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LogseqFMS/journals/2024_12_05.md

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- # #Tareas - DONE MIRAR el Excel de María Santamaría SCHEDULED: <2024-12-05 Thu> - DONE AÑADIR diapo a presentación Ale Marina SCHEDULED: <2024-12-05 Thu> - TODO TERMINAR de cortar el vídeo de Marina para Coalición Chagas SCHEDULED: <2024-12-19 Thu>

  • #Eventos

    • DONE 10:30 - 11:30: Reunión tarjeta fin de año SCHEDULED: <2024-12-05 Thu>

      • A tratar

        • Tarjetón de fin de año. Se le manda por mail a todas las áreas y a las sedes para que se la envíen a proveedores y colaboradores

      • Notas

        • Yo propongo usar la bolita logo
        • Dar un poco más de información
        • Reenvío por whatsapp, etc.

      • Decisiones

        • TODO Compartir ideas por email sobre la tarjeta de fin de año SCHEDULED: <2024-12-18 Wed>
    • DONE 15:00 - 16:00: Fw: STOP2030. Steering Committee Meeting - December 2024 @today SCHEDULED: <2024-12-05 Thu>

      • A tratar

        • WP1: Non cost extension Liconsa. Based on the timelines for the clinical trial. We need to ask EDCTP for a non cost extension. Delays in regulatory approval
        • WP1: Regulatory aspects.
        • WP5: PQ at WHO
        • WP1. Interim report
        • WP2. REALISE cliinical trial
        • WP2. Timelines REALISE
        • WP2. Procurement of samples

