In today’s ever-changing landscape of the life science and healthcare industry, there is a need for quick decision making and simplified lab processes to shorten the time needed for products to launch in the market. Studies  have derived that about 70% of medical decisions are made based on laboratory data and this is a testament to the importance data plays in the industry. Traditional paper-based methods of recording data can lead to human error and inefficiencies when it is handled by different parties and could result in a lag in pushing products out to the market. 50% of pre-clinical studies end up giving irreproducible results resulting in a loss of USD$28 billion every year.  This leads to cost inefficiencies and tedious effort when needed to repeat studies for accurate insights. Unifying data is crucial in ensuring that no data is lost or inaccurately interpreted and managing such valuable data using conventional methods could be time-consuming and operationally challenging.

Digitalizing the entire laboratory workflow minimizes effort taken on nominal tasks and allows scientists to invest more time in making decisions that are supported by key insights, interpreted by digital tools. An integrated platform can support the management of samples, automate data capture, reduce error-prone processes and drive innovations in the industry with faster decision making and standardized data for accurate interpretation of medical insights.

BIOVIA, a brand of Dassault Systèmes offers a unique approach to unifying solutions and improve process workflows by supporting research, development, and analytics in the life sciences industry. Boasting a holistic environment that champions efficiency and improved data interpretation, BIOVIA accelerates development and innovation by simplifying lab processes for increased productivity while reducing costs for operational excellence.

Addressing roadblocks in life science labs with a single end-to-end integrated platform

In day-to-day laboratory workflows, various levels of management and planning is needed to support testing and launch products to the market. The multiple-step approach involves decision making on all fronts from planning to execution and is resource and data heavy. The involvement of multiple parties often leads disconnected workflows and introduces the opportunity for inaccuracies. BIOVIA ONE Lab eliminates such challenges and is designed to increase collaboration within organizations by harmonizing crucial data and processes in a single platform. BIOVIA ONE Lab supports various capabilities in life sciences labs:

Reduced costs with standardized processes: Lab Research and Development processes can be cost heavy with the need for multiple products and raw materials needed to facilitate testing and manufacturing. By incorporating standardized processes, BIOVIA ONE Lab supports the replicability and re-use of data for experiments. Using a web- and cloud-based interface, ONE Lab supports multiple workflows within a single platform, reducing the need for various systems such as ELNs, LIMS, and LES. As a result, ONE Lab aids with 80% of experiments being re-used and up to 30% reduction in raw material use.

Data Management and Workflow automation: With multiple steps and resources required, life sciences labs are heavily reliant on data that can help with decision making. Processes also involve tedious workflows which are approved and managed by different parties. BIOVIA ONE Lab consolidates such important data in a single unified platform and supports data management through the seamless coordination from various sources, databases, and other systems. This increases efficiencies in consolidating data from different sources and reduces errors.

Compliance: The life science industry is responsible for launching important products for medical purposes and disease management, which warrants extra regulations and scrutiny on processes to manage risks and remove any risk of detrimental effect. As such it is important for processes to be traceable and adhere strictly to current standards. BIOVIA ONE Lab provides helps manage compliance through audit trials, electronic signatures, and data security features. The use of BIOVIA ONE Lab can lead to 80% reduction in human errors and 85% improvement in data traceability.

Increased collaboration within the industry: Collaboration in the life sciences industry can bring about many benefits with the expertise of many professionals being incorporated for decision making. It can be challenging to access and consolidate insights and data from researchers that use different management tools. BIOVIA ONE Lab boosts collaboration by supporting various formats and tools while allowing for researchers to access data and analytics from a single source of truth.

Intuitive capture of instrument data: BIOVIA ONE Lab allows for the tracking of instrument usage, maintenance schedules, calibration, and performance. With BIOVIA ONE Lab, instruments are easily integrated into the platform, enabling users to access data and manage instruments from a single location. This allows results to be imported seamlessly and reduce transcription errors.

Using data for increased collaboration and increased efficiency within the industry

To eliminate traditional approaches to data capture, organizations have been adopting digital technology for various processes in the life sciences industry. With a unified landscape, BIOVIA ONE Lab encourages data capture, available in a single platform to accelerate processes and reduce tedious effort in workflows. With reduced manual effort and time needed for paperwork, researchers can dedicate their time to decision making and crucial processes within workflows. This in turn can boost cooperation within the industry when different parties can access the same data and insights for innovations. BIOVIA customers have achieved up to a 35% increase in efficiency through streamlined workflows.

From Research to Development: Multi-step processes harmonized into one platform

To successfully launch products to market in record time, the processes shift from research to development where insights are optimized for product development, before being assured for quality in QA/QC and the final step of manufacturing. The processes in each of these steps are tedious with multiple levels of testing and checks from different parties to ensure quality of products that are being launched. However, organizations still run the risk of errors in data transcription, increasing costs, and delays in launch of products to market. Scientists face challenges where processes require multiple informatics touchpoints.

