Our latest industry leader interview is with Pascale Charbonnel, who tells us about how SCTbio supports customers through the cell therapy manufacturing chain.
In this instalment of our industry leader series, we speak to Pascale Charbonnel, Chief Business Officer of SCTbio. Pascale tells us about the work of SCTbio, how they collaborate with biotech developers, and why they are a great choice for outsourcing cell and gene therapy (CGT) manufacture.
SCTbio is a cell-based therapy and viral vector contract development and manufacturing organisation (CDMO). Originally part of the SOTIO group, we spun out in 2022 and operate a Good Manufacturing Practice (GMP) facility in Prague, Czech Republic. Recently, eureKING, a French special purpose acquisition company, or SPAC, has signed an agreement to purchase full ownership interest in SCTbio, which will further bolster our position as a leading CDMO service provider.
As part of SOTIO group, we were developing our own cell and gene therapies for 13 years, so we have a lot of experience in manufacturing for clinical trials from phase I to phase III across multiple geographies. Given this expertise, customers trust us to guide them through the development process as they navigate the GMP world and clinical development.
Our target customers are mainly early-stage biotechnology companies, who typically outsource all their production needs. We are sometimes also used as an additional facility to absorb around 20-30% of the production needs for large Ph II / Ph III phases. Our main goal is to establish trust with customers right from the beginning, so we can then support them as the project progresses through later clinical phases. The average customer project takes about two years.
With our history in SOTIO, we can ensure GMP compliance for the full drug development life cycle as we have also faced some of those same hurdles associated with developing therapeutics. Our team understands the importance of saving time and costs, and maintaining momentum to ensure approvals run smoothly and that we can move onto the next clinical stage. We use this experience to create optimised development plans, which give customers the assurance that we can support them and hopefully go on this journey with them for many years to come.
We are still very much in a mixed model – so we have turned to electronic systems in some cases, but we do still have paper-based approaches too. It’s useful to have both, as it means we can tailor our approach depending on customer requirements. We’ve built our own data management system, which has been developed specifically to fit our operation here – so while there is scope for us to move to a full digital system, it will take time and our customers’ current requirements do not warrant that.
When it comes to customer data, we typically start by storing the raw data in a validated platform which we can then manage regularly. We then export it to the customer in whatever format they wish. As each customer’s requirements differ greatly, there’s no need for us to move to full digital systems yet, but it’s definitely something we’re bearing in mind for the future.
Since last year, we’ve run four audits – three by customers, one by a regulatory body. They all follow a similar process, where we will receive a request or announcement about two weeks in advance that an auditor is going to visit, and they usually request specific documentation which of course we already have to hand. During the day they will look at everything in our facility, speak to some of our technical staff, and then make a report outlining any observations.
GMP culture is very deeply rooted in our company, to the point where our recent regulatory audit returned no observations at all! While this shows everything was as expected, our customers were particularly impressed. One of our customers came back to us following their audit to say that they can see we go above and beyond the standard for GMP, and that our team is clearly well organised and collaborative.
One thing I think really makes us special is our people. We are a team of about 80 people, many of whom have been with us since the inception of SOTIO, and the staff turnover rate is very low indeed. It gives our customers a great deal of assurance that as well as having far-reaching experience in developing drugs and a deeply rooted GMP culture, our people are committed to our customers and get to know them and their needs.
What set us apart is our 13 years expertise in the CGT field and our flexibility to accommodate different sizes/stage of projects. We plan to stay very flexible, so that we can continue to take a bespoke approach to supporting our customers.
In addition, we offer a really wide range of services. We can collect the starting material, process it in our facility, release it under quality assurance / qualified person (QP/QA) and GMP conditions, and we have a logistical advantage as we’re based in central Europe, so close to a number of key markets. Being able to offer a full start-to-finish process in one place is quite unusual, so it gives us a strong advantage.
The recipe for success as a CDMO in my eyes is to have mutual trust and transparent communication with partners and customers, so with highly skilled people and low turnover, as well as the cost benefits of our location, our customers rely on us for consistency, reliability, and quality.
