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  1. Asia Core Dossier: Standardizing CMC Requirement to Facilitate Best Case Submissions in Asia
    Boobalan J, Sohn KB, Shinawatra O
    Ther Innov Regul Sci, 2024 Mar;58(2):223-233.
    PMID: 38194164 DOI: 10.1007/s43441-023-00600-7
    When the regulatory requirements are converged or harmonized, the country-specific variance of countries is often reduced or omitted, and this facilitates the possibility of preparing a core dossier that caters to multiple countries. When such options of a core dossier are acceptable to multiple countries, the resource required to prepare the dossier and the time taken to prepare it is also reduced, thus eliminating resource constraints in supporting dossier planning and preparation and indirectly facilitating earlier submission in countries. In this paper, the authors have illustrated a process applied to standardize the dossier requirements amongst selected countries in Asia, producing an output of a core dossier that applies to four submission types amongst these countries. The core dossier adopts the International Council for Harmonization-Common Technical Dossier format as a reference. Main focus is the standardization of format and requirements within the Module 3 or Chemistry Manufacturing Controls sections of the dossier, which from the authors' organizational experience usually notes a higher variances and country-specific elements. Development of the dossier standardization process is due to an internal hurdle within the authors' organization, where global resource constraints and prioritizations of dossier preparation and compliance review process needed to be improved to facilitate earlier or near-simultaneously submissions in the majority of the Asia countries. The paper demonstrates an assessment of the dossier components and standardization to assemble a fit-for-purpose core dossier termed 'Asia Core Dossier' (ACD). ACD has been successfully implemented within the authors' organization to reduce country-specific requirements and facilitate earlier (fit for strategy) submissions in the selected Asia countries. The paper also discusses the tangible benefits of the authors' experiences from utilizing the ACD. Regulatory professionals in different organizations could reference the ACD as a template for preparing a simplified and efficient dossier and as a relevant component of Good Submission Practice (GSubP).
  2. Performance of point-of-care Xpert HIV-1 plasma viral load assay at a tertiary HIV care centre in Southern India
    Swathirajan CR, Vignesh R, Boobalan J, Solomon SS, Saravanan S, Balakrishnan P
    J Med Microbiol, 2017 Oct;66(10):1379-1382.
    PMID: 28901908 DOI: 10.1099/jmm.0.000514
    BACKGROUND: Sustainable suppression of HIV replication forms the basis of anti-retroviral therapy (ART) medication. Thus, reliable quantification of HIV viral load has become an essential factor to monitor the effectiveness of the ART. Longer turnaround-time (TAT), batch testing and technical skills are major drawbacks of standard real-time PCR assays.

    METHODS: The performance of the point-of-care Xpert HIV-1 viral load assay was evaluated against the Abbott RealTime PCR m2000rt system. A total of 96 plasma specimens ranging from 2.5 log10 copies ml-1 to 4.99 log10 copies ml-1 and proficiency testing panel specimens were used. Precision and accuracy were checked using the Pearson correlation co-efficient test and Bland-Altman analysis.

    RESULTS: Compared to the Abbott RealTime PCR, the Xpert HIV-1 viral load assay showed a good correlation (Pearson r=0.81; P<0.0001) with a mean difference of 0.27 log10 copies ml-1 (95 % CI, -0.41 to 0.96 log10 copies ml-1; sd, 0.35 log10 copies ml-1).

    CONCLUSION: Reliable and ease of testing individual specimens could make the Xpert HIV-1 viral load assay an efficient alternative method for ART monitoring in clinical management of HIV disease in resource-limited settings. The rapid test results (less than 2 h) could help in making an immediate clinical decision, which further strengthens patient care.

  3. Fulltext Regulatory agilities impacting review timelines for Pfizer/BioNTech's BNT162b2 mRNA COVID-19 vaccine: a retrospective study
    Patel P, Macdonald JC, Boobalan J, Marsden M, Rizzi R, Zenon M, et al.
    Front Med (Lausanne), 2023;10:1275817.
    PMID: 38020129 DOI: 10.3389/fmed.2023.1275817
    The appropriate use of regulatory agilities has the potential to accelerate regulatory review, utilize resources more efficiently and deliver medicines and vaccines more rapidly, all without compromising quality, safety and efficacy. This was clearly demonstrated during the COVID-19 pandemic where regulators and industry rapidly adapted to ensure continued supply of existing critical medicines and review and approve new innovative medicines. In this retrospective study, we analyze the impact of regulatory agilities on the review and approval of Pfizer/BioNTech's BNT162b2 mRNA COVID-19 Vaccine globally using regulatory approval data from 73 country/regional approvals. We report on the critical role of reliance and provide evidence that demonstrates reliance approaches and certain regulatory agilities reduced review times for the COVID-19 vaccine. These findings support the case for more widespread implementation of regulatory agilities and demonstrate the important role of such approaches to improve public health outcomes.
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