{"id":3483,"date":"2026-01-19T18:24:49","date_gmt":"2026-01-19T17:24:49","guid":{"rendered":"https:\/\/www.phinc-group.com\/?page_id=3483"},"modified":"2026-03-30T10:45:47","modified_gmt":"2026-03-30T08:45:47","slug":"midd","status":"publish","type":"page","link":"https:\/\/www.phinc-group.com\/en\/midd\/","title":{"rendered":"MIDD Strategy"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"3483\" class=\"elementor elementor-3483\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-20b7c06 e-con-full e-flex e-con e-parent\" data-id=\"20b7c06\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1b1a518 elementor-widget__width-inherit elementor-widget elementor-widget-html\" data-id=\"1b1a518\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<!doctype html>\r\n<html lang=\"fr\">\r\n<head>\r\n  <meta charset=\"utf-8\" \/>\r\n  <meta name=\"viewport\" content=\"width=device-width, initial-scale=1\" \/>\r\n  <title>PhinC \u2013 Offre MIDD (Preview)<\/title>\r\n<\/head>\r\n<body style=\"margin:0;background:#ffffff;\">\r\n<section class=\"phinc-midd\">\r\n\r\n  <style>\r\n    :root{\r\n      --phinc-blue:#00005f;\r\n      --phinc-pink:#D94B9F;\r\n      --ink:#0F172A;\r\n      --muted:#475569;\r\n      --line:#E6EAF2;\r\n      --bg:#F7F9FC;\r\n      --card:#FFFFFF;\r\n      --radius:18px;\r\n      --shadow: 0 10px 30px rgba(15, 23, 42, .08);\r\n      --max:1120px;\r\n    }\r\n\r\n    .phinc-midd{\r\n      font-family: inherit; \/* Inter via Elementor *\/\r\n      color:var(--ink);\r\n    }\r\n\r\n    .phinc-wrap{ max-width:var(--max); margin:0 auto; padding:72px 20px; }\r\n    .phinc-eyebrow{\r\n      display:inline-flex; gap:10px; align-items:center;\r\n      padding:8px 12px; border:1px solid var(--line); border-radius:999px;\r\n      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.phinc-side a.is-active{\r\n      border-color: rgba(0,0,95,.35);\r\n      box-shadow: 0 12px 30px rgba(15,23,42,.14);\r\n    }\r\n    .phinc-side a.is-active .phinc-side-dot{\r\n      background: var(--phinc-blue);\r\n    }\r\n\r\n    \/* Hide side menu on small screens *\/\r\n    @media (max-width: 980px){\r\n      .phinc-side{ display:none; }\r\n    }\r\n\r\n    @media (max-width: 920px){\r\n      .phinc-hero-grid, .phinc-split, .phinc-cta{ grid-template-columns: 1fr; }\r\n      .phinc-split.reverse .phinc-split-media{ order: 0; }\r\n      .phinc-cards, .phinc-steps-grid, .phinc-proof{ grid-template-columns: 1fr; }\r\n      .phinc-endorse-grid{ grid-template-columns: 1fr; }\r\n      .phinc-cs-grid{ grid-template-columns: 1fr; }\r\n      .phinc-h1{ font-size:36px; }\r\n    }\r\n  <\/style>\r\n\r\n  <!-- Floating Side Menu -->\r\n  <nav class=\"phinc-side\" aria-label=\"Navigation rapide MIDD\">\r\n    <a href=\"#top\" data-target=\"#top\"><span class=\"phinc-side-dot\"><\/span>MIDD Offer<\/a>\r\n    <a href=\"#deliverables\" data-target=\"#deliverables\"><span class=\"phinc-side-dot\"><\/span>Benefits<\/a>\r\n    <a href=\"#regulatory-endorsement\" data-target=\"#regulatory-endorsement\"><span class=\"phinc-side-dot\"><\/span>Regulatory acceptance<\/a>\r\n    <a href=\"#roadmap\" data-target=\"#roadmap\"><span class=\"phinc-side-dot\"><\/span>Roadmap<\/a>\r\n    <a href=\"#modules\" data-target=\"#modules\"><span class=\"phinc-side-dot\"><\/span>Custom solutions<\/a>\r\n  <\/nav>\r\n\r\n  <header class=\"phinc-hero\" id=\"top\">\r\n    <div class=\"phinc-wrap\">\r\n      <div class=\"phinc-hero-grid\">\r\n        <div>\r\n          <div class=\"phinc-eyebrow\"><span class=\"phinc-dot\"><\/span> <b>Complete MIDD offer - from lead optimization to registration<\/b><\/div>\r\n          <h2 class=\"phinc-h2\">Optimize your development with a clear and traceable MIDD strategy.