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Article ; Online: Small-molecule inhibitors of α-synuclein for the treatment of Parkinson's disease: a patent landscape.

Joubert, Jacques

Pharmaceutical patent analyst

2020 Volume 9, Issue 3, Page(s) 63–65

MeSH term(s)	Antiparkinson Agents/chemistry ; Antiparkinson Agents/pharmacology ; Antiparkinson Agents/therapeutic use ; Humans ; Parkinson Disease/drug therapy ; Parkinson Disease/metabolism ; Patents as Topic ; Treatment Outcome ; alpha-Synuclein/antagonists & inhibitors ; alpha-Synuclein/metabolism
Chemical Substances	Antiparkinson Agents ; alpha-Synuclein
Language	English
Publishing date	2020-06-30
Publishing country	England
Document type	Editorial
ISSN	2046-8962
ISSN (online)	2046-8962
DOI	10.4155/ppa-2020-0008
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Ever-expanding landscape: Alzheimer's - new targets and new patents.

Egunlusi, Ayodeji O / Joubert, Jacques

Pharmaceutical patent analyst

2022 Volume 11, Issue 5, Page(s) 135–138

MeSH term(s)	Alzheimer Disease/drug therapy ; Amyloid beta-Peptides ; Humans ; tau Proteins
Chemical Substances	Amyloid beta-Peptides ; tau Proteins
Language	English
Publishing date	2022-09-02
Publishing country	England
Document type	Editorial
ISSN	2046-8962
ISSN (online)	2046-8962
DOI	10.4155/ppa-2022-0031
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Article ; Online: Bicyclic bis-heteroaryl derivatives as inhibitors of the α-synuclein protein: a patent evaluation of WO2018138088A1.

Joubert, Jacques

Expert opinion on therapeutic patents

2018 Volume 28, Issue 12, Page(s) 939–945

Abstract: ... ...

Abstract	Introduction
MeSH term(s)	Animals ; Bridged Bicyclo Compounds/chemistry ; Drug Design ; Humans ; Neurodegenerative Diseases/drug therapy ; Neurodegenerative Diseases/physiopathology ; Patents as Topic ; Pharmacokinetics ; alpha-Synuclein/antagonists & inhibitors ; alpha-Synuclein/metabolism
Chemical Substances	Bridged Bicyclo Compounds ; alpha-Synuclein
Language	English
Publishing date	2018-10-31
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1186201-4
ISSN	1744-7674 ; 0962-2594 ; 1354-3776
ISSN (online)	1744-7674
ISSN	0962-2594 ; 1354-3776
DOI	10.1080/13543776.2018.1541234
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Article ; Online: Calcium Modulating Effect of Polycyclic Cages: A Suitable Therapeutic Approach Against Excitotoxic-induced Neurodegeneration.

Egunlusi, Ayodeji O / Malan, Sarel F / Palchykov, Vitalii A / Joubert, Jacques

Mini reviews in medicinal chemistry

2024

Abstract: Neurodegenerative disorders pose a significant challenge to global healthcare systems due to their progressive nature and the resulting loss of neuronal cells and functions. Excitotoxicity, characterized by calcium overload, plays a critical role in the ... ...

Abstract	Neurodegenerative disorders pose a significant challenge to global healthcare systems due to their progressive nature and the resulting loss of neuronal cells and functions. Excitotoxicity, characterized by calcium overload, plays a critical role in the pathophysiology of these disorders. In this review article, we explore the involvement of calcium dysregulation in neurodegeneration and neurodegenerative disorders. A promising therapeutic strategy to counter calcium dysregulation involves the use of calcium modulators, particularly polycyclic cage compounds. These compounds, structurally related to amantadine and memantine, exhibit neuroprotective properties by attenuating calcium influx into neuronal cells. Notably, the pentacycloundecylamine NGP1-01, a cage-like structure, has shown efficacy in inhibiting both N-methyl-D-aspartate (NMDA) receptors and voltage-gated calcium channels (VGCCs), making it a potential candidate for neuroprotection against excitotoxic-induced neurodegenerative disorders. The structure-activity relationship of polycyclic cage compounds is discussed in detail, highlighting their calcium-inhibitory activities. Various closed, open, and rearranged cage compounds have demonstrated inhibitory effects on calcium influx through NMDA receptors and VGCCs. Additionally, these compounds have exhibited neuroprotective properties, including free radical scavenging, attenuation of neurotoxicities, and reduction of neuroinflammation. Although the calcium modulatory activities of polycyclic cage compounds have been extensively studied, apart from amantadine and memantine, none have undergone clinical trials. Further in vitro and in vivo studies and subsequent clinical trials are required to establish the efficacy and safety of these compounds. The development of polycyclic cages as potential multifunctional agents for treating complex neurodegenerative diseases holds great promise.
Language	English
Publishing date	2024-01-24
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2104081-3
ISSN	1875-5607 ; 1389-5575
ISSN (online)	1875-5607
ISSN	1389-5575
DOI	10.2174/0113895575273868231128104121
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Article: Regulatory registration timelines of generic medicines in South Africa: Assessment of the performance of SAHPRA between 2011 and 2022.

