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.
Tell us about SCTbio
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.
What kind of customers do you support, and how do you support them?
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.
How do you manage the data you generate for customers, and what formats do you report in?
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.
What does a typical audit look like, and how do you ensure success?
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.
How does SCTbio stand out as a CDMO?
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.
What do you think the future holds for cell and gene therapy?
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.
We’re kicking off 2023 with a new industry leader interview, and shining a spotlight on Jana Fischer, Co-Founder and CEO of Navignostics.
In this blog, we speak to Jana about Navignostics’ mission, and how the team plans to revolutionise personalised oncology treatments with the help of data and AI.
Tell us about Navignostics
Navignostics is a start-up personalised cancer diagnostics business based in Zurich, Switzerland. Our goal is simple – we want to revolutionise cancer treatment by identifying a highly personalized and thus optimal treatment for every patient, to ensure that each patient’s specific cancer is targeted and fought as needed. Our capabilities allow us to do this by analysing tumour material, through extracting spatial single-cell proteomics information. and using this data to analyse many proteins simultaneously in individual cells within the tissue.
What is spatial single-cell proteomics?
Single-cell proteomics comprises of measuring and identifying proteins within a single cell, whereas spatial proteomics focuses on the organisation and visualisation of these proteins within and across cells. Combining these two research tools allows the team at Navignostics to characterise tumours on a cellular level, by identifying the proteins present across cells in a tumour, and also how these proteins and cells are organised. This means that the team can provide a more accurate estimate for how certain tumours will respond to different medications and treatments.
Proteins are typically the target of cancer drugs and measuring them on a cellular level allows us to identify different types of tumour cells, as well as immune cells that are present and how the two interact. This data is highly relevant to inform clinicians of the best form of (immuno-) oncology and combinatorial treatment for individual patients. Also, this information is highly relevant to pharma companies in order to accelerate their oncology drug development, by providing insight on drug mode of action, and signatures to identify responders to novel drugs.
The kind of data that we are able to extract from different types of tumours are monumentally valuable, so the work doesn’t stop there. All of the data we harness from these tumours is stored centrally, and we plan on utilising this data by building it into a system we refer to as the Digital Tumour, that will continuously allow us to improve the recommendations we can make to our clinical and pharma partners. Our journey has been rapid, though it is built on years of research and preparation: we founded the business in 2022, as a spin-off from the Bodenmiller Lab at the University of Zurich.
The dream became a reality for us in November 2022, when we secured a seed investment of 7.5m CHF. This seed funding will allow us to pursue our initial goals of establishing the company, achieving certification for our first diagnostic product and developing our Digital Tumour. By extension, collaborating with pharma and biotech partners in oncology drug development. It has also given us the resource we need to move to our own premises. We are due to move off university campus in May 2023. This offers us great opportunity to push forward with the certification processes for our new lab, and it gives us to the chance to grow our team and expand our operation. We will be located in a start-up campus for life science organisations in the region of Zurich, so we’ll be surrounded by companies operating in a similar field and at a similar capacity.
Tell us more about the Digital Tumour – how does it work?
The Digital Tumour will be the accumulation of all the molecular data we have extracted from every tumour that we have analysed to date, and ongoing. Connected to that, we store information on the clinical parameters and patient response to treatment. Over time, our aim is to utilize this central data repository to identify new tumour signatures, and build a self-learning system that will provide fully automated treatment suggestions for new patients, based on how their molecular properties compare to previously analysed patients that have been successfully treated.
Sounds interesting – are there any challenges to working with a database of this size?
Our data storage is quite advanced, so volume isn’t really a challenge for us. Our main focus is standardising the input of data itself. The technology is based on years of research and the data analysis requires a great deal of experience and in-depth expertise. In order to extract the full value from this data, it must be completely standardised. Data integrity is therefore vital to our work, and allows us to get the maximum value from past analyses. Our past experience in the Bodenmiller Lab allowed us to develop standardised processes to ensure that all of our data is fully comparable, which means that we can learn more and more from our past data, and apply this to new cases that we analyse.
It is also important to report on our complex data in a comprehensive but easily interpretable manner to the clinician/tumour board who needs to organise a treatment plan. We’re currently working with our clinical collaborators to develop readily understandable and concise reporting outputs. Unlike genomics analysis, our reports focus on proteins in tissue, which is the same information that clinicians are used to working with. So, there is a common language there that offers us the unique opportunity to provide clinicians with data they can easily interpret and work with.
What does this kind of research and data mean for oncology, both in terms of pharmaceuticals, biologics, and healthcare?
It’s important to note that personalised treatment approaches and precision medicine are not new concepts in the diagnostics space. However, our technology and algorithms allow us to extract novel types of biomarkers which were previously inaccessible or unknown, so we’re helping to level up the playing field and give clinicians and drug developers’ comprehensive information to individualize therapies.
