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1.
AAPS J ; 24(1): 19, 2022 01 04.
Article in English | MEDLINE | ID: covidwho-1605878

ABSTRACT

Over the past decade, artificial intelligence (AI) and machine learning (ML) have become the breakthrough technology most anticipated to have a transformative effect on pharmaceutical research and development (R&D). This is partially driven by revolutionary advances in computational technology and the parallel dissipation of previous constraints to the collection/processing of large volumes of data. Meanwhile, the cost of bringing new drugs to market and to patients has become prohibitively expensive. Recognizing these headwinds, AI/ML techniques are appealing to the pharmaceutical industry due to their automated nature, predictive capabilities, and the consequent expected increase in efficiency. ML approaches have been used in drug discovery over the past 15-20 years with increasing sophistication. The most recent aspect of drug development where positive disruption from AI/ML is starting to occur, is in clinical trial design, conduct, and analysis. The COVID-19 pandemic may further accelerate utilization of AI/ML in clinical trials due to an increased reliance on digital technology in clinical trial conduct. As we move towards a world where there is a growing integration of AI/ML into R&D, it is critical to get past the related buzz-words and noise. It is equally important to recognize that the scientific method is not obsolete when making inferences about data. Doing so will help in separating hope from hype and lead to informed decision-making on the optimal use of AI/ML in drug development. This manuscript aims to demystify key concepts, present use-cases and finally offer insights and a balanced view on the optimal use of AI/ML methods in R&D.


Subject(s)
Artificial Intelligence , Clinical Trials as Topic , Computational Biology , Drug Development , Machine Learning , Pharmaceutical Research , Research Design , Animals , Artificial Intelligence/trends , Computational Biology/trends , Diffusion of Innovation , Drug Development/trends , Forecasting , Humans , Machine Learning/trends , Pharmaceutical Research/trends , Research Design/trends
3.
Pharm Res ; 38(1): 3-7, 2021 Jan.
Article in English | MEDLINE | ID: covidwho-1384537

ABSTRACT

Biologics are complex pharmaceuticals that include formulated proteins, plasma products, vaccines, cell and gene therapy products, and biological tissues. These products are fragile and typically require cold chain for their delivery and storage. Delivering biologics, while maintaining the cold chain, whether standard (2°C to 8°C) or deepfreeze (as cold as -70°C), requires extensive infrastructure that is expensive to build and maintain. This poses a huge challenge to equitable healthcare delivery, especially during a global pandemic. Even when the infrastructure is in place, breaches of the cold chain are common. Such breaches may damage the product, making therapeutics and vaccines ineffective or even harmful. Rather than strengthening the cold chain through building more infrastructure and imposing more stringent guidelines, we suggest that money and effort are best spent on making the cold chain unnecessary for biologics delivery and storage. To meet this grand challenge in pharmaceutical research, we highlight areas where innovations are needed in the design, formulation and biomanufacturing of biologics, including point-of-care manufacturing and inspection. These technological innovations would rely on fundamental advances in our understanding of biomolecules and cells.


Subject(s)
Biological Products/standards , COVID-19/therapy , Pharmaceutical Research/standards , Refrigeration/standards , Biological Products/therapeutic use , COVID-19/epidemiology , Humans , Pharmaceutical Research/trends , Refrigeration/trends , Vaccines/standards , Vaccines/therapeutic use
5.
Biomed Pharmacother ; 142: 111998, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1347501

ABSTRACT

Lianhua-Qingwen capsule (LQC) is a commonly used Traditional Chinese Medicine (TCM) in China and has 11 herb components. The main active ingredient can target specific molecules and perform many clinic treatment roles. LQC has been authorized by National Medical Products Administration (NMPA) of China to treat severe acute respiratory syndrome (SARS) in 2002-2003, type A influenza virus HIN1 pandemic in 2009, H7N9, H3N2 and coronavirus disease-19 (COVID19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) in 2020. It is also widely used to treat common cold with wind-heat syndrome, chronic rhinosinusitis (CRS), amygdalitis and chronic obstructive pulmonary disease. This article summarizes the advanced research progress of LQC in clinical application, mechanisms and provides new clues in the clinical application of LQC.


