Nonclinical support of pediatric drug development in a global context: an industry perspective

Cappon, Gregg D.

doi:10.1002/bdrb.20303

Cited by 6 publications

(5 citation statements)

References 6 publications

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“…Using electronic databases of chemicals and protein targets and clinical data such as patient to patient variations in response to treatment, several strategies are being employed to reduce the cost of drug development and to increase the speed at which drugs are developed [ 193 ]. There are obvious challenges to the efficient development of drugs and these include the lack of models that can recapitulate the human body properly in terms of response to candidate compounds, the heterogeneity of individuals in terms of their response to candidate compounds and the inability to analyse biological processes properly during testing of candidate compounds [ 194 , 195 , 196 ]. Despite a heavy investment in research and development, most candidate compounds show weakened efficacy as the stages of drug development move towards clinical trials [ 197 , 198 , 199 , 200 , 201 ].…”

Section: Natural Products Drug Discovery Research and Development mentioning

confidence: 99%

Natural Products for Drug Discovery in the 21st Century: Innovations for Novel Drug Discovery

Thomford

Senthebane

Rowe

et al. 2018

IJMS

883

556

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The therapeutic properties of plants have been recognised since time immemorial. Many pathological conditions have been treated using plant-derived medicines. These medicines are used as concoctions or concentrated plant extracts without isolation of active compounds. Modern medicine however, requires the isolation and purification of one or two active compounds. There are however a lot of global health challenges with diseases such as cancer, degenerative diseases, HIV/AIDS and diabetes, of which modern medicine is struggling to provide cures. Many times the isolation of “active compound” has made the compound ineffective. Drug discovery is a multidimensional problem requiring several parameters of both natural and synthetic compounds such as safety, pharmacokinetics and efficacy to be evaluated during drug candidate selection. The advent of latest technologies that enhance drug design hypotheses such as Artificial Intelligence, the use of ‘organ-on chip’ and microfluidics technologies, means that automation has become part of drug discovery. This has resulted in increased speed in drug discovery and evaluation of the safety, pharmacokinetics and efficacy of candidate compounds whilst allowing novel ways of drug design and synthesis based on natural compounds. Recent advances in analytical and computational techniques have opened new avenues to process complex natural products and to use their structures to derive new and innovative drugs. Indeed, we are in the era of computational molecular design, as applied to natural products. Predictive computational softwares have contributed to the discovery of molecular targets of natural products and their derivatives. In future the use of quantum computing, computational softwares and databases in modelling molecular interactions and predicting features and parameters needed for drug development, such as pharmacokinetic and pharmacodynamics, will result in few false positive leads in drug development. This review discusses plant-based natural product drug discovery and how innovative technologies play a role in next-generation drug discovery.

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Section: Natural Products Drug Discovery Research and Development mentioning

confidence: 99%

Natural Products for Drug Discovery in the 21st Century: Innovations for Novel Drug Discovery

Thomford

Senthebane

Rowe

et al. 2018

IJMS

883

556

View full text Add to dashboard Cite

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“…In the US, however, the aim is availability of an agreed pediatric development plan by the beginning of phase III clinical trials and its completion before a new drug application (NDA) is filed. Hence, the first interaction between a pharmaceutical company and a regulatory authority with regard to pediatric drug development is much later in the US than in the EU (Cappon, 2011).…”

Section: Kineticsmentioning

confidence: 99%

“…A more standardized approach, including numerous parameters by default is favored instead, as it appears to be required by the regulatory agencies (Cappon, 2011;Cappon et al, 2009;De Schaepdrijver, 2010) (see also Chapter 2.4.6).…”

Section: Case-by-case Versus Standardized Approachmentioning

confidence: 99%

The need for juvenile animal studies – A critical review

Soellner

Olejniczak²

2013

Regulatory Toxicology and Pharmacology

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“…However, the type and number of studies needed can be complicated by the development of a global plan. There are clear examples of differences in approach for particular compounds in the EU and the US (Cappon, 2011). When preparing these juvenile animal studies, it was recognized that consultation with the regulatory authorities is important, as there may be changes to the pediatric plan (e.g.…”

Section: Case Studies: Emerging Productsmentioning

confidence: 99%

Value of juvenile animal studies

Leconte

Bailey

Davis-Bruno

et al. 2011

Birth Defects Research Part B: Developmental and Reproductive T

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The Developmental and Reproductive Toxicology Technical Committee of the ILSI Health and Environmental Sciences Institute has undertaken a project to address the impact of juvenile animal studies on pediatric drug development. A workshop, sponsored and organized by the Health and Environmental Sciences Institute Developmental and Reproductive Toxicity Technical Committee, was held on May 5-6, 2010, in Washington, DC, to discuss the outcome of a global survey and the value of juvenile animal studies in the development of drugs intended for use in pediatric patients. During this workshop, summary data from the 2009-2010 survey were presented, and breakout sessions were used to discuss specific case studies to try to assess the impact of juvenile animal studies performed to support specific pediatric drug development. The objectives of the Workshop on The Value of Juvenile Animal Studies were to (1) provide a forum for scientists representing industry, academia, and regulatory agencies to discuss the impact of juvenile animal studies on pediatric drug development, (2) evaluate summary data from the survey to understand how the juvenile study data are being used and their impact in labeling and risk assessment, (3) discuss selected case studies from the survey to highlight key findings, and (4) identify the areas of improvement for the designs of juvenile animal studies. The take home message that resonated from the workshop discussions was that well-designed juvenile animal studies have demonstrated value in support of certain pediatric drug development programs. However, it was also clear that a juvenile animal study is not always warranted.

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Nonclinical support of pediatric drug development in a global context: an industry perspective

Cited by 6 publications

References 6 publications

Natural Products for Drug Discovery in the 21st Century: Innovations for Novel Drug Discovery

Natural Products for Drug Discovery in the 21st Century: Innovations for Novel Drug Discovery

The need for juvenile animal studies – A critical review

Value of juvenile animal studies

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