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    20141103 Sanofi to FDA - Combined - Reduced Size

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    20141103 Sanofi to FDA - Combined - Reduced Size

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    20141103 Sanofi to FDA - Combined - Reduced Size

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
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    154K views12 pages

    Sanofi To FDA - Combined - Reduced Size

    Uploaded by

    ThinkingPinoy
    20141103 Sanofi to FDA - Combined - Reduced Size

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
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    of 12
    SANOFI Ve march 2004 KENNETH HARTIGAN-GO, MD Director General \dministeation, pa City ind Attention: Ms, Maria Lourdes C, Santiago MSc, MM Center for Drug Regulation and Research Subject MINUTES OF THE MEETING March 3, 2014 Dear Ms, Santiago, We would lik discuss update fatuls of our Candidate vaccine against \We woud to provide you Minutes of the Meeting far yaur validation. We hope yu find everything in order, Thank you very much. Respectfully yours, Jenin B. ae Regulatory 's Manager x Philippines FDA Ds eh 3, Attendees from PH FDA Ms Lulu Santiago (Director, Center for Drugs Regulation and Research) Dr Tito King (OIC, Clinical Trial Unit) Lanette Querubin (OIC, Pharmacovigilance Unit) Grace Medina (Vaceine Supervisor, CORR) Valerie Legaspi (Vaccine Evaluator, CORR) Alvin Bartolome (Evaluator, Central Laboratory) Alvie Paradia (Evaluator, Central Laboratory) Marge Lerin (Evaluator, CTU) Mallen Ofrecio (Pharmacist, CDRR) Attendees from Sanofi Pasteur Ching Santos (Country Manager) Dr Ruby Dizon (Medical Director) Jervin Papelleras (RA Manager) Rio Salas (RA Officer) Dr Joselito Sta Ana (Head, Dengue Group Asta Pac) Dr Anh Wartel (Senior Director, Clinical R&D Asia Pac) Jean-Baptiste Nicollet, PharmD (Regulatory Area Leader, Asia Pac) Time: 2:00 to 4:00pm Slide presentation (Attached as Annex) 1, Objective To present updates on dengue vaccine clinical development, and confirm the proposed registration strategy in 2015, following the last meeting with FDA in 2012 2. Executive Summary * Dengue vaccine Is the first vaccine for which a full clinical development is conducted In the Philippines, from Phase | to Phase I!l, with a wide range of age groups (i.e, 12 months to 45 yo) gnd numbers of patients. 5 10,278 Chlinam 2-14 Y)( tiheck ta ercrenrte ? J 3. Detailed discussion ‘As Dengue vaccine is aimed to address public healt in February 2015 and without walting pelos! the FDA. ‘approval To secure this strategy, there Is ho need to change the I a Panel of National Experts from the De gue Program of the will be involved in the file evaluation, FDA will take which a roster has been established already, The submission of the Priority CTD file fs planned In February the file evaluation as soon as possible. It is accepted by the FDA to receive the Master CTD file In June 2¢ as Drug Substance manufacturing site based on blocomparability ¢ to register the indication from 9 month of age and co administi capitalize on the NVL large capacity of Production. SP proposed to meet with the FDA in the 2nd Semester of 2014 to the CYD14 and CYD 15 and to prepare the submission planned In Ms Lulu Santiago opened the meeting by Introducing her te introduction of the SP Team by Ching Santos, Ching stated SP’s updates on dengue vaccine development especially those stu in PH. It was clarified with Ms Lulu that local clinical studies also be introduced ih | MLY, SG and also_THL, He continued SP's Dengue Vaccine ambition and global epidemiology se region. He also mentioned the Dengue vaccine is the first vat local clinical data in PH from Phase Ill, and Is targeted to be endemic countries. Dr Anh Wartel presented the slides on Dengue Epii Development with focus on studies conducted in PH from. elaborated on the Phase llb CYD23 results and nes t they were duly communicated to both the PH FDA explained that with the ‘upeoming results ‘of phase hypotheses of the low efficacy of serotype 2in O23, on Ms Lulu stated that given the current resources, FDA ; ‘evaluate new molecules that will be first registered in the cc in plan in the next 3-5 years for this capacity to be de acknowledged that as the product is aimed to address public can put on board other clinicians, epidemiologists, Dfastatstias and a high level meeting can be set-up to discuss the p added that they will also try their best to fast track the review the existing regulation which js 180wd or 9 months. Ms Lulu inquired if the Master File is similar to a variation file. J that both the Priority and Master files are full CTD Files. He ‘the Priority File (ie., non clinical part, Module 5 etc), before CTD of the Master File which will contain new parts (j.e. biocot analyses, etc) and sections that are the same as the previous file, Dr King confirmed the discussion on joint review when he attended the inquired how SP assessed as of this time the results of low efficacy of Phase IIB. Dr Anh Wartel explained that there are investigations/hypotheses to explain why there was a low efficacy in they will require reconciliation with CYD14/15 results. Dr Sta Ana further explained the purpose of DVI which is to facilitate regulatory process wherein the dengue manufacturers can offer countries through this organization, Jean-Baptiste continued on to explain the proposed regulatory timel targeted launch In 2036 following the feedback from FDA on the ref samples and Priority vs Master Filing, Dr Sta Ana added that SP. meeting with FDA and also with the Dengue Program of the DOH of 2014 to present the results of CYD14, same as what SP did when fib came out. Ms Lulu responded to Dr Sta Ana‘s inquiry that the dengue re biological product that has data of studies from Phase J, !l and Ill in dervin mentioned that during the previous meeting with registration is possible even without reference country con focal studies from Phase I-lll, like local herbal medicines, difference is that these herbal medicines were manufactur Ms Lulu that the French Health authorities will provide certificates, except the product license. Ms tulu acknowledged SP’s forecast of targeting approval by possible if SP can submit the dossier as planned, and if FDA can : product to be reviewed even without a reference country, available. However, FDA welcomes this type of drug development, Dr King acknowledged the proposal of having a registration a reference country is because no one can claim the expertise except the endemic countries, and not even the well developed | better. For this reason, FDA maybe can forego the reference will bring up for discussion. burden or endemic. As PH needs the product, FDA welcomes this a proper regulatory framework must be in place as there will be existing regulations. Ching Santos added that since 1993, the DOH started programs Dengue Disease Prevention and Vector Control) with increasing because of the endemicity of the disease in the country, Jean-Baptsite inquired FDA's process to set-tip the policy. Ms according to the existing regulations (i.e, A.O. 67) all imported registered first in other countries and CPP must be provided. She there has been no imported product approved in PH which has not this point would have to be addressed of which we have time before’ Ms Lulu clarified to Ching that It is an option to change the policy | case, there should be information coming from a higher technical regular application, the documents are only internally | consulted to external reviewers, But for the dengue — epidemiologists, biostatisticians, and public health experts fro the DOH, and CMC expert, who will conduct the review all te be an entirely new project and FDA will initiate the formation National Experts) which coincidentally FDA has a~ ‘prepared project, She confirmed that there is na ineed to change the simply to revise the review approach. Ms Lulu inquired about the commercial batch production in clarification to FDA regarding Priority and Mens Ries 3 Dr Sta Ana responded it depends whether the earlier than other countries, in which. doses withioece provided. It was clarified with Ms Lulu that the Dr wransferred from MLE to NVL, She acknowledged document that can be sha guidelines on RMP in PH. DrSta Ana concluded the meetit Lulu’s team SP’s Dengue File strat

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