The Stages of Drug Discovery and Development Process

Drug discovery is a process which aims at identifying a compound therapeutically useful in curing and treating disease. This process involves the identification of candidates, synthesis, characterization, validation, optimization, screening and assays for therapeutic efficacy. Once a compound has shown its significance in these investigations, it will initiate the process of drug development earlier to clinical trials. New drug development process must continue through several stages in order to make a medicine that is safe, effective, and has approved all regulatory requirements. One overall theme of our article is that the process is sufficiently long, complex, and expensive so that many biological targets must be considered for every new medicine ultimately approved for clinical use and new research tools may be needed to investigate each new target. From initial discovery to a marketable medicine is a long, challenging task. It takes about 12 - 15 years from discovery to the approved medicine and requires an investment of about US $1 billion. On an average, a million molecules screened but only a single is explored in late stage clinical trials and is finally made obtainable for patients. This article provides a brief outline of the processes of new drug discovery and development.

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Pharmaceutical Industry Update: Clinical Trials in Women's Health Research Part I: The Drug Discovery and Development Process

Journal of Women's Health ◽

10.1089/jwh.1996.5.103 ◽

1996 ◽

Vol 5 (2) ◽

pp. 103-107

Author(s):

DONNICA L. MOORE ◽

STAN BERNARD

Keyword(s):

Clinical Trials ◽

Drug Discovery ◽

Pharmaceutical Industry ◽

Women’S Health ◽

Women's Health ◽

Health Research ◽

Development Process ◽

Drug Discovery And Development ◽

Women’S Health Research

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Developing Novel Anticancer Drugs for Targeted Populations: An Update

Current Pharmaceutical Design ◽

10.2174/1381612826666201124111748 ◽

2020 ◽

Vol 26 ◽

Author(s):

Tadesse Bekele Tafesse ◽

Mohammed Hussen Bule ◽

Fazlullah Khan ◽

Mohammad Abdollahi ◽

Mohsen Amini

Keyword(s):

Drug Discovery ◽

Drug Development ◽

Anticancer Drugs ◽

Anticancer Drug ◽

Development Process ◽

De Novo ◽

Drug Repurposing ◽

Drug Discovery And Development ◽

Probability Of Success ◽

Selection Of

Background: Due to higher failure rates, lengthy time and high cost of the traditional de novo drug discovery and development process; the rate of opportunity to get new, safe and efficacious drugs for the targeted population including pediatric patients with cancer becomes sluggish. Objectives: This paper discusses the development of novel anticancer drugs focusing on the identification and selection of target anticancer drug development for the targeted population. Methods: Information presented in this review was obtained from different databases including PUBMED, SCOPUS, Web of Science, and EMBASE. Various keywords were used as search terms. Results: The pharmaceutical companies currently are executing drug repurposing as an alternative means to accelerate the drug development process that reduces the risk of failure, time and cost, which takes 3-12 years with almost 25% overall probability of success as compared to de novo drug discovery and development process (10-17 years) which has less than 10% probability of success. An alternative strategy to the traditional de novo drug discovery and development process, called drug repurposing, is also presented. Conclusion: Therefore, to continue with the progress of developing novel anticancer drugs towards the targeted population, identification and selection of the target to the specific disease type is important considering the aspects of the age of the patient and the disease stages such as each cancer types are different when we consider the disease at a molecular level. Drug repurposing technique becomes an influential alternative strategy to discover and develop novel anticancer drug candidates.

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Modern approaches to drug discovery and design: setting the scene

Biochemical Society Transactions ◽

10.1042/bst0310428 ◽

2003 ◽

Vol 31 (2) ◽

pp. 428-428 ◽

Cited By ~ 1

Author(s):

D.E. Kelly ◽

A. Clark

Keyword(s):

Drug Discovery ◽

Scientific Community ◽

Development Process ◽

Cell Cycle Control ◽

Drug Discovery And Development ◽

Biological Targets ◽

Competitive Edge ◽

Drug Companies ◽

Apoptosis Gene ◽

Expensive Process

The raison d'ítre for the drug discovery and development process is to provide safe and effective treatments for diseases. Bringing a new drug to market, however, is a time-consuming and expensive process and it remains an imperative for drug companies that they identify ways in which they can accelerate the identification of potential targets and their screening and development in order to maintain a competitive edge. Successful drug discovery efforts include biochemical, biophysical, genetic and immunological approaches, targeting such processes as signal transduction, cell cycle control, apoptosis, gene regulation and metastasis. As the number of these biological targets increases, reliance on bioinformatics and chemoinformatics to improve decision making, by identifying characteristics of successful drugs and sharing knowledge gained within the scientific community, has become a burgeoning area in the post-genomic era of drug discovery.

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STEPS IN THE PROCESS OF NEW DRUG DEVELOPMENT

10.36106/paripex/5306998 ◽

2021 ◽

pp. 73-75

Author(s):

Bandaru Hemanth Kumar ◽

Shaik Farooq Ahmed ◽

Prasanthi D

Keyword(s):

Clinical Trials ◽

Drug Discovery ◽

Drug Development ◽

Chemical Compound ◽

Therapeutic Efficacy ◽

New Drug ◽

Complex Process ◽

Compound Synthesis ◽

Initial Idea ◽

Drug Compound

This review determines the various stages of drug discovery, pre clinical trials and clinical trials. This process involves the identification of chemical compound, synthesis, characterization, validation, optimization, screening and assay for therapeutic efficacy. Once a new drug target or promising molecule has been identified the process of moving from the science laboratory to the pre clinical to clinical trials have been discussed in this article. The main aim of this process is identifying the chemical compound which is therapeutically useful in treating and curing the disease. The most common steps in the development of a new drug are discovery or synthesis of a potential new drug compound or elucidation of a new drug. Once a chemical compound has shown its therapeutic efficacy in these investigations, it will initiate the process of drug development earlier to clinical trials. The drug development from initial idea to the market is a very complex process which can take upto 5 to 10 years and cost of $17 billion. Due to high budget of research & development and clinical trials drug discovery process is the most expensive. The average time taken for the drug discovery is almost 12 -15 years to develop a single new compound and enter into market

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Sitagliptin: a potential drug for the treatment of SARS-CoV-2?