Moeti, Lerato / Litedu, Madira / Joubert, Jacques

Journal of pharmaceutical policy and practice

2023 Volume 16, Issue 1, Page(s) 34

Abstract: Background: Various regulatory authorities are experiencing backlogs of applications which result in delayed access to medicines for patients. The objective of this study is to critically assess the registration process utilised by SAHPRA between 2011 ... ...

Abstract	Background: Various regulatory authorities are experiencing backlogs of applications which result in delayed access to medicines for patients. The objective of this study is to critically assess the registration process utilised by SAHPRA between 2011 and 2022 and determine the fundamental root causes for the formation of a backlog. The study also aims to detail the remedial actions that were undertaken which resulted in the development of a new review pathway termed the risk-based assessment approach for regulatory authorities experiencing backlogs to implement. Methods: A sample of 325 applications was used to evaluate the end-to-end registration process employed for the Medicine Control Council (MCC) process between 2011 and 2017; 129 applications were used for the backlog clearance project (BCP) between 2019 and 2022; 63 and 156 applications were used for the risk-based assessment (RBA) pilot studies in 2021 and 2022, respectively. The three processes are compared, and the timelines are discussed in detail. Results: The longest median value of 2092 calendar days was obtained for the approval times between 2011 and 2017 using the MCC process. Continuous process optimisation and refinement are crucial to prevent recurring backlogs and hence implementation of the RBA process. Implementation of the RBA process resulted in a shorter median approval time of 511 calendar days. The finalisation timeline by the Pharmaceutical and Analytical (P&A) pre-registration Unit, which conducts the majority of the evaluations, is used as a tool for the direct comparison of the processes. The finalisation timeline for the MCC process was a median value of 1470 calendar days, the BCP was 501 calendar days and the RBA process phases 1 and 2 were 68 and 73 calendar days, respectively. The median values of the various stages of the end-to-end registration processes are also analysed in order to build efficiency within the process. Conclusions: The observations from the study have identified the RBA process which can be implemented to reduce regulatory assessment times while assuring the timeous approval of safe and effective, quality medicines. The continuous monitoring of a process remains one of the critical tools required to ensure the effectiveness of a registration process. The RBA process also becomes a better alternative for generic applications that do not qualify to undergo the reliance approach due to its drawbacks. This robust procedure can therefore be utilised by other regulatory agencies that may have a backlog or want to optimise their registration process.
Language	English
Publishing date	2023-03-02
Publishing country	England
Document type	Journal Article
ZDB-ID	2734772-2
ISSN	2052-3211
ISSN	2052-3211
DOI	10.1186/s40545-023-00537-0
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Article ; Online: The Implementation of a Risk-Based Assessment Approach by the South African Health Products Regulatory Authority (SAHPRA).

Moeti, Lerato / Litedu, Madira / Joubert, Jacques

Pharmaceutical medicine

2023 Volume 37, Issue 1, Page(s) 71–91

Abstract: Background: An extensive backlog of pending regulatory decisions is one of the major historical challenges that the South African Health Products Regulatory Authority (SAHPRA) inherited from the Medicine Control Council (MCC). Revising and implementing ... ...

