Preclinical Studies

We have several decades of IND research experience, a unique range of preclinical services, and best-in-class expertise to help clients successfully initiate and complete an IND-enabling program on time and within budget. Our continuous focus on scientific excellence and guidance allows us to offer cost-effective IND programs tailored to the specific needs of our clients.

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Our preclinical contract research team of board-certified toxicologists, veterinary pathologists, veterinary surgeons, regulatory specialists, and support personnel has designed and performed safety assessment programs for more than 40 years. These preclinical trials employ a broad range of animal models and numerous routes of administration, and assess acute through chronic toxicity and carcinogenicity.

Our industry-leading specialty and general toxicology preclinical studies include:

• Cell and gene therapy research
• Developmental and reproductive toxicology
• General toxicology
• Genetic toxicology
• Immunotoxicology
• Infusion toxicology
• Inhalation toxicology
• In vitro toxicology
• Musculoskeletal research
• Neonatal and juvenile toxicology
• Neurotoxicology
• Ocular toxicology
• Ototoxicity testing
• Phototoxicology
• Safety pharmacology

Over the years, we’ve made significant investments in highly trained scientific, technical, and support staff, superior facilities, and technologically advanced instrumentation. These combined give us the ability to rapidly produce reliable data for many types of preclinical and clinical analyses using networked, validated data management systems.

Our multidisciplinary laboratory science offerings include:

• Analytical chemistry
• Bioanalysis
• Biomarkers
• Formulation development
• Immunochemistry
• Immunogenicity
• Immunology
• Molecular biology
• Pharmaceutical sciences
• Physicochemical characterization

Our safety pharmacology program helps clients further the preclinical development of their product by investigating the potential undesirable effects of a compound on physiological functions in relation to exposure in the therapeutic range and above. We provide a comprehensive, global, harmonized program to meet the ICH guideline’s core battery and supplementary safety assessment tests that may be needed based on early observations or concerns.

Our safety pharmacology offerings include:

• ICH S7A core battery and supplementary tests
• CNS, cardiovascular and respiratory
• Renal and urinary
• Gastrointestinal
• Autonomic nervous system function
• Endocrine and immune effects
• ICH S7B
• hERG
• QT prolongation
• APD assays

A comprehensive safety assessment of pathologic changes is critical in the evaluation of toxicology and preclinical studies, as well as for animal colony maintenance. As a world-leading CRO, we provide the contract toxicologic, clinical, and specialty pathology services that support both early stage preclinical research with vivarium management and late-stage safety assessment.

Our unparalleled pathology preclinical services include:

• Clinical Pathology
• Digital Pathology
• Image Analysis & Stereology
• Immunohistochemistry & In Situ Hybridization
• Electron Microscopy Services
• Toxicologic Pathology
• Musculoskeletal Pathology
• Neuropathology
• Developmental & Reproductive Pathology
• Ocular Pathology
• Medical Device Pathology
• Archiving

With extensive experience in the conduct of preclinical studies to assess the environmental impact of test articles, we offer a full portfolio of preclinical services to support the environmental risk assessment requirement of a client’s marketing authorization application. Our deep understanding of both European and North American legislation allows us to guide clients through the regulatory maze. Dedicated environmental preclinical testing facilities provide modern, flexible laboratories that can accommodate all possible test scenarios.

Our services include:

• Environmental Risk Assessment
• Aquatic Ecotoxicology Studies
• Environmental Fate Studies
• Endocrine Disruptor Studies
• Physicochemical Testing

Routine and specialized in vitro and in vivo metabolism and pharmacokinetic services are available for complete characterization of the absorption, distribution, metabolism and excretion of test articles in rodent and nonrodent species.

These services include:

• Absorption and bioavailability
• Bioanalysis
• Dermal absorption
• Dosimetry
• Excretion/Mass balance
• In vitro ADMET
• Metabolite profiling and identification
• Micro-autoradiography
• Pharmacokinetics/Toxicokinetics
• Protein binding
• Radioanalysis
• Statistical analysis
• Tissue distribution (tissue dissection or QWBA)

To some extent the terminology is interchangeable. Nonclinical studies are typically considered as the group of in vitro and animal studies that are conducted from when the preclinical drug candidate is selected for development until the product is approved for marketing.

The term preclinical is generally used to describe the same studies but identifying those conducted before the first clinical trial. Nonclinical studies include ADME (absorption, distribution, metabolism, and excretion), pharmacology, safety pharmacology, genotoxicity, toxicity, carcinogenicity, and/or developmental toxicity of the drug.

A preclinical candidate is a molecule that has been selected to undergo comprehensive GLP-compliant safety assessment preclinical studies prior to testing in human clinical trials. A preclinical candidate has met the criteria of the Target Product Profile (TPP) and undergone an extensive screening process during the discovery phase. The TPP may include data from pharmacology, toxicology, in vitro ADME, and in vivo pharmacokinetic preclinical studies. The drug should have a well-characterized synthetic route and a formulation suitable for the route of administration to be used in animal studies.

There are different types of preclinical studies needed to get into the first clinical trial. In vitro studies, such as the Ames test, are conducted relatively quickly. Toxicity studies in animals normally start with short term studies with an experimental period of a few days and then move on to longer term repeated dose GLP preclinical studies of increasing duration. While one month toxicity studies are commonly conducted to support a first clinical trial, the length of the toxicity study is dependent on the duration of subject dosing. Other time considerations include developing and validating analytical methods to measure the test item in the formulations and blood matrices used for pharmacokinetic measurements. These need to be developed before the toxicology studies are conducted. All of these activities/studies need to be carefully coordinated and dovetail with the manufacturing campaign to minimize the time to IND/CTA filing.

Candidate drugs can fail during the preclinical stages of development for a number of reasons. The drug may be poorly bioavailable by the desired route of administration. Most small molecule candidates fail at the preclinical stage due to overt toxicity or safety pharmacology issues, with hepatotoxicity and cardiovascular safety pharmacology being particularly common reasons for failure. The industry is continually striving to reduce attrition rates by developing toxicology study designs that include additional safety biomarkers and endpoints in pre-candidate nomination preclinical studies to get an earlier safety assessment readout. Sponsors are also increasingly including more safety directed screening studies based on specific mechanisms of action and known target safety liabilities within their screening program prior to preclinical candidate nomination.

Preclinical development of a drug is a complex process involving a wide variety of interlinked studies. Using a preclinical research partner who can manage and conduct all, or the majority, of the preclinical studies that are required will simplify the process in terms of contracting, assay transfer, and moving quickly from one set of studies and activities to the next. You should use a preclinical research partner who has a good depth and breadth of scientific expertise to aid in developing an efficient and successful drug development program. They understand the quirks of the target and potential safety liabilities that will aid in designing the right preclinical studies. They can anticipate what regulatory authorities are likely to be focused on. Additionally, this experience and expertise will be critically important when (and it usually is when, rather than if), something unexpected happens. The right CRO partner will be able to quickly analyze the situation and suggest rational solutions.