The Future of the Biodefense Industry: Regulation, funding opportunities & company profiles

리서치사	Business Insights
발행일	2009년 09월	상품코드	100889
페이지 정보	183 pages
가격	US $ 3,835 ￦ 4,554,800 PDF by E-mail (Single User License) US $ 14,381 ￦ 17,080,300 PDF by E-mail (Corporate Use License)

한글목차
영문목차
관련자료

영문목차

Abstract

The major contemporary bioterrorist event which has opened up programs of research and development (R&D) in pharmaceutical countermeasures and treatments was the anthrax mail attacks which occurred only weeks after the 9/11 atrocities, in October 2001. The mailings killed five people and exposed hundreds more - with thousands of US citizens seeking prophylactic antibiotics. Since then the biodefense industry has grown massively, with the US releasing around $50bn in biodefense funding in 2001-2009. Other international bodies, such as the EU, have also increased their vigilance and research efforts. This report sets out to describe and analyze the work of the biodefense industry in terms of past, present and future pharmaceutical research, development and production to counter or treat diseases caused by biological attack. It also describes government policies and initiatives in several countries which have spurred research and production in pharmaceutical countermeasures and treatments for such diseases and will examine the various factors which influence those policies and the market, including current and future threats and how the industry is responding to new discoveries.

Executive summary

Setting the scene
Regulatory environment
Major pathogens for BW
Biodefense funding
Company profiles
Future perspectives

Chapter 1 Setting the scene

Summary
Introduction
The use of biological agents in warfare and terrorism
Warfare
Offensive BW programs
Bioterrorism: Extent and nature of the threat
Creation
Bulk manufacture
Weaponization
Delivery
Future threats
Pre-2001 bioterrorism
2001 - September 11 and the anthrax attacks

Chapter 2 Regulatory environment

Summary
Introduction
US bodies
FDA
- Center for Biologics Evaluation and Research (CBER)
- Center for Drug Evaluation and Research (CDER)
- Office of Counterterrorism and Emerging Threats
National Institutes of Health (NIH)
- The National Institute of Allergy and Infectious Diseases (NIAID)
- Biomedical Advanced Research and Development Authority (BARDA)
- Public Health Emergency Medical Countermeasures Enterprise (PHEMCE)
- Project Bioshield
Centers for Disease Control and Prevention (CDC)
US Army Medical Materiel Development Activity (USAMMDA)

European bodies
European Commission
European Council Health Security Committee
European Centre for Disease Prevention and Control (ECDC)
The European Medicines Agency (EMEA)
Economic Commission for Europe
Joint Commission/Pharmaceutical Industry Task Force
2009-2011 Indicative Program for the Instrument for Stability

International Agencies
World Health Organisation (WHO)
United Nations
Global Health Security Initiative (GHSI)

Chapter 3 Major pathogens for BW

Summary
Introduction
Anthrax
Developmental therapeutics and vaccines
Plague
Developmental therapeutics and vaccines
Tularemia
Developmental therapeutics and vaccines
Smallpox
Developmental therapeutics and vaccines
Viral Hemorrhagic Fevers - Ebola, Marburg, Crimean-Congo, Hantavirus, Lassa
Developmental therapeutics and vaccines
Botulism
Developmental therapeutics and vaccines
Ricin
Developmental therapeutics and vaccines
Staphylococcal enterotoxins
Developmental therapeutics and vaccines
Brucella group
Developmental therapeutics and vaccines
Glanders
Developmental therapeutics and vaccines
Melioidosis (Whitmore' s disease)
Developmental therapeutics and vaccines
Q fever
Developmental therapeutics and vaccines
Conclusion

Chapter 4 Biodefense funding

Summary
US funding
Department of Health and Human Services (HHS)
Biomedical Research and Development Authority (BARDA)
Department of Homeland Security (DHS)
Other departments
Grants available for biodefense R&D in the US
- NIH Challenge grants in health & science research
- NIH Cooperative Research & Development Agreement (CRADA)
- Small business awards
- NIH small business biodefense program awards
- Project BioShield awards
- Regional Centers of Excellence for Biodefense and Emerging
- Infectious Diseases (RCE)
Defense Threat Reduction Agency (DTRA)
US Army Medical Research Institute of Infectious Diseases (USAMRIID)
Technology transfer
Defense Advanced Research Projects Agency (DARPA)
European funding
United Kingdom
France
Germany
EU biodefense programs
- European Defense Agency (EDA)
- EDA' s Joint R&D Investment Program
- Bio-Edep
- Bioterrorism Research Resilience Reaction (BIO3R)
Biodefense industry
New and Emerging Science and Technology (NEST)
Health Protection Agency (HPA)
Defense Science and Technology Laboratory (Dstl)

