How Does Translational Research Fit Within Drug Development?
In this blog post, we'll explore how Translational Research functions within drug development, transforming biomarker tests and the echoes of clinical insights into therapeutic innovation.
Trailblazing with Biomarkers: The most obvious part of Translational Research, we identify and set up the trail markers—biomarkers, that is. They’re the beacons for disease detection (diagnosis), progress tracking (pharmacodynamics), and predicting who’s going to strike gold with a certain treatment (predictive). And in the clinical trial universe, they’re like VIP passes, ensuring we roll out the red carpet for those most likely to benefit.
Navigating the treatment landscape requires a compass, and in our world, biomarkers are the true north. Imagine we have a sleek, powerful drug at our disposal—let's say, an EGFR inhibitor. It's obviously not for everyone, though; we need to find the explorers who will chart the best course with it. That's where a predictive biomarker comes in, like a beacon, lighting up the way for those with EGFR mutations which signals, "Yes, this path is for you."
Then there's the pharmacodynamic biomarker—our trusty checkpoint along the journey. It's proof that our drug isn't just a hopeful trek in the wilderness; it's making the expected strides, touching down just where we planned. Think of the downstream markers pAKT and pERK here, confirming that, yes, the EGFR inhibitor is indeed taming the MAPK signaling pathways like a seasoned guide.
And what about ensuring that every participant in our clinical trial is the right one for the journey? Enter the diagnostic biomarker, acting as our meticulous travel agent, verifying each detail - lung cancer, non-squamous pathology - to confirm that patients stepping into the trial for an EGFR inhibitor are indeed the adventurers best suited for this venture. This part of the journey requires regular discussions with the healthcare management team at the hospital, to ensure the appropriate documents are gathered to screen each potential patient for the trial.
In this nuanced ecosystem of treatment, biomarkers are our map, compass, and guide, leading the way to a promised land of precision medicine where every step is calculated, every route is destined, and every patient's journey is as unique as the stars in the sky.
Crafting Cures Cut to Fit: It’s all about couture care. We’re stitching together tailor-made treatment for the individual, decking out patients in therapies designed for their genetic signature. This bespoke approach is not just vogue; it’s revolutionizing recovery rates and minimizing the fashion faux pas of treatments—side effects.
In a drug development setting, folks in Translational Research will be called upon to study the relevant biomarkers in the field of interest. For example, what are important clinical biomarkers associated with this field? Which patient subsets are doing poorly and therefore representative of an unmet need? How large are these subsets (ie will the cost of drug development be offset by revenue)?
Similarly, once safety has been seen in the clinic, you may embark on identifying which are appropriate companion drugs for the test drug. This involves identifying biomarkers that indicate a tumor will not respond to a drug and matching them to another drug to either show synergy of response, or improve the percentage of patients that respond.
From Lab Bench to Bedside: When we hit upon a potential winner in the drug stakes, it’s all systems go from lab samples to human trials. We’re talking drug crafting, prototype testing, and then—showtime!—clinical trials. It’s about making the journey from concept to cure as swift and smooth as silk.
Tests that may be suitable in the lab are not suitable for a clinical trial setting. This is where assay development comes in - you may be redesigning primers, testing the sensitivity and specificity of a test and establishing boundaries for the sample protocols.
Efficiency Is Our Middle Name: We’re in the business of streamlining success, syncing up lab learnings with clinical know-how to cut the red tape and costs of getting treatments from brainstorm to bedside.
The operations of a clinical trial are complex and require a lot of thought. Biomarker operations must fit within the overall trial operations seamlessly. When blood is drawn, how much, where it is sent to and to whom, are decisions made by the biomarker team in collaboration with the Clinical Operations team. Once these plans are made, you may be called upon to write the relevant sections of the clinical protocol, lab protocol, and other trial related documents.
Navigating the Rules of the Road: No journey’s without its rules, and we’re adept at steering through the regulatory roadmap, ensuring our innovations are not just game-changing but safe and sound, hitting all the checkpoints from trials to treatment shelves.
What does this mean? Continuous collaboration with the Regulatory Department ensuring samples are being collected according to protocol, any deviations that occur are being recorded, and all patient data is stored in a suitable manner.
Making Ethics Essential: We’ve got our moral compass set firm; it guides us through the trials (literally) of bringing new cures to light, ensuring every step is taken with respect, safety, and fairness.
As a Translational Research delegate, you may be asked to write part of the Informed Consent Forms that a patient may read and sign before they decide to participate in the trial. To ensure they understand what is being done with their samples, what happens to the results, and who will have access to them.
Teaming Up for Triumph: As you can see, it’s a rally, not a solo race. Our endeavors are the epitome of teamwork, drawing in wizards from every scientific field and forging alliances from the hospital to the regulatory bodies and to every corner of the company you’re developing in.
Stay tuned! Over the next few weeks I will cover many of these aspects in detail so you can see what goes on under the translational research hood during drug development!
#biotech #translationalresearch #biomarkers