BIOVIA ONE Lab is designed to optimize such processes by supporting the integration between various solutions such as ELN, LIMS, LES, inventory management and instrument management through a single end-to-end solution. Multiple processes and checkpoints can be managed through the integrated platform which improves data analysis and reduces time taken to manually derive insights for product development. BIOVIA supports various workflows from research to development to ease challenges that scientists face with data transcription and tedious processes.

With the reliance and use of different lab informatics point solutions such as ELNs in early research, and LIMS and LES common for process development and QC, there are set boundaries hampering data flow. Removing these boundaries by eliminating siloed systems, BIOVIA enables a holistic view of all processes from start to end and enable access at one-go. With access to project information at any time, BIOVIA ONE Lab brings data together for an overall view, providing stakeholders with the right information for decision making and analysis for future groundbreaking inventions.

BIOVIA transforms scientific innovation

In addition to ONE Lab, BIOVIA offers an extensive range of solutions focusing on transforming Research, Development, Manufacturing and Quality covering Biopharma Quality & Compliance, Data Science, Molecular Modeling & Simulation, Scientific Informatics, Formulations Design, and Manufacturing Analytics. These solutions make BIOVIA a trusted partner for nearly all aspects of life science product innovation and development.

BIOVIA has the potential to spur innovations in medical research with its unified ONE Lab solution, which ties in best practices with the latest features in technology to synergize R&D operations. BIOVIA ONE Lab can significantly improve the efficiency, accuracy, and reliability of laboratory data and procedures across product R&D, making it an essential tool for organizations to accelerate new therapies to market.

Read also >> Advancing innovations and collaboration – How BIOVIA increases efficiency and cooperation in life science R&D

At the Paperless Lab Academy® 2023 Europe, two real-life cases about global LIMS implementation will be presented by their respective project leaders.

Considering that a successful, simple LIMS implementation is already a challenge and rarely reaches its full potential, a global LIMS implementation is something of a rare pearl when carried out in all the laboratories concerned. To reach its full potential in a multi-site facility, systematic standardisation and harmonisation between all sites of the laboratory enterprise are required. As it involves bringing together multiple sites and systems into a single way of working with a clear master data plan, it is interesting to understand how this is technically managed and, more importantly, how the commitment of so many stakeholders is achieved.

Global LIMS implementation: use of cross-business synergies as a path to digitalisation

On the one hand, Sergio Nasi, Head of Global Laboratory Execution at Boehringer Ingelheim, will talk about the "leveraging cross-business synergies as a pathway to digitalisation".
Sergio is an electronic engineer by training and a techie manager by profession. He has been working in the field of laboratory informatics for more than two decades, in many different roles: Programmer, Business Analyst, Project Manager, Team Leader, Programme Manager and almost always Firefighter. Today, Sergio is responsible for the global LIMS roadmap at Boehringer-Ingelheim.
The case of the MyLIMS program currently underway, is presented as a pragmatic approach to address the digitisation of two seemingly disparate business areas such as animal health and biopharma with a holistic, template-driven solution that brings significant benefits in terms of simplifying the application landscape and provides the foundation for ongoing and future integration with ERP, MES, LES, CDS and paperless, mobile-based sample processing.

Standardisation of Laboratory processes for a global LIMS implementation

On the other side, Alessio Tremolada, Laboratory Global Process Owner at SGS, will talk about the "global program for digital laboratories at SGS".

Alessio is an industrial chemist whose professional experience started in laboratories where he enjoyed executing and innovating analytical chemistry processes. He spent more than 20 years at SGS, where he progressed from laboratory technician to manager for the environmental laboratory business in Italy and global technical manager for the same area, also taking responsibility for the business IT.

When SGS launched one of the most important IT programs for the company called "Digital Laboratory", Alessio had the role of Global Process Owner for the approximately 1,000 laboratories operating in many different areas. In this role, he leads the team responsible for standardising the lab's digital processes to achieve the best possible efficiency. He oversees the development of the IT products to ensure they meet user requirements and works with IT delivery and implementation managers to achieve business goals.

SGS provides services to customers from more than 1,000 laboratories around the world. It is a complex and geographically dispersed network that presents us with some operational challenges. We realised that without a standardised and integrated laboratory information management system, we had no consistent way to manage workflow, administration, finance, and operations across our laboratories. This made it difficult for us to utilise the complex data we have and affected our ability to introduce new technologies, increase productivity and improve efficiency. Aligning, optimising, and digitising our lab processes through our new Digital Labs Transformation programme enables us to increase efficiency, improve quality and optimise our testing methods. This in turn enables us to introduce new data analytics solutions, mobility and analytics, and fully automated labs with AI-powered insights and modelling and excellent scalability.