Comprehensive tumour data is truly at the heart of what we do, and one key benefit of our technology is that we’re able to analyse very small amounts of sample – such as fine needle biopsies – to provide therapy suggestions. We can also analyse bio banked tumour material, so if there is any old material that has been stored, we have the ability to analyse those samples retrospectively. Not only does this help us to fuel our Digital Tumour with more data, but it also allows us to examine new fields such as long-term survival rates of patients with these tumours. This is of huge value to fuel our product development pipeline because it allows us to identify different molecular properties between individuals that may not have been considered on a clinical level, but may have played a role in patient responses to treatments and survival outcomes in the long-term.
This kind of retrospective data also plays a key role in the evolution of healthcare and drug development, as having the technologies available to acquire this sort of data and mine it to our advantage will provide enormous benefits. These include improving individual treatment courses for patients, as well as expediting the development of novel cancer drugs so pharma companies can get more effective treatments to market sooner.
For example, one commonly cited statistic is that 90% of clinical drug development fails during phase I, II, III trials and drug approval. Often, this may arise from a lack of available information to identify the subset of patients most likely to benefit from a novel drug. Having access to Navignostics’ technology and algorithms and a database such as the Digital Tumour will offer the potential to pre-select the right patients to enroll in clinical trials, and more easily identify the patients that do respond to the novel treatment, which could substantially expedite the speed of drug development in the trial stage, and help bring more effective drugs to the market.
Even unsuccessful trials offer valuable opportunities: it is possible to repurpose and reanalyse material from previous failed trials. Such high rates of failure in clinical development means that there are a large number of companies that have invested $millions in developing drugs that have not come to fruition, so if companies want to re-mine their data, our team can reinterpret the existing work into identifying more successful strategies, so we can give those drugs another chance and offer a better chance of Return on Investment.
A failure no longer needs to be a failure. Navignostics and its offerings can bring value to our pharma and biotech partners, and will also bring direct benefit to patients and clinicians once we launch our diagnostics product. So, data from every facet of the oncology industry, from curing a patient to halting the development of a drug, can offer us valuable insight that both we and the Digital Tumour could learn from when developing treatments.
What does 2023 and beyond have in store for Navignostics?
The next three years will be critical for our work, and we have projected timelines and key milestones for our diagnostics developments that we will achieve until our next funding round. Along the way, we are actively speaking to biotech and pharmaceutical organisations to identify projects and build the foundation for long lasting collaborations. We are looking forward to a successful continuation of the Navignostics development in 2023!
Scimcon is proud to showcase start-up companies like Navignostics, 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.
Pets: No pets, four boys under the age of 10 is more than enough.
Favourite animal: None!
Favourite food: Mexican
Favourite film: The GodFather would be my ‘mature’ answer, but really it has to be Cars or ToyStory.
Fun fact: My wife Sarah and I are both right-handed and right-footed, but all our four sons are both left-handed and left-footed. Statistically it is millions to one against that happening.
What do you enjoy the most about working at Scimcon?
I didn’t really fit into the company I was in before, so firstly, I think to enjoy any role the people you work with are important. Realistically, I probably spend more time speaking with my colleagues than I do my own wife and kids, so having great colleagues definitely makes Scimcon enjoyable.
Secondly, the challenges within the role are exciting. Whenever you start a new contract – as we do regularly, supporting clients in pharma and biopharma – there is either an implementation project that needs carrying out, or an issue that needs resolving. Sometimes, the task at hand is not something I am directly familiar with or have the exact experience doing, but that makes it a challenge. And it’s the challenge that I enjoy.
In my prior role, we partnered with Scimcon on a number of projects. I had been involved in building a platform for our mutual client and when they needed to take the project forward, they needed someone to train, support, and project manage the implementation of the project software. It seemed a no-brainer for me to join the consultancy team at Scimcon, and to continue to support the project and the client to help them to progress. The transition into Scimcon was seamless, and I later moved from that initial project within the vaccines space onto a biotech company in the Netherlands, whom I have been supporting on e-systems.
My background helps me to bring people and team skills into play, so I am very suited to the Scimcon way of working, to support clients and to manage processes, SOPs, digital, and software projects for scientific companies. The client I am supporting currently was initially reluctant to appoint a lab informatics consultancy that was not local, and questions were raised as to whether or not we could perform the role from the UK without impacting the level of support we provide. As a test run, we were initially only working on a 3-month contract. Their processes are crucial to the business scale-up and growth, and our experience with other big pharma organisations has come into play helping them to navigate the decisions needed. I think we successfully demonstrated to them that it is feasible to be productive offering great support from the UK – so much so that the original 3-month project is now 30 months.
What do you enjoy doing in your spare time?
Every child has a hobby growing up, and of course in England, playing sports is probably one of the most popular activities. For me, football was my favourite pastime which evolved into more than just a hobby. It actually paved a pathway for all areas of my life.
What started out as a recreational game became a profession, as I left school at 16 to become a full-time football player, At 20, when my professional playing career finished, football again opened a window of opportunity to move to Southern California and coach football for 3 months. I returned 12 years later!
At 27, football again paid for my University education at Point Loma Nazarene University in San Diego, where I was sponsored via a soccer scholarship to study Business and Finance. I had never even enjoyed school, never mind imagined studying at University, but football provided a unique opportunity that was too good to refuse.
