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FDAの優先審査過程にあるがん治療薬パイプライン:最新動向

Cancer Drugs in the FDA Fast Lane Drug Pipeline Update

発行 BioSeeker Group AB 商品コード 279111
出版日 ページ情報 英文
納期: 即日から翌営業日
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FDAの優先審査過程にあるがん治療薬パイプライン:最新動向 Cancer Drugs in the FDA Fast Lane Drug Pipeline Update
出版日: 2016年08月04日 ページ情報: 英文
概要

当レポートでは、治験パイプライン上にある癌治療薬の内、米国FDA(食品医薬品局)が優先審査・承認過程(ファストトラック(Fast track)、迅速承認制度(Accelerated approval)、優先審査方針(Priority review)、ブレークスルー治療(Breakthrough therapy))に認定した薬剤の開発状況を調査し、開発事業者とそのパートナー、各薬剤の治験進行状況、標的の種類とその分子機能、標的の位置特定、発現プロファイル、関連する適応症などといった内容を取りまとめて、概略以下の構成でお届けします。

薬剤パイプラインの現状:概要

  • 研究開発企業・機関(全114社およびそのパートナー)
  • 薬剤の名称と別名
  • 創薬の段階(114種類の薬剤と771件の創薬プロジェクト)
    • パイプラインの各段階にある医薬品の件数
      • 上市済み:39件
      • 登録前:10件
      • 第III相:60件
      • 第II相:86件
      • 第I相:54件
      • 前臨床:18件
      • データ無し:4件
      • 中断:5件
      • 中止:45件
  • 適応症
  • 標的
    • 突然変異
    • 分子構造
    • 126件の標的(45種類)
    • 細胞内局在(16種類)
  • 標的の発現プロファイル
    • 正常組織(48種類)
    • がん(20種類)
    • 細胞株(47種類)
    • 一次血球(12サンプル)
  • 参照の経路
  • メカニズム
  • 化合物

薬剤プロファイル

  • 開発事業者とパートナー
  • 標的とその分子機能
  • 標的の位置確認
  • 突然変異
  • 目標経路
  • 薬剤のメカニズム
  • 薬剤開発プロジェクト
  • 薬剤の開設
  • 化合物データ
  • 特許データ
  • 登録・認証
  • 第IV相データ
  • 第III相データ
  • 第II相データ
  • 第I相データ
  • 第0相データ
  • 全臨床データ
  • 創薬データ

アプリケーションの特徴

  • 動的レポート作成機能

システム要件

  • Operating system: Windows (2000/XP/Vista/7/8) for Mac Users the service is only available online
  • Browser Application (Internet Explorer, Firefox, Chrome, Safari)
  • Internet access (to access related internet resources)

このページに掲載されている内容は最新版と異なる場合があります。詳細はお問い合わせください。

目次
Product Code: BSG18089

The US Food and Drug Administration (FDA) has throughout the last decades added four major ways it can speed up the market approval of new drugs, ranging from Fast track (1988), Accelerated approval (1992), Priority review (1992) to the most recent Breakthrough therapy (2012).

This pipeline update, Cancer Drugs in the FDA Fast Lane, gives a thorough account on which cancer drugs the FDA has chosen to favor for one or more of the above mentioned fast lane programs. Each drug carries in-depth information detailing overall developmental progression for each drug, targets, pathways, indications etc. helping you to analyze trends and facts on what could tip the FDA in your favor. Now be warned this is not really an exact science as Percy Ivy, associate chief of the Investigational Drug Branch at the US National Cancer Institute's Cancer Therapy Evaluation Program in Rockville, Maryland, expressed it by likens the definition of a breakthrough drug to US Supreme Court Justice Potter Stewart's notorious 1964 definition of pornography: "You're just going to know it when you see it," Ivy says.

There are today 142 companies plus partners developing 171 cancer drugs in the FDA fast lane drugs in 1660 developmental projects in cancer. In addition, there are 7 suspended drugs and the accumulated number of ceased drugs over the last years amount to another 65 drugs. Cancer Drugs In The Fda Fast Lane Drug Pipeline Update lists all drugs and gives you a progress analysis on each one of them. Identified drugs are linked to 177 different targets. All included targets have been cross-referenced for the presence of mutations associated with human cancer. To date 168 out of the 169 studied drug targets so far have been recorded with somatic mutations. The software application lets you narrow in on these mutations and links out to the mutational analysis for each of the drug targets for detailed information. All drugs targets are further categorized on in the software application by 51 classifications of molecular function and with pathway referrals to BioCarta, KEGG, NCI-Nature and NetPath.

How May Drug Pipeline Update Be of Use?