      • Notas

        • AK: We wont get everythinig clear before june 2026, therefore the non cost extension will be starting to discuss with Ana Duarte (project officer at EDCTP). For all to be clear, all info that pertains to WP3,4 and 5. All info that is needed should be ready by july august 2025. The main reason is to have wp2 finishing al the activities related to the visit on month eleven and everything related to closing the clinical trial. For how long? 6 or 12 months?
        • JM: STOP already needed that and was extended to 5 (it was 4 before). We need to know that they can stretch the budget on site. EDCTP is quite flexible in providing the ok, I don't think they'll deny it, but the budget need to allow teams to survive until then.
        • AK: Its more on the budget than the activity. Most can be done before month 11 and database closure.
        • SD: Some of the tasks of Sanger are not even going to start until very late so we request the full 12 months.
        • JM: We can forecast if we know when the CT starts and ends.
        • AK: How many shipments do you see? once all the samples are collected?
        • SD: 2 per country. one after the one month collection. and the second one by the middle of 2026.
        • AB: Relative to the project. It will be helpful to visualize it. Acknowledge that a no cost extension has a cost. We're mantaining the infra of the project for another year. Adjust budgets and levels of effort now for a potential extension. It is not as easy. WP5 will rely on data coming from the tail end of the studies. Aside from the budget implications, we're intereted in being transparent and reliable on what we say. Changes can make us risk us loosing credibility.
        • AK: No cost is for EDCTP, not for anybody else. The first thought is how to justify this request. Based on the latest input from EMA regarding their judgment. I have no issues regarding the requeest to EDCTP. To keep the trust in us is that there are good reasons to request this. I take your point that the effectiveness component is relevant for WP5. but as far as que have all the safety data, the main goal around this we can move forward. Confirmirng whether we do it or not, its just a matter of confirming 6 or 12 and SD made a good point for the 12 months.
        • JM: WP5 should do the argument with the prelimnary data.
        • AB: We work in stages.
        • AK. Collins, do you have any concerns or practical comments regarding this?
        • CO: I don't have any comments right now.
        • AK: This for Carla to interact with Ana Duarte. I'm putting in my calendar to visit the project officer sometime next year.
        • JM: We can meet for this forecast a dedicated session? See how many months we need.
        • AK: That s somehow happening. The team from liconsa and your team are setting the list of activities and laying them in the calendar. Regarding this non-cost extension, your advice and suggestions are welcome.
        • CV: I'll let you know whenever they tell me anything about this non-cost extension. She confirmed we need to do an ammendment.
        • CV: Si todo va bien la preliminary opinion será el 2025/01/30. In kenya still looking for a local agent. Submissions in latam and india after EMA.
        • AB: We're in a good place for PQ. Its not on liconsas side to make the offer. WHO makes out a call for expresions of interest. They have never put out a call for a FDC. We're in the process of supporting WHO to draft that call for a FDC. In early 2025 allow them to Liconsa to react to that: we have a product that can go for your consideration. That would start the formal PQ process. Maybe 6 months, maybe a bit longer. If things go as planned. We anticipate those pieces in early 2025 to follow closely on the tails of the EMA decission. That would fall nicely into place in 2025. They may say that they want to see or weight the extra effectiveness and expanded safety data.
        • AB: the call is only for STH. its for an indication and a specific medicine. The level of precision is very narrowly defined.
        • AK: They may request additional data. We have started to revise a new version of the systematic review of high dose ivm during the pandemic. Registered in PROSPERO. When any news brought here. That would be useful
        • AB: We've missed the EoI deadline. I didn't know until recently that ALB and IVM arae in the EML, and ALB does specific mention of combination with IVM. It makes it a lot easier than other medicines that have to make from scratch the case that they should be added. We're quite a few steps along the way.
        • CV: Interim report, add it to the word document
        • AL: Protocol 2.0 we received full approval from ERC and FDA. Kenya we have IRB, waiting for PPB. We have made some ammendments to the protocol. They have to be submitted to the countries. 3.0 pending submission. 4.0 it changes one of the inclusion criteria. Se sube a 110cm para que sean 15kg. Setup and preparation at sponsor and site levels is continuing. Liconsa will work on the export permit. The product has been manufactured and that allows the import permit in Ghana and wait for PPB for import in Kenya.
        • AK: Fernando aguirre said in an ideal situation we start on march. best case scenario. but the bulk of the recruitment seems to be happening in May. this is to justify we'll be in june 2026 will still have followup visits and then the db and queries and layers of review and clearing the data. Both countries seem to be aligning to a similar timeline. There are several items, but May june next year will be the most critical months for the trial.
        • SD: well be sampling people in may-june? Probably perfectly good news. After a productive site visit and finalize what we need in terms of samples. we have everything ready. My samples team hasn't had a lot of luck. But contact in ghana and kenya to receive consumables for sample collection. (ellos ya los tienen). We need people that makes sure they arrive safe. Almudena can get the info for them.
        • AB: The customs clearence is all clear?
        • SD: Our samples team is well versed and we should be fine
        • AK: Collins, how do you see to have the CRF ready for march?
        • CO: Yeah, no problem. We've been testing and retesting, programming at our level. Data management issues will be in place and the modelling will be working too.
        • AK. EDCTP forum. I think we should be having it in the horizon but dont want to disrupt any acitivies in the CT. It might be a little bit risky to go there. We need to put priority to the trial.
        • AB: le ha encantado lo de los placebos.
        • AK: Frank Richards: the tablets being orodispersible make them clump together after opening the bottle. That should not happen.
        • CO: Evidence action está muy interesado en trabajar con nosotros porque les interesa mucho la costeffectiveness porque evalúan mucho eso y están dispuestos a colaborar. Una de las discusiones de pasillo fue un grupo de italianos que está interesado en modelar st st en kenya. se ha hecho algo de trabajo en ruanda y a ver si pueden sinergizar.
        • JM: The paper to be online by mid november. The next few weeks will be published. Hopefully before christmas
        • CV: proxima reunión february 6th. Salvo que alguien no pueda decirlo hoy. ponerlo en el calendar y ya lo veremos a la vuelta.

      • Decisiones

        • TODO Añadir el interim report al documento de Word STOP2030 SCHEDULED: <2024-12-18 Wed>