NIH Reviewers II 
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NIH REVIEWERS

Picking up from last weeks thoughts, methods descriptions are also important for the NIH, whereas they are far less important for most other agencies.

NSF, DoD, DoE, and the other funding sources that I have worked with are very logical and goal oriented in their grant review process. They are clearly focused on whether the product is significant, whether the team can make the product, and whether a market exists for the product. This is clearly seen from the bare bones and focused approach to writing the application and reviewing the application for these funding sources.

On the other hand, the NIH is more focused on academic credentials, as opposed to real life credentials and methods versus “can this group do it?”

Most other funding agencies assume that you can do the experiments outlined in your application as long as you have demonstrated success in this area or similar areas before. The agencies do not require a complete description of the experimental design and methods, as would be found in a publication. Most NIH reviewers do require this type of detail.

There are numerous reasons for this. First and foremost, this type of information is asked for in the application from the NIH, whereas it is not asked for in the applications of the other agencies. Again, this reflects the academic bent of the NIH, as opposed to a real life get it done attitude of the other agencies.

Thus for NIH applications, be sure to put in all the details of an experimental design and methods. Lack of details is one of the most common reasons why truly outstanding applications do not get funded by the NIH. Other agencies avoid this problem by assuming that if an applicant can show that they have already accomplished a task, then they should not have to describe that task in detail…clearly the team already knows how to do it. The NIH insists on knowing how you did the task, just in case you did not do it right the first time; so be sure to include sufficient details for NIH proposals.

Reviewers are instructed to not get caught up in the details and to ask the bigger question: can the team succeed given the overall approach? However, my experience has shown me time that most reviewers do get caught up in the need for details of the experiments. As a result, they sink excellent applications when all of the details of the methods are not present. A typical reviewer response is: “How can I evaluate the application if the methods are not complete?” To avoid this problem, be sure to include all of the details for NIH applications.

This weakness is being addressed by the current head of CSR, however it is difficult to change the course of a large ship overnight. In the meantime, be sure to put in the necessary details for the experimental approach and methods.

For more specific and additional information on this topic, click on this link: High Level SBIR/STTR Grant Writing Techniques.

If you have any questions, please feel free to contact me or go to SBIR-STTRgrantshelp.com.



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NIH Reviews 
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NIH REVIEWERS

There are numerous sources for SBIR/STTR funding. The NIH is the largest source of such funding. However, the NIH has its idiosyncrasies in terms of grant review.

DoD, DoE, and the other funding sources that I have worked with are very logical and goal oriented in their grant review process. They are clearly focused on whether the product is significant, whether the team can make the product, and whether a market exists for the product. This is clearly seen from the bare bones and focused approach to writing the application and reviewing the application for these funding sources.

On the other hand, the NIH is more focused on academic reviewer credentials as opposed to real life credentials and methods versus “can this group do it?”

PI credentials are very important; however the NIH focuses mainly on publications versus real life product development. For example, if a person does not have a PhD but has started a successful company, and developed numerous products, has tested those products, and has millions of dollars in sales, this is still not enough for the NIH reviewer. Most NIH reviewers will still insist on a PhD level member of the team with a current publishing record in the area of interest, regardless of how solid the proposed set of experiments may be. Therefore be sure to have a member of your team with such credentials in order to avoid an unnecessary resubmission.

Here is an example: a BS level person has started a software company for process control software. The main algorithm has been patented and won numerous awards from the process control industry. The software is universally accepted in the process control industry and the company is making millions of dollars a year. The person applies for an NIH SBIR grant multiple times and the reviewers consistently nit pick the algorithm without actually ever understanding it from a real life perspective. This person then applies for an SBIR from DoD and the application is accepted the first time based on the innovative and cutting edge aspect of the algorithm being used.

By adding a PhD level software engineer with recent publications in the control algorithm area, the above mentioned person can now also receive funding from the NIH for improving health care.

This is a practical matter. You will not be at the NIH review meeting to personally convince the reviewers that you can do the job. Therefore, the simplest solution is to have someone on board whom the reviewers will find acceptable from their vantage point.

Be assured that this weakness is being addressed by the current head of CSR, however it is difficult to change the course of a large ship overnight. In the meantime, be sure to put your team together knowing what is required to get funding as opposed to what is required to get the real job done.

More on this subject next week.

For more specific and additional information on this topic, click on this link: High Level SBIR/STTR Grant Writing Techniques.

If you have any questions, please feel free to contact me or go to SBIR-STTRgrantshelp.com.



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New SBIR/STTR Rules 
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SBIR FUNDING ON THE UPSWING

SBIR/STTR funding is very likely to increase substantially.

http://www.govtrack.us/congress/bill.xp ... ab=summary

Get those applications ready to submit to all agencies now. Previously, the NIH was preferable when possible because the NIH allowed much higher Phase I and II awards than any other SBIR funding agency. The DOE (Energy) for example, limited most of its Phase I awards to only 70K. It is highly likely that all agencies will increase their levels.

Here are some highlights of likely coming changes:

Increases, for FY2009 and thereafter, from: (1) 2.5% to 3.0% of participating federal agencies' extramural research budget the set-aside for SBIR program activities; and (2) 0.3% to 0.6% of such budget the set-aside for STTR program activities.
Increases, for both the SBIR and STTR programs, the individual small business award levels from: (1) $100,000 to $300,000, for participation at a Phase One level; and (2) $750,000 to $2.2 million, for participation at a Phase Two level. Allows participating federal agencies (agencies) to exceed such award levels if such agencies notify, and provide annual reports concerning such increase to, the congressional small business committees.