<\/h2>\r\n          <p class=\"phinc-sub\">\r\n            Through integrated quantitative approach applied from the earliest stages of drug development, MIDD (Model-Informed Drug Development) enables the generation of robust predictive models to inform decision-making and guide development through Phase III.\r\n          <\/p>\r\n\r\n          <div class=\"phinc-actions\">\r\n            <a class=\"phinc-btn primary\" href=\"#contact\">Get in touch<\/a>\r\n            <a class=\"phinc-btn\" href=\"#roadmap\">See the MIDD roadmap<\/a>\r\n          <\/div>\r\n\r\n          <div class=\"phinc-badges\">\r\n            <span class=\"phinc-badge\">PK\/PD - PopPK<\/span>\r\n            <span class=\"phinc-badge\">PBPK<\/span>\r\n            <span class=\"phinc-badge\">QSP<\/span>\r\n            <span class=\"phinc-badge\">Clinical Trial Simulation<\/span>\r\n            <span class=\"phinc-badge\">NCA-CDISC<\/span>\r\n          <\/div>\r\n        <\/div>\r\n\r\n        <div class=\"phinc-hero-card\">\r\n          <div class=\"phinc-visual\" aria-label=\"Visuel MIDD\"><\/div>\r\n          <p class=\"phinc-p\" style=\"margin-top:14px;\">\r\n            Our experts support you from the earliest development stages through regulatory submission.\r\n          <\/p>\r\n        <\/div>\r\n      <\/div>\r\n    <\/div>\r\n  <\/header>\r\n\r\n  <section class=\"phinc-section\" id=\"deliverables\">\r\n    <div class=\"phinc-wrap\">\r\n      <div class=\"phinc-kicker\">What you earn<\/div>\r\n      <h2 class=\"phinc-h2\">Evidence\u2011based decision\u2011making and a well-justified dose.<\/h2>\r\n\r\n      <div class=\"phinc-cards\">\r\n        <div class=\"phinc-card\">\r\n          <h3>Informed strategic decisions<\/h3>\r\n          <p>Anticipate outcomes and reduce risk at key stages of development.<\/p>\r\n          <div class=\"phinc-mini\"><span>go\/no-go<\/span><span>prioritization<\/span><span>time-to-PoC<\/span><\/div>\r\n        <\/div>\r\n        <div class=\"phinc-card\">\r\n          <h3>Smarter clinical trials<\/h3>\r\n          <p>Reduce the number of cohorts, optimize dosing regimens, and shorten timelines.<\/p>\r\n          <div class=\"phinc-mini\"><span>FIH<\/span><span>escalation<\/span><span>populations<\/span><\/div>\r\n        <\/div>\r\n        <div class=\"phinc-card\">\r\n          <h3>Strengthened regulatory dialogue<\/h3>\r\n          <p>Support your decisions with transparent, model-based evidence.<\/p>\r\n          <div class=\"phinc-mini\"><span>dose justification<\/span><span>Q&amp;A authorities<\/span><\/div>\r\n        <\/div>\r\n      <\/div>\r\n    <\/div>\r\n  <\/section>\r\n\r\n  <section class=\"phinc-section alt\" id=\"regulatory-endorsement\">\r\n    <div class=\"phinc-wrap phinc-endorse\">\r\n      <div class=\"phinc-kicker\">Regulatory acceptance<\/div>\r\n      <h2 class=\"phinc-h2\">MIDD is supported by regulatory agencies.<\/h2>\r\n      <p class=\"phinc-p\">\r\n        Regulatory agencies increasingly value MIDD Strategy to improve development efficiency, strengthen dose justification, and support robust decision-making.\r\n      <\/p>\r\n\r\n      <div class=\"phinc-endorse-grid\">\r\n        <div class=\"phinc-endorse-card\">\r\n          <h3>\r\n            <a href=\"https:\/\/www.fda.gov\/drugs\/development-resources\/model-informed-drug-development-paired-meeting-program\"\r\n               target=\"_blank\" rel=\"noopener noreferrer\">\r\n              \ud83c\uddfa\ud83c\uddf8 FDA Paired Meeting\r\n            <\/a>\r\n          <\/h3>\r\n          <p>\r\n            FDA Paired Meetings enable early alignment of modeling strategies with the agency expectations, helping to secure key decisions and de-risking future submissions.