Subject(s)
COVID-19/drug therapy , Drugs, Chinese Herbal/pharmacology , SARS-CoV-2/drug effects , Antiviral Agents/pharmacology , Capsules , Humans , Medicine, Chinese Traditional/methods , Pharmaceutical Research
7.
Therapie ; 76(6): 549-557, 2021.
Article in English | MEDLINE | ID: covidwho-1230795

ABSTRACT

AIMS: The French pharmaceutical companies' association (LEEM) biennially carries out a study on the attractiveness of France in pharmaceutical clinical research. This study aims to measure France's global competitiveness for international clinical trials (CT) and assess its strengths and areas of excellence. METHODS: A descriptive and comparative analysis was conducted using the data from both the ClinicalTrials.gov registry for the 2015-2019 period and those reported in a national web-based database (OSCAR) involving the major pharmaceutical companies operating in France in 2018-2019. OSCAR allows to describe the administrative authorization and starting process for all drug trials conducted in France. RESULTS: Among 8607 worldwide drug trials initiated in 2019, 34.3% (n=2.954) were funded exclusively by pharmaceutical companies (52.1% in France). On average, France was involved in 10.5% of all global industrial CTs launched over 2018-2019, still ranking in the 4th position among European countries. Early-phase trials represented 17.3% of trials conducted by the drug companies in France, versus 25% in Germany and 29% in United Kingdom. Oncology remains an area of excellence in France with 18.7% of all worldwide CTs conducted in this therapeutic area over the study period involving at least some French centres, ranking France 2nd among European countries. The median of total deadline before the first patient inclusion of 204 days in 2018-2019 with no marked improvement as compared to 2016-2017 period. However, the delay getting initial trial authorization was slightly reduced and an overall deadline of 167 days was observed for CTs entered the pilot phase initiated recently by the European regulation. CONCLUSION: After ten difficult years, areas of excellence, such as oncology and rare diseases and more recently, the outstanding mobilization for the COVID-19 research, have enabled France to maintain its pharmaceutical research. Furthermore, a set of additional decisions would strengthen this position in the next years.


Subject(s)
COVID-19 , Pharmaceutical Research , Drug Industry , France , Humans , SARS-CoV-2
8.
Int J Environ Res Public Health ; 18(5)2021 03 04.
Article in English | MEDLINE | ID: covidwho-1129700

ABSTRACT

Pharmaceuticals enhance our quality of life; consequently, their consumption is growing as a result of the need to treat ageing-related and chronic diseases and changes in the clinical practice. The market revenues also show an historic growth worldwide motivated by the increase on the drug demand. However, this positivism on the market is fogged because the discharge of pharmaceuticals and their metabolites into the environment, including water, also increases due to their inappropriate management, treatment and disposal; now, worldwide, this fact is recognized as an environmental concern and human health risk. Intriguingly, researchers have studied the most effective methods for pharmaceutical removal in wastewater; however, the types of pharmaceuticals investigated in most of these studies do not reflect the most produced and consumed pharmaceuticals on the market. Hence, an attempt was done to analyze the pharmaceutical market, drugs consumption trends and the pharmaceutical research interests worldwide. Notwithstanding, the intensive research work done in different pharmaceutical research fronts such as disposal and fate, environmental impacts and concerns, human health risks, removal, degradation and development of treatment technologies, found that such research is not totally aligned with the market trends and consumption patterns. There are other drivers and interests that promote the pharmaceutical research. Thus, this review is an important contribution to those that are interested not only on the pharmaceutical market and drugs consumption, but also on the links, the drivers and interests that motivate and determine the research work on certain groups of pharmaceuticals on water and wastewater.


Subject(s)
Pharmaceutical Preparations , Pharmaceutical Research , Water Pollutants, Chemical , Environmental Monitoring , Humans , Incidence , Quality of Life , Waste Disposal, Fluid , Waste Water/analysis , Water , Water Pollutants, Chemical/analysis
9.
Viruses ; 12(9)2020 09 22.
Article in English | MEDLINE | ID: covidwho-1120792

ABSTRACT

Traditionally, drug discovery utilises a de novo design approach, which requires high cost and many years of drug development before it reaches the market. Novel drug development does not always account for orphan diseases, which have low demand and hence low-profit margins for drug developers. Recently, drug repositioning has gained recognition as an alternative approach that explores new avenues for pre-existing commercially approved or rejected drugs to treat diseases aside from the intended ones. Drug repositioning results in lower overall developmental expenses and risk assessments, as the efficacy and safety of the original drug have already been well accessed and approved by regulatory authorities. The greatest advantage of drug repositioning is that it breathes new life into the novel, rare, orphan, and resistant diseases, such as Cushing's syndrome, HIV infection, and pandemic outbreaks such as COVID-19. Repositioning existing drugs such as Hydroxychloroquine, Remdesivir, Ivermectin and Baricitinib shows good potential for COVID-19 treatment. This can crucially aid in resolving outbreaks in urgent times of need. This review discusses the past success in drug repositioning, the current technological advancement in the field, drug repositioning for personalised medicine and the ongoing research on newly emerging drugs under consideration for the COVID-19 treatment.


Subject(s)
Coronavirus Infections/drug therapy , Drug Repositioning , Pneumonia, Viral/drug therapy , Betacoronavirus , COVID-19 , Coronavirus Infections/epidemiology , Drug Repositioning/economics , Drug Repositioning/trends , Humans , Pandemics , Pharmaceutical Research , Pneumonia, Viral/epidemiology , Precision Medicine , Rare Diseases/drug therapy , SARS-CoV-2
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