During my senior year at University, while coaching football in Denver during the summer, I was introduced to my fiancé Sarah who had also – coincidentally – attended University in the USA on a football scholarship. She was almost in a parallel to me, only she was based in Florida while I was on the total opposite side of the country in California.
Sarah and I had our first child then returned to the UK shortly after, where we now have four sons – aged 10, 7, 5, and 1. Our 10 and 7-year-olds are, like their mum and dad, football-mad, so we spend our weekends travelling to watch them play. Our 5-year-old is starting to get the bug, and we are yet to see if football is something our youngest warms to, but I can’t see the apple falling too far from the tree.
I still spend every day at some sort of football activity. Both our older boys are at the football academies so they each have 3-4 days a week training and playing. Football remains our outside-of-work life, having brought us together all those years ago.
And with the skills I learned at university, studying business and finance, as well as the team skills associated with playing sport, I am well placed to bring team leadership to the Scimcon family, and to focus on the best tactics and teams to work on a winning side.
What is your favourite travel destination?
Southern California was my home for 12 years, and having attended University in San Diego, that would be my obvious choice. We have a lot of friends and happy memories there, and we love the area – and the food!
2020/21 has been an interesting couple of years – how has it impacted you outside of work?
We made the decision to return to UK as a family when we had the boys, for the support network of close family and friends. As I have been working from home for so many years anyway, personally my life hardly changed. However, it was a terrible impact for the boys. For any young kids, that transitional age and loss of companionship has been a huge negative experience. Luckily, the boys are pretty resilient and seemed to have bounced back into the new normal without any issues.
Scimcon as a business is deeply rooted in technology – but how technology-oriented are you? What devices do you use?
Funnily enough, I am not really a techie! I use a PC and a phone, but not much else.
Does your use of technology differ outside of work?
Even though I don’t spend a great deal of time on gadgets and gizmos, I love the knowledge and benefits you can see from technology. For example, having spent so many of my formative years playing and coaching football, I am now still involved with my sons and their training and I see the technology to hand, which was never available when I was playing in the US. It’s absolutely fascinating, and there’s two pieces of tech in particular that I’m seeing used regularly at my sons’ training and matches. One is a Veo sports camera, which follows the ball and records the play, the other is an APEX GPS tag. This handy piece of kit is worn in the back of my son’s shirt when he’s playing, and all the data collected throughout the match is recorded on a smartphone, recording metrics such as speed, average position, and provides an overall performance review.
It’s amazing to see two of my previously completely separate worlds – football and technology – coming together, and it is really interesting to see how this technology is enabling football. As a coach, it also allows me to see and read the data available, so that we can then determine what is needed to improve in a game.
Scimcon is not a technology company, it is a people company that helps to solve the technology challenges for our clients, whether they be implementation, process or project-related. I am happy that I am not a techie, but very much a team and a people-person who can always learn and bring new skills to the table.
Maintaining data quality is critical in clinical trials. As a follow up to his first blog, we have worked with Industry Leader Mark Elsley to create this infographic, outlining Mark’s top tips for managing clinical trial data.
Mark Elsley is a Senior Clinical Research / Data Management Executive with 30 years’ experience working within the pharmaceutical sector worldwide for companies including IQVIA, Boehringer Ingelheim, Novo Nordisk and GSK Vaccines. His specialist area of expertise is in clinical data management, and he has published a book on this topic called A Guide to GCP for Clinical Data Management.
2020 has been a difficult year for most industries, not least for event and tradeshow providers. Luke Gibson, Founding Director of Open Pharma Research and Lab of the Future, shares his experience of running events in the laboratory industry, and what makes Lab of the Future such a unique event.
Luke, please tell us a bit more about yourself and Lab of the Future
My name is Luke Gibson, and I am one of the three founding directors of Open Pharma Research. I have 30 plus years of experience in developing and running events, primarily in the financial and trade and commodity sectors. My colleagues Kirianne Marshall and Zahid Tharia bring a similar level of experience to the company.
Kirianne has had many years of experience in managing the commercial side of large congresses, such as Partnering in Clinical Trials, and research and development congresses. Zahid has 30 years of events experience too, particularly in running life science portfolios, and launching congresses/events. Our paths have crossed many times throughout our years working in events, and we eventually hit a point where all 3 of us had the capacity to try something new – something that was worthwhile, fun, and different to the corporate worlds we had become accustomed to. So that was why we created Lab of the Future – with a view to running events in a different way.
Did you feel that there was a gap in the market for this type of event?
I’m not sure if I would describe it as a gap in the market, more an ambition to do things differently. There was a desire from all of us to build an event with a different approach to the one we would take when working for large organisations, because when you’re working on a large portfolio of global events that cover a variety of topics, you and your team are always looking ahead to the next event, and the focus on the longevity of a single event isn’t always there.
We wanted something that we can nurture and grow, something that we can work on year-round without getting distracted by the next thing on our list. It also allows us to stay within this space and build our community, without having to face pressures such as a year-on-year development strategy or diverse P&L. Our desire was to avoid these constraints, and create an event that we can continue to work on for a long time.