At the Paperless Lab Academy® 2023 Europe conference, more real cases of successful digital transformation projects in labs will be presented, together with  various discussions on how to get the most out of the data generated.

Seek out the program we have prepared for you

Still on time to register!

In the fast-paced landscape of today’s life science and healthcare industry, there is a need to constantly adapt and improve lab operations to increase efficiency and maximize quality. Labs face the pressure of delivering results and key insights in record time to push products to market, and the use of traditional paper-based methods of recording data can lead to a loss in productivity, compliance issues and increased costs.

Digitalizing the laboratory workflow helps tackle challenges with inefficiencies and productivity by minimizing non-value tasks and minimizing the time needed to interpret data required for decision making. Ultimately this reduces the lab-to-market time of products and operational costs. Working in a unified “paperless” environment with automated data capture, management of samples, and lab test procedure execution allows scientists and stakeholders to collaborate seamlessly and utilize standardized data for further interpretation.

BIOVIA, a wholly owned subsidiary of Dassault Systèmes offers end-to-end and unified solutions that improves R&D processes in the life science industry for increased efficiency, significantly shortening the lab-to-market time. BIOVIA enables cooperation amongst collaborators by providing better access to data to derive at powerful insights for decision making and reducing physical testing. With the digitalization of healthcare and life sciences processes, BIOVIA drives operational excellence throughout the product lifecycle, boosting innovation in the industry.

Using a unified platform to tackle challenges present life science labs

BIOVIA ONE Lab is an integrated solution which streamlines research development processes to simplify scientists’ digital lives in the lab. BIOVIA ONE Lab is designed to address the challenges faced by life science labs:

• Data management: Life science labs generate vast amounts of data and managing this data can be a major challenge. BIOVIA ONE Lab provides a centralized platform for managing data from multiple sources, including instruments, databases, and other systems. This helps to improve data quality, reduce errors, and increase efficiency.
• Collaboration: Collaboration is essential in life science labs, but it can be difficult when researchers are working in different locations or using different tools. BIOVIA ONE Lab provides a collaborative environment that enables researchers to work together seamlessly, regardless of their location or the tools they are using.
• Compliance: Life science labs are subject to strict regulations and standards, and compliance can be a major challenge. BIOVIA ONE Lab provides tools for managing compliance, including electronic signatures, audit trails, and data security features. This helps labs to meet regulatory requirements and maintain data integrity.
• Workflow automation: Life science labs often have complex workflows that involve multiple steps and stakeholders. BIOVIA ONE Lab provides workflow automation tools that help to streamline these processes and reduce the risk of errors or delays. This can improve productivity and reduce costs.
• Instrument integration: Instrument management is a critical aspect of laboratory operations, as it involves the tracking of instrument usage, maintenance schedules, calibration, and performance. With BIOVIA ONE Lab, instruments are easily integrated into the platform, enabling users to access data and manage instruments from a single location.

Going paperless – How BIOVIA optimizes the use of data for product development

Organizations have been increasingly adopting digital technology in an effort to “go paperless”. BIOVIA encourages the initiative by omitting the need to capture data on paper and allowing for a continuum of data that is recorded.  Apart from being able to access data in a single platform, BIOVIA boosts efficiency by helping organizations reduce inaccuracies when capturing data. The data that is captured is also crucial in accelerating the product lifecycle and BIOVIA optimizes this process by removing any discrepancies at the start. With the presence of critical information available at any time, there is a potential for increased partnerships within the ecosystem when data can be analyzed, and insights can be adapted for product development. Workflows within organizations can also be enhanced when manual paperwork and efforts are seamlessly replaced by digital automation via BIOVIA.

The time for boundaries has passed

As product development shifts from Research, to Development, to QA/QC and then Manufacturing, relevant data must be compiled and packaged up before being passed to the next part of the organization. Each step is time consuming, and introduces the possibility of data transcription errors, or loss of context. But even within one domain, using multiple different point solutions is cumbersome for scientists and can introduce errors.

In place of compartmentalized point solutions, BIOVIA ONE Lab eliminates the boundaries between solutions such as ELN, LIMS, LES, inventory management and instrument management—integrating all the capabilities in a single, unified solution. This approach reduces the need for manual data transcriptions and ensures that data is consistently and accurately captured across different systems. Additionally, a unified solution improves the efficiency of data analysis by providing a centralized location for accessing and analyzing data. This saves time and reduces the risk of errors that can occur when data is spread across multiple systems. Workflows also become seamless, with scientists operating in a single lab informatics environment, instead of having to operate multiple systems at once.

