Belgium-based clinical laboratory and diagnostic solution provider Cerba Research offers core therapy expertise in oncology, liver indications and infectious disease. Research teams in Belgium, South Africa, China and other countries develop and deploy assays across APH, flow cytometry (16 colors globally) genomics, metabolomics, microbiology + virology and molecular biology.
Adrien Ko, medical advisor at Cerba Research, told Outsourcing-Pharma that encouraging their researchers and other staff to work with each other and with customers leads to better outcomes.
“Our subject matter experts enjoy open collaboration at the pace our clients require to optimize their therapeutic development and draw pivotal insights earlier,” Ko said. “We partner with these clients to speed up their research and development, whether it be by discussing, agreeing on and then delivering specialized custom assays and panels; assay transfer; or perhaps overcoming operational peculiarities baked into studies by way of challenges regarding stability of samples for testing.”
Outsourcing-Pharma (OSP) discussed Cerba Research’s work in oncology and other therapeutic areas, as well as its patient-centric, collaborative approach to discovery and development.
OSP: What does “patient-driven insight” mean—how does it work, and why is it important?
AK: The idea behind “patient-driven insight” is to place the patient back at the heart of disease management. Patients desire clarity and greater security to improve their health journeys; this is achieved by using new technologies.
These digital tools not only allow patients to directly contribute to their medical files (as in patient-reported outcomes, PROs), but they also allow physicians to better follow the evolution of pathologies. New technologies enable care to be based on analytics, data and prediction rather than on conventional medical understanding.
This approach is very important because it allows for increased clinical efficiency. Two highlights are:
- Improving patient adherence through data-driven insight
- Saving time for physicians by having a single view of the patient through integrated data
OSP: Could you please talk about challenges in oncology patient recruitment and retention, and how you might be working to help deal with such challenges?
AK: Sponsors, CROs, researchers and investigational sites still rely on decades-old methods to identify patients meeting the complex eligibility criteria of a clinical trial. We believe that there are three main hindrances to patient recruitment in clinical trials:
- Increase in the number of inclusion and exclusion criteria in clinical studies
- Centralization of clinical trials at referral investigational sites that are not always accessible to patients
- Lack of digital tools dedicated to helping health professionals manage patient recruitment and retention
Cerba Research is therefore setting up a new digital tool developed by Biokortex to bring clinical trials to patients. This new technology will enable medical staff to recruit patients, applying all types of eligibility criteria.
Cerba Research has prospective access to millions of patients presenting every year within the Cerba Healthcare clinical laboratories network.
OSP: Could you please share some of the challenges unique to clinical trials when the disease at the center of the research is a rare form of cancer?
AK: Challenges in trials for rare forms of cancer as well for orphan diseases are various. The key is to identify the specific combinations of markers that signal a cancer’s status, origin and progression, and to make that information available to clinicians.
Further, in order to target malignancies with precision, treatments must be personalized. Finally, enrolling a sufficient number of patients in trials remains a chief bottleneck in the drug development process.
OSP: What are some of the recent developments in precision medicine in the area of oncology?
AK: Clinical trials have evolved, shifting from tumor-type-centered to gene-directed. Here are some developing understandings in precision medicine in the area of oncology:
- Precision medicine should be used early in the course of the disease
- Complete tumor profiling (genomic, transcriptomics, proteomics, immune markers, etc.) is necessary
- Therapeutic approaches may be combined: gene-targeted, hormonal or novel therapies, chemotherapy, immune-targeted approaches
- Real-world data is being used, facilitated by new digital tools
Other recent developments include tumor and cell-free DNA profiling using NGS, liquid biopsies, personalized vaccines and immunotherapy and cellular therapy.
OSP: Please tell us more about immuno-oncology—how has that field evolved in recent years, and what’s especially notable/exciting about recent advancements?
AK: Among the most interesting developments are new therapies related to the study of the interaction between the tumor, its microenvironment and the immune cell repertoire. Several novel approaches are currently being explored: checkpoint blockade, oncolytic viruses, cell-based products, modified cytokines, CD3-bispecific antibodies, vaccine platforms and adoptive cell therapy. Novel immunotherapies have shown immense promise for significant advancements in cancer treatments.
It is nevertheless important to realize that the success of future immunotherapy cannot increase without defining the molecular profile of patients. Therefore, the incorporation of biomarkers into the selection of patients for immunotherapy needs to be optimized.
OSP: Can you please gaze into your crystal ball, and offer some perspective on how you think the field of oncology research and precision medicine might appear in the near or distant future?
AK: We don’t need a crystal ball to know that patient journey management will be the key to guide treatment choices. For us, there are a few challenges to address. We will bring clinical trials to patients, at home or in city labs, for example, to follow their progress more closely. I see further development and use of the liquid biopsy — circulating tumor cells (CTCs) and circulating cell-free tumor DNA (ctDNA), immune cells and the microenvironment.
In addition, there will be an algorithm that can combine real-world data and clinical trial data. And lastly, new digital tools and artificial intelligence will facilitate the management of millions of patients’ health data.