Are you building just the one event, or are you looking at hosting a series? Has your business plan changed since starting?
We want to be able to live and breathe Lab of the Future, but one of the interesting things about it is that it’s such a broad concept. On the one hand we deal with informatics, but on the other hand, we deal with equipment, technology, and all the connectivity between them – but even that’s just one part of it. We are not an informatics conference; we are not strictly an instrumentation conference; we also look at the innovation side of things.
I think the best way to describe how we see Lab of the Future is as a proxy for how you do science in the future. Everything pertains to more efficient processes; better results; or ways of creating breakthrough innovation, and these are all part of the picture of science in the future. And that is the lab of the future – where the lab is the proxy for the environment where you do the science that matters.
So what is the main focus for Lab of the Future?
When we started off, we found we received a lot of queries from industry contacts who wanted to get involved, but certain topics they wanted to discuss didn’t necessarily pertain to the physical laboratory itself. But if it was relevant to science, then it was relevant to us. Things like data clouds and outsourced services may not be directly linked to the lab, but they still relate to how you work. So, within that, the scope for the Lab of the Future gets wider still, looking at areas such as how we can create virtual clinical trials, or use real world-data to feed back into R&D.
People are also keen to learn more from their peers and from other areas of the industry. Lab of the Future allows us to host senior speakers and keynotes who can tell us where we’re heading, and show us how the efforts of one area within life science feed into other areas. It presents us with an almost ever-changing jigsaw image, and it’s this strategic element that I think sets us apart from other events.
Who is your main audience for Lab of the Future?
We attract a real mix of attendees, and that’s what I love about it. You can run a conference for people in a specific job function, such as a data scientist or an R&D manager, but what people really want to know is what the people around them are doing, to almost give them context of the industry as a whole. So, our conference doesn’t just exist to help you do your own job better, but it helps you to develop a concept of where your department is heading in the future, and what you should think about longer term. We aren’t telling scientists how to do their job today; we’re helping them think about their responsibilities for delivery in the future. Lab of the Future is about the delivery of science of the future.
Our sponsors and solution providers that support the conference are also very much part of our community, as they’re all innovating and making waves in this space as well. They’re in a space that’s always evolving to build the Lab of the Future; and they are part of that solution. So, we don’t merely facilitate a conference of buying and selling between providers and services, we offer a space where everyone is evolving together. It’s a real melting pot, and that’s the fun bit really.
How do you build the Lab of the Future Community?
Zahid’s background in life sciences definitely gave us a starting point. Further to that, we’ve found that every time we put something out, that our community engages, and as a consequence we’re introduced to people we never expected to be introduced to. The fact we’re always talking to people enriches our content – the people we meet and conversations we have change our way of thinking, and shape what we’re doing.
Although I’m in charge of our marketing operations, I have to say I’m not always sure where some of our contacts come from! One thing I’ve found quite surprising is the lack of reliance on a database – there’s a lot of power in word-of-mouth, especially in this space where everyone is working on something – why not share that? As we’re seen as adding value to the conversation, it allows people to find us through their connections and our supporters.
Scimcon is proud to sponsor Lab of the Future, and we can’t wait to see you at the Autumn virtual congress on 26 – 27th October 2021. Contact us today to learn more about our participation in the event, and stay tuned on our Opinion page for part 2 of our conversation with Luke.
I am Mark Elsley, a Senior Clinical Research / Data Management Executive with 30 years’ experience working within the pharmaceutical sector worldwide for companies including IQVIA, Boehringer Ingelheim, Novo Nordisk and GSK Vaccines. I am skilled in leading multi-disciplinary teams on projects through full lifecycles to conduct a breadth of clinical studies including Real World Evidence (RWE) research. My specialist area of expertise is in clinical data management, and I have published a book on this topic called “A Guide to GCP for Clinical Data Management” which is published by Brookwood Global.
Please can you explain what data quality means to you?
Data quality is a passion of mine and now receives a lot of focus from the regulators, especially since the updated requirements for source data in the latest revision of ICH-GCP. It is a concept which is often ill-understood, leading to organisations continuing to collect poor quality data whilst risking their potential rejection by the regulators.
White and Gonzalez1 created a data quality equation which I think is a really good definition: They suggested that Data Quality = Data Integrity + Data Management. Data integrity is made up of many components. In the new version of ICH-GCP it states that source data should be attributable, legible, contemporaneous, original, accurate, and complete. The Data Management part of the equation refers to the people who work with the data, the systems they use and the processes they follow. Put simply, staff working with clinical data must be qualified and trained on the systems and processes, processes must be clearly documented in SOPs and systems must be validated. Everyone working in clinical research must have a data focus… Data management is not just for data managers!
By adopting effective strategies to maximise data quality, the variability of the data are reduced. This means study teams will need to enrol fewer patients because of sufficient statistical power (which also has a knock-on impact on the cost of managing trials).2 Fewer participants also leads to quicker conclusions being drawn, which ultimately allows new therapies to reach patients sooner.
Why is data quality such an important asset in pharma?