Abstract	Background: An extensive backlog of pending regulatory decisions is one of the major historical challenges that the South African Health Products Regulatory Authority (SAHPRA) inherited from the Medicine Control Council (MCC). Revising and implementing new regulatory pathways is one of the strategic mechanisms that SAHPRA employs to circumvent this problem. Objectives: To alleviate the backlog, the use of a new review pathway termed the risk-based review on the scientific quality and bioequivalence assessments was explored. The objective of the study was to articulate the risk-based assessment (RBA) pathway, to determine robust criteria for the classification of the levels of risk for medicines, and to define the improved process to be followed in the assessment and approval of medicines. Methods: In 2015, an extensive exercise was conducted by SAHPRA to identify the unknown status of in-process applications. The RBA pilot project commenced in 2016 and further piloted in 2021 using the knowledge gained from the 2016 study for optimisation of efficiency. Results: By 2015 the backlog was quantified as 7902 applications in the pre-registration phase. The 2015 project entailed two phases. The initial phase was conducted to identify the status of 3505 in-process applications, which resulted in the registration of 198 applications. The second phase commenced in 2016 on 4397 applications not yet reviewed whereby the RBA approach was explored. With the developed criteria for risk classification and refined end-to-end registration process, the pilot resulted in a finalisation time with a median value of 90 calendar days and a median approval time of 109 calendar days. The throughput of the RBA pilot study conducted in 2021 was 68 calendar days finalisation time for the 63 applications used. These finalisation times are lower in comparison to the 501 calendar days for the current process employed by SAHPRA for the backlog clearance programme initiated in 2019. Both the 2016 and 2021 studies had similar approval times calculated from the date of allocation of scientific assessments. The reported evaluation timelines for both studies were within 6-7 h for a low-risk quality assessment, 9-10 h for a high-risk quality assessment, 7-8 h for a bioequivalence assessment, and 2-3 h for a biowaiver and initial response assessment. Conclusions: The refined processes used in the risk-based pilot studies to alleviate the SAHPRA backlog are described in detail. The process managed a reduction of the finalisation time to 68 calendar days in comparison to 501 calendar days for the current process that was employed by SAHPRA for the backlog clearance programme initiated in 2019. The RBA approach, therefore, reduces the finalisation and approval times for quality and bioequivalence assessments for regulatory authorities without compromising on the quality, safety and efficacy of the medicinal products. In addition, the approach provides a prototype solution to counteract the influx of medicinal product applications received by the regulatory authorities.
MeSH term(s)	Pilot Projects ; South Africa ; Risk Assessment
Language	English
Publishing date	2023-01-04
Publishing country	New Zealand
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2415165-8
ISSN	1179-1993 ; 1178-2595
ISSN (online)	1179-1993
ISSN	1178-2595
DOI	10.1007/s40290-022-00452-w
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Article: Editorial: Channel Modulation in Neurodegeneration and Neuroprotection.

Joubert, Jacques / Malan, Sarel F / Geldenhuys, Werner J

Frontiers in pharmacology

2022 Volume 13, Page(s) 872103

Language	English
Publishing date	2022-03-23
Publishing country	Switzerland
Document type	Editorial
ZDB-ID	2587355-6
ISSN	1663-9812
ISSN	1663-9812
DOI	10.3389/fphar.2022.872103
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Article ; Online: Chronic non-communicable diseases--where to now in Africa?

Joubert, Jacques

Journal of the neurological sciences

2015 Volume 348, Issue 1-2, Page(s) 3–5

MeSH term(s)	Diabetes Mellitus/therapy ; Global Health/standards ; Health Education/standards ; Humans ; Stroke/therapy ; Telemedicine/standards
Language	English
Publishing date	2015-01-15
Publishing country	Netherlands
Document type	Comment ; Editorial
ZDB-ID	80160-4
ISSN	1878-5883 ; 0022-510X ; 0374-8642
ISSN (online)	1878-5883
ISSN	0022-510X ; 0374-8642
DOI	10.1016/j.jns.2014.11.021
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Article ; Online: Diagnostic accuracy and reliability of smartphone captured radiologic images communicated via WhatsApp®.

Ntja, Unathi / Janse van Rensburg, Jacques / Joubert, Gina

African journal of emergency medicine : Revue africaine de la medecine d'urgence

2022 Volume 12, Issue 1, Page(s) 67–70

Abstract: Introduction: Sending radiographic images as instant messages have become a common means of communication between physicians, aiding in triaging and transfer decision-making in emergencies. While use of technology is increasing, this is not the case for ...