This also pays dividends when considering that different stages of the product lifecycle tend to rely on different lab informatics point solutions-ELNs are common in early research, LIMS and LES are more heavily used in process development and QC. As a project progresses, relevant data must be captured in different places, often in different formats, and it is a daunting task to get a good overview of all the data from these different silos. By eliminating these boundaries, BIOVIA ONE Lab brings all the core capabilities of disparate informatics solutions together and enables instant access to all relevant project information, regardless of what stage of product development the data was originally captured.

BIOVIA ONE Lab transforms scientific innovation

In addition to ONE Lab, BIOVIA offers an extensive range of solutions focusing on transforming Research, Development, Manufacturing and Quality covering Biopharma Quality & Compliance, Data Science, Molecular Modeling & Simulation, Scientific Informatics, Formulations Design, and Manufacturing Analytics. These solutions make BIOVIA a trusted partner for nearly all aspects of life science product innovation and development.

BIOVIA has the potential to spur innovations in medical research with its unified ONE Lab solution, which ties in best practices with the latest features in technology to synergize R&D operations. With features that are catered to increase cooperation between various stakeholders who exist within the same ecosystem, BIOVIA ONE Lab will play a crucial part in driving the next stage of product development for breakthroughs in the medical and health sciences industry.  BIOVIA ONE Lab can significantly improve the efficiency, accuracy, and reliability of laboratory data and procedures across product R&D, making it an essential tool for organizations to accelerate new therapies to market.

Download BIOVIA - The Digital Lab is Here Whitepaper to find out more
More information about BIOVIA ONE Lab is available here.

I just had the pleasure of interviewing Miguel Alvariño Gil, Manager Quality OpEX at Lonza. A long-awaited presentation on their automation project, now completed and ready to be shared with the audience.

We talked about the enormous impact the pandemic had on digitisation projects. We talked about the delicate aspect of hiring qualified staff when the business urgently needs to grow, and we looked into the future and hypothesised about what the situation in the labs will look like from a digital point of view.

The Paperless Lab Academy® is celebrating 10 years, an opportunity for retrospection. If you look back 10 years, which technology and/or concept has enabled the digital transformation for laboratory processes?

I would say that the pandemic had a huge impact. 10 years ago, everyone was focused on implementing a LIMS, and today everyone has one installed. I think today it's all about systems interfaces, limiting the use of paper and human intervention.

The pandemic drove this drastically and was the biggest catalyst we had. Suddenly people were sent home and asked to work remotely and yet businesses were expected to function at their best. I am part of the ISPE robotics and automation work team. When we started 3 years ago, there were only 15 of us from Switzerland, Germany, and Austria, now we have to limit the number of participants when we organise events.

What has changed then? Have finally the top management realized there was something to be done regarding Digital Transformation?

They have indeed realised that they would be in great trouble if they do nothing. The competition does not stand still, and they could fall behind very quickly. For instance, if there were reservations at first, working from home is now a fact of life. And it will stay that way. I myself now only go to the office 2 days a week. Before, it was neither accepted nor possible.

It is also a plus point for new applicants in job interviews. When they see the roadmap of our projects and know that they could have something to do with it, it is a strong introduction and positioning as a modern company.

Let me give you an example of the impact of the pandemic. In February 2020, I led the lab digitisation project, and we introduced the RMN lab project. It was the very first lab to be fully digitised. The methods and processes were pretty standard, so we decided to start with that.

At the presentation in February 2020, the comments were just "Oh nice", "maybe" ... A month later the question was, "What do we need to do to convert all the other labs?"

The fact is that the head of this laboratory could not come to his workplace during the pandemic for health reasons. However, since we had fully digitised his lab, he could access all the necessary information: raw data, weights, methods used...So he could work out the resource allocation remotely, he could lead the team, decide on analysis priorities, release results, and approve reports.

This lab would have been shut down if we had not been ready before the pandemic.

I have taken on a different role now, but the path is set and for everyone at Lonza, this is the way to go from now.

In summary, you see a change in mentality that was accelerated by the pandemic, rather than by new technology or concepts.

Well, technology is a given. It comes down to the management team. Managers have a certain view, a certain strategy and even a different culture compared to another company, which leads you to focus more on one aspect or another.

For example, at Lonza, we will soon be doing software validation online. If you had told me that 5 years ago, I would have laughed out loud. That just happened because of the pandemic. Validation requires 2 people in parallel, which can be perfectly realised remotely from a computer which allows to see and record what the other one is doing. This is already happening with software validation, and it can soon be the case with validation of analytical methods.

Of course, no one has the capacity to be fully digitised today, and not everything needs to be digitised.

The processes with more return of investment will go first. Each company will have its own decision-making strategy based on quality, effectiveness, competitiveness, business revenue, ... Some processes won’t be of much interest to invest into their digitalization, so there won’t be need to go for all.