Chapter 5 Company profiles

Summary
Introduction

US
Achaogen
Contracts
Advanced Life Sciences
Contracts
Alnylam Pharmaceuticals
Contracts
Cleveland BioLabs
Contracts
Dynavax Technologies Inc.
Contracts
Dynport Vaccine Company Llc (DVC)
Contracts
Elusys Therapeutics
Contracts
Emergent BioSolutions
Contracts
Ichor Medical Systems
Contracts
Nanotherapeutics
Contracts
Peregrine Pharmaceuticals, Inc.
Contracts
PharmAthene
Contracts
SIGA Technologies
Contracts
VaxGen
Contracts
XOMA
Contracts

Canada
Affinium Pharmaceuticals
Contracts
Cangene
Contracts
ID Biomedical Corporation
Contracts

UK
Acambis
Contracts
Cambridge Biostability (CBL)
Contracts
MNLpharma
Contracts

Denmark
Bavarian Nordic
Contracts

Australia
Vaxine Pty
Contracts

India
Panacea Biotec Ltd.
Contracts

China
Sinovac Biotech Ltd.

Israel
Medison Pharma

Conclusion
Biodefense products: the risks

Chapter 6 Future perspectives

Summary
Introduction
Assessing future threats
GM technology
Synthetic biology
US funding - the reality
Has the US got value for its £50 billion-worth of funding since 2001?
- Potential biodefense business
- Getting a grant in the US
- Project Bioshield
Is Europe doing enough?
Lack of coordination
US
EU
Biodefense - at the expense of other research?
Mismanagement of the stockpile
Case study: VaxGen
Problems of biosecurity
US
Russia and the FSU
Fulfilling unmet needs

Chapter 7 Appendix

CDC characterization of biological threats
Glossary
Index

List of Figures

Figure 1.1: Bioterrorism incidents 1970-2008
Figure 2.1: US biodefense funding by department 2001-09
Figure 3.1: R&D funding pathway for biodefense medical countermeasures
Figure 4.1: Project BioShield procurement process
Figure 4.5: US biodefense funding ($m), 2001-12
Figure 4.6: BARDA funding forecasts ($m), 2009-14
Figure 5.7: Cleveland BioLabs research spending on Protectan CBL502 for biodefense applications ($m), 2008-09
Figure 5.8: Emergent BioSolutions operating results ($m), 2008-09
Figure 5.9: PharmAthene financial results ($m), 2008-09
Figure 5.10: Cangene financial results ($m), 2004-08
Figure 5.11: Bavarian Nordic financials (DKKm), 2004-08
Figure 6.12: US biodefense funding ($m), 2001-09
Figure 6.13: VaxGen financials ($m), 2005-08
Figure 6.14: NIH funded biocontainment laboratories
Figure 7.15: CDC characterization of biological threats

List of Tables

Table 2.1: US biodefense presidential acts
Table 2.2: US biodefense acts post-2001
Table 2.3: European Biodefense Legislation
Table 3.4: Developmental therapeutics and vaccines for anthrax
Table 3.5: Developmental therapeutics and vaccines for plague
Table 3.6: Developmental therapeutics and vaccines for tularemia
Table 3.7: Developmental therapeutics and vaccines for smallpox
Table 3.8: Developmental therapeutics and vaccines for VHF
Table 3.9: Developmental therapeutics and vaccines for botulism
Table 3.10: Developmental therapeutics and vaccines for ricin
Table 3.11: Developmental therapeutics and vaccines for staphylococcal enterotoxins
Table 3.12: Developmental therapeutics and vaccines for brucella
Table 3.13: Developmental therapeutics and vaccines for glanders
Table 3.14: Developmental therapeutics and vaccines for melioidosis
Table 3.15: Developmental therapeutics and vaccines for Q fever
Table 4.16: US biodefense funding by department ($m), 2001-10