I believe that clinical trials data are vitally important. These assets are the sole attribute that regulators use to decide whether to approve a marketing authorization application or not, which ultimately allows us to improve patient outcomes by getting new, effective drugs to market faster. For a pharmaceutical company, the success of clinical trial data can influence the stock price and hence the value of a pharmaceutical company3 by billions of dollars. On average, positive trials will lead to a 9.4% increase while negative trials contribute to a 4.5% decrease. The cost of managing clinical trials amounts to a median cost per patient of US$ 41,4134 or US$ 69 per data point (based on 599 data points per patient).5. In short, clinical data have a huge impact on the economics of the pharmaceutical industry.
Why is the prioritization of data quality so important for healthcare organizations?
Healthcare organizations generate and use immense amounts of data, and use of good study data can go on to significantly reduce healthcare costs 6, 7.Capturing, sharing, and storing vast amounts of healthcare data and transactions, as well as the expeditious processing of big data tools, have transformed the healthcare industry by improving patient outcomes while reducing costs. Data quality is not just a nice-to-have – the prioritization of high-quality data should be the emphasis for any healthcare organization.
However, when data quality is not seen as a top priority in health organizations, subsequently large negative impacts can be seen. For example, Public Health England recently reported that nearly 16,000 coronavirus cases went unreported in England. When outputs such as this are unreliable, guesswork and risk in decision making are heightened. This exemplifies that the better the data quality, the more confidence users will have in the outputs they produce, lowering risk in the outcomes, and increasing efficiency.
Data quality, where should organisations start?
ICH-GCP8 for interventional studies and GPP9 for non-interventional studies contain many requirements with respect to clinical data so a thorough understanding of those is essential. It is impossible to achieve 100% data quality so a risk-based approach will help you decide which areas to focus on. The most important data in a clinical trial are patient safety and primary end point data so the study team should consider the risks to these data in detail. For example, for adverse event data, one of the risks to consider could include the recall period of the patient if they visit the site infrequently. A patient is unlikely to have a detailed recollection of a minor event that happened a month ago. Collection of symptoms via an electronic diary could significantly decrease the risk and improve the data quality in this example. Risks should be routinely reviewed and updated as needed. By following the guidelines and adopting a risk-based approach to data collection and management, you can be sure that analysis of the key parameters of the study is robust and trust-worthy.
If you were to give just one tip for ensuring data quality in clinical trials, what would it be?
Aside from the risk-based approach which I mentioned before, another area which I feel is important is to only collect the data you need; anything more is a waste of money, and results in delays getting drugs to patients. If you over-burden sites and clinical research teams with huge volumes of data this increases the risks of mistakes. I still see many studies where data are collected but are never analysed. It is better to only collect the data you need and dedicate the time saved towards increasing the quality of that smaller dataset.
Did you know that:
Approximately 30% of data points collected in Pivotal medical device clinical trials do not support core endpoints or regulatory submissions for marketing approval.10
And only 18% of clinical trial data in cancer studies is ultimately used in peer-reviewed journal manuscripts.11
In 2016, the FDA published guidance12 for late stage/post approval studies, stating that excessive safety data collection may discourage the conduct of these types of trials by increasing the resources needed to perform them and could be a disincentive to investigator and patient participation in clinical trials.
The guidance also stated that selective safety data collection may facilitate the conduct of larger trials without compromising the integrity and the validity of trial results. It also has the potential to facilitate investigators and patients’ participation in clinical trials and help contain costs by making more-efficient use of clinical trial resources.
What is the role of technology on data quality?
Technology, such as Electronic Health Records (HER) and electronic patient reported outcomes (ePRO), drug safety systems and other digital-based emerging technologies are currently being used in many areas of healthcare. Technology such as these can increase data quality but simultaneously increase the number of factors involved. It impacts costs, involves the management of vendors and adds to the compliance burden, especially in the areas of vendor qualification, system validation, and transfer validation.
I may be biased as my job title includes the word ‘Data’ but I firmly believe that data are the most important assets in clinical research, and I have data to prove it!
Scimcon is proud to support clients around the globe with managing data at its highest quality. For more information, contact us.
3Rothenstein, Jeffrey & Tomlinson, George & Tannock, Ian & Detsky, Allan. (2011). Company Stock Prices Before and After Public Announcements Related to Oncology Drugs. Journal of the National Cancer Institute. 103. 1507-12. 10.1093/jnci/djr338.
4Moore, T. J., Heyward, J., Anderson, G., & Alexander, G. C. (2020). Variation in the estimated costs of pivotal clinical benefit trials supporting the US approval of new therapeutic agents, 2015-2017: a cross-sectional study. BMJ open, 10(6), e038863. https://doi.org/10.1136/bmjopen-2020-038863
5O’Leary E, Seow H, Julian J, Levine M, Pond GR. Data collection in cancer clinical trials: Too much of a good thing? Clin Trials. 2013 Aug;10(4):624-32. doi: 10.1177/1740774513491337. PMID: 23785066.
