scholarly journals AI in drug development: a multidisciplinary perspective

2021 ◽  
Author(s):  
Víctor Gallego ◽  
Roi Naveiro ◽  
Carlos Roca ◽  
David Ríos Insua ◽  
Nuria E. Campillo
Keyword(s):  
Drug Development ◽  
Development Process ◽  
Basic Research ◽  
Attrition Rate ◽  
Drug Development Process ◽  
Bayesian Approaches ◽  
Clinical Phase ◽  
Commercial Market ◽  
Multidisciplinary Perspective ◽  
The One

Abstract The introduction of a new drug to the commercial market follows a complex and long process that typically spans over several years and entails large monetary costs due to a high attrition rate. Because of this, there is an urgent need to improve this process using innovative technologies such as artificial intelligence (AI). Different AI tools are being applied to support all four steps of the drug development process (basic research for drug discovery; pre-clinical phase; clinical phase; and postmarketing). Some of the main tasks where AI has proven useful include identifying molecular targets, searching for hit and lead compounds, synthesising drug-like compounds and predicting ADME-Tox. This review, on the one hand, brings in a mathematical vision of some of the key AI methods used in drug development closer to medicinal chemists and, on the other hand, brings the drug development process and the use of different models closer to mathematicians. Emphasis is placed on two aspects not mentioned in similar surveys, namely, Bayesian approaches and their applications to molecular modelling and the eventual final use of the methods to actually support decisions. Graphic abstract Promoting a perfect synergy

scholarly journals Lost in Translation - Bridging the preclinical and clinical worlds concepts, Examples, Successes, and Failures in Translational Medicine

2019 ◽  
Author(s):  
Attila A Seyhan
Keyword(s):  
Drug Development ◽  
Biomedical Research ◽  
Development Process ◽  
Public Funding ◽  
Human Studies ◽  
Attrition Rate ◽  
Drug Development Process ◽  
Preclinical Research ◽  
Attrition Rates ◽  
Research Findings

The biopharmaceutical companies involved in developing drugs for human diseases are facing considerable challenges, both politically and fiscally. There is growing pressure from the general public, funding agencies, and the policymakers for scientists and industry to improve drug development process, better bridge basic and translational human studies, and ultimately improve the process of the development of more effective, safer, and less costly drugs.The crisis involving the scale of the reproducibility and translatability of preclinical research to human studies and high attrition rate of drug development process is widely recognized both in academia and industry. Despite all this, the high attrition rates of drug development and the magnitude of the reproducibility and translatability problems with the preclinical research findings to human studies remain a fact.Recent reports in literature also suggest that many published research findings in preclinical research are misleading, not as robust as they claim, or cannot be reproduced and hence cannot be translated to human studies. The reasons are complex and challenging. Potential culprits range from the complexity of modern biomedical research to the limitations of tools, the trivial methodological differences, to poor experimental designs, inappropriate data analysis, misuse of statistics, the poor predictability of animal results in humans, as well as training and perverse incentives in academia.There are many reports suggesting solutions to overcome these roadblocks in biomedical research. However, how scientists, researchers, and the biopharmaceutical industry deal with this problem depends on the understanding of the root causes of the problem and the strategies and approaches to solving this problem to improve biomedical research.The purpose of this article is to conduct a thorough literature review to evaluate the nature of some of the problems leading to high attrition rates of drug development and to provide some suggestion to overcome the obstacles that impede the drug development process.

Intelligent Drug Development

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.

scholarly journals Bayesian meta-analytical methods to incorporate multiple surrogate endpoints in drug development process

2015 ◽  
Vol 35 (7) ◽  
pp. 1063-1089 ◽  
Author(s):  
Sylwia Bujkiewicz ◽  
John R. Thompson ◽  
Richard D. Riley ◽  
Keith R. Abrams
Keyword(s):  
Drug Development ◽  
Analytical Methods ◽  
Development Process ◽  
Surrogate Endpoints ◽  
Drug Development Process

scholarly journals Precision Medicine: From “Omics” to Economics towards Data-Driven Healthcare - Time for European Transformation

2017 ◽  
Vol 2 (Suppl. 1) ◽  
pp. 1-10 ◽  
Author(s):  
Denis Lacombe ◽  
Lifang Liu ◽  
Françoise Meunier ◽  
Vassilis Golfinopoulos
Keyword(s):  
Drug Development ◽  
Development Process ◽  
Precision Oncology ◽  
Drug Development Process ◽  
Cancer Treatments ◽  
True Value ◽  
Efficient Access ◽  
Funding Agencies ◽  
Anti Cancer

There is room for improvement for optimally bringing the latest science to the patient while taking into account patient priorities such as quality of life. Too often, regulatory agencies, governments, and funding agencies do not stimulate the integration of research into care and vice versa. Re-engineering the drug development process is a priority, and healthcare systems are long due for transformation. On one hand, patients need efficient access to treatments, but despite precision oncology approaches, efficiently shared screening platforms for sorting patients based on the biology of their tumour for trial access are lacking and, on the other hand, the true value of cancer care is poorly addressed as central questions such as dose, scheduling, duration, and combination are not or sub-optimally addressed by registration trials. Solid evidence on those parameters could potentially lead to a rational and wiser use of anti-cancer treatments. Together, optimally targeting patient population and robust comparative effectiveness data could lead to more affordable and economically sound approaches. The drug development process and healthcare models need to be interconnected through redesigned systems taking into account the full math from drug development into affordable care.

scholarly journals Pharmacovigilance in Cameroon: Past, Present and Future Developments in Unlocking the Drug Development Process

2020 ◽  
pp. 21-44
Author(s):  
Estella Achick Tembe Fokunang ◽  
Bruna Njeba ◽  
Marie Jose Essi ◽  
Rose Ngono Abondo ◽  
Banin Andrew Nyuki ◽  
...  
Keyword(s):  
Drug Development ◽  
Development Process ◽  
Target Population ◽  
Human Consumption ◽  
Drug Development Process ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Development Processes ◽  
High Standards ◽  
Knowledge Attitude And Practice

The drug discovery and development processes are designed to guarantee that drugs are efficacious, nontoxic and of high standards of quality for human consumption. However, patient’s population with access to drugs at approval is only a fraction of the final target population. Therefore, a thorough understanding of the safety of medicines is generally only achieved after the marketing authorization of the drug, followed by pharmacovigilance or post marketing surveillance. Pharmacovigilance (PHV) is defined by WHO as “the science and activities that deals with the detection, assessment, understanding and prevention of the adverse drug reactions or any other possible drug-related interactions”. Health professionals, patients, drug manufacturers and drug regulatory authorities are therefore highly involved in the practice of PHV. Cameroon imports 95 % of drugs and health care products. Therefore, an effective mastery of the knowledge, attitude and practice of PHV will help to elaborate the development of our pharmacovigilance systems. This paper gives an overview of pharmacovigilance in Cameroon for unlocking the drug development process focusing on the past, present and future.

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