What’s Critical for Assay Development Today?
The needle in the haystack…
In the world of drug development, many are looking for solutions during the process – needles in the haystack – from discovery through commercialization. One of the areas of highest frustration in the proverbial haystack of drug development is assay development. As any pharmaceutical CSO or research head can tell you, they look to themselves and their people to develop a study design.
In most cases, the problem with assay development is that there’s no “off the shelf” assay to support of your target. If you don’t have an Assay Development Department, your people spend countless hours of research, only to discover that there’s no pot of gold at the end of the rainbow. If you already have an Assay Development department, in some cases, this will work out in your favor. But given the complexity of today’s biochemical, enzymatic, and hormonal compounds, you likely need more complex in vivo assays to represent molecular behaviors and interactions at the cellular level.
Enter the field of Molecular Imaging.
Molecular imaging is the visualization, characterization, and measurement of biological processes at the molecular and cellular levels in humans and other living systems. Molecular imaging typically consists of 2- or 3-dimensional imaging as well as quantification over time. But you probably already know this.
And you need experts.
“Simply generating an image, for which the implications to the patient are not understood, does not confer benefits to the patient.” – FDA.gov (Ref 1)
Be warned. A molecular image is not an exchange for success down the road.
What is Critical for Assay Development?
Imaging is critical when you want to capture how an organism reacts to changes in the environment or physiology. Preclinical imaging is the visualization of a small-bodied animal specimen for translational research purposes.
Translational research has changed how we practice medicine and solve health problems today. By relying on imaging, we get a chance to bridge discoveries made at the molecular level and implementation in clinical diagnostics. Read that last sentence again. It’s important to keep this in mind. Bridging discoveries. Bringing solutions.
Critical to your work. Critical to your program. Critical to your approval.
“Molecular Imaging has become the crux of Pharmaceutical Drug Development – in particular with the arduous area of Assay Development. Molecular Imaging brings capabilities not possible by other analytic approaches. This is where expertise brings efficiency, as this path of research should not be taken lightly…” – Mario Bourdon, BioLaurus CEO
Trust the experts. Then you can trust the timeline that will get you to your goals.
Why Imaging Is So Important to Pharma Companies?
Discovering and introducing a new medical drug to market is a multi-stage process. And a very costly one at that. Many research directors and CSOs at large pharma companies are under pressure to make the whole process of drug discovery and development more efficient. Currently, drug discovery and development is a resource-intensive process.
It can cost a staggering $2.56 billion to complete. Not small change.
And that’s where molecular imaging is an invaluable resource.
Molecular imaging is an advanced mechanism to bridge those needs mentioned earlier, (remember that sentence you read twice?), and often the expense of utilizing experts in Molecular Imaging is less than internal in-vivo assay development, with faster timelines.
“Bridge discoveries made at the molecular level and implementation in clinical diagnostics”
Simple assays don’t meet the needs of advanced compounds anymore. Molecular Imaging is the key of the present, and definitely the future. Needle found!
Thank you for taking the time to read this article! Feel free to express your thoughts below on Drug Development, Molecular Imaging, or other aspects of Pharmaceutical life.
If you’d like to learn more about preclinical imaging and how it affects you, feel free to visit the website of one of the experts quoted here – Mario Bourdon, President and CSO of BioLaurus. Check out the BioLaurus website.
BioLaurus is a company composed of In Vivo Preclinical Molecular Imaging Contract Research Specialists. We partner with clients to design and implement successful scientific studies and imaging assays. We are a new kind of contract research company focused on working collaboratively with you to provide solutions to the complex research challenges you face in drug discovery and translational research.
Kimberly Brue-Leone is an author, scientific writer and advisor, business development representative, and consultant to various great companies in the Life Sciences. Feel free to check out more on her LinkedIn profile.
- Another great article on the current state of Drug Development: http://wavefunction.fieldofscience.com/2017/06/bottom-up-and-top-down-in-drug-discovery.html