Molecule to Medicine: An Introduction to Pharmacology in Drug Development Training Course

Part of Lunch & Learn: Molecule to Medicine series:

Course overview

Pharmacology is the study of how drugs produce their effects, and an appreciation of its basic principles is central to understanding how drugs are developed from discovery in a laboratory to being approved for the prevention and/or treatment of disease. There is increasing expectations from regulatory authorities (including the FDA, EMA, and PMDA) for pharmaceutical companies to not only characterise a new drug in terms of chemistry, biology, toxicology and pharmacology, but to understand the relationship between dose, exposure and response (both intended and unintended).

The concise course covers the fundamental principles of drug action, including small molecules, monoclonal antibodies, oligonucleotides and other advanced therapies. We will move step by step along the drug development process from in vitro experiments, in vivo animal studies to first-into-human Phase 1 clinical trials, and on to phase 2 and 3 clinical trials, reviewing what pharmacological data is required in order to guide decision making and progression towards drug approval. The main factors that can affect a drug's action will be explored, together with how these can be evaluated in clinical studies performed in parallel with the main Phase 1, 2 and 3 trials.

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Benefits of attending

• Understand the basic scientific concepts underlying how a new drug is characterised in terms of mechanism of action and both safety and efficacy
• How the body absorbs, distributes, metabolises and excretes a drug (pharmacokinetics), and how a drug produces biological effects (pharmacodynamics), and the relationship between the two
• Explore the importance of understanding how factors such as food, other medications, age, race can affect the pharmacokinetics and pharmacodynamics of a drug
• Learn the pathway for developing a drug from preclinical studies through to Phase 1, 2 and 3 clinical trials, and the role pharmacology plays in each step
• Discuss the concept of risk-benefit and how the drug approval process incorporates pharmacology into decision making

Who should attend?

This course is designed for life science professionals across academia, CRO, biotech and pharmaceutical sectors looking to increase their understanding of how pharmacology is used to take a new molecule from first discovery in a laboratory to improving the health and lives of patients. This includes stakeholders from:

• Drug discovery
• Pre-clinical development
• Biostatistics & data management
• Clinical operations
• Clinical science
• Clinical development
• Clinical project management
• Regulatory affairs
• Quality assurance
• Pharmacovigilance
• Executive/management roles

Enrol/reserve