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市場調查報告書
以研究治療方法為目的的動物模式
Animal Models for Therapeutic Strategies
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以研究治療方法為目的的動物模式 是由出版商Insight Pharma Reports在2010年03月所出版的。
這份英文市場調查報告書價格從美金3195起跳。
針對以研究新治療方法為目的的動物模式，本報告書提供相關的調查分析，包括目前動物模式的個案研究、運用於藥物開發的新型動物模式、新型動物模式的製作、動物福利的相關課題，和思想領袖的見解等，內容摘要概略如下。
第1章 序言
- 模式生物的運用
- 新型動物模式的需求
- 動物福利、藥物開發和臨床實驗對動物模式的影響
第2章 線蟲C. elegans的模式系統
- 帕金森氏症的C. elegans動物模式
- 利用C. elegans動物模式作為藥物開發平臺並由生化遺傳學確定目標
- 延髓肌萎縮症的C. elegans動物模式
第3章 果蠅的模式系統
- 利用RNAi篩檢，明確果蠅細胞內的製藥目標，和新型的抗癌法
- 神經膠質瘤的果蠅動物模式
第4章 斑馬魚的模式系統
- 利用斑馬魚正向基因篩檢以明確製藥目標
- 多囊性腎病(PKD)的病例
- 黑色素細胞癌的斑馬魚動物模式
- 青鱂魚：新型模型生物
- 斑馬魚的相關企業
第5章 非洲爪蟾：新型模式系統
- 開發非洲爪蟾的基因工程
- 和人類疾病相關的非洲爪蟾研究
第6章 老鼠的模式系統
- 背景：複雜疾病的動物模式相當困難
- 改善老鼠動物模式的整體策略
- 改善老鼠動物模式的其他策略：環境因子表現型的形成和模擬
- 個案研究：老鼠和人類的差異及對藥物開發的影響
- 個案研究：採用胰臟癌的改良型老鼠動物模式以開發劃時代的治療方法
第7章 新型哺乳類的模式系統
- 老鼠動物模式
- 老鼠以外的哺乳類動物模式所引發的定點突變
- 利用鋅指核酸酶的基因工程製作基因剔除大鼠
- 培養精原幹細胞以製作基因剔除小鼠和基因剔除大鼠
- 培育基因轉殖猴
第8章 由動物模式進入臨床實驗
- 模型和模擬
- 以動物模式進入臨床實驗為目的所進行的電腦模型及模擬
- 轉譯醫學生物標記
第9章 未來預測
- 動物福利的相關課題
- 已完整開發的動物模式和新型的動物模式
- 採用無脊椎動物模式的優勢以及運用於藥物開發的斑馬魚
- 動物模式的結果有助於研究者的開發
- 以提升藥效為目的的動物模式開發
第10章 思想領袖的訪談
第11章 INSIGHT PHARMA REPORTS的動物模式問卷調查（2010年1月）
參考資料
索引
Abstract
The use of animal models in development of novel therapeutic strategies is the
main emphasis of this report. Creation of new animal models is an important
part of this research. Discussed in this publication:
- Case studies of the use of established animal models in developing novel
therapeutic strategies
- Emerging animal models for use in drug discovery and the development of
new therapeutic strategies
- Development of animal models that are more predictive of drug efficacy
- Technological developments in progress
- Use of computer models and translational biomarkers to move more
effectively from preclinical animal studies to the clinic
- Thought-leader interviews and a user survey are also included
Although animal models based on mammalian species have been long employed,
more recently the pharmaceutical/biotechnology industry has also adopted
several invertebrate and lower vertebrate animal models. The aim of using
animal models to develop novel therapeutic strategies is to achieve knowledge
of pathways and targets that leads to new paradigms for drug discovery and
development.
Chapters 2, 3, 4, and 6 focus on the nematode Caenorhabditis elegans, the
fruit fly Drosophila, the zebrafish, and the mouse, respectively. Each chapter
includes cases studies of the use of each of these established animal models
in developing novel therapeutic strategies for human disease. Chapters 5 and 7
focus on emerging animal models, the African clawed toad Xenopus tropicalis
and emerging mammalian animal models. Each of these chapters focuses on
technological developments in progress to develop tractable animal models
based on these organisms. Chapter 7 also includes a discussion of the rat as
an animal model, which is "reemerging" as the result of new technologies and
collaborations.