Includes energy-related and rare disease-related research topics as "special consideration" SBIR research topics.

Adds nanotechnology-related research to the SBIR list of research topics deserving special consideration.

Requires agencies to give a priority to SBIR and STTR award applications submitted by rural companies.

Directs the Administrator to make two-year grants to organizations to: (1) conduct SBIR outreach efforts to increase small business participation; and (2) provide application support and entrepreneurial and business skills support to prospective participants. Provides assistance limits. Requires organizations receiving grants to direct activities towards small business concerns located in underrepresented geographic areas and/or small business concerns owned and controlled by women, small business concerns owned and controlled by service-disabled veterans, and small business concerns owned and controlled by minorities.

A business concern shall be deemed to be independently owned and operated if it is owned in majority part by one or more natural persons or venture capital operating companies, there is no single venture capital operating company that owns 50% or more of the business concern, and there is no single venture capital operating company the employees of which constitute a majority of the board of directors of the business concern; and (4) to be eligible to receive an award under the SBIR or STTR program, a small business concern may not have an ownership interest by more than one venture capital operating company controlled by a business with more than 500 employees, and that venture capital operating company may not own more than 10% of that small business concern.

If you have any questions, please feel free to contact me or go to SBIR-STTRgrantshelp.com.



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Reviewers' Comments 
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INTERPRETING REVIEWERS’ COMMENTS

When you read the critiques of your application, be sure to listen to the reviewers. They are telling you how to improve your application.

It is always possible to improve an application. Even the best applications can receive unfundable scores or be unscored because of an unforeseeable interpretation of a sentence. Simply respond to the reviewers’ comments in such instances.

Keep in mind that at least two of the three reviewers of your application are probably not true experts in the field of your application. Instead they are generalists in that field. You have to strike the right balance between technical writing and generalist writing in order to avoid loosing your reviewers.

Usually, if you respond well to reviewers’ comments, your score will improve, but not always. This occurs for two reasons. First, you may have a different set of reviewers who pick up on different aspects of the application. Secondly, many reviewers do not address all of the major weaknesses in an application. They only address enough to justify the low score. Therefore, when you rewrite your application, be sure to correct or improve all areas and not just the ones that the reviewers comment on.

That being said, I find that it is very difficult for many applicants to get the key messages that the reviewers are giving them. If a reviewer says that your team needs strengthening in a specific area, then find the best person in that area that you can. Do not defend the qualities of the team member. Instead find a new or additional team member. Do not find a new team member who is just adequate, however. Find someone who is excellent in that area. This shows not only that you have responded seriously to the reviewer, it also shows that you can attract top notch people.

Likewise, if a reviewer suggests that your significance is low because the market for your product is small, document that size of the market. You may feel that you already documented the size of the market, but the reviewer is telling you that you have not done so! Basically, this does not mean the reviewer did not read your application, it more likely means that the reviewer does not believe your market projections. Therefore you need to find more convincing evidence the next time around. Listen to this feedback. Address this type of weakness by including better evidence or get better letters of commitment in order to demonstrate your market size.

This same line of reasoning applies to many areas of the application. Next time, instead of assuming that the reviewer did not read the application closely, assume that the reviewer did not believe what you said. When you rewrite the application, keep this in mind to address what is probably the real issue. Therefore do not simply repeat what you said in the previous application or put it in bold. Instead find better support for the statements and restate the assertions in a different manner.

For more specific and additional information on this topic, click on this link: High Level SBIR/STTR Grant Writing Techniques.

If you have any questions, please feel free to contact me or go to SBIR-STTRgrantshelp.com.



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Letters of Support II 
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LETTERS OF SUPPORT

Letters of support are very important to include in your application. These letters fall into several different categories. These categories include: significance, investigators, and environment.

Last week I addressed letters of support from KOLs. This week I will address letters of support from entities that might help you get your product to market, that is to support the development of your product.

This type of letter is from a financial supporter, co-developer, marketer, or purchaser of the technology.

Letters of this type are usually from investors or other companies, but can also be from State agencies.

It is important to provide a letter of support from one to three such entities. The letter should start with the title of the application and the submission date. Next, the entitiy should give their relevant background information, as a way of establishing their credentials. Next, the entity should state something to the effect that “This is a valuable and innovative product……say why it is valuable and innovative….” Next, it is necessary to have a statement of willingness to support this type of product during the product development. Finally, the letter should conclude with a strong statement of desire to consider providing matching funds, license the product, etc., if certain milestones are met. You go on to name the milestones in a general way. These milestones must of course be specifically proposed in the grant application.

It is unusual for an entity to provide an actual letter of commitment. That is why there is usually hedging in the wording of these types of letters. Most reviewers understand this. Some do not, but there is not much that can be done about that level of naïveté on the part of the reviewer. Again, the NIH recognizes this weakness and is taking steps to correct it.

It is important to remember that this is not a letter of commitment to provide funding; it is a letter of serious interest. However, sometimes it is possible to obtain letters of commitment for matching funds if the grant application is funded. These are strong letters of support.

When you are already working with a partner, especially a well recognized partner, you will of course have a letter of commitment, but this letter falls into a different category. I will address that type of category next week.

For more specific and additional information on this topic, click on this link: High Level SBIR/STTR Grant Writing Techniques.

If you have any questions, please feel free to contact me or go to SBIR-STTRgrantshelp.com.



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