  • Show investors/board/management that you are right on top of drug development progress in your therapeutic area. * Find competitors, collaborations partners, M&A candidates etc. * Jump start competitive drug intelligence operations * Excellent starting point for world wide benchmarking * Compare portfolio and therapy focus with your peers * Speed up pro-active in-/out licensing strategy work * Fast and easy way of tracking drugs using search engines; just one click from inside the application and you may search the World Wide Web and PubMed for any drug. Drug Pipeline Update is delivered to you as a downloadable application, which requires no installation on your computer. Please read more about application features and system requirements below.

Table of Contents

Drug Pipeline Update at a Glance

Investigators

  • Includes more than 142 principal companies plus their collaborators. There is direct access from inside the application to web pages of all principal companies.
  • Note: You are able to sort and find drugs according to companies and partners from drop-down menus in the application. You may also sort and find drugs according to country of companies.

Drug name & Synonyms

  • Lists commercial, generic and code names for drugs.

Developmental stage

  • This Drug Pipeline Update contains 171 cancer drugs in the FDA fast lane drugs in development, which have a total of 1660 developmental projects in cancer. In addition there are suspended and ceased drugs.
  • Pipeline Breakdown According to Number of Drugs
  • Marketed# 71
  • Pre-registration# 15
  • Phase III# 84
  • Phase II# 134
  • Phase I# 90
  • Preclinical# 19
  • No Data# 16
  • Suspended# 7
  • Ceased# 65
  • Note: You are able to sort and find drugs according to developmental stage from drop-down menu in the application.

Indications

  • Included cancer drugs in the FDA fast lane drugs are also in development for 298 other indications, where of 201 are different cancer indications.
  • Note: You are able to find and sort drugs according to type of indication from drop-down menu in the application.

Targets

  • Mutations
  • All targets are cross-referenced with the Catalogue of Somatic Mutations in Cancer (COSMIC). It is designed to store and display somatic mutation information and related details and contains information relating to human cancers. To date 168 out of the 169 studied drug targets so far have been recorded with somatic mutations and the software application lets you narrow in on these mutations and links out to the mutational analysis for each of the drug targets for detailed information.
  • Biological Structures
  • The identity of available biological structures on 140 drug targets was retrieved from the RCSB Protein Databank for you to easily review the 3391 structures available today among drug targets.
  • Identified drugs are linked to more than 177 different targets, divided into 51 classifications of molecular function:
  • Acid phosphatase activity
  • Auxiliary transport protein activity
  • Carboxypeptidase activity
  • Catalytic activity
  • Cell adhesion molecule activity
  • Chaperone activity
  • Chemokine activity
  • Cofactor binding
  • Complement activity
  • Cysteine-type peptidase activity
  • Cytokine activity
  • DNA topoisomerase activity
  • DNA-directed DNA polymerase activity
  • G-protein coupled receptor activity
  • Glutathione transferase activity
  • Growth factor activity
  • Heat shock protein activity
  • Hydrolase activity
  • Isomerase activity
  • Kinase activity
  • Kinase binding
  • Kinase regulator activity
  • Ligand-dependent nuclear receptor activity
  • Ligase activity
  • Lipid kinase activity
  • Lipid phosphatase activity
  • Metallopeptidase activity
  • MHC class I receptor activity
  • Molecular function unknown
  • Oxidoreductase activity
  • Peptidase activity
  • Peptide hormone
  • Phosphorylase activity
  • Protein binding
  • Protein serine/threonine kinase activity
  • Protein threonine/tyrosine kinase activity
  • Protein-tyrosine kinase activity
  • Receptor activity
  • Receptor binding
  • Receptor signaling complex scaffold activity
  • Serine-type peptidase activity
  • Structural constituent of cytoskeleton
  • T cell receptor activity
  • T cell receptor binding
  • Transcription factor activity
  • Transcription regulator activity
  • Transferase activity
  • Translation regulator activity
  • Transmembrane receptor activity
  • Transmembrane receptor protein tyrosine kinase activity
  • Transporter activity
  • Sub-Cellular Localization
  • Identified targets are categorized into 20 different primary and alternate sub-cellular localizations:
  • Cell surface
  • Centrosome
  • Clathrin-coated vesicle
  • Cytoplasm
  • Cytoskeleton
  • Cytosol
  • Endoplasmic reticulum
  • Endosome
  • Extracellular
  • Golgi apparatus
  • Kinetochore
  • Lysosome
  • Microtubule
  • Mitochondrion
  • Nucleolus
  • Nucleus
  • Perinuclear region
  • Plasma membrane
  • Sarcoplasmic reticulum
  • Secretory granule
  • Note: You are able to find and sort drugs according to target gene name, protein name, molecular function of target, target localization, presence of mutations and availability of biological structures of target from drop-down menus in the application.

