Which part of the drug discovery life cycle

Drug discovery and development can be described as the sum total of steps taken by research-intensive entity to identify a new chemical or biological substance and transform it into a product approved for use by patients. This highly knowledge and capital intensive process takes, on average, 10-15 years and over $2 billion (2021 figures), to pull off. But exactly what is involved? Who does what and when? In this article, we outline key concepts of drug discovery and development, including target identification, clinical trials, pharmaceutical development and commercialisation. 6 Summary Points about Drug Discovery and Development Drug Development Drug development covers all the activities undertaken to transform the compound obtained during drug discovery into a product that is approved for launch into the market by regulatory agencies. This is a pivotal process, and a lot rides on its success, thus, efficiency is absolutely critical, but mainly for two key points: Firstly, development is expensive – accounting for 70% of the total R&D costs. Even though the number of projects is much smaller compared with those under discovery, the cost per project is significant, and increases exponentially as the project progresses through into the latter stages. Secondly, speed is the essence in drug development as it determines how soon the company can start earning a return on the huge investment ploughed into the project. Besides, any delays eat away into exclusivity arrangements gr...

by Sebastian Rowe What would you do if I gave you $2.6 billion? For pharmaceutical companies, the answer is develop a drug. Not a handful, not a few… a single drug. $2.6 billion is the estimated development cost of each Food and Drug Administration (FDA)-approved drug. For perspective, 48 new medicines were FDA approved in 2019. Therefore, the total development cost of all the approved medicines amounted to $125 billion; a figure roughly equivalent to the 2019 GDP of Nebraska! The process of discovering a drug involves many scientists running thousands of experiments over many years (Figure 1). However, technological advances in various steps of this process have not translated into a dramatic increase in FDA-approved drugs. To understand why so many reported breakthroughs fizzle out and why the cost of drug discovery remains so high, let’s walk through these steps to tackle an Unknown Human Disease (UHD). Figure 1: The process of discovery, from finding a target to FDA approval. Each step in this process normally takes years and collaboration across many scientific fields. Finding a target How, and where, might you begin the search for a drug to help with the UHD? In living beings, there are many kinds of molecules, but for the most part, they can be classified into four groups: DNA, RNA, proteins, and metabolites (Figure 2). In the modern age, one will likely use an “omics” approach to start the search. “Omics” are a group of techniques that use large data sets to identi...

A newly emerged coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), belongs to the β-coronavirus family and shows high similarities with SARS-CoV. On March 11, 2020, the World Health Organization (WHO) declared SARS-CoV-2 a global pandemic, and the disease was named the coronavirus disease 2019 (COVID-19). The ongoing COVID-19 pandemic has caused over 46 million infections and over one million deaths worldwide, and the numbers are still increasing. Efficacious antiviral agents are urgently needed to combat this virus. The life cycle of SARS-CoV-2 mainly includes the viral attachment, membrane fusion, genomic replication, assembly and budding of virions. Accordingly, drug development against SARS-CoV-2 currently focuses on blocking spike protein binding to ACE2, inhibiting viral membrane fusion with host cells, and preventing the viral replication by targeting 3C-like protease, papain-like protease, RNA-dependent RNA polymerase as well as some host-cell proteins. In this review, the advances of drug development in these three major areas are elaborated. • Previous article in issue • Next article in issue Haixia Su received her B.S. degree (2016) from East China University of Science and Technology and is now pursuing her Ph.D. degree at Shanghai Institute of Materia Medica (SIMM), Chinese Academy of Sciences (CAS). She is interested in the determination of crystal structures of drug targeted proteins, and structure-based drug design. Yechun Xu receive...

The drug development lifecycle is a lengthy and meticulous process. While most people in the In the simplest sense, in-depth research and rigorous testing are conducted to determine both safety and efficacy. However, how the work progresses is a bit more complex. Here is an overview of the entire process. The Lifecycle of Drug Development Discovery The first stage in the development of a drug is discovery. Typically, this involves one of several events. It could be new information about a medical condition or disease or an emerging technology, giving researchers a different angle to pursue when developing treatments. In some cases, it’s an unanticipated effect of an existing treatment or beneficial findings relating to the study of molecular compounds. When researchers find a point worth pursuing, initial clinical research begins. This often involves lab-based experiments involving the compound with potential, giving researchers insights into whether the compound is a candidate for further study. Preclinical Testing After the discovery phase, if the decision is made to pursue, it’s time for preclinical testing. Preclinical testing must be completed prior to conducting any human clinical trials. The goal is to determine the safety, such as toxicity of the compound. Preclinical trials can be conducted in human cells or animals. Good laboratory practices (GLP) must be followed during this phase, ensuring the study is conducted correctly and in line with regulations. As with h...