One of my university friends with similar responsibilities works in a company that has gone through several acquisitions. 4 years ago, she managed to build a team to harmonize the 11 LIMS they had to maintain. They were able to identify the systems they wanted to work with and in the meantime new acquisitions with new LIMS came in. There will always be situations like this that one is confronted with. The point is to be ready to work for integration and harmonisation.

Can you tell us a bit more about your career pathway?

My professional career started in quality control at Takeda. I then moved to the laboratory at Lonza, where I even worked as an analyst. When I moved to the laboratory digitalisation team, it was very useful to bring in my knowledge of laboratory processes.

in 2021, I moved to a group called Quality Innovation, now Quality Operational Excellence. We work to make the labs as efficient as possible.

There are three areas we work in: Lean Lab, Automation of test processes (bots with Power Apps, software analytics, data integrity, artificial intelligence...) and Automation and Robotics.

How much do you interact with Manufacturing with those projects?

More and more. In the beginning these projects were self-sufficient, within the laboratory and for the laboratory. There is always a moment when we have to interact with operations, but not only. We now have a lot of interactions with environmental, health and safety, and with quality assurance and qualification.

Because nowadays we do not rely so much on standard equipment. Sometimes, for example, we work with robots that are brand new or have been specially developed for us.

We have learned a lot about qualifying this new type of equipment. We now have an addendum to the standard qualification of equipment that we can use.

 What does industry 4.0 means for you and your team at Lonza?

We do not talk so much internally about 4.0. It's a nice concept, nice for the presentations, books, and theoretical definitions. Ultimately, you have to put it into practice. We knew we were going to grow a lot, build new plants, and we never expected to grow so much during the pandemic.

The main problem was that we realised we had to hire a lot of people without finding so many qualified people. So, we started to think about how we wanted to proceed in quality control and looked at different projects and areas that could be improved through automation.

Some projects were discarded because the technology was not yet available, others because as CMO we had to inform our clients to confirm their support and they were not always ready for innovative approaches.

So, we started with microbiology, because the methods are limited, about 15 standard methods from the pharmacopoeias. Thank you to all the knowledge we gained from this project, we are now confident that we can transfer this experience to other areas.

If we had started with a more complex and less standardised area, we would not be where we are today. Thanks to this "simple" project, we now know better how we want to proceed.

Regarding your presentation at PLA2023 Europe " End-to-End Automation, Digitisation of Bioburden Analysis in a GMP Environment", what were the primary goals you wanted to achieve?

In my presentation, I will be very prosaic, because the goal was to overcome the need to hire a large number of qualified employees. The Swiss and German markets are saturated. It is impossible to get lab technicians on a constant basis. So, we worked out a project to limit the number of staff needed, purely out of cost avoidance.

At the beginning they were 3 separate projects, but then we realised that they had much more in common and we could work them out together. In the end we achieved much more than expected and eliminated every paper-based process.

In your opinion, how far are you from fully digitised QC processes? is it your final goal?

Definitely not for everything. We are considering more and more projects for digitaslisation and automation, but as I mentioned earlier, there will always be processes that are not worth the investment.

Even a fully automated process cannot cover a punctual high demand of analysis. Investing in a second or third robot to cover such a selectively high demand is not worth the money.

The decision is always business-driven.

There are two main reasons why you decide to go digital: firstly, because of the business benefits and secondly, because otherwise you will be out of the market not only because of the competition, but also to comply with regulations.

What do you foresee for the next 10 years? 

I' am sure that many things will change because new technologies will emerge. At Lonza, we have a roadmap of features that are already there and that we could install or test.

Some of them have not yet been introduced in the pharmaceutical industry. They are being tested at universities and may not come to market for 3 or 5 years, or at all. We keep a close eye on what is being tested. Ultimately, this topic of digitalisation and automation prepares you for everything that has to do with artificial intelligence. We have ideas, but we cannot predict where we will be in 5 years. It could look very different in terms of business intelligence.

What we are doing today was science fiction 10 years ago. In that sense, we are pioneers.

The automated mobile robots that do the sampling are mentioned extensively today. They collect the sample at the production site and pass it on to another robot that takes it to the lab. This is just a start, but things are happening. There are also many publications about the "Lab of the Future". Probably not everything will be implemented or possible, but we are facing a huge learning curve. Any company that is not working in this direction will be left behind.

I see 5G as another important change. I think in the pharmaceutical world you could look forward to dedicated communication lines for quality control, operations, and quality assurance, which would make everything much more efficient.

 

I would like to thank Miguel Alvariño Gil for this interesting and enjoyable conversation. We cannot wait for him to be on stage at the Paperless Lab Academy® 2023 Europe and get more insight of this amazing project about robotization of bioburden process.