The market has faced many challenges over the last few years, but we’re now starting to see an upturn. Funding is becoming available again, and we believe that ‘the good science’ will prevail. We’re excited to see what projects will come our way and to keep supporting customers to develop life-changing medicines.
Scimcon is proud to showcase CDMOs like SCTbio, and we’re looking forward to seeing how the company will grow over the coming years. To contribute to our industry leader blog series, or to find out more about how Scimcon supports organisation with lab informatics and data management solutions, contact us today.
The SmartLab Exchange Europe 2023, whichtook place from 22-23 February in Amsterdam, Netherlands, is one of the global meetings for lab informatics leaders. Scimcon continues its proud sponsorship of this event, as well as this month’s North American event in San Diego on 22-23 March, facilitating one-to-one meetings with a number of informatics customers from all major lab-centric sectors. The continued sponsorship of the event provides access to the community of senior R&D, Quality Assurance and Quality Control decision-makers from industry in both North America and Europe.
Attending from Scimcon was co-founder and lead consultant, Geoff Parker, who took the opportunity to poll attendees and delegates of the attending organisations, to identify the current 2023 trends in the lab informatics industry. This includes R&D executives, Quality Assurance and Control leaders, and Regulatory specialists from organisations such as GSK, P&G, AstraZeneca, BioNTech, and more.
In the informal poll of attendees at SmartLab Exchange, Scimcon has been able to identify key trends and themes that are important to the modern lab in 2023.
Of the total 73 delegates polled, 68 delegates – with budgets ranging between 500k to millions in GBP – volunteered which technologies they are interested in investing in within the coming 12 months.
Some of the key investment priorities included:
When asked about additional investment priorities, 7 delegates stated that the following areas were also of interest this coming year:
Attendees also ranked their interests and what topics they wanted to address at SmartLab. As illustrated, lab automation, and AI/ML in particular, are high priorities for lab leaders in 2023, with other high priority areas including data quality and integrity, instrument connectivity and IoT, and data integration.
This year’s event also saw the Scimcon team hosting the opening panel discussion, ‘What is the future for human scientists as AI and ML deliver the promised step change in laboratory practice?’, where key opinion leaders were invited to participate in the discussion to kick off the event. Panellists at the European conference were Edith Gardenier from Genmab, and Andy Phillips and Robin Brouwer from AstraZeneca.
Geoff summarises “As lab informatics consultants with a global customer base in leading lab centric organisations, it is important to us to check in frequently with influential decision-makers from the lab. SmartLab Exchange offers us a useful ability to poll the attendees and see trends that will impact the modern lab decision-maker, and will help us at Scimcon to hone the way we partner with our customers. The attendees we spoke to were split between R&D and QA/QC – with 43% in R&D, 24% in Quality, and 16% in both. We very much look forward to catching up with delegates at the US event in March, and it will be interesting to see how trends and priorities differ or align between the US and Europe.”
SmartLab Exchange is attended by invite-only decision-makers. The unique invite-only format of the event means that both sponsors, speakers and delegates can access a closed community that meets their individual needs.
Scimcon is proud to continue its sponsorship of the SmartLab Exchange Europe and US events in 2023, and the team is excited to connect with delegates at the US event on 22-23rd March 2023.
To learn more about how Scimcon supports science centric organisations with data solutions and lab digitalisation, or to organise a meeting at the US event, contact us today.
To catch up on the themes discussed in our EU panel discussion, you can read our blog here.
The countdown to SmartLab Exchange US is on, and we will be officially sponsoring the event and taking part in an insightful panel discussion on Wednesday 22nd March 2023. After our success at SmartLab Exchange EU this year, we are delighted to be travelling to San Diego for the US summit from 22nd to the 23rd March 2023. Here, we will explore what the two-day event will involve.
Our co-founder Geoff Parker, will be leading the opening panel discussion on how artificial intelligence (AI) and machine learning (ML) is will affect the flesh and blood scientists of the future. A cohort of industry leaders will join our lead consultant, including Robert Pluim from Genmab, Miu-Ling Lau from Merck, and Scott Stanley from the University of Kentucky.
