Non-Clinical and Preclinical Trials

As developers ourselves, Altus Drug Development understands the needs of your company and your goals to commercialize your drug. We also understand that the path to generating your IND or CTA is fraught with costly pitfalls and potential dead ends. That’s why Altus has assembled a team of preclinical experts to help you navigate pre-clinical/non-clinical development and bring your drug from discovery to your first in human (FIH) study quickly and efficiently.

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Altus’s preclinical trial services

Altus and our team of experts provide integrated services and solutions for all the testing stages needed to get to your clinical testing phases. Altus preclinical services include;

These are the pharmacology studies and research you need to perform to demonstrate whether your drug candidate displays its intended effects with respect to mechanism of action (MoA), including receptor selectivity, enzyme inhibition or cellular functionality to name a few. Primary pharmacology will also study the macro effects of your candidate, such as its effects on blood pressure, pain or tumour growth.

Altus offers the following preclinical services via its collaborating Quebec companies;

In vitro and in vivo testing

Trials to support lead identification, lead optimization and clinical candidate selection including receptor affinity (binding) and potency, receptor selectivity, enzyme assays, pharmacokinetics and ADME (absorption, distribution, metabolism and excretion) studies.

Rodent experimental model development and access to established experimental models specific to the disease state you are investigating.

This type of research generally doesn’t have to be conducted in compliance with Good Laboratory Practices (GLP).

These are the studies you need to perform to evaluate the non-intended or off-target effects of your drug candidate. This research helps predict the potential your drug candidate will show toxicity in humans or conversely that your candidate is unlikely to be toxic.

Secondary pharmacology can also have positive outcomes for your drug candidate if off-target binding identifies a new therapeutic role for your drug.

Altus, via its team of experts, can design and perform studies to determine the potential for off-target receptor binding for over 130 targets commonly associated with drug side effects and can assess functionality for those where binding occurs.

Once you have selected your clinical candidate, safety pharmacology studies are the tests you will need to do to demonstrate it is fit for human use. This testing evaluates potential impacts of the new compounds on vital organ systems before first-in-human drug testing and are required by the FDA and other Regulatory Agencies.

These toxicology studies (‘tox studies’) are performed under GLP and must be carefully planned to fit the needs of your drug candidate. Altus and its group of expert partners in Quebec can provide the scientific and regulatory support you need to design your IND or CTA enabling studies, liaise with regulatory agencies, and deliver the studies safety results you need to move into clinical studies.

Why partner with Altus for Preclinical Testing?

The Altus team has developed and commercialized its own drugs across a wide range of therapeutic areas. By working with Altus, not only do you gain expert preclinical testing, research advice and invaluable data, you will also benefit from all the pharmaceutical product development and testing services you need to ensure a smooth transition from Lab to Clinic to Market.

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FAQs about Preclinical Testing

What are non-clinical and preclinical trials?

When we first start out on the drug development journey, it seems even the vocabulary is out to confuse us. What’s the difference between pre-clinical testing and non-clinical? Nothing. FDA refers only to non-clinical testing while EMA uses both. Helpful. We’ll stick with the terms preclinical testing and trials.

Preclinical testing occurs between the discovery of a new pharmaceutical compound in a lab and its first test in humans. This is a long, and often expensive phase, where the potential safety and effectiveness of the new compound or new drug is first determined.

The focus of preclinical testing is first to demonstrate your drug candidate is effective in vitro and then in animal models, but mainly aims to ensure that the compound is safe for human use. No human subjects are involved in the preclinical phase.

What is the objective of preclinical testing?

Simply put, preclinical testing is a series of studies made to assess the level of risk of a drug candidate and to extrapolate this to a potential later effect on humans. Preclinical studies allow researchers to accurately model the effects of a drug candidate in vitro and in animals to determine its efficacy and safety. This provides insight into what should be done before moving on to clinical trials on humans. It is a necessary first step that prevents potentially dangerous drugs from making it to trials where they would put human lives in danger.

Certain preclinical tests are required by regulatory bodies, such as the FDA, during the preclinical phase of development. Those can be specific to the nature of the developed compound and its intended use. Deciding which tests are necessary and avoiding excess is an important aspect of preclinical testing, and having experts involved can save pharmaceutical companies a lot of time and money by shortening the preclinical phase.

What are In vitro and In-vivo preclinical testings?

In vitro tests are conducted using human or animal cells in culture, that is in a Petri dish. In vitro tests can establish the receptor binding profile of a drug, it’s potency (i.e. the strength of binding to a receptor) and its functionality, that is what pharmacological and mechanistic effects its binding to a receptor brings about. Other in vitro tests can assess the metabolic profile that drug will be likely to display in humans and yet others, e.g. the Ames test, can assess the potential for genotoxic effects. In vitro tests are generally low cost and fast to conduct but they lack the potential to measure the effects of a drug in the complex and dynamic environment of a living animal.

In-vivo preclinical tests are performed in living animals and allow improved predictions of efficacy, safety and duration of effect. Such studies can only be performed by accredited and licensed laboratories. Outsourcing your preclinical testing via Altus Drug Development ensures the highest levels of scientific rigour, ethics and compliance.

What are considerations needed for preclinical testing?

Preclinical or non-clinical testing is a process starting with low-cost in vitro tests that may be performed on a range of candidate molecules to help with lead candidate selection. Higher cost In vivo and further in vitro testing may then be performed with a smaller number of candidates to select only those meeting your strict target product profile or TPP. Primary and Secondary Pharmacology studies are performed during this stage. Finally, a limited, perhaps only one, lead candidate can move forward to the IND or CTA enabling GLP safety pharmacology studies.

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