Target Expression Profile

  • Direct links are provided from inside the application to 253 protein expression profiles of 159 drug targets in various human tissues and cancer types, cell lines and primary cells, including up to:
  • 48 different normal tissue types
  • 20 different types of cancer
  • 47 cell lines
  • 12 samples of primary blood cells

Pathway Referals

  • Identified targets have been cross referenced against their involvement in different cellular pathways, according to BioCarta, KEGG, NCI-Nature and NetPath.
  • BioCarta# 221 Pathways
  • KEGG# 172 Pathways
  • NCI-Nature# 230 Pathways
  • NetPath# 32 Pathways
  • Note: You are able to find and sort drugs according to targeted pathways from drop-down menus in the application.

Mechanism

  • In total there are different drug mechanism of action represented in this Drug Pipeline Update.
  • Note: You are able to find and sort drugs according to mechanism of action from drop-down menu in the application.

Compound

  • Identified drug compounds are described by:
  • Compound type, Chemical name, CAS Number and molecular weight
  • Note: You are able to sort and find drugs according to compound type from drop-down menu in the application.

Drug Profile

  • Progress analysis and review of drug development. A typical drug profile reports on, depending on stage of development and available information:
  • Drug Name & Synonyms
  • Presentation of drug name and synonyms

Principal Company & Partners

  • Presentation of principal company and partners

Target and Molecular Function of Target

  • Described target(s) is/are presented with:
  • Official Gene Symbol - Chromosome Location - Gene & Protein Name - Molecular Function

Target Localization

  • Described target(s) is/are presented with primary and alternate localizations.
  • Target Expression Profiles
  • Links to protein expression profile(s) of target(s) in various human tissues, cell lines and primary cells, including up to:
  • 48 different normal tissue types
  • 20 different types of cancer
  • 47 cell lines
  • 12 samples of primary blood cells

Mutation

  • All targets are cross-referenced with the Catalogue of Somatic Mutations in Cancer (COSMIC). It is designed to store and display somatic mutation information and related details and contains information relating to human cancers.
  • Biological Structures
  • The identity of available biological structures on drug targets was retrieved from the RCSB Protein Databank for you to easily review what available structures of drug targets exist.

Targeted Pathways

  • Described target(s) is/are matched for the involvement in cellular pathways according to BioCarta, KEGG, NCI-Nature and NetPath.

Mechanism

  • Drug mechanism of action

Developmental Projects

  • Summary field of developmental projects for the drug, including indication, developmental stage and status.
  • Example:
  • Cancer, myeloma - Phase II Clinical Trial - Active
  • Cancer, prostate - Phase III Clinical Trial - Ceased

Drug Description

  • Short introduction to drug

Compound Data

  • Compound type, Chemical name, CAS Number and molecular weight

Patent Data

  • Available patent information related to the drug is presented here.

Fillings and Approvals

  • Approvals and submissions
  • Analyst comments
  • Deals & Licensing
  • Collaborations and deals
  • Availability for licensing

Phase IV Data

  • Available Phase IV development data, developmental history and scientific data.

Phase III Data

  • Available Phase III development data, developmental history and scientific data.

Phase II Data

  • Available Phase II development data, developmental history and scientific data.

Phase I Data

  • Available Phase I development data, developmental history and scientific data.

Phase 0 Data

  • Available Phase 0 development data, developmental history and scientific data.

Preclinical Data

  • Available preclinical development data, developmental history and scientific data.

Discovery Data

  • Available discovery development data, developmental history and scientific data.

Application Features

  • Search, Find and Filter Panel with Initial Result Presentation
  • With this panel you can define your selectivity in each drug search with up to 24 different drug specific parameters. Each parameter has multi-select options to them and can be used as either an inclusion parameter or exclusion parameter.
  • The initial result table is a dynamic sortable table which gives you a fast overview of found results and can be narrowed down further by your own additional keywords.
  • Direct linkage from inside the application to related internet resources
  • Drug data is linked to search engines like Google and PubMed
  • Drug target data is linked directly to BioCarta, Human Protein Atlas, KEGG, NCI-Nature, NetPath etc.
  • Direct links to company web pages of companies

Dynamic Report Generator

  • Our dynamic report generator lets you with ease and speed generate html reports directly in your web browser (Internet Explorer and FireFox), whether it is a single drug profile or an entire search you want have a report of.

System Requirements

  • Operating system: Windows (2000/XP/Vista/7/8) for Mac Users the service is only available online
  • Browser Application (Internet Explorer, Firefox, Chrome, Safari)
  • Internet access (to access related internet resources)
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