6Khunti K, Alsifri S, Aronson R, et al. Rates and predictors of hypoglycaemia in 27 585 people from 24 countries with insulin-treated type 1 and type 2 diabetes: the global HAT study. Diabetes Obes Metab. 2016;18(9):907-915. doi:10.1111/dom.12689
7Evans M, Moes RGJ, Pedersen KS, Gundgaard J, Pieber TR. Cost-Effectiveness of Insulin Degludec Versus Insulin Glargine U300 in the Netherlands: Evidence From a Randomised Controlled Trial. Adv Ther. 2020;37(5):2413-2426. doi:10.1007/s12325-020-01332-y
11O’Leary E, Seow H, Julian J, Levine M, Pond GR. Data collection in cancer clinical trials: Too much of a good thing? Clin Trials. 2013 Aug;10(4):624-32. doi: 10.1177/1740774513491337. PMID: 23785066.
12FDA. Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations Guidance for Industry. Feb. 2016.
Pets: A Chocolate Labrador, who eats enough for 10
Favourite animal: Red squirrel
Favourite food: Sushi
Favourite film: Forbidden Planet
Fun fact: I played Angel Gabriel in the school nativity.
What do you enjoy the most about working at Scimcon?
That’s an easy question, I love the constantly changing challenges that informatics consultancy throws up and helping customers and our own internal teams to creatively meet those challenges.
We help customers in pharma, biopharma, and clinical trials to identify and evaluate the goals and challenges ahead and use this to influence information system strategies. We assist with programme and project direction; vendor and product selection (of LIMS, SDMS, ELNs and ePRO solutions); and to drive successful software implementations.
The works is often equal parts frustrating, challenging, and exciting but as people who have been involved in this type of work will recognise, it is ultimately extremely rewarding.
What do you enjoy doing in your spare time?
I am somewhat cursed by having multiple passions to fit into my spare time. Being a keen mountain biker, avid photographer and relentless traveller does present some time-management dilemmas.
Photography is something I have been fascinated by since I was at school, and is something that I have picked up and put down intermittently since then. However, three years ago I was lucky enough to spend a week riding bikes with a professional photographer and this really inspired me to develop my skills and style. You can view some of my results of my photography journey on my portfolio site.
My addiction to mountain biking started when I moved to Scotland ten years ago, as there is some of the best riding in the world, right here. The mixture of physical demands, technical riding skills and the pure pleasure of being surrounded by forest and mountains has proved irresistible. Not that the abundance of local riding has stopped me traveling with my bike. Ten years of truly amazing riding has taken me to some of the best trails in Morocco, Nepal, USA, New Zealand, Switzerland, Norway, Iceland, and Chile! Like most people, I am looking forward to when travel once again becomes possible, then maybe I can put my planned trips to Kyrgyzstan and Bhutan into action.
What is your favourite travel destination?
I’m not sure I can pick a favourite, as it depends on the activity involved. For a chilled afternoon walk drinking coffee, I would have to say San Francisco. Relaxed attitude, wide open streets and great culture make it a hard place to beat.
For mountain biking, it could be any of those places I mentioned above. My trip spending a week on HMS Gassten, a converted World War Two minesweeper, with a group of good friends riding high above the fjords in Norway deserves special mention. Also, I think Nepal’s Mustang Valley was a special trip. Amazing culture, fantastic people, and as for those mountains – they build them big over there!
2020/21 has been an interesting year – how has it impacted you outside of work?
The biggest difference is that I have been at home for the longest period in about 22 years! In the last 12 months, I have only managed to travel down to our office in Newmarket twice (from my home in Scotland). I would normally travel 2 or 3 weeks out of 4, so it has been a big change.
Distancing from family and friends has also been difficult, as it has for most. I have stayed in touch as much as possible with family and friends the same way anyone else has; telephone calls, meeting in car parks and standing 4 metres apart, in addition to several Zoom quizzes!
Scimcon as a business is deeply rooted in technology – but how technology-oriented are you? What devices do you use?
I have had a long fascination with technology, which of course in part has led to my role at Scimcon. We have obviously come a long way since I first became involved in technology. I started programming on home computers during the explosion of affordable devices in the UK during the early 1980s.
Everything has continued to stem from there, to a point where I’m now the co-founder of a scientific technology consultancy, using technology to drive change and deliver scientific value.
In terms of devices, I use pretty much anything you can imagine. I have electronic shifting on a couple of my bikes, and I have some amazing camera equipment that even five years ago would have been inconceivable.
Does your use of technology differ outside of work?
I don’t think my use of technology in my everyday is too different to how I would use it at work. At Scimcon we try to use technology in a way that enhances people’s work lives, so that they can focus on what is important. If I look at technology in bikes and cameras, what excites me is the same thing – not the technology itself, but what it allows you to do.
For example, when I started photography at school, the process was incredibly different to how it is now. You tried different methods of taking photographs and would be left with a roll of film afterwards that if you were lucky, you’d get developed a week later. Of course, you could guarantee that you would get the photos back after all that time and wonder “what on earth was I trying to do?” Nowadays, we have digital cameras, so you take the photo, see the result, and if it does not work you can just try again instantly.
