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.
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
Certifications:
- CPD: 1.5 hours for your records
- Certificate of completion
Speakers
Simon Hutchings,
WeatherdenDr Simon Hutchings MPharmacol PhD CHP is Senior Clinical Pharmacologist and Drug Development Consultant at Weatherden Ltd. He has over 20 years’ practical experience and scientific knowledge of the design, management and reporting of human pharmacology and early clinical development projects across the biotech, CRO and academic sectors. This experience includes pre-clinical pharmacology/toxicology, phase I (including first-in-human) pharmacology/PK studies and investigator-led phase II and phase III trials.
He has successfully designed, managed and delivered multiple first-in-human and proof-of-concept studies across various therapeutic areas, including oncology, fibrosis, inflammation, neurology and infectious diseases. Simon is knowledgeable in the regulatory and ethical requirements of conducting early phase trials, and has also contributed to the health technology assessment submissions for several novel compounds.
In addition to undergraduate and postgraduate qualifications in pharmacology, Simon also holds a Certificate in Human Pharmacology from the Faculty of Pharmaceutical Medicine, Royal College of Physicians and a Certificate in Regulatory Affairs from the University of Hertfordshire.
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
