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市場調查報告書

適應性授證:藥物開發、規定的綜合辦法

Adaptive Licensing - A Holistic Approach to Drug Development and Regulation

出版商 CBR Pharma Insights 商品編碼 312352
出版日期 內容資訊 英文 79 Pages
商品交期: 最快1-2個工作天內
價格
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適應性授證:藥物開發、規定的綜合辦法 Adaptive Licensing - A Holistic Approach to Drug Development and Regulation
出版日期: 2014年07月31日 內容資訊: 英文 79 Pages
簡介

所謂適應性授證(以下AL),是推動藥物開發、規定的靈活方法,在歐洲藥品管理局(EMA)已經有2件試驗計劃認證。這個制度,在「創新的治療方法經常伴隨某種程度的不確定性」的前提整備。最初的授證,是比傳統系統更早的階段受到認可,隨機對照試驗(RCT)的臨床資訊的必要量,也比以前少。可是,最初的許可證核準之後,進入市場也有嚴格限制,患者經觀察調查和電子設備、註冊(登記資訊),受到仔細監測。使用來自現在進行中的RCT資料,及許可證交付後調查研究的更準確的資料,來決定是否完全認可許可證交付。由於解決了相關人員全體的需求,可縮小整體成本和患者方面的取用時間等。可是,不確定性存在於任何的方法中,為了完全發揮AL的潛在力,文化、政治性的變化是必須的。

本報告提供適應性授證(AL)的活用狀況與今後預測相關分析、適應性授證的概要與優點、缺點、目前制度整備、有效利用的狀態、今後與狀況變化、利用擴大潛在的可能性、朝向商業性成功的必要事項等調查、考察。

分析方法

適應性授證:概要

  • 簡介
  • 縮小趨勢有的產業
  • 優勢
  • 課題
  • 適應性授證的提倡者

適應性授證現況

  • 先驅者
  • 合法性
  • 適應性授證的引進

適應性授證的未來性

  • 變革策略

在商業方面的考慮事項

  • 價格設定和醫療費給付
  • 市場排他性
  • 市場收益的獲得
  • 風險值(VaR)
  • 摘要
目錄
Product Code: GBI049CBR

Adaptive Licensing (AL) is a flexible approach to drug development and regulation, with two live pilot schemes accepted by the European Medicines Agency (EMA). The system acknowledges that levels of uncertainty will always surround innovative treatments. An initial license is granted at an earlier stage than possible under the traditional system, with less clinical information from Randomized Controlled Trials (RCTs). After the initial license is granted, the entry to market is heavily restricted, and the patient population is carefully monitored through observational studies, electronic devices and registries. Data from ongoing RCTs, and the more robust data from post-license surveillance studies are used to determine full license permission. By improving the alignment of stakeholder needs in a fluid system, overall costs and patient access times can be reduced. However, uncertainty still exists around the approach, and it is clear that cultural and political changes will be necessary to realize the full potential of AL.

Scope

  • Adaptive Licensing: Overview
  • Introduction
  • A Declining Industry - How AL can tackle issues with the current system
  • Strengths
  • Challenges for AL
  • Proponents
  • Current Adaptive Licensing
  • Precursors - Current systems within the traditional drug licensing framework that will act as facilitators to AL
  • Legality - Feasibility of AL across different jurisdictions
  • Employing Adaptive Licensing - EMA pilot scheme information, practical strategies
  • Future Adaptive Licensing
  • Transformative Strategies - Future utility of AL requiring legislative change
  • Commercial Considerations
  • Pricing and Reimbursement with AL
  • Market Exclusivity
  • Achieving Value through AL
  • Value-at-risk

Key Reasons to Purchase

  • Adaptive Licensing is a highly current topic. In March 2014, the EMA (European Medicines Agency) began to invite drug developers to apply for involvement in the pilot projects.
  • Currently, two drug development programs have been accepted by the EMA as pilots. Three were rejected, four are in reserve and 11 are still under consideration.
  • AL is part of a suite of global initiatives with shared features. These include: Staggered Approval, Progressive Authorisation, Conditional Licensing and, more recently, Medicines Adaptive Pathways (MAPs) or Medicines Adaptive Pathways to Patients (MAPPs).
  • The high level of variance in AL approaches and scarcity of practical information justifies the need for an unbiased report of the strengths, weaknesses and opportunities for this system.
  • If pilots are successful, AL may become more widely used across all regions, and also play an important role in shaping future regulatory policy, with the potential to affect all healthcare stakeholders.
  • This new CBR report examines all existing information, and builds on that with conference attendance and new primary research with KOLs and figures central to the movement. It creates a balanced view, and provides an understanding of the current status and potential implications.

Table of Contents

  • Methodology
  • Adaptive Licensing: Overview
  • Introduction
  • A Declining Industry
  • Strengths
  • Challenges
  • Proponents of Adaptive Licensing
  • Current Adaptive Licensing
  • Precursors
  • Legality
  • Employing Adaptive Licensing
  • Future Adaptive Licensing
  • Transformative Strategies
  • Commercial Considerations
  • Pricing and Reimbursement
  • Market Exclusivity
  • Achieving Value
  • Value-at-risk
  • Summary
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