\r\n          <\/p>\r\n        <\/div>\r\n\r\n        <div class=\"phinc-endorse-card\">\r\n          <h3>\r\n            <a href=\"https:\/\/database.ich.org\/sites\/default\/files\/ICH_M15_Step4_Final_Guideline_2026_0129.pdf\"\r\n               target=\"_blank\" rel=\"noopener noreferrer\">\r\n              \ud83d\udcd8 ICH M15 \u2013 Guideline MIDD\r\n            <\/a>\r\n          <\/h3>\r\n          <p>\r\n            The ICH M15 guideline formalizes the principles of Model-Informed Drug Development and recognizes its central role in development decision-making.\r\n          <\/p>\r\n        <\/div>\r\n\r\n        <div class=\"phinc-endorse-card\">\r\n          <h3>\r\n            <a href=\"https:\/\/www.ema.europa.eu\/en\/guideline-assessment-reporting-mechanistic-models-used-context-model-informed-drug-development\"\r\n               target=\"_blank\" rel=\"noopener noreferrer\">\r\n              \ud83c\uddea\ud83c\uddfa EMA &amp; mechanistic models\r\n            <\/a>\r\n          <\/h3>\r\n          <p>\r\n            The EMA highlights the value of mechanistic models to strengthen assessment, interpretation, and the robustness of decisions within a MIDD framework.\r\n          <\/p>\r\n        <\/div>\r\n      <\/div>\r\n    <\/div>\r\n  <\/section>\r\n\r\n  <section class=\"phinc-section alt\">\r\n    <div class=\"phinc-wrap\">\r\n      <div class=\"phinc-split\">\r\n        <div class=\"phinc-split-media\" aria-label=\"Visuel\"><\/div>\r\n        <div>\r\n          <div class=\"phinc-kicker\">Approach<\/div>\r\n          <h2 class=\"phinc-h2 translation-block\">A comprehensive MIDD strategy,<br>designed to guide your key decisions.<\/h2>\r\n          <p class=\"phinc-p\">\r\n            From hypothesis definition to final recommendation, we combine modeling, simulation, and regulatory expertise to deliver clear, actionable outputs directly usable by your non-clinical, clinical, and regulatory teams.\r\n          <\/p>\r\n          <div class=\"phinc-actions\">\r\n            <a class=\"phinc-btn primary\" href=\"#roadmap\">Build my development strategy<\/a>\r\n            <a class=\"phinc-btn\" href=\"#modules\">Explore modules<\/a>\r\n          <\/div>\r\n        <\/div>\r\n      <\/div>\r\n    <\/div>\r\n  <\/section>\r\n\r\n  <section class=\"phinc-section\" id=\"roadmap\">\r\n    <div class=\"phinc-wrap\">\r\n      <div class=\"phinc-kicker\">MIDD Roadmap<\/div>\r\n      <h2 class=\"phinc-h2\">From lead optimization to filing<\/h2>\r\n\r\n      <div class=\"phinc-steps\">\r\n        <div class=\"phinc-steps-grid\">\r\n\r\n          <article class=\"phinc-step\">\r\n            <div class=\"phinc-step-top\">\r\n              <span class=\"phinc-num\">\u2609<\/span>\r\n              <span class=\"phinc-stage\">Lead Optimization<\/span>\r\n            <\/div>\r\n            <p>Speed up candidate and target profile selection. PhinC helps you prioritize options through a mechanistic modeling.<\/p>\r\n            <a class=\"phinc-link\" href=\"\/en\/phases\/#s1\"><span>\u2192<\/span> Discuss framing<\/a>\r\n          <\/article>\r\n\r\n          <article class=\"phinc-step\">\r\n            <div class=\"phinc-step-top\">\r\n              <span class=\"phinc-num\">\u2609<\/span>\r\n              <span class=\"phinc-stage\">Preclinical<\/span>\r\n            <\/div>\r\n            <p>Anticipate translation to humans. PhinC helps you secure exposure, starting dose and key assumptions.