SIG: Cell and Gene Therapy

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  • 1.  URGENT: Input required for submission to new ISPE call for manuscripts (on behalf of Jodie)

    Posted 09-27-2023 15:18
    Edited by Lourens Bloem 09-27-2023 15:19
      |   view attached

    Dear all, 

    As discussed, Jodie has been working on a new proposal for the latest ISPE call for manuscripts. Please find the call text below. The preliminary manuscript title reads "A current state analysis of patient expectations, experiences, and outcomes for gene therapies. Implications for health technology assessment and post-marketing surveillance.".

    Your input and contribution are greatly appreciated. I have created a dedicated Teams page and underlying Sharepoint to hopefully work on this together. Please indicate if you would like to be involved and I will add you to the Sharepoint. Either send me an email (l.t.bloem@uu.nl) or request access through this link or ISPE CGT SIG funded manuscript proposal_September 2023_V1.docx. I think that should also result in a nudge to give you access.

    In the meantime and for sake of efficiency, please already find the proposal attached to this message. However, please do not respond to this message with any comments but provide these through the Sharepoint directly into the shared document. Also kindly provide your contributors information in the file.

    Please note that the deadline for submission is this Sunday, 11:59 PM ET (or Monday, 02:29 PM in Adelaide - Jodie's time). So there's very little time!

    Best wishes, 
    Lourens 

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    ISPE annually funds proposals for manuscripts that could be used for guideline development, or reference documents for pharmacoepidemiology, including pharmacovigilance, drug utilization research, outcomes research, comparative effectiveness research, and therapeutic risk management.
    Suggested topics of interest to the Society include (see instructions for more):
    • Methodological topics/considerations in the area of COVID-19 vaccines and therapeutics safety ‎and effectiveness
    • Real-world evidence
    • Precision medicine
    • Patient-generated health data
    • Signal detection in emerging large data sets such as EHR or social media
    • Use of pharmacological / mechanistic data in pharmacoepidemiologic studies
    • AI and machine learning approaches vs classical PE to examine causal hypotheses
    • New methods in pharmacoepidemiology
    • Best practices related to specific approaches in pharmacoepidemiology
    • Evaluation of risk minimization approaches
    • Measuring impact of pharmacovigilance activities
    • Guidance/methods (design/analysis) of multi-database studies
    • Any topic contributing to ISPE's strategic mission
    Proposal are assessed against the following criteria:
    • Appropriateness of issue to the general ISPE membership
    • General interest of topic to ISPE membership
    • Feasibility to accomplish the stated objectives
    • Importance (or significance) of proposal to the field of pharmacoepidemiology
    • Visibility (the extent to which the proposed manuscript will be used and, if so, raise the visibility of pharmacoepidemiology)
    • Collaboration among multiple organizations, work sectors, and geographic regions, and
    • Consistency with ISPE strategic goals, objectives and priorities
    Proposals must conform to the format described in this document.
    Submissions for 2023, which may only be submitted online, are now being accepted at this website with a deadline of 11:59 PM US Eastern Time on Sunday, October 1. The deadline will not be extended, and proposals submitted via other means will not be accepted.
     
    General Timeline
    Oct 1 – submission deadline
    Oct 31 – Joint Manuscript Proposal Review Subcommittee completes first review, provides feedback
    Nov 30 – author responses to feedback due
    Dec 20 – final selections made; notifications to lead contacts



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    L.T. (Lourens) Bloem, PharmD, PhD
    Assistant Professor Clinical Therapeutics | Division of Pharmacoepidemiology and Clinical Pharmacology | Utrecht Institute for Pharmaceutical Sciences | Utrecht University | +31 (0)6 1861 7658 | www.uu.nl/staff/LTBloem
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  • 2.  RE: URGENT: Input required for submission to new ISPE call for manuscripts (on behalf of Jodie)

    Posted 09-29-2023 18:20
    Edited by Katie Miller 09-29-2023 18:21

    Dear Lourens, Jodie and All - this draft looks good to me but I am having trouble accessing microsoft teams. I would like to participate in this activity with respect to 'patient preferences' aspect and wonder if calling out IMI-Prefer, at least as a reference, would be prudent (https://www.imi-prefer.eu/public-consultation/the-prefer-framework/)? Thank you for putting this together and sharing. Katie 



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    Katie Miller
    Genentech
    Lakewood OH
    +650-278-5056
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  • 3.  RE: URGENT: Input required for submission to new ISPE call for manuscripts (on behalf of Jodie)

    Posted 10-01-2023 02:14

    Hi Katie, thank you for this information. I will include this as a reference. I too am having trouble accessing Teams at the moment. If you would like to send your contact details and a brief bio directly to me at: jodie.hillen@unisa.edu.au I will include you as a co-author on the proposal.



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    Jodie Hillen
    Research Fellow
    UniSA, Australia
    jodie.hillen@unisa.edu.au
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