That’s exactly how we try to use technology at Scimcon. We don’t want technology to get in the way or slow down the result you want to achieve, we want it to enable you to do the work you are trying to do – whether that’s riding bikes, taking photographs, or integrating your LIMS to streamline your workflow.
Do you start a business with the intention to divest, or is this something that becomes clear as the business grows?
I find building a company from the ground up very exciting, so that is always a leading factor behind starting a new business. Divesting is never the intention when building a business, it is more something that becomes clear over time. The motivation behind starting my businesses is to create value and deliver a meaningful impact into the pharmaceutical and life science space, in whatever shape that may take.
Take Sciformix, for example. As with my other businesses, Sciformix was created in the right place at the right time, offering our ability to combine science and process at a time when other outsourced businesses were only offering one or the other. When creating Sciformix, the intention was not to divest at a later stage, but to deliver value in what was, at the time, a new area in science.
CROs and regulatory consultants had been around for a long time when I founded Sciformix, but pharmacovigilance (PV) was a relatively new area in the industry. As regulations tightened on the reporting of adverse events within clinical trials, the pharmaceutical industry sprang into action, and it soon became clear that the new pharmacovigilance processes were too much, and too lengthy to all be completed in-house within the 15-day deadline for reporting serious reactions. These regulations were very new when we built Sciformix, and as a result we grew very quickly and worked through roughly one and a half million cases per year. When the time was right to divest, Sciformix was acquired by Covance, and it was time to move on to the next venture (Scitara).
How do you know when it is time to divest and move onto your next project?
When you are working on your business, there is not a conscious decision to divest. You know when the time has come to move on – it is like you flip a switch and realise it is time for something new, and you begin to ask yourself “why would I sell?”
Timing is critical when considering divesting. Is it the right time for your customers? Is it the right time for your employees? And is it the right time for your investors? If it is the right time for all three of these areas, then you can begin the transition fairly quickly. However, if only one or two of these areas are ready for this change, you need to step back and ask yourself “how can I make it the right time for all three?”. Thankfully, all of my exits have been at a point where the time has been right for all three parties, so I have left my businesses smoothly and on good terms.
Does divesting affect the company’s customer base, or is there a smooth transition?
Interestingly, a lot of our customers often prefer to work with smaller companies, such as those which I founded, over larger companies who offer similar services. The benefit of smaller outsourced companies – well, small in comparison to the customer – is that the culture is quite different. Smaller companies and agencies can offer a level of flexibility and innovation to customers that can be difficult to pass through larger organisations. In addition, there is a real sense of an “I have your back” attitude, as you are able to work closely with your customers. Culturally and contractually, my companies have been able to offer something different to larger companies, and we have been willing to do anything and everything our customers needed, which is why they would often choose to sign up with us.
However, as the business grows, those customers tend to stay. When customers become a part of your journey, your relationship with them evolves and your company becomes better equipped to protect their business. Because I aim to divest at a time when my customers are ready for it, there is generally a smooth transition.
You mentioned in our last blog that Scitara was your ‘finale’ – what do you mean by this?
As my previous three ventures were in tech, services, and global delivery, Scitara is the summation of all of my previous projects. As I mentioned in the last blog, Scitara aims to solve the major problem within the lab industry of data connectivity and is leading the digital revolution in labs to address this issue. To do this, we will require the cooperation of every connection we have made over the years, as by helping us, we can help them. If we can reach out to everyone in the ecosystem, we will be able to help companies take a huge leap into their digital transformation projects by creating a platform through which they can communicate their lab data through their digital systems, something which at present is proving a real hindrance to digital transformation projects.
This is why I believe Scitara is my finale. It is almost as if we have come full circle, as Scitara pulls together the skills and relationships I have built over my entire career – into creating a final solution. I intend to go out with a bang!
Pets: We have a guinea pig. During the summer it likes to roam free in the garden.
Favourite animal: Elephant
Favourite food: Fish, chips and mushy peas
Favourite film: The Star Wars collection
Fun fact: I have jumped out of an airplane
What do you enjoy the most about working at Scimcon?
Prior to joining Scimcon I had worked for large and medium sized corporations. I enjoyed my time in these organisations, but one of the qualities that initially attracted me to Scimcon was the small, close nit team that felt more like a family where every individual really matters to the success of the company. As it is a small company, you cannot hide, sit back and let others do the work for you. Everyone pulls their weight, and we back each other up if we face challenges.
Scimcon has also allowed me to work on a variety of interesting projects in areas I may not have been able to access in my previous roles.
What do you enjoy doing in your spare time?
I have always had an interest in photography, but my real passion lies in astrophotography. My degree was in Physics and Astronomy, and I have therefore always had a fascination with the Universe. I like to take photos of the Milky Way, and I have travelled to Lapland and Iceland where I was lucky enough to have been able to get photos of the Aurora Borealis. I also recently took a photo of the Neowise comet over Ely Cathedral. My 9-year-old daughter has recently become interested in photography, so when we get chance to go for a walk in the countryside as a family, we take our cameras and try to get some landscape photos or photos of flowers, birds, and similar.
