• Biodefense

BDO knows Biodefense

For life sciences companies developing products and technologies to address Chemical, Biological, Radiological or Nuclear (CBRN) threats, Influenza and Emerging Infectious Diseases, access to capital is a critical need.

Federal contracts can provide much-needed resources to life sciences companies and nonprofits in the biodefense space. Before pursuing these contracts, life sciences organizations must be confident that they can compliantly secure and manage government funds.

BDO’s Biodefense team affords clients a broad range of support to navigate the federal funding process: strategic guidance to include alignment with medical countermeasure priorities, technical advisement, project management, financial management and compliance services across the biodefense lifecycle. 

Our team has a wealth of experience leading strategic partnerships between Pharma/Biotech and US Government agencies including the Biomedical Advanced Research and Development Authority (BARDA), National Institutes of Health (NIH), Defense Threat Reduction Agency (DTRA), as well as expertise engaging with the Defense Contract Audit Agency (DCAA). This enables our Biodefense team to provide exceptional service in identification of appropriate funding opportunities, engagement strategies and navigation of compliance requirements when partnering with the US government.
 

Service Offerings

BDO’s Biodefense group offers support across the full lifecycle of engagement with the US government:
  • Product Development Strategy
    • Product development strategy alignment with government requirements
    • Funding opportunities
    • Integrated approach for non-dilutive funding from funding agencies (e.g. NIH, BARDA, DTRA, JEPO)
  • Funding Agency Stakeholder Engagement (e.g. Tech Watch)
    • Key stakeholder identification
    • Government process & briefing package
    • White paper and rough order of magnitude (ROM) cost estimates
  • Development of Technical and Cost Volumes
    • Technical approach and development plan
    • Required technical deliverables
      • Statement of Work (SOW)
      • Work Breakdown Structure (WBS)
      • Integrated Master Schedule (IMS)
      • Integrated Product Development Plan (IPDP), etc.
    • Cost recovery, pricing/costing requirements and budget strategy
    • Indirect rates
    • Subcontractor compliance
  • Award Negotiations
    • Negotiation Strategy
    • Technical and cost revisions
    • Contract award terms
  • Post-award Contract Management
    • Technical project management
      • Required deliverables
      • Project schedule
      • Project meetings
    • Government compliance gap assessment, implementation or remediation
      • Accounting
      • Procurement
      • Legal
      • Human Resources
      • Information Technology
    • Financial management
      • Monthly invoices and required reports
      • Project budgets
      • Annual incurred cost submission (ICS) and indirect rates
    • Subcontractor management
      • Contracting Officer Approval (COA) packages
      • Subcontractor budgets
    • Earned value management (EVM)