Chapter 8 discusses the use of computer models and translational biomarkers in
helping researchers move more effectively from preclinical animal studies to
human clinical trials. Pharmaceutical and biotechnology company researchers
have been increasingly applying pharmacokinetic/pharmacodynamic modeling to
all stages of drug development. These models, as well as biophysical models
such as those developed by Novartis and physiological models such as those
developed by Entelos, can help researchers more effectively use animal model
data in the design of clinical trials. In particular, they can help
researchers reduce drug attrition in clinical trials due to suboptimal dosing.
Chapter 6, which focuses on the mouse, concludes with a discussion of the
issue of developing more predictive animal models of drug efficacy,
specifically more predictive mammalian models. One main reason for
researchers' difficulties in producing predictive mouse models is major
unknown factors in disease biology. Although these factors make developing
predictive animal models difficult, researchers can use animal models to learn
about unknown or poorly understood areas of disease biology. This is expected
to lead to the development of improved animal models as well as the
development of new therapeutic strategies and drugs.
Developing animal models that are more predictive of efficacy is an iterative
process. But progress is being made, as researchers apply new knowledge and
experimental approaches in elucidating the biology of particular diseases to
creation of animal models.
Table of Contents
CHAPTER 1 INTRODUCTION
- 1.1. Uses of Model Organisms
- Basic Research
- Developing Therapeutic Strategies
- Target Evaluation
- Preclinical Studies
- 1.2. Why Do We Need New Animal Models?
- Animal Models Used in Drug Discovery and Preclinical Studies Need to be
More Predictive of Clinical Results
- Can animal models be replaced with human cellular models in drug
discovery?
- New Animal Models to Aid Researchers in Understanding Disease Biology
and Developing New Therapeutic Strategies
- 1.3. The Issue of Animal Welfare and Its Effects on Animal Research in
Drug Discovery and Preclinical Studies
- The 3Rs
- The Effects of Public Perception and Behavioral Research on Support of
Animal Research
CHAPTER 2 THE NEMATODE CAENORHABDITIS ELEGANS AS A MODEL SYSTEM
- 2.1. Introduction
- 2.2. A C. elegans Model of Parkinson' s Disease
- 2.3. Using C. elegans as a Platform for Drug Discovery and Target
Identification via Chemical Genetics Studies
- 2.4. A C. elegans Model of Spinal Muscle Atrophy
- 2.5. Conclusions
CHAPTER 3 THE FRUIT FLY DROSOPHILA MELANOGASTER AS A MODEL SYSTEM
- 3.1. Introduction
- 3.2. Use of RNAi Screens to Identify Drug Targets in Drosophila Cells and
a Novel Approach to Cancer Therapy
- 3.3. A Drosophila Model for Human Glioma
- 3.4. Conclusions
CHAPTER 4 THE ZEBRAFISH DANIO RERIO AS A MODEL SYSTEM
- 4.1. Introduction
- 4.2. Use of Forward Genetic Screens in Target Identification in Zebrafish:
The Case of Polycystic Kidney Disease (PKD)
- 4.3. Zebrafish Models of Melanoma
- The Relationship between Melanocyte Development and Metastatic Melanoma
- Using Melanoma Genetics to Design Zebrafish Models of Melanoma
- Genes Involved in Melanocyte Development Can Synergize with Oncogenes to
Produce Metastatic Melanoma
- Design of Zebrafish Model Systems for Use in Developing Further
Understanding of Melanoma Pathobiology
- 4.4. The Japanese Medaka (Oryzias latipes): An Emerging Fish Model
- 4.5. Zebrafish Companies
- Phylonix
- Znomics
- Evotec' s Zebrafish Technology Platform
- The Future of Zebrafish Platform Companies
- 4.6. Conclusions
CHAPTER 5 XENOPUS TROPICALIS: AN EMERGING MODEL SYSTEM
- 5.1. Introduction
- 5.2. Developing Genetic and Genomic Tools for X. tropicalis
- 5.3. Studies with X. tropicalis with Relevance to Human Disease
- 5.4. Conclusions
CHAPTER 6 MOUSE MODEL SYSTEMS
- 6.1. Introduction
- 6.2. Background: Complex Diseases Are Difficult to Model
- 6.3. Comprehensive Strategies to Improve Mouse Models
- Gene Disruption Technologies, Functional Genomics, and Target Validation
- Natural Variation and Quantitative Trait Loci
- Chemical Mutagenesis to Create Point Mutations
- Modeling of Polygenic Traits to Improve the Predictiveness of Mouse
Model Studies
- Modeling of Copy Number Variation
- Humanized Mouse Models
- 6.4. Other Strategies for Improving Mouse Model Studies: Phenotyping and
Modeling Environmental Factors
- Phenotyping 74
