative solutions from multiple sources. Manufacturers should seek out technology partners, start-ups, and research institutions to tap into cutting-edge advancements in laboratory automation, data analytics, Machine Learning and AI.

• Scalability: Digital transformation in laboratories should be scalable and allow for the integration of new tools and technologies when needed. An ecosystem approach ensures flexibility to adapt to evolving requirements.

• Data Sharing: Laboratories generate valuable data that can benefit other parts of the organization. An ecosystem mindset approach encourage data sharing across departments to enable better decision-making and process optimization.

• Compliance and Security: Regulatory compliance and data security are paramount in laboratory operations. An ecosystem mindset includes robust governance mechanisms to ensure that all digital processes comply with regulatory requirements and reinforce data integrity.

Benefits of an Ecosystem Mindset in Laboratory Digitalization

• Accelerated Innovation: Collaboration within an ecosystem can lead to faster innovation cycles. Scientists can access external expertise and resources, leading to the development of breakthrough products and processes.

• Improved Quality Control: Real-time data sharing and analytics enable better control of the production. Manufacturers can identify and address quality issues early in the production process, reducing waste and improving product quality. With adequate ML and AI models, issues can even be anticipated and avoid.

• Enhanced Efficiency: Streamlined laboratory workflows and automated data analysis can significantly improve operational efficiency. This leads to cost reductions and a shorter time-to-market for new products.

• Better Regulatory Compliance: An ecosystem mindset approach ensures that regulatory compliance is built into digital processes from the outset, reducing the risk of costly regulatory issues.

• Futureproofing: The scalability and adaptability inherent in an ecosystem mindset make it easier for manufacturers to keep pace with technological advances and market trends.

The digital transformation of laboratory processes in the manufacturing industry is not a stand-alone endeavour. To succeed on this complex and data-intensive path, organizations must adopt an ecosystem mindset. By fostering collaboration, openness to innovation, scalability, data sharing, and a strong focus on compliance and security, manufacturers can realize the full potential of digitalization in their laboratories. The ecosystem mindset is not just a strategic choice; it’s the key to staying competitive and resilient in the rapidly evolving landscape of modern manufacturing.

Opening session: Adopt an ecosystem mindset for successful digital transformation + panel discussion

The Ecosystem for Digital Transformation is All Around Us!

Pat Pijanowski, former Managing Director at Accenture Scientific Informatics Services

The Cloud, Edge Computing, 5G Networks, Low-Code/No-Code BPM solutions, Artificial Intelligence & Machine Learning, Augmented and Extended Reality, Broadband communications around the world….  The ecosystem for digital transformation is all around us!  One only needs to look at the many ways in which our everyday lives have been transformed over the past couple decades to see the promise of the tools available to us in today’s world.  And yet, so many organizations have struggled to leverage these same digital enablers within the laboratory environment.  Why is that?  And what must we do?

Successfully bringing Digital Transformation to the Lab requires us all to think about things a bit differently than we have in the past.  Successful Digital Transformation requires us to adopt an “Ecosystem Mindset” instead of an “Application Mindset.” And the good news is……. It’s Happening!!!

There is No Such Thing as “Just” a Digital Transformation

John F. Conway, Chef Visioneer Officer at 20/15 Visioneers

Culture Change enables strategy adoption and the ability to adopt new strategies such as a Scientific Data/Process and Decision Strategy and make them actionable. What also transforms is the science and technology as well as all their processes and very importantly the “unknown” art of the possible! This talk will highlight current use cases and lessons learned.

Fundamental Problem Solving, a simple but transformative discipline

Lloyd Colegrove, former Director of Data Service at Dow Chemicals

Digital transformation and culture change go hand-in-hand and are critical to taking advantage of what new digital technologies have to offer, but in your operational environment have you ever considered how your newly transformed and digitally enabled workforce will successfully perform to solve operational problems and improve operational performance?

“Fundamental Problem Solving” is a discipline formalized around the old elementary school science fair concept of hypothesis and testing, combined with the complexities of “adult” technological issues around problem identification and solving.

Three questions, which your elementary school science teacher did NOT teach you, form the basis for powerful industrial problem solving of operational issues that mysteriously recur even after you think you have put them to rest, or identifying and mitigating so-called “multi-effect” problems – problems that do not have one clear or obvious root cause. Serendipitously, the precepts of fundamental problem solving can be applied to all aspects of life including but not limited to – career development, family vacation debates, and even where you and your partner may go for dinner tonight!

Join the discussions at the Paperless Lab Academy® 2023 USA!

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In fact, when it comes to digitising R&D and QC lab processes that operate in regulated environments, discussions start (or better, should start) with how to properly manage the data generated in the labs. On the list of requirements set by the project stakeholders, compliance with industry regulations is certainly one of them and the measures to be taken are an essential part of the project plan.
Precisely because it is so important, discussions on quality are addressed in a special session at the #PLA2023USA consisting of presentations delivered by internationally recognised experts and followed by a panel discussion to further deepen the conversation with participants.

Defining the Quality Culture

We will talk about risk management, computer software validation and data integrity, but… this will not be a training session on concepts or an endless list of guidelines… this session will mainly deal with the concept of quality culture within an organisation and how to ensure appropriate behaviour of all components of the group.