The conference in San Diego, North America takes place annually and provides leading experts in the lab informatics field with the opportunity to build connections and take part in thought-leadership discussions. As the event is invite-only, this means that attendees share the same mindset, enabling attendees to connect with the right people and extract the most value out of interactions.
After a short welcome and opening address from NASA data scientist, Timothy Darrah, the panel on ‘What Is The Future For Human Scientists As AI & ML Deliver the Promised Step Change in Laboratory Practice?’, will commence at 8.40am on Wednesday 22nd March 2023. As a panel chair at the event, Geoff will be leading the discussion with key opinion leaders across the lab informatics space, facilitating the discussion among US delegates on what the future benefits may hold for human scientists as AI and ML come to the fore. From 10am onwards, there will be an opportunity for one-to-one business meetings, as well as peer-to-peer networking for delegates and attendees to form new and lasting connections with other industry experts.
At Scimcon, we find real value in attending conferences and tradeshows on a global scale, to meet with informatics industry experts: particularly as SmartLab Exchange US provides us with a platform to debate themes such as: Lab of the Future, Data, Digitalisation, Quality Management and Standardisation, AI and ML, and more. Throughout the event, you can expect to receive expert advice on laboratory digitalisation through automation, cutting-edge informatics tools and technologies that will become part of our daily lab life.
Scimcon’s unique hands-on experience in the lab makes us a trusted partner for many of our clients, as knowing the science as well as the systems is at the heart of what we do. If you’re someone that benefits from face-to-face interactions and networking, come along to the US summit and organise a meeting to find out more about how we can support your informatics endeavours.
Can’t make it to SmartLab Exchange US? Then look out for our upcoming blog that will detail the next event Scimcon is attending…
To organise a meeting with our team at the event, or to learn more about how Scimcon can support your digital lab transformation, contact us today.Scimcon leads SmartLab Exchange panel session ‘What is the future for human scientists as AI and ML deliver the promised step change in laboratory practice?’?
In February and March 2023, Scimcon is hosting panel discussions at both SmartLab Exchange Europe and SmartLab Exchange US. The events, taking place in Amsterdam, The Netherlands and San Diego, North America take place on an annual basis as a forum for scientists in the modern lab to interact, form new connections, and learn more about the evolving technology that is disrupting the lab. Attendees and speakers will debate themes including: Lab of the Future, Data, Digitalisation, Quality Management and Standardisation during the conferences.
As a sponsor and panel chair in 2023, Scimcon’s opening panel discussion ‘What Is The Future For Human Scientists as AI & ML Deliver the Promised Step Change in Laboratory Practice?’ explored the future of human input in the lab, and how artificial intelligence (AI) and machine learning (ML) could impact the structures and processes in place.
Following introductions by Birthe Nielsen of the Pistoia Alliance, the session discussions will be led by Geoff Parker, co-founder of Scimcon. The panel discussion in Amsterdam took place on Wednesday 22nd February 2023, and featured key opinion leaders on the panel including, Edith Gardenier from Genmab, and Andy Phillips and Robin Brouwer from AstraZeneca. The San Diego panel is scheduled for Wednesday 22nd March 2023, and panel participants include Robert Pluim from Genmab, Miu-Ling Lau from Merck, and Scott Stanley from the University of Kentucky.
AI and ML are everywhere we look – in the news, on our phones and other smart devices, and are increasingly making their way into other areas of our daily lives. In transport, we’re seeing steps being made towards self-driving vehicles. But what will happen to those engaged with the transport sector when human input is no longer required?
The same questions can be asked about the lab. We have seen similar disruptions in the past, and many scientists will still remember the days of cutting out chromatograms to weigh them and calculate peak areas – a task which now is fully automated. Through the employment of similar automated technologies – from sample prep, to HTS, and sophisticated instrumentation – we have been able to give more time back to scientists, to allow them to spend longer on the science that matters.
Our panel at SmartLab Exchange Europe and US will dig deeper into AI and ML, and how it will impact the role played by human scientists in years to come.
The panellists will debate the big questions facing scientists on the topics of AI and ML during the sessions, including:
Following the SmartLab Exchange, Scimcon will summarize topics of key interest to the audiences in a future blog.