<\/p>\r\n            <a class=\"phinc-link\" href=\"\/en\/phases\/#s2\"><span>\u2192<\/span> See PBPK \/ PKPD<\/a>\r\n          <\/article>\r\n\r\n          <article class=\"phinc-step\">\r\n            <div class=\"phinc-step-top\">\r\n              <span class=\"phinc-num\">\u2609<\/span>\r\n              <span class=\"phinc-stage\">Phase I<\/span>\r\n            <\/div>\r\n            <p>Secure first administration and escalation. PhinC helps you control PK, tolerance and cohort design.<\/p>\r\n            <a class=\"phinc-link\" href=\"\/en\/phases\/#s3\"><span>\u2192<\/span> Optimizing a FIH<\/a>\r\n          <\/article>\r\n\r\n          <article class=\"phinc-step\">\r\n            <div class=\"phinc-step-top\">\r\n              <span class=\"phinc-num\">\u2609<\/span>\r\n              <span class=\"phinc-stage\">Phase II<\/span>\r\n            <\/div>\r\n            <p>Accelerate patient proof-of-concept.<\/p>\r\n            <p>PhinC helps you optimize the dose-exposure-response relationship for dose selection.<\/p>\r\n            <a class=\"phinc-link\" href=\"\/en\/phases\/#s4\"><span>\u2192<\/span> CTS & PoC<\/a>\r\n          <\/article>\r\n\r\n          <article class=\"phinc-step\">\r\n            <div class=\"phinc-step-top\">\r\n              <span class=\"phinc-num\">\u2609<\/span>\r\n              <span class=\"phinc-stage\">Phase III<\/span>\r\n            <\/div>\r\n            <p>Confirm your dosing strategy. PhinC helps you anticipate variability and strengthen the robustness of your results.<\/p>\r\n            <a class=\"phinc-link\" href=\"\/en\/phases\/#s5\"><span>\u2192<\/span> De-risk my Phase III study<\/a>\r\n          <\/article>\r\n\r\n          <article class=\"phinc-step\">\r\n            <div class=\"phinc-step-top\">\r\n              <span class=\"phinc-num\">\u2609<\/span>\r\n              <span class=\"phinc-stage\">Filing<\/span>\r\n            <\/div>\r\n            <p>Turn your data into a regulatory argument. PhinC helps you justify dose and regimen with a clear, traceable narrative.<\/p>\r\n            <a class=\"phinc-link\" href=\"\/en\/phases\/#s6\"><span>\u2192<\/span> Regulatory Support<\/a>\r\n          <\/article>\r\n\r\n        <\/div>\r\n      <\/div>\r\n    <\/div>\r\n  <\/section>\r\n\r\n  <section class=\"phinc-section alt\" id=\"modules\">\r\n    <div class=\"phinc-wrap\">\r\n      <div class=\"phinc-split reverse\">\r\n        <div>\r\n          <div class=\"phinc-kicker\">OUR CUSTOM SOLUTIONS<\/div>\r\n          <h2 class=\"phinc-h2\">Tailored approaches, adapted to every development challenge.<\/h2>\r\n          <p class=\"phinc-p\">\r\n            One objective, one deliverable: from a fast, targeted answer to a full mechanistic model.\nWe tailor the level of complexity to the maturity of your data.\r\n          <\/p><br>\r\n          <div class=\"phinc-actions\">\r\n            <a class=\"phinc-btn primary\" href=\"\/en\/contact\/\">Get in touch<\/a>\r\n          <\/div>\r\n        <\/div>\r\n\r\n        <div class=\"phinc-cards\" style=\"margin-top:0;\">\r\n          <div class=\"phinc-card\">\r\n            <h3><a href=\"\/en\/service\/pbpk\/\">PBPK - PBBM<\/a><\/h3><p>Extrapolate across species, routes, and populations when data are limited.<\/p>\r\n          <\/div>\r\n          <div class=\"phinc-card\">\r\n            <h3><a href=\"\/en\/qsp\/\">QSP<\/a><\/h3>\r\n            <p>Make fast, consistent, data-driven decisions aligned with clinical objectives.