Introduction to Small Molecule Drug Discovery & Development from Coursera

What does it take to advance a new drug from the laboratory bench to the patient’s bedside? Historically, drugs were discovered serendipitously and were usually isolated from natural sources. Today, drug discovery efforts take many years and cost hundreds of millions of dollars. They also require the input of dozens of specialists from a multitude of backgrounds to ensure that therapeutic molecules are efficacious and safe.

This four-week course takes a high-level tour of what it takes to research and develop a new drug. We will meet different scientists and professionals across the drug discovery value chain as we explore the different stages of discovery and development, including the different tools and technologies that are influencing how we think about new medicines today.

Starting off with the needs of the patient and the early phases of drug discovery, we will cover drug metabolism, pharmacokinetics and drug safety all the way to clinical development and beyond. This course is relevant for scientists who are new to drug discovery research or already have some experience, health professionals, or anyone who is interested in knowing what had to happen to ensure that their medicine is effective and safe.

What's inside

Syllabus

The starting point for drug discovery: The needs of the patient

This week covers an introduction to the drug discovery and development process. It starts off by considering the patient, as the ultimate beneficiary of new and improved drugs, to ensure that they are kept at the centre of and integrated into all subsequent decision-making. Through a case study, the concept of an unmet medical need is introduced and provides a backdrop for understanding further critical concepts which underlie drug discovery and development. An overview of various drug discovery strategies is presented, along with approaches to screening and hit discovery. Various scientific, medical and humanitarian considerations need to be taken into account if effective delivery of new and improved drugs is to be achieved. Some of the challenges are presented, and a panel discussion highlights different, and similar, perspectives in the academic and industry approach to drug discovery projects.

The early phases of drug discovery

This week explores the early phases of drug discovery. As outlined previously, the starting point is always the needs of the patient and their biomedical realities. Understanding disease biology is a critical next step and sets the scene for mapping the context for immune response and the origins of ill health and how the progression of disease can be controlled or arrested. Case studies, particularly in the context of tuberculosis (TB), demonstrate the rationale behind molecular biology studies of the pathogen and the host. Key concepts such as the essentiality and vulnerability of targets and their 'druggability' are introduced. Medicinal chemistry drives the chemical modification of drug-like molecules to improve their activity and safety. The various tools and approaches that the medicinal chemist has at their disposal, including the value of the screening cascade, will be discussed.

Drug metabolism, pharmacokinetics and drug safety

This week picks up the drug discovery and development story at the point at which promising drug candidates have already been identified. The crucial importance in this phase of investigating the pharmacokinetics and pharmacodynamics of potential drugs is introduced, as these are key parameters for the effectiveness of a new drug and a positive patient experience. These properties have a bearing on bioavailability and metabolic processes and provide a backdrop for animal model studies, and the extent to which the biological properties of the drug are retained in mammalian systems. The ethical considerations and technological advances pertaining to in vivo testing are discussed. Drug testing, safety profiling, and toxicology and efficacy in preparation for clinical trials are presented, and an introduction to process optimization and API manufacturing is also discussed.

Development phase

This week outlines and examines the clinical development phase. Once a drug candidate has successfully progressed through the phases outlined previously, it qualifies for filing as an Investigational New Drug (IND) and a Clinical Trial Application (CTA) and the accompanying review process. An overview is given of the regulatory framework governing this, and a description of the various phases of clinical trials. The extensive teamwork that is required during the clinical trial is outlined, as well as the various role-players in this process, and some of the critical aspects, such as the submission and approval process, protocols that need to be established, informed consent and site management, are described. Finally, we look to the future and consider how new technologies are changing the face of drug discovery and development and how this may ultimately bring newer and safer medicines to the patient more rapidly.

Good to know

Know what's good

, what to watch for

, and possible dealbreakers

Develops knowledge and tools for professionals across the drug discovery value chain

Provides a comprehensive overview of drug discovery and development

Taught by Dr Susan Winks, a recognized expert in drug discovery

May be too high-level for those with extensive experience in drug discovery

Requires some knowledge of biology and chemistry

Does not cover advanced topics in drug discovery

Career center

Learners who complete Introduction to Small Molecule Drug Discovery & Development will develop knowledge and skills that may be useful to these careers:

Biomedical Scientist

This course can help you build a foundation in the drug discovery and development process, with a focus on the needs of the patient. This knowledge is essential for Biomedical Scientists, who are involved in all aspects of drug development, from research and development to clinical trials and marketing.

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Regulatory Affairs Specialist

This course provides an overview of the regulatory framework governing drug discovery and development. This knowledge is essential for Regulatory Affairs Specialists, who are responsible for ensuring that new drugs are developed and marketed in compliance with all applicable regulations.

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Pharmacokineticist

This course provides an overview of pharmacokinetics and its importance in drug discovery and development. This knowledge is essential for Pharmacokineticists, who are responsible for studying the absorption, distribution, metabolism, and excretion of drugs in the body.

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Medicinal Chemist

This course introduces the concepts of medicinal chemistry and discusses the tools and approaches used to modify drug-like molecules to improve their activity and safety. This knowledge is essential for Medicinal Chemists, who are responsible for designing and synthesizing new drugs.

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Clinical Research Associate

This course provides an overview of the clinical development phase of drug discovery and development. This knowledge is essential for Clinical Research Associates, who are responsible for managing clinical trials and ensuring that they are conducted safely and ethically.

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Pharmacologist

This course provides an overview of pharmacology and its relevance to drug discovery and development. This knowledge is essential for Pharmacologists, who are responsible for studying the effects of drugs on the body.

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Toxicologist

This course provides an overview of toxicology and its importance in drug discovery and development. This knowledge is essential for Toxicologists, who are responsible for evaluating the safety of new drugs and ensuring that they are safe for patients.

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Drug Safety Scientist

This course provides an overview of drug metabolism, pharmacokinetics, and drug safety. This knowledge is essential for Drug Safety Scientists, who are responsible for evaluating the safety of new drugs and ensuring that they are safe for patients.

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Health Economist

This course provides an overview of the economic aspects of drug discovery and development. This knowledge is essential for Health Economists, who are responsible for evaluating the cost-effectiveness of new drugs and ensuring that they are affordable for patients.

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Drug Discovery Scientist

This course provides an overview of the drug discovery process, from target identification to clinical trials. This knowledge is essential for Drug Discovery Scientists, who are responsible for identifying and developing new drug candidates.

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Science Writer

This course may be of interest to Science Writers, who are responsible for writing and editing scientific content related to drug discovery and development.

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Statistician

This course may be of interest to Statisticians, who are responsible for analyzing data related to drug discovery and development.

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Medical Writer

This course may be of interest to Medical Writers, who are responsible for writing and editing scientific documents related to drug discovery and development.

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Patent Attorney

This course may be of interest to Patent Attorneys, who are responsible for protecting intellectual property rights related to drug discovery and development.

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Project Manager

This course may be of interest to Project Managers, who are responsible for managing drug discovery and development projects.

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