7 Wonders of the [PreClinical] World
Ever had a sleepless night wondering what miracles exist in the preclinical world that enable studies to support research pipelines?
Me neither. But let’s explore in a humorous way and have some fun…
If you work in the medical field, you know how important preclinical trials can be. Often, when you hear about clinical trials, you expect to see amazing advancements in medical science soon. And you do.
But, you might not be aware how crucial preclinical trials are for the future of the potential drug product. These studies set the foundation – even gatekeeping the future – of the life of that drug. And it’s not easy or always clear-cut, but there are new “Wonders” within this preclinical stage that have changed the landscape of preclinical analysis.
Can you take a guess what they are? Here are some clues:
Let’s start with #1. It might be obvious, but if not…
1. It’s in the Clouds
If you were to walk into the average research lab 20 years ago you’d see a few computers. But you’d also see file cabinets full of paper files that have essential information. Paper records have been widely used in labs and hospitals, but they’re inefficient – they can get lost or destroyed, and they can’t be easily accessed by people that aren’t near where records are stored. Not cool.
The digital revolution has significantly impacted medical science – for the better. Keeping essential research data in one computer system was important, but now it’s possible to upload important information to a secure place for people around the world to use. And this has changed everything – the cloud is everywhere.
How about a guess for #2?
2. Einstein-like Analytics
Data and analytics are an important part of preclinical trials, but historically the capabilities for analysis were limited. There was only so much information you could collect with technology of years ago. Thanks to advances over the years, researchers are able to see, analyze, and learn things like never before. The analytics are as powerful as Einstein’s thinking. A hundred years later.
Big data has infiltrated nearly every business, and it stands to transform the way we handle preclinical trials. The information uncovered, and analysis of the findings, can illicit conclusions and discoveries that transcend many hypotheses, pushing science forward at light speed.
Okay, so admittedly, I am a fan of quantum physics.
How about Wonder #3?
3. Custom Animal Models
Years ago, preclinical studies were performed in animals of various species (non-human primates, rodents, rabbits, rats and mice, etc) – of standard sex, age, weight and general physiological characteristics – in order to test new drug compounds in a mammalian species environment. Animal selection was simple and standard, there was nothing fancy about it.
Now, with the advances of genetic engineering, animals are available that exhibit certain disease or physiological characteristics – a.k.a. the ‘animal model’. You can even custom order animals that may have been engineered to possess (or lack) the gene or phenotype of your heart’s desire, making the entire study better designed to suit the hypothesis at hand. This option speeds up the analysis – and allows the researchers to generate very specific results, tailored to the disease model. Okay, so the ‘tiger-rabbit’ isn’t available yet, but this is pretty wild, huh?
See if you can guess #4 before scrolling too far:
4. Get on Stage
Want to be a performer? Well, not me either… But this is different –
During preclinical studies, it is essential to understand the state of the disease in the animal (and ultimately the patient) – which is why staging is critical to understanding the characterization of the diagnosis. It’s not enough to know that disease is present – you also need to understand how far it has progressed to properly determine what treatments might be an option.
Technology has progressed to allow for detailed staging of diseases through the use of micro-CT, SPECT and even a combination of both SPECT/CT and other methodologies available. Using these techniques, staging can be determined by evaluating the disease state over a period of time (timepoint imaging).
All of this is made possible through advanced imaging technology. When we have greater insight into what is being studied, we can see small changes that signal the progressions of diseases – crucial for preclinical studies as well as patient care.
Next up, Wonder #5’s hint is a good one for the chemistry geeks out there:
5. Nuclear Medicine, Ultrasound, and MRI… OH MY!
These three methods (and several others) blew the tops off of the abilities of preclinical imaging by shifting the paradigm of how we view living things:
- Nuclear medicine (the use of radiolabeled isotopes which ‘light up’ during analysis),
- Ultrasound (the ability to see within tissues and organs using radiofrequences, and
- MRI (use of reverberative effects of magnetic waves through tissues, bones, and whole specimens – alive or not).
Thanks to advances in imaging technology results have become more precise and widely used. With the right imaging technology, you can see changes as they occur in test subjects as if you were looking directly into the body.
Pretty cool, huh? We are just getting started. How about a guess for Wonder #6?
6. Is there a Frog in your Throat?
One of the beauties of the 21st century was the precarious finding of how to combine the use of different techniques, with time itself, to create one of the most advanced abilities for human kind. Utilizing existing methods such as PET and SPECT imaging, when you add functional monitoring over time you create a ‘quantum’ world – solving a nebulous puzzle of identifying where the radiolabeled molecule might be at a certain timepoint – as if that actually could happen! Quantum science tells us that identifying a single location is not physically possible, and without getting into the nitty gritty of Schrödinger’s Cat, molecular imaging [Wonder #6] creates an analysis over time – perhaps a sort of ‘assembly of snapshots’ in time, similar to creating a cartoon on a pad of paper…. the resulting flow of images shows the potentiality of what might be happening over time at the molecular level of the cell, organ, or entire living being. Or frog in your throat.
“Molecular imaging is the cross-roads of several static technologies … the result of which creates a dynamic, time-based assessment regarding the hypothesis at hand. A powerful and intrinsic 3D model which not only supports your study, but shows living functionality. It’s not just images anymore…” – Mario Bourdon, President & CSO, BioLaurus, Inc.
And lastly, here is Wonder #7…
7. Let the Experts do it
As the technologies of preclinical studies have become more complex, it has become increasingly difficult (tremendously expensive) for companies and academia to perform various methods in house.
Enter a solution – a third-party service provider.
Outsourcing has been a major trend in various economies over the past few decades. Nearly every industry has been affected by the outsourcing of labor, and the medical research industry is no different. Many pharmaceutical companies and drug manufacturers have decided to outsource certain aspects of their research, for many different reasons – such as competency gaps. This is similar to a patient going to a neurosurgeon for spinal surgery, instead of having a family member do the surgery – you outsource when you need to.
Sounds like a logical solution, right?
Outsourcing specialists has a variety of benefits that go beyond being able to save money. Outsourcing also exposes you and your staff to competencies not normally present within your organization (excellent for networking!). True expertise in these areas requires advanced experience and deep data processing skills, in a specialized subset of a field which is still expanding. Finding the right company and aligned competencies are key. You don’t want to hire a tugboat when you need the directional expertise and speed of the QE2.
There’s a lot changing in preclinical trials. Medical science has advanced considerably, and certain methods have changed the way we look at the preclinical stage. And there are only going to be more wonderments from here.
As you can see, there are a lot of “Wonders” in the world of preclinical research, and more are coming. Perhaps you are surprised, or in awe, or perhaps you are even wondering how you read this far. Hopefully you at least enjoyed a chuckle along the way.
Have some feedback about other wonders of the preclinical world? Post below, or contact us – we would love chat.
And for all you quantum physics fans out there [myself included], here’s more about Schrödinger’s Cat.
And one more cartoon for the road:
Thank you for taking the time to read this article! Hopefully you enjoyed it! Feel free to express your thoughts below.
If you’d like to learn more about preclinical / medical imaging, 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 entrepreneur, 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.