10.31222/osf.io/78mbt ◽

2020 ◽

Author(s):

Sanaa Bardaweel

Keyword(s):

Clinical Trials ◽

Drug Discovery ◽

Antimalarial Drug ◽

Drug Repurposing ◽

Spike Protein ◽

Diabetic Patients ◽

Potential Drug ◽

Chemokine Production ◽

Drug Discovery And Development ◽

Sequence Identity

Recently, an outbreak of fatal coronavirus, SARS-CoV-2, has emerged from China and is rapidly spreading worldwide. As the coronavirus pandemic rages, drug discovery and development become even more challenging. Drug repurposing of the antimalarial drug chloroquine and its hydroxylated form had demonstrated apparent effectiveness in the treatment of COVID-19 associated pneumonia in clinical trials. SARS-CoV-2 spike protein shares 31.9% sequence identity with the spike protein presents in the Middle East Respiratory Syndrome Corona Virus (MERS-CoV), which infects cells through the interaction of its spike protein with the DPP4 receptor found on macrophages. Sitagliptin, a DPP4 inhibitor, that is known for its antidiabetic, immunoregulatory, anti-inflammatory, and beneficial cardiometabolic effects has been shown to reverse macrophage responses in MERS-CoV infection and reduce CXCL10 chemokine production in AIDS patients. We suggest that Sitagliptin may be beneficial alternative for the treatment of COVID-19 disease especially in diabetic patients and patients with preexisting cardiovascular conditions who are already at higher risk of COVID-19 infection.

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Clinical Drug Development for the Treatment of Pulmonary Arterial Hypertension: Collaboration With the Pharmaceutical Industry and Regulatory Agencies

Advances in Pulmonary Hypertension ◽

10.21693/1933-088x-9.4.214 ◽

2010 ◽

Vol 9 (4) ◽

pp. 214-219

Author(s):

Robyn J. Barst

Keyword(s):

Clinical Trials ◽

Pulmonary Arterial Hypertension ◽

Drug Development ◽

Phase 1 ◽

Preclinical Studies ◽

Phase 2 ◽

Phase 3 ◽

Preclinical Testing ◽

New Drug ◽

Pulmonary Arterial

Drug development is the entire process of introducing a new drug to the market. It involves drug discovery, screening, preclinical testing, an Investigational New Drug (IND) application in the US or a Clinical Trial Application (CTA) in the EU, phase 1–3 clinical trials, a New Drug Application (NDA), Food and Drug Administration (FDA) review and approval, and postapproval studies required for continuing safety evaluation. Preclinical testing assesses safety and biologic activity, phase 1 determines safety and dosage, phase 2 evaluates efficacy and side effects, and phase 3 confirms efficacy and monitors adverse effects in a larger number of patients. Postapproval studies provide additional postmarketing data. On average, it takes 15 years from preclinical studies to regulatory approval by the FDA: about 3.5–6.5 years for preclinical, 1–1.5 years for phase 1, 2 years for phase 2, 3–3.5 years for phase 3, and 1.5–2.5 years for filing the NDA and completing the FDA review process. Of approximately 5000 compounds evaluated in preclinical studies, about 5 compounds enter clinical trials, and 1 compound is approved (Tufts Center for the Study of Drug Development, 2011). Most drug development programs include approximately 35–40 phase 1 studies, 15 phase 2 studies, and 3–5 pivotal trials with more than 5000 patients enrolled. Thus, to produce safe and effective drugs in a regulated environment is a highly complex process. Against this backdrop, what is the best way to develop drugs for pulmonary arterial hypertension (PAH), an orphan disease often rapidly fatal within several years of diagnosis and in which spontaneous regression does not occur?

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Intelligent Drug Development

10.1093/oso/9780199974580.001.0001 ◽

2014 ◽

Author(s):

Michael Tansey

Keyword(s):

Clinical Trials ◽

Cost Effectiveness ◽

Drug Development ◽

Clinical Research ◽

Development Process ◽

Drug Development Process ◽

Individual Trial ◽

Specific Technology

Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringent that researchers often approach trials too cautiously, convinced that the process is bound to be insurmountably complicated and riddled with roadblocks. A step back is needed, an objective examination of the drug development process as a whole, and recommendations made for streamlining the process at all stages. With Intelligent Drug Development, Michael Tansey systematically addresses the key elements that affect the quality, timeliness, and cost-effectiveness of the drug-development process, and identifies steps that can be adjusted and made more efficient. Tansey uses his own experiences conducting clinical trials to create a guide that provides flexible, adaptable ways of implementing the necessary processes of development. Moreover, the processes described in the book are not dependent either on a particular company structure or on any specific technology; thus, Tansey's approach can be implemented at any company, regardless of size. The book includes specific examples that illustrate some of the ways in which the principles can be applied, as well as suggestions for providing a better context in which the changes can be implemented. The protocols for drug development and clinical research have grown increasingly complex in recent years, making Intelligent Drug Development a needed examination of the pharmaceutical process.

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