To join the discussion and hear more how AI/ML will impact laboratories and scientific operations, contact our team for more information.Scimcon commits to Blood Cancer UK charity?
Scimcon, the decades-strong leader in scientific informatics for the lab, has announced in 2021 that it has made a company-wide commitment to support Blood Cancer UK. After years of ad hoc charitable donations, Scimcon has decided that from 2021 the company will support one charity, and going forward all its charitable donations will be related to fundraising in the cause of Blood Cancer UK.
Geoff Parker, our co-founder explains: “When we really thought about it, it makes sense to ensure that the entire company aligns behind one cause. A company’s charitable contributions are not insignificant over time, and that’s why we are determined that every dollar and penny of our charitable contributions going forward will all be donated to our charity of choice. This means that every member of staff in Scimcon understands that from this year, without fail, we will all support this charity.”
Blood Cancer UK is a community dedicated to beating blood cancer. They do this by funding research and supporting those affected. Since 1960, the charity has invested over £500 million in blood cancer research, transforming treatments and saving lives. Right now, the Blood Cancer UK community is funding 167 researchers and staff across the UK who are searching for the next breakthrough. The day we will beat blood cancer is now in sight, and the charity’s researchers are determined to finish the job.
The charity also campaigns for change, helping to make sure that people get the healthcare they deserve, and that new treatments that come from research breakthroughs are available on the NHS.
Geoff adds, “As scientists working with scientific companies, Scimcon is committed to investment in science – it is our lifeblood. The fact that Blood Cancer UK is funding lifesaving research appeals to our ethos as a business. You only have to read the most recent annual report from the charity to learn what their money is spent on: Survival rates have improved dramatically over the last few decades, and even over the last 10 years we have seen blood cancer survival rates increase faster than survival rates for other cancers.”
In 2020, investing in life-saving research remained at the heart of their work, with the announcement of £6.5 million of new research funding. This money was spread across 15 projects, supporting the work of 169 researchers at 30 research institutions. This included a series of projects focused on acute myeloid leukaemia, which has one of the poorest outcomes. The researchers will identify better treatment targets, test the potential for repurposing existing drugs, and develop new ways to predict which patients will respond to current treatments.
They are also funding research that will look at how a key gene drives cancer development in children with Down’s Syndrome. Two Lymphoma teams will look at the role of the Epstein Barr Virus in the development of lymphomas, focusing on lymphomas and other blood cancers that develop as a result of treatment in people who have had an organ transplant. Blood Cancer UK also funded new research in myeloma, that will look at how myeloma develops and how patients respond to immunotherapies.
Thanks to previously funded research, there were 117 papers published in scientific journals during 2019/20. These papers covered a wide range of science, from laboratory research to clinical trials, and covered the full range of blood cancers. Geoff explains “In our small way, Scimcon might be working with companies who contribute to this mammoth effort. Our customers in laboratories worldwide are part of this great community, and Scimcon believes that money is only part of the effort to save lives. We are proud to be associated with Blood Cancer UK as our charity of choice.”
To learn more about the life-saving work Blood Cancer UK does, visit www.bloodcancer.org.ukScimcon goes carbon neutral?
Scimcon is proud to announce that it has been certified by Carbon Neutral Britain as a carbon neutral business in 2021. We were originally founded in 2000, and in the 20 years since have committed to our global strategy and decided that the next step was to commit to our sustainable future as a business. As such, Scimcon committed to becoming carbon neutral and received the certification in 2021 from Carbon Neutral Britain (www.carbonneutralbritain.org)
Geoff Parker, co-founder at Scimcon explains:
“Scimcon like many businesses operates more globally than locally. Our customer base consists of diverse range of lab centric organisations including large pharma and biopharma companies, wherever they are located, and our service provision often is in their laboratories on site. We have therefore become increasingly conscious of our sustainable future and our carbon footprint, and during 2020 and 2021, we decided to review our carbon footprint and commit to how the business operates in future. Once we engaged with Carbon Neutral Britain, the certification process became a priority.”
