“The right treatment for the right patient”. Everyone is familiar with the main dogma of personalised medicine. However, to get there, pharma companies must first develop the drug and make it safe and effective for the right patient population. None of this is possible without the tools that quantify whether the drug is working as expected and whether the patient, which has a particular biology, will likely benefit from it. These tools are biomarkers (which become diagnostics once regulated, packaged and distributed) and are fundamental both during drug development and the patient journey.

Launching diagnostics at the speed of software

Existing biomarkers and assays can often be repurposed for novel applications. For example, let’s take cholesterol, a popular and commoditised biomarker. The same cholesterol test may be used for different use cases, such as:

• Calculating risk of developing cardiovascular disease, which may require a doctor to access QRISK3 calculations from a dashboard. 
• Monitoring if a cholesterol-lowering drug is working in a decentralised clinical trial, which may require at-home capillary blood collection kits to be fulfilled to participants and samples to be sent to a GCLP laboratory. 

What changes is not the biomarker(s) or the assay(s) but the infrastructure required to make the biomarker(s) accessible. 

Developing and launching a diagnostic using traditional methodologies is complex and expensive. Diagnostics-as-a-service (DaaS) platforms have become effective tools to launch diagnostics in weeks, not years, and at a fraction of the cost.

However, many new therapeutics work through new drug targets or biological mechanisms. Complex diseases (such as cardiovascular disease or Alzheimer’s) may require novel biomarkers that capture the effect. So what happens if we don’t have a biomarker for the right drug, condition or population? We need to develop it. This is where biomarker R&D comes to the rescue.

How is a novel biomarker developed?

Let’s take the most complex scenario (i.e. those diagnostics that traditionally may cost 20-100 million USD and take 3-7 years to launch). Let’s say that you are a pharma company that has potentially discovered a novel drug to treat patients with a specific molecular subtype of blood cancer. You have pre-clinical phase evidence that it works and want to bring it to clinical trials. You will need biomarker(s) that can help you stratify patients and identify those most likely to respond to the drug based on their molecular profile, increasing the chances that the clinical trials are successful.   

It is fundamental to have a biomarker strategy from early in the drug development pipeline so the biomarker(s) make it into the clinic as diagnostics (maybe even as companion diagnostics). Here is a high-level outline of the different phases required to take a biomarker from conception to global scale and how an R&D + DaaS partner like Hurdle may support you across them:

• 1. Biomarker discovery (3-6 months). This step identifies the biomarker(s) associated with the disease/drug of interest (clinical utility). Integrated datasets, including public datasets (e.g. TCGA), biobanks (e.g. Generation Scotland, UK Biobank) or proprietary datasets, can be leveraged. Additionally, novel datasets may need to be generated through the analyses of clinical samples, working with our CRO partners for recruitment and lab network for data generation. In the cancer example, we could apply our machine learning multi-omics biomarker discovery engine to identify molecular signatures that can find patients that are most likely to respond to your drug (this is the same engine that led to the launch of the first saliva-based NGS epigenetic biomarker for human ageing!).
• 2. Biomarker development (3-6 months). In this step, the biomarker(s) are deployed in the right assay, and its performance is validated (analytical and clinical validity). Typically biomarker discovery is performed using high-throughput technologies that are expensive and not scalable in a clinical setting. We work to deploy the biomarker(s) in assays that reduce cost, have the correct performance (e.g. high reproducibility and success rates) and are compatible with your clinical trials. We always do this with an “at-home first” approach, so the biomarker will be more accessible in the future (e.g. in the cancer example, maybe capillary blood collected using upper-arm sample collection kits are the right specimen type to validate the claims).
• 3. Launch through DaaS (3-4 weeks). Our platform facilitates the global distribution of the biomarker, so your clinical trial participants can access it in different countries. In addition, this enables you to seamlessly offer it as a companion diagnostic to the right population at any point in the future. 

During this process, our team of regulatory, medical and scientific experts work closely with you to ensure the success of the final solution.

 

 

“We have been working with the Hurdle team for over 2 years now on the co-development of novel diagnostics. We are really excited to leverage their biomarker R&D and DaaS capabilities to complement our future consumer propositions by offering consumers health and wellness tests rooted in cutting edge science.”

 

Karl Wishart, Global R&D Emerging Science & Innovation Director

 

We like to move fast, and our R&D + DaaS machine is proven to accelerate this process (3-10X) and support regulatory submissions. For example, during the COVID-19 pandemic, our scientists took primers and probes that had already been tested for clinical utility by the CDC and WHO, and plugged them into steps 2 and 3, resulting in the first CE-marked saliva-based SARS-CoV-2 PCR test, which diagnosed thousands of people from their homes and supported corporate partners in the workplace.

Diagnostics for anyone, anytime, anywhere.

Hurdle is the only company in the world that combines deep biomarker R&D expertise with the power of DaaS to launch novel diagnostics: from conception to global scale. Whether biomarkers are required for population screening, patient stratification, or monitoring the safety and efficacy of a new treatment in a DCT, we are the one-stop shop for all diagnostics. We are relentless in our mission to make them accessible to our partners, patients and users.