In medicine, biotech and pharmacology, drug discovery is the entire process to discover new candidate medications.
The process is long and complex, the budget needed is expansive and the skills required are not necessarily all found in either one company or organisation involved in the entire development of the drug.
As it is extremely complex to keep and maintain all the skills required in-house (because of budget or management constraints, or others), the sponsors leading the research for a new drug can contract what is called a Contract Research Organisation (or CRO for short).
Using a CRO has the added benefit of outsourcing not only some of the more arduous processes in drug discover, but also to control budget by avoiding all the associated costs with maintaining the ability to perform these tasks (for instance, the upkeep costs for human resources, or all the technical costs associated with conducting these processes).
This is why more and more research sponsors or pharmaceutical companies outsource to a CRO, especially in the pre-clinical research field.
The process of drug discovery
Drugs used to be discovered by trying to find what was the active ingredient in traditional remedies or by chance discoveries (like penicillin).
However, with modern medicine’s progress, scientists gained access to chemical libraries (a collection of stored chemicals with associated information, that scientists can pick and choose from) of molecules, products or extracts that were tested on intact cells or organisms to find out which had an interesting effect to be leveraged.
This method of finding new drugs is called classical pharmacology. But then the sequencing of the human genome allowed for rapid cloning and synthesis of large quantities of purified proteins, which in turn made high throughput screening (the practice of conducting quick laboratory tests to identify the active compounds, antibodies or genes’ effect) of large compound libraries against specific targets (cells) in order to identify their interactions with diseases a common practice.
This is called reverse pharmacology. Modern drug discovery involves the identification of these interactions with high throughput screening and then the optimization of these findings to refine the search for the most effective component for the best effect possible.
A significant cost for research
This is why the entire process requires large investments, mostly shouldered by the pharmaceutical industry and national governments. It is an extremely expensive and complex process which yields very low rates of actual new, efficient drugs being discovered.
Each new molecular entity’s research and development comes with an estimated price tag of 1.8 billion dollars in the United States.
Nowadays, most basic research is done by the public sector or philanthropic NGOs (think about academic, public research or organisations such as the Cancer Research Foundation). While most applied, late-stage development is conducted by pharmaceutical companies or venture capitalists (the people or organisations with the most capital enter the final stages of applied research with the aim of generating profits).
After applied research has been successful and the drug’s efficiency (as well as low toxicity) has been proved in laboratories and clinical trials, the sponsors still need to apply for patents and jump through bureaucratic hoops before the drug makes it to market.
An efficient way to reduce costs at all stages of the drug discovery and development process has been to outsource to CROs.
Why outsource to CRO
These days, CROs come in a wide variety of flavours. All aspects and stages of Pharmaceutical R&D are covered by these extremely useful outsourcing companies. As for the drug design and discovery processes in themselves, most organisations prefer to focus on Medicinal Chemistry first.
That being said, several more disciplines form the backbone of drug discovery; for instance, ADME (absorption, distribution, metabolism, and excretion) and Biology (particularly Pharmacology) are pivotal in the preclinical stage. And yet, inexperienced organisations and companies still disregard ADME studies as just another unwarranted expense that may even block further studies.
ADME and pharmacology (and even more so the toxicity and effectiveness studies) make or break drug candidates, and experienced CROs can anticipate development issues. For instance, toxicology is performed at toxicological doses (which are, by definition, much higher than therapeutic levels). And early clinical studies are led on small patient numbers at doses permitted by said earlier toxicology.
To make clinical trials as successful as they can be, they need to reach maximum drug concentrations over a significant time sufficient to show statistical benefit in (a small number of) patients – and all that without having concentration levels so high that they pose health risks to the trial’s patients.
So, in order to allow these clinical trials to proceed in the best possible conditions requires reliable candidate drugs with exemplary performance characteristics. And to reach that goal, ADME is key: it will determine the quality of the design of compounds that do not yet exist (and not simply measure properties of those already made).
This is why you want experienced companies working on these topics to give your research an optimal chance of success in the long run. No two CROs are alike and you want to select the very best for your budget and requirements.
Choosing the right professional for your drugs
Getting the most precise information possible on dosing and toxicity levels will actually dramatically enhance a drug candidate’s chances at eventually entering the market. This is why you should first opt for professionals whose entire specialisation is in preclinical development.
In the drug development process, CROs offer sponsors the possibility to lower its extremely onerous costs; a boon most cannot even afford to refuse when one sees the associated success rates of drug discovery.
But above all, CROs bring their experience to the table. As we have seen, the preclinical stage of drug discovery might be the most crucial, and it is at that stage most candidates are weeded out.
Even if you have in-house talent and experience capable at the pre-clinical development stage, you should look to make room in your budget to afford the services of a specialised CRO – you have everything to gain from getting an experienced perspective at that level, and it can only benefit you when you reach the later stages of drug development. And if you do not, well, you have found the right place to start looking.