Preclinical Recruitment
What is Preclinical Development?
Preclinical development refers to the stage in drug development where a potential new drug or therapy is tested in the laboratory and in animal models to evaluate its safety, efficacy, pharmacokinetics, and toxicity, before it is tested in humans in clinical trials.
Preclinical studies are typically conducted to establish the basic safety profile and to determine the optimal dosing regimen of a new drug candidate. This stage of drug development involves a range of activities including drug formulation, pharmacological and toxicological testing, and efficacy studies in animals.
Preclinical development is a critical phase in drug development as it provides important information that informs the decision to move forward with clinical trials.
Our Experience
Each team within our business specialises in a different function. This ensures that we have experts dedicated to continued learning within each field, as well as building relationships with relevant talent within each market place.
Due to this approach, we have access to a talent pool or highly skilled individuals within Preclinical Development, as well as a keen understanding of the skills and qualifications needed to support your organisation.
Key Roles We’ve Filled
Senior Medical Chemist
Senior Preclinical Consultant
Head of Preclinical Toxicology
Our Expert
Lizzy Gartland
Senior Consultant
Preclinical Development
Having previously worked as a Scientific Officer, Lizzy joined the recruitment space in 2021. With her first hand experience working within Life Science, Lizzy has managed to build an impressive network of preclinical talent.
Current Regulatory Roles
Frequently Asked Questions
What are the goals of preclinical development?
The goals of preclinical development are to evaluate the safety and efficacy of a new drug or therapy in a laboratory and animal models before it is tested in humans in clinical trials. Some of the specific goals of preclinical development include:
- Determine the basic safety profile of the new drug candidate
- Establish the pharmacokinetics (absorption, distribution, metabolism, and excretion) of the drug in animals
- Determine the appropriate dosage and dosing schedule for the drug
- Evaluate the potential toxicity and side effects of the drug
- Assess the potential efficacy and therapeutic benefits of the drug in animal models
- Identify any potential drug-drug interactions or other safety concerns
- Provide data that can inform the design of clinical trials.
By achieving these goals, preclinical development helps to identify and mitigate potential risks associated with the new drug candidate, as well as optimise its potential benefits before it is tested in humans.
How long does preclinical development take?
The duration of preclinical development can vary depending on several factors, including the complexity of the drug candidate, the type of disease being targeted, the number and types of animal models required, and the overall scope of the preclinical testing program. In general, preclinical development can take anywhere from 1-5 years or more to complete.
The preclinical development process typically begins with the identification and validation of a new drug target or molecule, followed by lead optimization and testing in vitro and in animal models. The duration of each of these stages can vary widely, depending on the complexity of the molecule and the number of iterations required to optimize its activity and pharmacokinetic properties.
Once a lead candidate has been identified and optimized, preclinical studies are conducted to evaluate its safety, efficacy, and toxicity in animal models. These studies can take several months to a few years to complete, depending on the scope and complexity of the testing program.
Overall, the duration of preclinical development can be influenced by a wide range of factors, and can vary significantly from one drug candidate to another.
What is pharmacokinetics and why is it important in preclinical development?
Pharmacokinetics is the study of how a drug is absorbed, distributed, metabolized, and excreted by the body. It is important in preclinical development because it helps to determine the optimal dosage, dosing schedule, and route of administration of a new drug candidate. By understanding the pharmacokinetic properties of a drug, researchers can identify any potential safety concerns, such as toxicity or drug-drug interactions, that may impact its efficacy in humans.
What is toxicology and why is it important in preclinical development?
Toxicology is the study of the adverse effects of chemicals, including drugs, on living organisms. In preclinical development, toxicology studies are conducted to identify any potential safety concerns associated with a new drug candidate. These studies evaluate the toxic effects of the drug on various organs and systems in animal models, and can help to identify the safe dosage range and potential side effects of the drug in humans.
What is the role of regulatory agencies in preclinical development?
Regulatory agencies, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), play a critical role in preclinical development by establishing guidelines and regulations for the testing of new drug candidates.
These agencies review and evaluate preclinical data to determine the safety and efficacy of a drug, and to assess whether it is appropriate to proceed with clinical trials. Regulatory agencies also provide guidance to researchers on the design and conduct of preclinical studies, and monitor the safety and ethical standards of animal studies.
How do the results of preclinical studies inform clinical trials?
The results of preclinical studies are used to inform the design and conduct of clinical trials. Clinical trials are typically designed to test the safety, efficacy, and pharmacokinetics of a new drug candidate in humans, and the data obtained from preclinical studies can help to optimise the dosage, dosing schedule, and route of administration of the drug in humans.
Preclinical studies can also identify any potential safety concerns or drug-drug interactions that may impact the safety or efficacy of the drug in clinical trials. Overall, the results of preclinical studies provide critical information that helps to guide the development of new drugs and therapies, and ensure their safety and efficacy in humans.