<\/p>\r\n          <\/div>\r\n          <div class=\"phinc-card\">\r\n            <h3><a href=\"\/en\/poppk-pd\/\">PopPK \/ PK-PD<\/a><\/h3>\r\n            <p>Understand systemic exposure and quantify variability to guide dosing.<\/p>\r\n          <\/div>\r\n          <div class=\"phinc-card\">\r\n            <h3><a href=\"\/en\/service\/qt-qtc\/\">QT\/QTc Analysis<\/a><\/h3>\r\n            <p>Provides robust, critical predictions to assess the risk of QTc prolongation.<\/p>\r\n          <\/div>\r\n          <div class=\"phinc-card\">\r\n            <h3><a href=\"\/en\/service\/pknca\/\">PK NCA CDISC<\/a><\/h3>\r\n            <p>Ensures robust, fully compliant analyses for regulatory submission.<\/p>\r\n          <\/div>\r\n          <div class=\"phinc-card\">\r\n            <h3><a href=\"\/en\/clinical-trial-simulation\/\">CTS<\/a><\/h3>\r\n            <p>Structures the clinical strategy and secures key development decisions.<\/p>\r\n          <\/div>\r\n        <\/div>\r\n      <\/div>\r\n    <\/div>\r\n  <\/section>\r\n\r\n  <section class=\"phinc-section\" id=\"proof\">\r\n    <div class=\"phinc-wrap\">\r\n      <div class=\"phinc-kicker\">Delivrables<\/div>\r\n      <h2 class=\"phinc-h2\">Predictive models to de-risk drug exposure-response<\/h2>\r\n      <p class=\"phinc-p\">Concrete recommendations and justification models.<\/p>\r\n\r\n      <div class=\"phinc-proof\">\r\n        <div class=\"phinc-card\">\r\n          <h3>Dose recommendations<\/h3>\r\n          <p>Proposed dose(s) and regimen, with defined confidence levels and safety margins.<\/p>\r\n        <\/div>\r\n        <div class=\"phinc-card\">\r\n          <h3>Scenarios simulation<\/h3>\r\n          <p>Test trial scenarios to optimize doses, sample sizes, and endpoints.<\/p>\r\n        <\/div>\r\n        <div class=\"phinc-card\">\r\n          <h3>Regulatory Support<\/h3>\r\n          <p>Support development decisions in discussions with health authorities.<\/p>\r\n        <\/div>\r\n      <\/div>\r\n\r\n      <div class=\"phinc-cta\" id=\"contact\">\r\n        <div>\r\n          <h3>Let's build your MIDD roadmap<\/h3>\r\n          <p class=\"translation-block\">Share your development stage, available data, and next target. <br>We will propose a clear strategy, timeline, and deliverables.<\/p>\r\n          <div class=\"phinc-actions\" style=\"margin-top:16px;\">\r\n            <a class=\"phinc-btn primary\" href=\"\/en\/contact\/\">Get in touch<\/a>\r\n          <\/div>\r\n        <\/div>\r\n        <div class=\"phinc-cta phinc-slim\" style=\"margin-top:0; box-shadow:none;\">\r\n          <ul class=\"phinc-list\">\r\n            <li><span class=\"phinc-check\"><\/span>Objective &amp; expected decisions<\/li>\r\n            <li><span class=\"phinc-check\"><\/span>Mandatory data (minimum viable)<\/li>\r\n            <li><span class=\"phinc-check\"><\/span>Delivrables &amp; timelines<\/li>\r\n            <li><span class=\"phinc-check\"><\/span>Support for regulatory submission<\/li>\r\n          <\/ul>\r\n        <\/div>\r\n      <\/div>\r\n    <\/div>\r\n  <\/section>\r\n\r\n  <script>\r\n    \/\/ Smooth scroll for side menu + active section highlight\r\n    (function(){\r\n      const menuLinks = Array.from(document.querySelectorAll('.phinc-side a'));\r\n      const targets = menuLinks\r\n        .map(a => document.querySelector(a.getAttribute('href')))\r\n        .filter(Boolean);\r\n\r\n      \/\/ Smooth scrolling (works in modern browsers via CSS, but safe 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