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.
With 20 years’ experience in the Biotech and Life Sciences industry, Micah Rimer’s success has been primarily due to his ability to read organisations, frame the problems and identify the best path to bring people together to achieve the desired goals. During Micah’s time working in Biotech and at big pharma he has successfully deployed consultancy groups within lab informatics and clinical projects.
Scimcon has supported Micah and his teams extensively on high profile projects in big pharma and Biotech. In this blog, Micah draws on his valuable experience to provide insight and tips on how to best to engage and work with consultancy groups.
Deciding on the right Informatics Consultant for your pharma or Biotech company is not a simple task, despite the various vendors available. Informatics in the Life Sciences industry covers a wide scope, so it is unlikely you will find an appropriate consultant through Google’s search algorithms. To find the best fit, you should consider what the key priorities are for your engagement, find a partner that you can trust and work well with and one that can bring a unique perspective to your collaboration.
Starting out with the key skills and contributions that are needed, as in any selection process, is the first step in identifying the right Informatics Consultant.
While technology is constantly advancing, I would encourage you to think hard if the tech skills are really the most important aspect for a successful collaboration. From my experience, while an understanding of the underlying technology and what it is capable of is important (be that LIMS, ELN, eCOA, eDiaries, PV software etc), what is of more importance is someone who can both communicate and partner with the organisation. A successful computerised system consists not just of the software, but also the people that will use it and the processes they will follow. All of those components must be balanced for a successful implementation, so while the technology piece may feel like the most obvious area to address, do not underestimate the work with the people and processes.
For example, there was a point in my career where I was asked to implement a Pharmacovigilance (PV) signal detection system for an organisation I was employed by. This had been a critical gap in the organisation for a long period of time, and there were several options on how to proceed, but no easily defined right answer. We could look to either evaluate and buy something off the shelf, hire a company to build a custom-designed tool, or alternately we could try to finalise a prototype that a programmer in the department had been playing around with for a while. (His tool had nice features, but still some technical gaps and no clear path forward to make it robust enough to use in such a highly regulated environment). In looking for external help, some may have favoured looking to recruit Informatics Consultants with a background in Pharmacovigilance, or perhaps with the technology skills to leverage the drug safety system platform. But in choosing Scimcon, I went with the partner I trusted to help evaluate the options and lead a successful implementation in that particular organisation. A fantastic off-the-shelf tool would never have been a success if people did not want to use it because they preferred the home grown highly customized (but invalidated) prototype.
With Scimcon on board, we were able to evaluate the pharma and drug safety landscape and determined that there could be a good path forward with the prototype that had already been developed. We were able to establish an effective team, drawing upon the Pharmacovigilance expertise in the department to address business process and usage questions. The programmer who built the prototype had the vision for how the software should work and what needed to be done from a technical perspective. Scimcon was able provide the knowledge and experience of how to move a prototype to a production system and validate a custom-defined tool that had been built by a programmer who does not have expertise in documentation. The output was widely recognised as a huge success.
It is important to keep in mind what gaps you are trying to close and what capabilities are needed to fill them: – Maybe you need the knowhow to get a project completed in a challenging environment; the technical skills to do the programming; the expertise with documentation; or you need to access people who have exceptional attention to detail to make sure a system is appropriately qualified and works as intended.
Whatever your challenge, you should ensure that the skillsets available from your informatics consultancy match the challenges you are facing.
As with many relationships, the more time you work together, the more trust you build up. This just proves that the importance of having established relationships and ways of working cannot be understated. No one is perfect, but the devil you know may indeed be a better fit than someone new to you. Always think about building up relationships for the future; it is a small world.
With this in mind, when looking for life science Informatics Consultants to partner with, one key consideration is to determine how they will be able to deal with adversity. What are they prepared to do if they see that a project is starting to go sideways? When speaking with them, ask them about projects that did not go according to plan or did not work out, and how did they manage that situation? What did they learn from that? Do they do anything differently from those lessons learned? Consultants, and Informatics Consultants especially, have all been thrown into projects where the requirements and expectations were not appropriately set in the beginning, which lead to problems later. Good consultants always learn from these situations and avoid repeating the mistakes that led them down that path.
Another key consideration for the interviewing and recruitment process is the quality of the questions the consultants ask and how well they listen.
Before you speak with them, think about what questions you would ask if you were in their shoes, and not having access to all the internal information you have: – Do they ask the right questions? Maybe they ask some questions you had not thought of? And how well are they able to play back what you have told them?
Often sales or account managers are very focused on telling you how easy it is for their teams to deliver, and how they will be able to deliver no matter what restrictions and conditions you add into the situation. Are there any conditions of the setup that would prevent the consultants from accepting the assignment? If there is nothing you can state that would cause them to be concerned, then maybe they are too good to be true! Look for their understanding that implementing systems is not usually a walk in the park. A truthful consultant is extraordinarily valuable.
Of course, it is always good to check the references as well. Does the life science informatics consultant have customers that have worked with them over a long period of time at different companies?
Bringing in consultants is typically not so easy, so numerous long-term engagements at different stops can itself also be a sign of delivering quality.
You should also look for feedback on the work the consultants delivered. There is a huge business out there for the larger agencies which spend time and resources selling at the executive level, but then use more junior resources to do the work. Having senior people presenting and being able to provide a concise message is important, but by and large you typically want to find people who are getting the work done. You must never lose sight of the goals to deliver projects on time and the overall drive for results.
Consider all of these aspects and listen to your instincts. Typically, these are not small or unimportant investments in the first place. Taking time to ensure you have the right fit is important. At the end of the day, you need to feel comfortable and confident that the people you choose can be counted on to deliver for you.
To me, one of the most valuable skills I look for with Informatics Consultants is the ability to bring a unique perspective. In a management training course I once took, the advisor summed it up this way: “Look, you are all smart people. If you come to a situation where you do not see a solution, it is probably because there is not just one solution. When you arrive at a situation like that you will have to find some way to balance and continually adjust, as there is likely no one right answer.” When I am bringing people in to support me on projects, I am looking for that ability to connect the dots and leverage previous experiences to help find the best solution.
One of the valuable parts of working as a consultant is that you get to see a variety of companies, all with different setups. While some people find that lifestyle stressful or challenging, there is an inherent value in being exposed to so many alternative organisational environments. If you can synthesize new information and learn rapidly, all these experiences add up to quite some knowledge. The more you can see things repeated with modified parameters, the easier you can find what works and what does not work, which is why we look to simulations to find some solutions. Informatics Consultants that have worked in different Biotech and big pharma settings with a wide exposure to different projects can help bring that knowledge to your organisation.
Finding consultants who have worked in various parts of life sciences or in other fields can also help to provide a more well-rounded view. At times, that enables seeing solutions in places you might not expect. They can also recognise patterns in the organisation you may be too close to see. The combination of being able to share these insights, as well having seen so many challenges and varying situations, can allow consultants to provide services to you that you simply are not able to manage internally.
Finding the right Informatics Consultant for your life sciences organisation is not an easy task; you need to make sure that you are bringing in the right skillset to match your situation.
The priority is to find people you can trust and who you feel confident can work in your environment. While the technology of course plays a role, do not overstate the importance of it and dismiss the (not insignificant) people and the processes aspect to our work. The system in itself will not be considered successful if people are not comfortably using it. Look for companies that can adjust to your needs and find solutions to your challenges as the landscape continues to change. In the end, that is what counts, finding a way to get the job done.
Scimcon is proud to offer its consultancy services to Biotech and big pharma companies around the world. To find out how we can help you achieve success in your implementation project, contact us.