- Modeling Environmental Factors
- 6.5. Case Study: A Mouse Model of Autism Based on Copy Number Variation
- 6.6. Case Study: A Difference between the Mouse and Humans May Affect Drug
Discovery in Diabetes
- 6.7. Case Study: Using an Improved Mouse Model of Pancreatic Cancer to
Develop Novel Therapeutic Strategies
- 6.8. Conclusions 84
CHAPTER 7 EMERGING MAMMALIAN MODEL SYSTEMS
- 7.1. Introduction
- 7.2. The Reemergence of the Laboratory Rat
- 7.3. Site-Directed Mutagenesis in Mammalian Models Other than the Mouse
- 7.4. Zinc-Finger Nuclease Genome Editing to Produce Knockout Rats
- 7.5. Creating Knockout Mice and Rats from Cultured Spermatogonial Stem
Cells
- 7.6. Production of Transgenic Marmosets That Transmit Transgenes to Their
Offspring
- 7.7. Conclusions
CHAPTER 8 MOVING FROM ANIMAL MODELS TO THE CLINIC
- 8.1. Modeling and Simulation
- Computer Modeling and Simulation is Complementary to, but Cannot
Replace, Animal Studies
- 8.2. Computer Modeling and Simulation for Moving From Animal Models to the
Clinic
- Allometric Scaling: Determining the Human Equivalent Dose (HED)
- Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling
- Modeling and Simulation at Novartis
- Entelos
- Entelos/American Diabetes Association virtual NOD mouse model
- 8.3. Translational Biomarkers
- 8.4. Conclusions
CHAPTER 9 OUTLOOK
- 9.1. Animal Welfare Issues
- 9.2. "Established" and "Emerging" Animal Models
- 9.3. Advantages of Using Invertebrate Models and the Zebrafish in Drug
Discovery Research
- 9.4. Animal Model Studies Help Researchers Learn About New Aspects of
Disease Biology
- 9.5. Developing More Predictive Animal Models of Drug Efficacy
CHAPTER 10 THOUGHT LEADER INTERVIEWS
- 10.1. Adrian Hill, PhDAssociate DirectorEvotecAbingdon, Oxfordshire, UK
- 10.2. Davide Molho, DVMCorporate Senior Vice President Charles River
Wilmington, MA
- 10.3. Brian W. Soper, PhDResearch Affiliates Program, Scientific
LiaisonThe Jackson LaboratoryBar Harbor, ME
- 10.4. Ann Sluder, PhDDirector of BiochemistryScynexisResearch Triangle
Park, NC
CHAPTER 11 INSIGHT PHARMA REPORTS' ANIMAL MODELS SURVEY: JANUARY 2010
- Question 1. Please classify your organization.
- Question 2. What aspect(s) of the drug development process do you work in?
(You may answer more than one.)
- Question 3. What class(es) of drugs do you work on? (You may choose more
than one answer.)
- Question 4. Do you work directly with animal models?
- Question 5. If you answered yes to question 4, in what aspect of drug
development do you work with animal models? (You may answer more than one if
applicable.)
- Question 6. What types of animal models does your company use in-house?
(May answer more than one)
- Question 7. What types of animal models are used in studies that your
company outsources to CROs? (May answer more than one)
- Question 8. Do you agree that poorly predictive animal models have been a
major reason for the low productivity of drug development?
- Question 9. Has there been any improvement in the predictiveness of animal
models for use in discovery research and in preclinical studies since the
initiation of the FDA' s Critical Path Initiative in 2004?
- Question 10. Do you expect any improvements in the predictiveness of
animal models for use in discovery research and in preclinical studies in the
next five years?
- Question 11. Do you expect human cellular models based on induced
pluripotent stem cells or similar technology to replace some uses of animals
in pharmaceutical/biotechnology research over the next five years?
- Question 12. Does your company use modeling/simulation to move from animal
studies in discovery and preclinical studies into human trials?
- Question 13. Do you expect computer models ("virtual animal models,"
"virtual human models," "virtual physiological systems," "virtual tumors,"
etc.) to replace some uses of animal models over the next five years?
- Question 14. Is development of computer-based animal or human models
severely limited by researchers' limited knowledge of biological systems and
of disease biology?
- Question 15. How do regulations designed to promote animal welfare (e.g.,
the Animal Welfare Act, the Public Health Services' Guide for the Care and Use
of Laboratory Animals, local regulations, the 3Rs) affect your operations?
- Question 16. Does your company work with any of the following to develop
novel animal models? (May choose more than one answer)
REFERENCES
COMPANY INDEX WITH WEB ADDRESSES
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