Biomarkers offer clinical researchers and drug developers ways to elevate patient care, work toward more preventive measures, identify appropriate study candidates, and more. Now, researchers are turning to advanced imaging analytical technology, or radiomics, to discover new kinds of biomarkers and take their work to the next level.
Rose Higgins (RH), CEO of HealthMyne, discussed with Outsourcing-Pharma (OSP) how radiomics works, recent developments in biomarker technology, and what might lie ahead.
OSP: Could you please share an overview of how personalized medicine has evolved in recent years, including the technologies behind the evolution of the field?
RH: The identification of genetic biomarkers that predict certain health conditions -- such as an individual’s likelihood of developing specific types of breast cancer -- has represented among the most important advances towards personalized medicine in recent decades.
These biomarkers not only help frontline clinicians improve patient care and take preventive measures, but also help life sciences organizations find the research study candidates who are most predisposed to success when given a particular therapy.
Now, advanced imaging analytics and the extraction of high dimensional data from medical images, called radiomics, are emerging as the other side of the personalization coin. By adding an individual patients’ tumor phenotypic (structural) information through imaging biomarkers coupled with the patients’ genetic data, drug developers can create more precise therapies.
OSP: What are imaging biomarkers and how do they relate to genetic biomarkers and how might they make a clinical trial professional’s job easier?
RH: Imaging biomarkers leverage tumor biology to define a novel set of quantifiable patterns. These markers – which provide clinical signatures as unique as each patient –act as a catalyst to evaluate disease progression, monitor therapy response and predict clinical outcomes.
Life sciences companies look to improve drug development with imaging biomarkers generated through the science of radiomics, or advanced imaging analytics. Today, private industry is working with academia to develop these imaging biomarkers that can be coupled with genetic biomarkers to add another layer to the personalization of medicine.
Here’s an example of how biomarkers help researchers: By targeting certain biomarkers to narrow the field at the beginning of a clinical trial to the patients most likely to benefit from a particular therapy, life sciences organizations can save time in the early stages and get to Phase 3 with higher prospects of success.
OSP: What is radiomics? What are its implications for drug development?
RH: Radiomics is the cutting-edge field of extracting novel data and predictive biomarkers from medical images that can help life sciences companies conduct clinical trials with more accuracy and speed while driving greater personalization of treatment.
When research and clinical radiologists have traditionally reviewed images of lesions or tumors during clinical trials, the view has been limited to just two dimensions – the long and short axes. As a result, the primary method of evaluating a lesions progress has been simply measuring the vertical and horizontal axes to ascertain any changes, which leaves a great deal of important information out of the equation.
The reality is that lesions and tumors possess multiple dimensions, along with numerous other structural and physical characteristics that define them. Many types of cancer demonstrate notable structural differences that can be quantified noninvasively by Radiomics and advanced imaging analysis.
By using artificial intelligence to collect and quantify medical-imaging data, radiomics enables drug developers to profile patients, tumors, and therapies across multiple dimensions to find patterns and similarities that would otherwise be unobtainable. In addition, radiomics builds an evidence knowledge base that accelerates the development and delivery of the best possible treatments and assesses the efficacy of clinical trials— both critical to drug development.
OSP: Please share some examples of how research, diagnostics and treatment of certain conditions have benefited from use of imaging biomarkers.
RH: For cancer patients, radiomics can deliver a positive impact across the entire care journey from early identification and diagnosis to treatment and recovery.
Here’s an example of how radiomics can be applied to personalize a treatment plan: When a lesion is discovered, providers can use the patient’s genetic information along with phenotype data from radiomics to match the patients to others with similar profiles. They can then review the outcomes those previous patients achieved with various treatment plans to determine which yielded the best results on a consistent basis. This then becomes the starting point for treatment.
The added advantage of radiomics, however, is that providers can continue to monitor the effect the treatment is having across thousands of data points. If it is not achieving the intended results at certain checkpoints, providers can change the treatment plan immediately rather than waiting until the treatment plan is completed.
Radiomics provides a non-invasive, and cost-effective approach for better, more accurate diagnoses and personalized therapies specific to each patient.
OSP: Could you please tell us about the primary goals of imaging biomarker research, and the challenges associated with them?
RH: Using advanced imaging analytics data, researchers in the field of radiomics are investigating what is happening in the cellular structure of tumors or lesions. There are two primary goals of this research:
The first is to identify the unique attributes of the tumor’s biology. Once the data is revealed, patterns can be identified which may indicate how a patient will respond to a specific treatment. While challenging to develop the data, the potential impact is substantial.
The second goal of research into imaging biomarkers is to provide real-world imaging evidence that predictions and outcomes for certain disease are tied directly to specific biomarkers. After various imaging biomarkers are identified from a theoretical perspective, more analytics will be required to ensure that the perceived relationship is true in all cases rather than coincidental or valid only under certain conditions.
OSP: Do you have anything else to add about your company, the field of radiomics, evolution of clinical trials, etc.?
RH: Although the life sciences industry has made great progress in its pursuit of fulfilling personalized medicine’s promise, there is no question that work remains to be done. Radiomics represents the missing link that adds individualized patients’ phenotypic data to their genomic information, enabling drug developers to advance more targeted, precise therapies.
The use of both genomic and radiomic biomarkers is expected to have a substantial, positive impact on the way clinical trials are constructed and managed. The combination of the two will significantly narrow which patients are selected to receive a specific treatment, saving time and money at each stage.
Now, it’s just a question of seeing where the research takes us.
