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

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)

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)

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

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

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

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