My uncle was diagnosed with cancer, and this pushed me, among other personal reasons, to completely change my career; this was a life-changing event.
Clinerion: What are you trying to achieve with Massive Bio?
S.K.: As a matter of fact, there are 11,000 oncology clinical trials right now in the repository, but only 3% of adult cancer patients are enrolled into trials.
One of the reasons for this is that 85% of these patients are treated, in the US, in community practices. These are not large academic cancer centers where most of the cutting-edge research resides, but smaller, limited structures.
The reason Massive Bio was founded is to provide access to innovative trials for these patients, regardless of the patients’ location, and regardless of the patients’ financial stability.
Once, during one of these “family situations” that I had, I recognized how big that enrolment problem was. Someone had to solve this. I nominated myself to start this journey, for lack of anyone else, and came up with Massive Bio!
Clinerion: Why the name: “Massive Bio”?
S.K.: Well, Next Generation Sequencing (NGS), or 2nd Generation Sequencing, or also high-throughput sequencing allow for sequencing of DNA much more quickly and cheaply than previous methods and revolutionised the study of genomics and molecular biology. We can look at patients’ DNA and identify what treatment could be used to target a specific mutation. The industry has been evolving drastically in this way, over the last decade.
For example, we can identify and diagnose what is driving cancer, looking at misalignments or rearrangements in the DNA.
Another name for NGS or high-throughput sequencing is also “Massively parallel sequencing”. That’s where we took the “Massive” from. Massive Bio is all about the new generation of oncology treatments, which includes a lot of targeted therapies and immunotherapies.
There are two points which I’d like to elucidate regarding the techniques that are used to detect and treat cancer nowadays.
First, what those innovative therapies do isn’t “hacking” the genes but looking at someone’s genomics and then being able to apply very personalized treatments depending on the results – e.g. applying the right therapy to a given patient in order to be able to develop his / her immune system. Patients can now be treated based on biomarkers.
Second, there are 2 types of events: genetic events, and genomic events. Genetics is the study of heredity, of events within a patient’s DNA that are inherited from your mother and father. These can of course drive cancer. Genomics is the study of genes and their functions; it addresses all genes and their interrelationships in order to identify their combined influence on the growth and development of the organism. This can be influenced by external, environment factors and by daily habits such as sleep, nutrition, levels of stress and so on.
For example, breast cancer is a unique kind of cancer, and there are ‘genetic’ cases. Angelina Jolie, as a well-known example, could use recent methods for early detection of a very high likelihood for her to develop breast cancer. She had a double mastectomy as a preventative measure against this increased probability of getting breast cancer. This doesn’t change the future generation’s genes and her daughter will need to take the test, too. This tells future generations: “it might happen to you, too”.
However, today we know that most cancers are due to genomics. Genomics is the “real thing” that drives one’s cancer. One develops cancer from environmental factors, from something that goes wrong with one’s own body.
Clinerion: Why partner with Clinerion – what are the objectives?
S.K.: The main reason is Clinerion’s global coverage, particularly its footprint in many countries outside the US! International trials are very interesting because they help us understand patients outside the US.
We will use Clinerion’s real-world data for certain common oncology projects. We are able to analyse the data based on our understanding of oncology and will filter the given information based on our intelligence on the oncology field. This information will then be used for site selection. To summarize, we are combining Clinerion’s data capacities with Massive Bio’s expertise in oncology.
Clinerion:How do you think the use of data in trials will evolve (not only in oncology but in general, for all medical fields)? Will we ever be able to build a comprehensive and qualitative global patient database?
S.K.:In my view, there are two aspects to this. I think it will evolve in two different steps. First, what we are currently doing is consolidating, streamlining and structuring data. Data is usually not structured enough yet. Second, the next step will be to bring intelligence to that data to accelerate drug development. I don’t think the industry is there yet. In simple terms, we need to “clean” and “assemble” the data first, so that we can use it afterwards. The data must be complete and accurate, otherwise we can’t leverage it properly.
In terms of new data generation tools, I think we are at the infancy phase and there’s much room for improvement. Certain markets outside US, already have more centralized healthcare systems. The data quality and harmonization in Europe, for example, is very different than in the US, because governments harmonize patient data collection in their own country’s healthcare system and that allows for a lot of high quality, streamlined data. In the US, there is no centralized decision-making in healthcare and data, which results in poor data harmonization. Being more of a free-market economy with a private healthcare system, the government doesn’t get involved in fundamental issues such as healthcare data models.
From my perspective, we are very far from an ideal “global, harmonized patient database”. For this to happen, we would need at least three generations. The main roadblock would be that the major markets would need to make sure their data is structured and streamlined, which is not yet the case. And even after that, all the countries would still need to align with each other, and that would be very expensive and time-consuming, too. These are huge projects and it would take years, if not decades.
Clinerion: How do we get people to consent to giving out their data, anonymized, for research purposes?
S.K.: We have a patient contact center where we receive patients, and they can discuss their case with one of our patient advocates. After that conversation, they sign a consent form to opt in to become part of a given research study.
The information, the “talk” part, is crucial. In order to succeed, we must educate and engage patients, first. You can’t get a consent just for the sake of it.
Patients accept to share their information, anonymously, for research purpose. We find that cancer patients aren’t usually concerned about sharing their data. They’re more concerned about giving it without their knowledge. Once they understand “why” and “how” we will use it, and “with whom” it will be shared, patients are extremely open.
Clinerion: What are the gaps still to be closed in cancer trial enrolment? What role can data play?
S.K.: The gaps in cancer trials correspond to the problem we want to solve, i.e. “only 3% of all adult cancer patients are enrolled in trials”, because most of them are in community practices and not aware that they have this possibility.
We want to fill this gap with Massive Bio.
To ensure success, we need to service patients with both technology, and expertise & patient information. The oncology clinical trial environment is very special and unique.
Until now, the combination of these 2 approaches was missing. There are a lot of organizations involved in oncology clinical trials, but they are usually focused either on technology, or on expertise and patient information, and there’s no integrated platform to do this.
Oncology clinical trials must be what I like to call “High Tech Plus High Touch”. Just having a brilliant technology doesn’t involve the patient for a trial. We need to provide a good service for patients, too, in order to make sure patients won’t fall from the enrolment funnel.
To me, technology is inclusive of data. We will use it more and more, but we still have a long way to go. Also, we will need to focus on very narrow applications, in very specific areas. We need to start small and targeted, this will ensure success and will bring “use cases”. Only then can we build upon this.
The idea is really to start with “not so smart” things, to show some progress and show the way. I trust the technology will improve over time. For example, streamlining some current processes would be relatively easy, as opposed to using AI to discover something new. We need to adopt this step by step approach because we don’t expect to solve something super difficult in one shot. We need to start with something that we can actually achieve. We will find success by breaking down the very complex issue of cancer trial enrolment, into smaller pieces of realistic and achievable projects.
< Back to Clinerion Expert Corner