As a result of LBG’s expert support, a client proposed an animal rule pathway product development plan and was awarded a BARDA contract to allow expansion of an indication for an antibiotic to include select agent infections.
Challenge:
A mid-sized biotech company was recently granted FDA approval for an antibiotic and wanted to expand the indication to include treatment of select agent infections. Although they were experienced in the development of antibiotics for the commercial market, they needed support engaging the U.S. Government (USG) and navigating the non-dilutive funding landscape to support the indication expansion.
Solution:
The client hired LBG to help develop a strategic plan to engage the USG and identify non-dilutive funding opportunities aligned with their business strategies. We worked directly with them to submit two proposals to two separate federal agencies. The proposal strategy focused on developing an animal rule pathway product development plan to expand FDA approval of the antibiotic to select agent infections. We provided an experienced team of USG proposal developers and subject matter experts (SMEs) to ensure a compliant, technically viable, and appropriately budgeted plan.
As a result of our support, the client was invited to negotiate by both agencies. We helped them through the contract negotiations by providing strategic guidance, a detailed review of contract terms, and a revision of the full proposal. Ultimately, the client entered into an almost $300 million contract with one of the agencies. An award of this magnitude required additional expertise and guidance on both management of the USG contract and technical execution of the activities.
Following award of the contract, we continued to support the client. First, we armed them with Government Contracting Program Managers who had experience managing government-funded product development programs. These managers offered support for the fundamental foundation of the program and ensured successful delivery on all technical requirements. Second, we provided a Contract Compliance team for guidance on all terms and conditions associated with the contract. Finally, we leveraged our team of Product Development SMEs who had in-depth experience working with select agents and understood the unique challenges/requirements of navigating a USG-funded program.
Results and Impact:
We remained engaged with the client beyond contract award to ensure successful product development and a prosperous relationship with the USG. In addition to supporting proposal development activities, we leveraged our Program Management, Contract Compliance, and Product Development teams to ensure long-term success with both contract execution and product procurement. The contract provided the client with additional financial support to develop products and a customer for the final drug product.