Many global procurement companies are focused on the sustainable supply chain, so the ability of Scimcon to demonstrate its carbon neutral status is an important business decision for the future. Carbon Neutral Britain estimates that companies who adopt a carbon neutral footprint lead their industries in terms of climate impact. In 2016, 92% of Fortune 500 and FTSE 100 companies followed the GHG Protocol or ISO 14064 Standard for their Carbon Emissions Calculation. The certification is therefore a demonstrable achievement for the customers of Scimcon to audit it as part of their sustainable supply chain, and is part of Scimcon’s investment in the future of the business, its customers and the environment.
Scimcon achieved its carbon neutral certification by the three steps to carbon neutrality identified by Carbon Neutral Britain:
“Our role in our customers’ supply chain is important: Scimcon is part of the workflow that enables our customers to operate seamlessly with high-performing laboratory informatics strategies. We therefore are aware of the importance of our role in investing in the future supply chain for those companies. We are accustomed to supporting their audits and to being audited ourselves, and the Carbon Neutral certification is a vital part of that process. We are proud that Scimcon has become a carbon neutral business in 2021.
Scimcon has been on quite a journey since its founding in 2000. Our co-founder Geoff Parker recently spoke with John Storton at Yellow Spider Media for its Business Spotlight podcast, where he discussed Scimcon’s experience in informatics projects over the last 21 years, how implementation projects have changed, and trends in digital lab transformation.
You can listen to the discussion below.
From trends and challenges in the informatics space, to data decoupling, and the impact of COVID-19 on digital transformation projects, Geoff’s conversation with Rizwan and Dave draws on years of experience in informatics consulting and helping scientists to transform their workspace and operations.
Watch the full conversation here:
Ajit, please introduce yourself.
My career history is uncomplicated because straight out of college I started working for myself, and it has been that way for my entire career. I graduated in the US with a background in computing science and I decided I did not want to take the traditional path of finding a job and building a career that way. I always liked to be doing things differently. Coming out of college with very little money and a limited skillset, the reasonable thing to do was to get into software consulting because that did not require a whole lot of capital. Since then, I have founded four companies in the life science sector.
What led you to the science industry?
I ended up in the pharma and life science industry very early on by chance. After I graduated, I was in Boston with database and computing skills, and I started a small consulting company called Megaware. I found out there was a large life science vendor in Massachusetts which had some opportunities around a new life science product they were building. After a lot of persistence, the CIO reluctantly gave me 15 minutes to speak with him. I told him about my background and what I was attempting to do – he said they didn’t have anything for me within his organisation, but he would connect me to his counterpart at their analytical instrument division. I then got a contract to help this analytical instrument company build a part of their (then) new product, the first database driven instrument software, and that was my entry into the pharma world. That seems simple, but it was fortuitous and persistence more than anything else.
Can you give us a potted history of each of your companies?
My first company was Megaware. Back in those days labs were making the transition from VAX.VMS-based systems to PC-based systems. Enterprises had huge investments in VAX.VMS systems and in HP printers. We produced a product to be able to print from a VAX.VMS system onto a HP printer. It seems straightforward (but it was not!) because you are printing to a Windows-based printer but from a non-Windows system. We built a whole system to rectify this issue. I ran and built Megaware for 4 – 5 years and it was then sold to a boutique consulting company.
NuGenesis was my second company. We identified the issue that labs had several different instruments, from different vendors, but they did not talk to each other. You had large pharma companies, printing reams of paper, spending $millions of dollars on running labs across the globe and eventually all of that intellectual property ended up on paper! In those times when they submitted a new drug application, those applications were on tens of hundreds of pieces of paper which were carried to the regulatory agencies on trucks for review! It made no sense that something started out electronically and ended up on paper to be read by somebody manually. We were able to intercept print streams and capture a lot of information to make the data live. It is remarkable that 20 years later it is still being used – that says a lot about the value and sustainability of NuGenesis. I sold the business to Waters in 2004.
After I sold NuGenesis I was clear I wanted to stay in life sciences but do something different. I went back to many of my clients and ask what problems they are facing – that is when I landed into outsourcing in the area of drug safety, clinical and regulatory.
