BHGC Step-By-Step: Direct to Phase II
The NIH SBIR Direct to Phase II mechanism is an accelerated pathway for established small businesses to jump straight into substantive research and development. It's a high-stakes application that demands not just a compelling research plan but also proof of technical feasibility. At Blue Haven Grant Consultants (BHGC), we bring our decades of experience to bear to help you navigate this task, partnering with you across the entire grant lifecycle, from project evaluation to post-award management.
This post highlights the key steps for a partner applying for a Direct to Phase II SBIR/STTR project.
Project Evaluation and Feasibility Check
Not all projects are ready for a Direct to Phase II application. Our team of experts examines your current research, ensuring it meets the stringent criteria for eligibility, feasibility, and scientific merit demanded by Phase II reviewers. This thorough assessment confirms your project's competitive edge, which warrants bypassing Phase I. By identifying and addressing potential weaknesses early, we minimize wasted effort in proposal writing and significantly increase your chances of success.
Significance-Innovation Analysis™
The BHGC Advantage includes our proprietary Significance-Innovation Analysis™. Our in-depth analysis produces a compelling narrative for your application by clearly outlining the market need (significance) and the inventive aspects of your solution (innovation) for reviewers. This process is crucial for distinguishing your application from those of competitors, especially when bypassing Phase I.
Prioritizing Preliminary Data Presentation
An SBIR/STTR Phase II application requires robust preliminary data to demonstrate technical feasibility. While skipping Phase I, applicants must still meet the rigorous scientific standards expected of a Phase I project. We assist you in strategically presenting your collected data to fulfill these criteria. To further demonstrate your competitiveness, we clearly articulate the link between your current data and your proposed Phase II specific aims and milestones, constructing a coherent and compelling scientific argument.
Defining Product-Focused Aims and Milestones
Your work plan must be specific and forward-looking. We translate your proposed research into the precise NIH language of specific aims and milestones, with a strong focus on product development and commercialization. As professional grant writers, we ensure these aims are supported by concrete, quantitative milestones, maximizing clarity for NIH reviewers.
Developing the Commercialization Plan
The Commercialization Plan is the most heavily scrutinized non-technical section for a Phase II application. To help demonstrate competitiveness, our team assists in developing this crucial section by ensuring it thoroughly addresses three core pillars:
● Market Viability and Need: Clearly articulate the critical unmet need your innovation solves. Provide quantitative data on your target market size and growth and detail your plan for market penetration.
● Competitive Landscape and IP: Demonstrate understanding of the competition by identifying current and potential substitutes. You must outline your unique competitive advantage and detail the Intellectual Property (IP) rights you have already secured to protect your solution.
● Execution and Finance Strategy: Detail your plan for moving beyond the grant. This includes defining your business model (e.g., licensing vs. manufacturing), outlining your go-to-market approach, and presenting a robust Finance Plan that demonstrates how you will secure necessary third-party investor funds after Phase II to achieve final commercialization.
With a strong commercialization plan, your application creates reviewer confidence that distributed funds are driving innovation forward and into the marketplace.
Coherent Application Assembly and Advisory Support
Assembling this complex application requires meticulous attention. BHGC not only writes and compiles these materials into a coherent grant application, we also provide crucial post-submission advisory support. This includes facilitating meetings with NIH Program Officers and helping you interpret the Impact Score and detailed Summary Statements, guiding you toward the best next step, whether it's an award or a resubmission.
Full-Lifecycle Reporting and Next Steps
Direct to Phase II funding requires administrative commitment. As a full-service provider, BHGC helps you produce required grant reports throughout the duration of your Phase II award. Furthermore, we maintain an integrated approach, always looking ahead at potential additional grant opportunities following the completion of your Phase II project to further accelerate your path toward commercialization.
Whether you are ready to apply for a Phase II SBIR/STTR grant or you’re still assessing your project's competitiveness, Blue Haven Grant Consultants offers a No Risk “Pay Upon Award”™ option for you. Ready for the BHGC advantage? Schedule a free consultation with our team of experts.