The evolution of clinical trials, with increases in globalization, study complexity and technological capabilities, means there is a need to bring innovative approaches to drug development. Artem Andrianov, a Cass Business School MBA, is making that a reality.
He is the co-founder and chief executive officer of Cyntegrity, a start-up that offers risk-based monitoring services for clinical trials. By leveraging data analytics, Cyntegrity believes it can help reduce patient risk and optimize preventive care.
The Frankfurt-based venture is poised to benefit from regulatory changes, which will facilitate innovation in clinical trials, including risk-based monitoring and the use of technological tools to ensure robust oversight and reporting. New regulation to usher in these changes was endorsed by the Steering Committee of the ICH, the global umbrella of regulatory authorities, last year.
Cyntegrity, which is backed by Commerzbank, was founded in 2013. Artem graduated from Cass the same year. Before that, he was a software development manager at ERT, the leading cloud platform solutions provider for the pharmaceutical industry. Prior to that he worked at CareFusion, the US medical devices business.
Artem, who has a doctorate in mathematical modelling, believes the Cass MBA unlocked his entrepreneurial spirit.
The challenge for the former computer science student will be proving that Cyntegrity’s tech can improve companies’ chances of passing clinical trials. Just 13% of drugs make it from phase one of clinical testing through to development, according to research published in the Clinical Pharmacology & Therapeutics journal.
What potential do you see for clinical data analytics to reduce patient risk and optimize patient care?
We see enormous potential in applying risk information and data analytics to clinical research. By means of smart data evaluation, pharma companies can reduce patient risk and the cost of clinical monitoring.
By making the clinical data available through analytical dashboards, clinical trials become safer for patients. Safety risks are controlled by smart data-engines. It checks sloppiness and misconduct, and can even identify fraudulent behaviour.
Global regulatory scrutiny and post-approval commitments are increasing driving pharmaceutical companies to think about optimization.
The Food and Drug Administration in its 2013 guidance advised the use of risk information and computerized data analytics in clinical trials. The European Medicines Agency followed the FDA’s example in 2014. This year we expect that risk management and data analytics will become part of the ICH Good Clinical Practice code, and push more pharmaceutical companies to apply data-driven risk models to their clinical research.
Three things have played an important role here: R&D returns have nearly halved over the past 10 years; the likelihood of drug approval has decreased; and clinical trial complexity increases dramatically as drugs become more targeted and more personalized.
How was the technology developed?
The idea came to us six or seven years ago while we were working for an e-Clinical provider. Our team was responsible for data quality and data cleaning, and supported big pharma clinical trials — among them were trials by GSK, Novartis, Roche and Otsuka.
We recognized that the large amount of clinical data captured was “dirty data” — damaged by different factors, such as technology or human error. We started to investigate, but the management refused to invest into this branch. We all quit and founded an independent company.
Interestingly, a year after we left, our former employer acquired our competitors — proving to us that we moved in the right direction.
Your technology uses data from clinical recording systems. Are there potential privacy and security problems or considerations?
Absolutely not. We stop our analysis at the clinical site-level. No privacy issues are possible.
However security is a hot topic for our company. We deal with the sensitive data of a sponsor and protect it in the best way possible. We have developed a specialized concept, similar to BizTalk from Microsoft, where each part of the system communicates in encrypted messages.
What is your USP and who are your competitors?
There are a number of characteristics that differentiate our approach: Cyntegrity accesses all a clinical trial’s recording systems and converts them under one umbrella of efficient risk management; we are able to identify risks with the minimum amount of information available; and we have a willingness to share experience and knowledge. Cyntegrity believes in the global sharing of risk indicators — improving clinical research.
We are also always objective and rely on technological innovation.
A very small percentage of products pass clinical trials. Is there evidence that the business can improve the chances of a product/drug passing?
Such evidence will be available from a research project that we have developed with partners. The preliminary data were so persuasive that the funding of the project was provided by the German governmental program LOEWE [an initiative for supporting the development of scientific and economic excellence].
Together with the program, we are investing €360,000 to provide the evidence.
Risk management is an increasing focus for boards. What demand have you seen for your services? Who are your biggest clients?
There are three main categories of customers who approach us: SME contract research organizations (CROs), which run clinical trials and use our system for data quality control; pharmaceutical companies, which apply our intelligent, data-driven dashboards to oversee the CROs; and established technology providers for clinical trials, which integrate our systems into their solutions.
What impact has an MBA had on your personal entrepreneurial journey and how has it been of benefit to your company?
The MBA unlocked my entrepreneurship spirit. After graduation, I was not scared to start a venture. The MBA provided me with the necessary tools for planning and launching a technology start-up.
Additionally, the academic study gave me a number of soft skills — for example presentation and negotiation skills — and the belief that I can do this.
What is your opinion of Frankfurt/Germany as a hub for a start-up?
Germany and Frankfurt in particular remains very traditional. We cannot speak about a healthy start-up atmosphere in Germany yet, compared to the UK and US.
For many years German businesses, often family-run businesses, have been developing slowly and consequently, have been reluctant to take risks and innovate.
The absence of tolerance of business failure makes many people refuse to try their ideas out. An MBA in London allowed me to observe how many young people try and succeed.
What funding has the business received?
We funded the business ourselves and with a start-up loan from Commerzbank. We are still growing “organically” without venture capital.
However, after an expected change in regulatory guidelines, the draft version of which means our services become almost a law, we plan to go a step further.
The change in regulation opens a huge market for us, as we solve the exact problem of the centralized monitoring of a clinical trial. We plan to make the first investment round just immediately after the publication of the document — presumably in autumn 2015.