BiotechDispatch spoke to recently appointed Medidata general manager Mark Glover at the recent AusBiotech national conference.
Medidata is one of the world’s leading technology-focused clinical research organisations. Mr Glover said 18 of the world’s top 25 pharmaceutical companies, and most of the major device companies, use the company to derive their clinical data.
Mr Glover is a well-known figure in the Australian-based pharmaceutical industry, having led a number of companies, most recently iNova.
He said the move to Medidata was not a big change for him because it is an R&D company.
“We invest 25 per cent of our revenue back into our own R&D. Now, we are a software company and we are a data interrogation company, but we are still an R&D company.
“We are on the cutting edge of R&D when it comes to supporting clinical trials and development in this sector. So, from that point of view, I sit very comfortably with it being an R&D company because really what we are about is bringing smarter treatment to patients as quickly as possible.
“We are the connective tissue that sits underneath the clinical eco-system and brings everything together through software applications and management.”
Mr Glover said the company sees it itself as an enabler of the quality management of data. “In the end, it is this data that is going to inform smart people to make good decisions, quickly.”
He also spoke practically in terms of the needs of companies, particularly in terms of the cost of bringing a treatment to market. “It is about finding the right patients and getting them into clinical trial trials but also retaining them is just as important. Every time you do not retain a patient, or you do not qualify them properly, it adds time and money to the journey.”
According to Mr Glover, the emergence of e-consent has been important in properly engaging patients on their involvement in a clinical trial.
“When you e-consent a patient, you are educating and helping them to understand why they are getting into it. If I just give you a bit of paper and say, ‘read this and sign this form’, you will read it and sign, but is there really an understanding of why you would be participating in the trial?
“This is important because if you do not properly consent people around 30 per cent will drop-out.”
He said that, while fundamentally clinical trials have not changed since he started in the industry, some key developments have been increasing the demands of regulators and payers as well as the opportunity to apply more sophisticated analytics.
Mr Glover highlighted a recent trial where a therapy showed a 19 per cent response rate. However, when the company applied some analytics, including artificial intelligence algorithms, a patient subset was identified with a 65 per cent response rate.
“There is also now an opportunity for companies to go back and re-interrogate their old data, as long as it is robust.”
He said another challenge is in the identification of patients for trials of rare disease. “Once we find them and give them the opportunity to be in a trial, a biomarker may tell us before we even start whether the treatment is likely to be successful. We then need to be able to efficiently capture and analyse the data.”
He continued, “We have 17,000 trials on the Medidata platform, which increases every day, with more than five million discrete and deidentified patients at the level of regulatory controlled data requirements.
“We have 1.5 billion images of images of clinical trial patients. So, within that ecosystem, and it all now sits in a database, what that is now leading to is the opportunity for a synthetic control arm.”
Mr Glover said the concept of the synthetic control arm is a mechanism to address issues with trials of treatments for rare and more life-threatening diseases.
“Patients do not want to participate if they think they are going to get a placebo. In fact, I was talking to the CEO of a company this morning and this is exactly his issue – he is an oncology company and he cannot recruit patients into their placebo-controlled trial.
“Medidata can now start to offer this synthetic control arm. A company may approach us and ask if, based on our data, do we have a group of patients like this? We take an artificial intelligence smart algorithm, look for patients with the relevant characteristics, and say to the company here is your control arm.
“The key is these are highly qualified patients and their data is clean as you ever get in clinical trials. For companies, it means they can just go and recruit their active trial arm.”
He continued, “The FDA is starting to accept this and it really is the way to go because, in the world of precision medicine, if I know the therapy is going to work for you, can I really withhold it order to create an evidence-base and approval?”