In the search for a definition of culture, every anthropologist has a slightly different view of what culture means. However, there are common elements in answering the question of what culture encompasses. Culture is the holistic combination of learned and shared beliefs, values and practises that create cohesion in a group.

The employees of a company thus form a group that works and acts in the way they believe is expected of their company, or better still, in the way expected of everyone role and responsibility.

For this very special session, we are honoured to have as guests three internationally renowned experts who will share their experiences and use cases and lead us to a concluding Panel Discussion on challenging the paradigm of getting things done just for the sake of the next audit. Provocative but healthy and certainly respectful discussions.

Discussing Quality with our international keynote speakers

Mark Newton, owner at Heartland QA, will address the delicate topic of balancing business needs with compliance gaps. It is important that compliance remains a function that is judged on how it supports the business. However, it is important that the business understands how important quality requirements, and therefore compliance, are to the success of the business itself. Mark will take us in his presentation from his 30+ years at Eli Lilly as an Associate Quality Assurance Senior Consultant and his great contribution as co-editor of several GAMP guides.

Chinmoy Roy, CSV and Data Integrity SME, Independent Consultant, will develop further about the approach to data integrity risk management using data integrity maturity model and process mapping. He will also bring a case study about conducting DI risk assessment in a QC laboratory.
Chinmoy is a biopharmaceutical consultant with over 40 years of experience in CSV, Data Integrity, 21 CFR Part 11, Annex 11 and manufacturing process automation. His presentations blend his field experience to highlight the intricacies of implementing regulations

George Bernstein, Ph.D., President of MAI Consulting, will then focus largely on the human factor in the compliance execution: the Data integrity wild card. George has a Ph.D. in Chemical Engineering and over 30 years of experience in pharmaceutical manufacturing, laboratory operations, data integrity, effective training, and quality risk management. In his presentation, George will touch upon the opportunities and human factors that lead to data integrity breeches, and strategies to further mitigate that risk.

“We have engineering and software solutions to reduce opportunities for data integrity breech, but these are applicable for some but not all areas of exposure. Use of legacy equipment, logbooks, and manual entry into batch records requires training and QA oversight to minimize data integrity risk. Unfortunately, training is often ineffective, and QA staffing may be in short supply.” commented George during our interview.

Following these 3 master presentations, the panel discussion will be used to discuss the next steps for your projects.

Invitation to #PLA2023USA

Mark, Chinmoy and George are far more than senior advisors who can identify problems and potential root cause when they visit a customer site. They are independent voices with a strong desire to close the gaps identified with their clients.

Open and honest, they will tell you their truth. Whether you like it or not, no one is left untouched by what they have to say, based on their vast experience in the field and their vision from international exposure.

Whether your laboratory operates in a highly regulated environment such as the pharmaceutical, but also the forensic or the cannabis industry, whether your laboratory is dedicated to research and development or quality control… Quality is not only a matter of compliance, but also a matter of business success.

Join the discussions at the Paperless Lab Academy® 2023 USA!

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Mark Newton has been employed for 33+ years by Eli Lilly and Company in several cross-functional roles.  Starting as a Microbiologist, he spent 14 years within the chemical, pharmacological, and microbiological areas of QC Laboratories as an analyst, method developer and supervisor.  The balance of his career has been within IT and Quality, implementing GMP software, serving as computer system QA, then a Laboratory Data QA representative, developing standards for qualification of laboratory computerized systems and training lab personnel in data integrity auditing, gap identification and remediation techniques.
He is co-editor of the GAMP Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (2nd ed), and currently co-leader of the GAMP Data Integrity Special Interest Group (SIG) and the ISPE Global Documents Committee.  He has recent publications in Pharmaceutical Engineering, Scientific Computing and the ISPE Blog (ISPEAK).

Chinmoy Roy, CSV and Data Integrity SME, Independent Consultant. Chinmoy Roy is a biopharmaceutical consultant with over 40 years of experience in CSV, Data Integrity, 21 CFR Part 11, Annex 11and manufacturing process automation. He was one of the architects for designing and implementing the largest paperless biologics manufacturing plant in the world. He was a member of ISPE’s Data Integrity Special Interest Group (S.I.G). He travels the world to train industry personnel in the areas of his subject matter expertise of CSV and Data Integrity as well as to conduct data integrity audits…
Chinmoy has a bachelor’s degree in electrical engineering and a master’s degree in computer science.

George Bernstein, Ph.D., is President of MAI Consulting. He has a Ph.D. in Chemical Engineering and over 30 years of experience in pharmaceutical manufacturing, laboratory operations, data integrity, effective training, and quality risk management. Since 1988, Dr. Bernstein has consulted both nationally and internationally with major pharmaceutical companies to address compliance actions by Health Authorities. He has lectured internationally on quality systems and root cause analysis to industry trade groups, quality organizations, and at PDA and Interphex conferences. Dr. Bernstein’s experience, insights, and innovative problem solving have been integral to his work which ranges from training effectiveness, GMP compliance, facility design, construction, and commissioning to business process re-engineering and process optimization. He has developed global quality standards (GLP, GCP, GPP) for a major international pharmaceutical company, and has assisted many clients with audit preparation, remediation activities, and communications with the US FDA.

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