Abstract	Introduction: Sending radiographic images as instant messages have become a common means of communication between physicians, aiding in triaging and transfer decision-making in emergencies. While use of technology is increasing, this is not the case for the underserved or rural areas of South Africa with no picture archiving and communications system or advanced hardware in place. In these areas, the medical staffing population have nearly universal access to smartphones and could benefit from the ability to share images quickly and easily with trained radiologists. South African data on diagnostic reliability of smartphone captured radiology images is lacking. The objective of the study was to determine the accuracy and reliability of diagnoses made on radiologic images captured with smartphone compared to radiologic images on picture archiving and communication system(PACS). Methods: A cross-sectional study was conducted with radiographs from June 2018 to July 2019 selected from the PACS system at Pelonomi Tertiary Hospital. Images were displayed on PACS computer screen and captured by principal researcher using a smartphone. Five radiology registrars received the images via WhatsApp® and reviewed them on smartphones. After three weeks, registrars viewed images in random order on PACS stations. McNemar's test was used to compare the diagnostic accuracy of smartphone vs PACS and Kappa values calculated for agreement. Reliability was assessed by analysing the results of different registrars and diagnoses separately. Results: 135 X-rays, representative of common emergency conditions, were selected. For all registrars, PACS accuracy was generally higher than smartphone accuracy. The Kappa values all indicated fair to moderate agreement between smartphone and PACS diagnosis. Conclusion: Capturing radiographic images using at least 12-megapixel smartphone and sharing them via WhatsApp® is a reliable method that can be used with a high degree of confidence in emergencies to aid clinical decision making. This method of viewing medical imaging is however not a substitution for images viewed on PACS.
Language	English
Publishing date	2022-01-12
Publishing country	Netherlands
Document type	Journal Article
ISSN	2211-4203
ISSN (online)	2211-4203
DOI	10.1016/j.afjem.2021.11.001
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Article: Common deficiencies found in generic Finished Pharmaceutical Product (FPP) applications submitted for registration to the South African Health Products Regulatory Authority (SAHPRA).

Moeti, Lerato / Litedu, Madira / Joubert, Jacques

Journal of pharmaceutical policy and practice

2022 Volume 15, Issue 1, Page(s) 6

Abstract: Background: The aim of the study was to investigate the common deficiencies observed in the Finished Pharmaceutical Product (FPP) section of generic product applications submitted to SAHPRA. The study was conducted retrospectively over a 7-year period ( ... ...

Abstract	Background: The aim of the study was to investigate the common deficiencies observed in the Finished Pharmaceutical Product (FPP) section of generic product applications submitted to SAHPRA. The study was conducted retrospectively over a 7-year period (2011-2017) for products that were finalised by the Pharmaceutical and Analytical pre-registration Unit. Methods: There were 3148 finalised products in 2011-2017, 667 of which were sterile while 2089 were non-sterile. In order to attain a representative sample for the study, statistical sampling was conducted. Sample size was obtained using the statistical tables found in literature and confirmed by a sample size calculation with a 95% confidence level. The selection of the products was according to the therapeutic category using the multi-stage sampling method called stratified-systematic sampling. This resulted in the selection of 325 applications for non-sterile products and 244 applications for sterile products. Subsequently, all the deficiencies were collected and categorised according to Common Technical Document (CTD) subsections of the FPP section (3.2.P). Results: A total of 3253 deficiencies were collected from 325 non-sterile applications while 2742 deficiencies were collected from 244 sterile applications. The most common deficiencies in the FPP section for non-sterile products were on the following sections: Specifications (15%), Description and Composition (14%), Description of the Manufacturing Process (13%), Stability Data (7.6%) and the Container Closure System (7.3%). The deficiencies applicable to the sterile products were quantified and the subsection, Validation and/or Evaluation (18%) has the most deficiencies. Comparison of the deficiencies with those reported by other agencies such as the USFDA, EMA, TFDA and WHOPQTm are discussed with similarities outlined. Conclusions: The overall top five most common deficiencies observed by SAHPRA were extensively discussed for the generic products. The findings provide an overview on the submissions and regulatory considerations for generic applications in South Africa, which is useful for FPP manufacturers in the compilation of their dossiers and will assist in accelerating the registration process.
Language	English
Publishing date	2022-01-12
Publishing country	England
Document type	Journal Article
ZDB-ID	2734772-2
ISSN	2052-3211
ISSN	2052-3211
DOI	10.1186/s40545-021-00398-5
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