Discussing Your Preliminary Data

Typically, both SBIR Phase I and Phase II applications present preliminary data. However, the purpose of this preliminary data is different for Phase I and Phase II applications. You probably already have preliminary data located on your desktop in a folder called “data.” It is crucial you assemble your preliminary data appropriately to effectively communicate an effective story to NIH reviewers in both Phase I and Phase II applications. Given the strategic importance of preliminary data in both Phase I and Phase II applications, you are probably asking yourself; “How do I assemble this data appropriately?”  Blue Haven Grant Consultants (BHGC) has over 10 years of experience crafting compelling, cohesive, and successful grant applications. This post will discuss some of our insights regarding communicating preliminary data in both Phase I and Phase II applications.

As with many of the decisions you will be making while writing an SBIR/STTR grant application, it is important to identify which phase your project most appropriately falls into, as it impacts a reviewer's expectations of preliminary data. In short, Phase I preliminary data should support foundational claims of innovation and as well as the team’s capacity to perform the work proposed in Phase I. In contrast, preliminary data in a Phase II application should prove the feasibility of your technology to create your product. These descriptions might be a little too simple, so let’s dig in a little more.

Phase I Preliminary Data

The goal of a Phase I application is to demonstrate feasibility of your technology to create a product to solve an important problem. Therefore, the work plan (specific aims) must be developed to achieve technical feasibility. If you are considering an SBIR/STTR grant for the first time, you probably already possess some preliminary data that you’ll need for a Phase I application. Any data that you or your team have collected regarding your project, especially data in publications, patent applications, and other outlets are eligible as preliminary data. Your product does not yet need to exist, however, there needs to be some demonstration that your technology exists.

For example, imagine that you and your team hypothesized that a newly discovered raw material found in asteroids can treat bone degeneration. For an SBIR/STTR Phase I grant application, your preliminary data does not need to demonstrate reduced bone degeneration utilizing this new raw material. Instead, the Phase I preliminary data might suggest reduction of biophysical processes known to cause bone degeneration. Building off the preliminary data you present in Phase I, you might propose a Phase I work plan (specific aims) to demonstrate feasibility by evaluating this materials ability to bond to bone, lack of toxicity, and durability. Your application would make the claims that because this material has positive attributes of durability, low toxicity, and bone bonding, it could potentially be developed into an innovative treatment.

In addition to demonstrating the existence of your technology and its underlying mechanism of action, you also want the preliminary data to showcase your team’s ability to conduct the work proposed in Phase I. Preliminary data showing the team’s capability of conducting similar work provides confidence to the reviewers you will successfully complete the proposed specific aims in your Phase I application.

Phase II Preliminary Data

To obtain a Phase II grant, the preliminary data in the Phase II proposal must demonstrate the feasibility of your technology to create a product solving an important problem. Unlike the Phase I project, the Phase II project does not have a specific endpoint goal, such as demonstrating technological feasibility in Phase I. Instead, Phase II work should be the logical follow-on research and development activites based on the preliminary data presented. Consequently, the preliminary data presented in Phase II must also set the stage for the work (specific aims) proposed in your Phase II application. In summary, the preliminary data presented in the Phase II proposal must 1) clearly demonstrate feasibility of your technology to create your proposed product and 2) support the work proposed in your Phase II application.   For many Phase II SBIR/STTR grant applications, the data collected during Phase I will be the data presented as Phase II preliminary data. However, you are not limited to just the data collected in the Phase I project. Instead, you can include any data your team or your collaborators have collected in the past.

Let’s consider our asteroid-based bone treatment again. For a Phase II SBIR/STTR application, the feasibility of our new material to reduce bone degeneration has been proven, but we have not yet developed a formulation or product that demonstrates reduced bone degeneration. Consequently, here are Phase II preliminary data will support the work in our Phase II application, which may include developing a formulation or prototype based on our new material and evaluating its ability to reduce bone regeneration in the appropriate animal model.

Blue Haven Grant Consultants Can Help

Preliminary data assembling and presentation are important components of a successful SBIR/STTR grant application. In this post, we have laid out some general observations from our decade of grant writing experience. That said, at BHGC we know that each project is unique and faces distinct challenges and preliminary data needs. Our grant writers will help you assemble and discuss your preliminary data to accomplish the most important goal of any grant application – provide a clear, concise, and compelling case to a reviewer. 

If you have the data and are ready to explore our no risk “BHGC Pay Upon Award”™ approach, contact us for a free consultation.