What was new and different was an area called pharmacovigilance. If you recall, there were a couple of landmark cases related to drugs in the market that had caused deaths. That is when the regulatory agencies realised they do not have a handle around adverse events. They approve drugs, they come to market and years later you start seeing adverse reactions that you did not see during the trial period. The regulatory agencies started mandating reporting of all adverse effects. With the visibility and potential liability, the biopharma industry sprang into action and the flood gates opened to drug safety outsourcing. This was when we launched Sciformix – a scientific knowledge-based outsourcing provider for the life science industry. Any given year when we got to the maturity stage we were doing around 1 million cases. We did everything from cancer drugs to consumer products, from cancer medication to sunscreen lotion. Our success at Sciformix was due to our ability to combine enough science and a very good process. Again, the company grew very rapidly to over 1300-1400 people globally, and it came to a point where it felt like the time was right to divest in 2018. Sciformix was acquired by LabCorp/Covance, a top three CRO (and currently a leader in COVID19 diagnostic testing).
What was the motivation behind the launch of Scitara?
Having done tech, services and global delivery, I thought I should combine these skills and focus on my finale!
Our core team believes Scitara is more than just a business, it is a goal of ours to solve a major problem that still exists in the scientific laboratory: data connectivity. We are pioneering a new digital revolution when it comes to lab data connectivity. We have invented a platform called Scitara DLX (data lab exchange), and our goal with this platform is to connect your instrument, application, or anything else you use in the lab to our platform and we guarantee they can talk to each other.
Our goal is that science labs can log into any system that they are currently using and can access data from any other system that is in the lab. We have a mantra of ‘no application or instrument left behind’. For us to achieve this goal we need cooperation from the industry, which is why I am calling this a finale. It will require all our connections we have made over the years and the reputation we have built to reach out to everyone in the ecosystem. Companies are making significant headway in their digital transformation initiatives, except they do not know how to get their lab data onto their digital platforms, and that is where we come in.
How did you find your entrepreneurial drive?
I am very driven to be independent. I am useless when it comes to working for someone else and fortunately, I have never had to. My personality drives me to try new things and dive into uncertainty and this has always pushed me into something completely new.
The building of my companies motivated me. What excites me is the building from the ground up. Each time the building is easier, but the expectations are higher. I do not build to divest – I build to create value, disrupt, and hopefully deliver a meaningful impact, and the rest takes care of itself.
If anyone comes to me for advice or mentoring, I ask them why? Why do you want to do it? Why you? What is the motivation? That tells a lot very early on about the chances of success that a person may or may not achieve. It does not guarantee success, but if you have a good understanding of the ‘why’ it helps you go a long way. Beyond that I’d say it is important to find a mentor from the industry – people need to recognise that investments happen in teams not necessarily ideas. Do not latch onto an idea too much because things can change.
Create a loyal fanbase, people often think I have 500+ clients, but it is not the number that counts, it is whether you have a handful of loyal clients who make a lot of noise and reopen doors. That becomes exceedingly important.
What would you say makes you a successful entrepreneur?
We do not rely on big sales engines in our industry. It is about building solid connections and networks. When clients learn that I created the concept behind several successful companies, people admire that. There is no better way to connect with a client than something that they are fond of and that I am proud of.
I have learnt the hard way; you build the best partnerships in tough times. When things do not go right, it is how you react that defines not only your relationship but your career as an entrepreneur. I have sold to the same clients across multiple companies. Most of those clients I have had difficult moments with, and it has made our relationship much more resilient.
Having a non-scientific viewpoint has also really helped, particularly when it comes to products. To be able to look at the consumer world, or industrial world or finance world and understand how technology has evolved there and bring those learnings into the scientific world is invaluable.
What does the future hold for Ajit Nagral?
This is the first time after having done this for 20+ years that I have the liberty and luxury to say if this part of my journey were to end, what would be my new journey? It is the first time I have thought about it, and I think it comes with experience and the safety net I have built for me and my family. I am eternally grateful to my customer, employees and investors to put me in this position.
Hopefully Scitara is my last company, as an operating founder. There are many other things I want to do. In addition to being a tech guy I am also a musician. There are things I am doing in music production that I have started already – hopefully in a few years once I am done with Scitara, that is where I will end up!