Isabel Munoz Willery

 

 

The Paperless Lab Academy®2023 Europe agenda is rich with hot and trending topics for the lab sector. On stage will be prominent keynote speakers who will come to the Congress to share their experience and knowledge on specific topics.

A major contribution to Agenda 2023 will be a presentation we are all eagerly awaiting: "Artificial Intelligence in Action in the GXP Environment". The presentation will be given by Toni Manzano, Chief Scientific Officer at Aizon.

I had the pleasure and privilege of interviewing Toni to get some insights into his presentation and to start the discussion before he covers the topic on stage at the Paperless Lab Academy®

What do you think has changed technologically or conceptually in the last 10 years to get to the artificial intelligence we have today? 

From today's perspective, I would say that not too much has changed technologically since the disruption. 10 years ago, there was a lot of talk about Big Data, not really about AI. Even though the term artificial intelligence was coined as early as 1950 ^(1).

Technologically, all the tools we need for AI were created 10 years ago with the cloud, Big Data, and computation.  Those 3 concepts, 3 ingredients made it possible for AI.

It was necessary to have data of all kinds and to break down data silos that prevented the information from which knowledge is created from being brought together. The cloud makes it possible to democratise global access to data. It overcomes the barriers on premises and enables logistical distribution of data around the world by overcoming VPN and all technological barriers.

in my opinion, these are the 3 ingredients that make artificial intelligence possible. In fact, AI has already had 2 winters. When the scientific community realised it needed more space and did not find it, and when it realised it needed more computing power and did not have it. That has now been resolved.

From 10 years ago up to now, technology has not evolved, it has not changed as drastically as it did with the advent of the cloud.

The term artificial intelligence or anything to do with digital twins, augmented robotisation, augmented knowledge are concepts that are part of this popular digitised culture. Today, nobody leaves home without asking google Maps or similar app: When is the next train coming? No one looking for a picture looks for the photos one by one, we use search tool.

As a society, we are maturing in terms of digitalisation, and we are maturing faster than the pharmaceutical industry. But if you look at the projects, we have done at Aizon. Companies have a need that can only be solved if you deal with the complexity and variability of the information; realistically, you should not try to simplify, you should accept it. In this case, you cannot work with classical statistics because it is very complex, so you have to work with artificial intelligence. In this transition, digital maturity has emerged but in the pharmaceutical industry we are still far from the maturity that society has today.

As we have all matured digitally as a society, as you say, we use digital information every day, perhaps even unconsciously or automatically. My phone connects to my car and immediately tells me how long it will take to get home. What do you think are the obstacles that hinder or slow down the digital maturity process in the pharmaceutical industry?

In a recent study of the average age of CEOs, boards of the twenty largest companies, the average age is 57.

I am 51 and have long considered myself a digital person, yet already I struggle to keep up.

When there is no urgency to be optimal in a company that has classically always lagged behind technology, it turns out that there is no need. These people do not have that need either, they adopt the part they can from a social and personal point of view, but without designing a strategy to bring it into everyday industrial life.

A strong message to the boards! Toni, help us better understand AI then.  Artificial intelligence is about the data, but what about the algorithm you need to design for every specific process?

Do you know that there are 75 new patented artificial intelligence algorithms every day? You cannot imagine how many unpatented algorithms there are every day. let me explain you why there are so many.
Imagine a production line, a 6000-litre fermenter. It turns out that you need a different model for each stage of the fermentation. A model being the combination of data and algorithm. A single product in different formats, 20 models for 24 hours of fermentation Imagine that multiplied by all the bioreactors for all the lines. Also, every bioreactor needs a different model because every bioreactor is different.
AI cannot tell you why, but it can tell you what is happening.

In other words, the new challenge is how to manage AI, am I understanding right?

Indeed. There are two types of data: the historical data used to build the model, and the real-time data used to feed the model that outputs the real data value. Then comes the accuracy between the reality and the prediction to know if your model is good or even deteriorating.

Who is behind all this work to make it happen?

It is a combination of data scientists and subject matter experts in the process. They work to identify the algorithm that will provide the best approximation. The algorithm is fed with data, and this is how the model is then created. The model that represents reality is ultimately a statistical mathematical model that, after review by the subject matter expert, can be deemed ready for production

And then there's the compliance part. I mean, is this all approved?

We are part of a committee coordinated by the AFDO, Association of Food And Drug Officials ⁽²⁾, which includes the FDA, which has the greatest interest in this development.

In fact, the FDA is already building artificial intelligence into its own processes for two reasons: first, of course, for the patients, to get a safer, higher quality and more efficient product; and second, because the agency itself needs to coordinate better to cover the entire pharmaceutical industry, which extends to outsourced CMOs. They need to automate their monitoring and control process.