Lapland – Aurora and Milky Way
Ely Cathedral
Something else I do in my spare time is exercise – I would not say it was a hobby, but more of a chore! I exercise for at least an hour a day, six days a week. This consists of two days at my local bootcamp at 6:20am, outside in the cold, dark and often rain in the winter, with an instructor and a team of about 20 other people. The other four days are purely aerobic, either jogging or using the cross trainer. I am a member of my local gym where I used their cross trainer, but due to the lockdown closing all gyms back in March I bought my own, and haven’t been to the gym since.
When I get the opportunity, I like to have a round of golf too. I usually play with my Dad who is a member of his local golf club, however I do not do it very often as 18 holes usually takes up three hours at least. As I do not play too often, I’m not terribly good, but conversely, I’m not terrible.
What is your favourite travel destination?
When we go on holiday we like to travel to interesting places and try to immerse ourselves in the culture. Some of the more interesting places we have been on holiday are; as mentioned above, Lapland and Iceland, but we have also been to Beijing and walked along the Great Wall of China, Istanbul, Malaysia, Singapore. Once COVID-19 is behind us we would like to take the kids to Australia and Japan.
2020 has been an interesting year – how has it impacted you outside of work?
Prior to COVID-19, it was nice to spend time with friends, having a drink and a laugh, however with the changing restrictions it is not something we get to enjoy regularly at the moment. One thing my friends and I enjoyed doing was a games night. Poker, Black-Jack and Trivial Pursuit; it’s very light-hearted, but it brings out the competitive nature in people.
With the restrictions discouraging activities with people outside of your household, we have recently taken up coarse fishing as a family. It is something that we thought would be something fun to do, to get out of the house and enjoy together. We fish on the nearby Great Ouse river and catch fish such as perch, roach and rudd. It is purely something we do for fun, so we always return the fish back to the river.
Scimcon as a business is deeply rooted in technology – but how technology-oriented are you? What devices do you use, and does your use of technology differ outside of work?
This question brings a smile to my face as my wife knows only too well how much I like technology, much to her annoyance. Over the years I have added more and more Philips Hue lights to the house, to the point where every room has at least one. We use Alexa to turn lights on and off.
Similarly, we have a number of Sonos speakers around the house which are also controlled through Alexa. I like the idea of having an electronic assistant, I think it reminds me of some scifi films of the 80’s and 90’s.
I use a Macbook and Adobe Lightroom to edit photos and I share them on Instagram (if I think they’re good enough).
My use of technology at home is very different to work. However, I think the skills I learn from setting up a new device or configuring the way it works can be applied to my work. The use of these devices, and the associated interconnectivity in the home setting helps me keep abreast of the latest technology, which has applications within projects at work too
Demonstrating the need for ePRO: COVID-19 makes the point
Outbreaks in recent years, such as SARS, avian flu, and Ebola, in retrospect seem to have been a testing ground for the current COVID-19 lockdown.
During those outbreaks, study sponsors experienced the challenges of managing clinical trials in traditional ways, and many therefore pushed forward their adoption of eClinical platforms to ensure they could still manage their trials in remote locations, while reducing the impact on their project timelines, ensuring their investigators and monitors remained safe, and enabling their subjects to demonstrate compliance.
Why ePRO works so well in lockdown
The traditional process of conducting clinical trials involves face-to-face interaction with subjects, which is proving difficult in the current lockdown. Subjects still need to make visits to clinical study sites to meet with healthcare professionals however the need to take part in lengthy reviews of their paper diaries is removed when using ePRO. By adopting ePRO for subject reporting, it is possible to significantly reduce the need for close face-to-face interaction with subjects and speed up the collection of quality data. In addition study sponsors benefit from a huge reduction in the travel of the onsite monitoring teams as ePRO increases the ability to conduct remote study monitoring.
With ePRO, the reporting and audit trail is also improved, since it is possible to prove that patients respond daily in accordance with the study Protocol (not possible with manual records).
BYOD (Bring your own device) is another consideration. It is recognised by Scimcon that BYOD reduces hardware challenges associated with the shipment of devices, but more importantly in the current situation removing the need for devices to be passed from human to human both within the logistics departments of the vendors and between the investigators and subjects (often ePRO devices are reused between subjects on an individual study). An upcoming post will cover the BYOD topic in more detail,
Moving from paper: better reporting and ALCOA principles
The regulator’s requirements for Accurate, Legible, Contemporaneous, Original and Attributable (ALCOA) data are achievable with ePRO platforms, where it has always proved difficult to remove doubt with paper-based Patient Reported Outcomes. In paper records, it is far more difficult for instance to prove when information was recorded, whereas in eClinical platforms when and by whom data is entered is automatically recorded, giving more accurate insight. Legiblity issues obviously become an issue of the past with ePRO.
The clinical trials community has been debating the benefits of ePRO for many years, and with the advent of COVID-19 where face-to-face interactions need to be limited, its adoption seems prescient. ePRO is the no-brainer product for now and future trials, both on data quality and in order to reduce concerns of unnecessary social interactions. Scimcon has hands-on experience with global clinical trials projects and is proven with ePRO platforms, doing what we do best: serving the science community with our skilled project teams to manage data projects globally.
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