Your guide through every phase of the funding process
Harmony Biotech Consulting helps life sciences companies secure non-dilutive government funding through BARDA, ASPR, DoD, NIH, DARPA, ARPA-H, and other U.S. and international agencies. From TechWatch meetings and white paper submissions, to proposal development, contract negotiations and program execution, our embedded experts will be your trusted guide.
How we work
Our services cover the full lifecycle of federal contracting and proposal strategy, including:
Opportunity identification and submission planning for BARDA, DoD, ASPR, ARPA-H, CEPI, NHS, and global agencies
TechWatch meeting preparation and white paper development tailored to agency-specific review criteria
Full proposal writing and cost proposal development that maximize funding potential
Contract negotiation, project management, DCAA/DFAS compliance, and closeout support
Whether you're responding to the BARDA BAA, preparing for a critical TechWatch presentation, or seeking funding for onshoring manufacturing under Reshore Rx, we bring deep regulatory and development expertise to each engagement. Harmony is known for rapidly understanding your technology, identifying program gaps, and building government-aligned development plans that secure funding and drive execution.
Case Study
$1.8 Billion in BARDA and Operation Warp Speed Funding
During the COVID-19 emergency, a major U.S. vaccine manufacturer turned to Harmony to lead the rapid development of a BARDA proposal from scratch. Harmony created a complete technical and cost proposal covering clinical trials, manufacturing, regulatory, supply chain, and program management. The proposal was submitted under urgent timelines for BARDA/Operation Warp Speed.
$1.8 billion
in government funding awarded
Largest biotech grant to date under BARDA/Operation Warp Speed
Ongoing partnership for contract, CMC, and program management support
Successful vaccine produced and commercialized under EUA and BLA
Chief Commercial Officer
Vaccine Manufacturer
"Harmony Biotech Consulting guided us through the government funding process, helped us develop our program, wrote our proposal, and got us the largest biotech government grant during Operation Warp Speed. We've worked with them ever since-they made sure we got the most value from the contract possible"
FAQ
The process typically includes:
- Monitor government announcements for funding opportunities
- Match government needs to company technology
- Notify government of company interest
- Meet with government representatives
- Submit an initial white paper or abstract
- Incorporate feedback and submit a full proposal
- Contract negotiations
- Receive award and begin development
Requirements vary by program and technology. Generally, funding is non-dilutive and supports government unmet needs. The government often requires:
- A specific phase of development having been reached (non-clinical, early-clinical or late clinical)
- Show clear path forward to licensure
- Company must have freedom to operate with intellectual property
- Plan for eventual commercial success
- First-right-of-access in emergencies of products developed with government funding
Yes. With 30+ years of drug development experience, Harmony identifies gaps in your plan and creates solutions to meet government requirements.
Yes. We frequently manage both technical and cost proposals, but can also support cost proposals only. Our goal is to maximize the funding amount and its effective use. We can also help with guidance on indirect rates and government accounting standards.
Absolutely. We've led many TechWatch meetings and know how to tailor presentations to BARDA's priorities. Harmony also holds the record for the most-attended TechWatch meeting (108 attendees across BARDA, DoD, NIH, NIAID, JPEO, and others).
The U.S. government is prioritizing domestic pharmaceutical manufacturing, with programs like the Reshore Rx initiative. Harmony has secured over $100M in onshoring funding and continually tracks new opportunities. We can connect you with the right programs and partnerships to support your business.