Your talk is entitled "Artificial Intelligence in Action in the GXP Environment". Will you come on stage with a use case and explain to the audience what is happening today in terms of compliance and the FDA situation?

I will definitely bring in use cases, otherwise it is too abstract. I think it is necessary to present some use cases so that people can see what kind of applications are running with AI today. The FDA question is crucial, and the audience needs to understand that there is explicit support.

Another point is that many people of the audience do not know where to start. the message will be that without the right data, without reliable data, you cannot run AI. AI is pure statistics, nothing more than statistics, and you cannot trust a result whose final statistics are based on unreliable data.

Pure statistics? I suspect it's more than that, given the complexity and multivariable you explained earlier. How do you start?

The first step we take when we are sure of the data is to find out which of the hundreds of variables really explain the problem.

How can you be sure of the data? How can you check its quality?

An excellent question. Data quality can only be validated if you have a lot of data. That is the first premise. Only when you have a good amount of information can you determine which of that information is valid and which is not. With the help of algorithms, you can identify the outliers on the one hand and the truly representative samples on the other. So the data cleaning starts automatically. This only happens when you have a large amount of information.

Thank you, Toni, for the valuable messages you have conveyed in this interview. We look forward to meeting you in April at the 10th edition of the Paperless Lab Academy ® and diving deep into the topic of "AI in GXP environments, compliance and the FDA approach to AI".

Isabel Munoz Willery, owner and organiser of Paperless Lab Academy ^® 

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1.By the 1950s, a generation of scientists, mathematicians, and philosophers with the concept of artificial intelligence (or AI) culturally assimilated in their minds. One such person was Alan Turing, a young British polymath who explored the mathematical possibility of artificial intelligence. Turing suggested that humans use available information as well as reason to solve problems and make decisions, so why can’t machines do the same thing? This was the logical framework of his 1950 paper, Computing Machinery and Intelligence in which he discussed how to build intelligent machines and how to test their intelligence.

2.About The Association Of Food And Drug Officials (AFDO). The Association of Food and Drug Officials (AFDO) is a well-recognized national organization that represents state, territorial, and local regulatory. The Association’s principal purpose is to act as the leader and a resource to state, territorial, and local regulatory agencies in developing strategies to resolve and promote public health and consumer protection related to the regulation of food, medical products, and cosmetics. afdo.org

 

 

 

In this fruitful interview I had the pleasure of conducting with Daniel Juchli, he touched on a hot topic and a key challenge for labs: change management on the one hand, user experience with lab informatics solutions on the other.
Let us dive deep into the topic with Daniel, Head of Lab and Research Informatics at Wega Informatiks, Premium Sponsor at the Paperless Lab Academy® 2023 Europe.

We are celebrating the 10th anniversary of the Paperless Lab Academy. So, the first question as we look back 10 years is: “how would you see the lab of today in 10 years? How much has it evolved?”

“That's a really good question, and while I was preparing this interview, I was thinking hard about what has really changed in laboratories within 10 years.

There have been many, many digitisation initiatives. There have been many lighthouse projects where you could see visions of the lab of the future with AI or AR.

Unfortunately, in my opinion, it has not yet really arrived in the everyday work at the bench. If you look at the processes in the lab, there are still too many media breaks. Simple things like weighing procedures are still very manual and involve too many steps, like typing in the weight that you read on the display. The USB stick that comes from a chromatograph that you plug into your notebook and then create the report or copy the data back and forth.

But there are also a number of really nice new software products that have come onto the market in the last 10 years. The ELN, which has evolved from the classic electronic lab notebook to real applications with better usability for end users. We are now seeing sample management applications and ELN developed with better usability in mind.

As you go further into the office connected to the lab, where you do your evaluations and reports in a computer, digitalisation has not really reached the lab technicians yet.”

What do you think the reason for this gap is?

“I think the problem is not an easy one to solve. When you are sitting at the bench, you just do not have enough hands free, nor really space for IT infrastructure. Keyboard and mouse are not really suitable when you have to wear gloves and concentrate on your experiment. From a user experience and pure working point of view, it's just 10,000 times easier to write everything down on a piece of paper and after two hours of work go to PC and type it in again.”

So, in your opinion even if the industry offers newer solutions, there is still a gap from a technological point of view to make it easier for the lab technician, is that right? What is still missing to make the solutions more suitable for benchwork?

“I think that most of the software solutions available do not make it easy for laboratory technicians. There are a few examples of very modern LIMS or ELN systems, but they are still not designed for them. They are designed from a lab manager's point of view for today's office applications. The solution really needs to be thought through from the point of view of the users, the chemists, the QC staff, and the technicians.

On the other hand, users are reluctant to change, and digitisation projects have an acceptance problem in the lab. When you are used to doing things a certain way, you are also used to taking some shortcuts that are most convenient for you. If someone tries to force you to work in a different way, you probably will not accept it.

