prelim 1 - drug discovery and development overview

Covers all the activities undertaken to transform the compound obtained during drug discovery into a product approved for launch by regulatory agencies

Drug development

Development is expensive, accounting for __________% of the total R&D costs

70

__________ is the essence of drug development as it determines how soon the company can start earning a return on the huge investment plowed into the project

Speed

Entailing the conceptualization of the therapeutic into a molecule with known pharmacologic effects (Phases of creating a new drug product)

Drug discovery

Covering the steps taken to convert the molecule above into an approved and registered drug product (Phases of creating a new drug product)

Drug development

Includes all the steps taken to convert the product into an approved therapeutic, launch it into the market, and generate sales (Phases of creating a new drug product)

Commercialization

Is about deciding whether or not to embark on a new project

Therapeutic concept selection

It technically starts with the choice of a disease area and a definition of the therapeutic need that should be addressed (Phases of creating a new drug product)

Drug discovery

During this phase, effort is focused on identifying a lead chemical structure (Phases of creating a new drug product)

Drug discovery

Screening that is applied to identify “hits” which demonstrates interesting activity (Drug discovery)

High throughput screening (HTS)

A key aspect of the validation stage is to find relationships between chemical structure and biological activity and to find out if the compounds belong to any existing families of compounds known as __________ (Drug discovery)

Hits series

Is a critical process in drug discovery since it determines whether a suitable compound can be identified for taking forward into preclinical and clinical studies (Drug discovery)

Lead optimization

Solving technical issues related to the synthesis and formulation of the drug substance to ensure the quality and safety of the drug product (Drug development)

Technical development

The key functions involved in technical development are __________, __________, and __________ development (CMF)

Chemical, Manufacturing, Formulation

Establishing the safety and efficacy of the product; including assessment of whether it’s pharmacokinetically suitable for clinical use (Drug development)

Investigative studies

The main functions involved in investigative studies are safety __________, __________, and __________ (PTC)

Pharmacology, Toxicology, Clinical development

Refers to all the different tasks undertaken to transform the drug substance identified as a candidate during the discovery phase into a dosage form (Phases of creating a new drug product)

Drug development

Studies which specifically investigate physical and chemical properties of the drug substance (Drug development)

Preformulation studies

Studies that are essentially, chemical engineering efforts aimed at converting a powder or a liquid form of the drug substance into a stable and deliverable product (Phases of creating a new drug product)

Formulation studies

Describes the whole set of activities undertaken by the team in support of testing of a new drug substance in humans (Phases of creating a new drug product)

Clinical development

It includes clinical trials, which refer to the administration into man the new drug under controlled conditions to investigate bioavailability, efficacy, safety, tolerability, and acceptability (Phases of creating a new drug product)

Clinical development

A health authority that is responsible for safeguarding the public’s health against defective and unsafe products

Food and drug administration (FDA)

Authority that develops regulations and guidelines for companies and others in the value chain to follow

Regulatory authority

Authority that is responsible for approving clinical trial applications, approving marketing authorization applications, and monitoring the safety and efficacy claims of the marketed drugs

Regulatory authority