This is also one of the reasons why we are planning this workshop around the topic of OCM, Organisation Change Management. I believe that this topic has been ignored too much or it has not been given enough attention to it in the last 20 years. Paperless projects or projects to digitise labs were driven by technology and not by users. Only recently there has been a change and many discussions about the impact on people and the need to include this topic in your digital transformation project have started.”

We have talked about change management again and again in every edition of the Paperless Lab Academy® in the last 10 years, but it seems to remain a hot topic.
So, in summary, if I listen to you, on the one hand there is a need for a better user experience with the software systems, and on the other hand there is the need for the organisation to consider change management as a priority into their digital projects.

"So, I would say it's the combination of the two. It goes hand in hand. If you have a system that is really difficult and inflexible to use, you will also not be able to do proper change management to convince users to accept the change. SAP is a classic example of a super stable system and probably with very high consistency and data quality. But usability is extremely difficult. In those cases, with a not so intuitive user interface and a poor experience, people start using shortcuts and keeping their own Excel list of document numbers.

Instead of entering them into the system, numerous Excel files are created in parallel to support the interface with the system. The closer you get to the bench where you work with the chemicals, the more of such workarounds there are. Even with a good OCM, it is still difficult when, on the other hand, people use smartphones every day because they see the great benefit in it.

In fact, we are now seeing very strong competition, higher demand for user interface improvement for laboratory information providers. Everyone has a smartphone and uses it from morning to night for different purposes. We pick an app, install it, log in and configure it the way we like it. If we do not like it, we just delete it and find another one. Then you come to work, and you face some challenges to work digitally smoothly in the lab. Is there a particular technology or concept that you think has been crucial in the last 10 years?

“The cloud. The Cloud is now definitely accepted, even for validated, regulated environments. We have moved many validated chromatic data systems into the cloud today, and it is no longer a discussion. 10 years ago, any move to the cloud would have been a big discussion; today it is almost a commodity.

The principles of FAIR, in general, there is now a new mindset that data needs to be fair to be useful in the future. There are many aspects that need to be taken into account to become truly fair. There are many projects going on in big pharmaceutical companies. Wega is involved in many projects about Data Verification for the implementation of fair concepts.”

 

How do you see the next 10 years in the laboratories?

“I think that digitalisation will really move closer to the working level of scientists, chemists, or laboratory technicians. Of course, fair and communication standards like SILA, devices with speech recognition will be important components. You see more and more vendors moving towards how they can really add value.

Imagine if the work of scientists was automatically documented, creating a lot of contextual data that could be used by data scientists for more business intelligence, for better cross-links between clinical trials and research.

Then real value is created when you start combining all the information from the beginning where the data is generated, where your source of knowledge is.”

Daniel Juchli, Head of Lab & Research Informatics at Wega: can you tell us a bit more about you?

“I am a chemist. I have always been curious and fascinated by everything to do with technology, mechanics, electronics, computers and so on. But I decided to study chemistry because of a very fascinating teacher. But soon I realised that bench was not my thing and I started to specialise in technical and computational chemistry. I did a master’s specialising in computational chemistry, molecular modelling and computer-aided design. As a software developer for laboratory equipment, I developed software to control spectroscopy workflows. That was 20 years ago when we first introduced electronic records, electronic data, and electronic signatures in the field of spectroscopy, where you generate a lot of quality control data

At some point, I started thinking about what I was going to do next. That was the birth of Wega. At that time, we were 20 employees. I just came back from a social event, we were 170”

And now, to close off, about Wega Informatiks: what are the services they offer to the market?

“We build a bridge between life science business and informatics, for any informatics solutions you need to drive your life science business. We provide strategic advice on the implementation of bespoke software solutions: from vendor evaluation, tendering and product selection to implementation and, of course, management of organisational change management along the line. We have 3 pillars of expertise: Informatics, Life Sciences and Regulated Environments. We currently have a team of 35 experienced CSV consultants who are knowledgeable from high-level strategy to hands-on work, as they are involved in the project from start to finish.”

So, is it correct to conclude that this year you are coming to the Paperless Lab Academy® with a very pragmatic workshop about best the way to approach a digitalization project?

“Yes, it is really all about what we have mentioned so far. The workshop is also about sharing experiences. How have projects been carried out successfully? Why did other projects fail? It is really about that. It is about focusing on the neglected aspects”

Thank you, Daniel, for the insightful time we spent with you in this interview. We look forward to meeting you in April at the 10th edition of the Paperless Lab Academy ^® and diving deep into change management and digitalisation projects with you and your colleagues at Wega Informatik.

 

Isabel Munoz Willery, owner and organiser of Paperless Lab Academy ^®