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Finding the right grant is only the first step in the process. The second part is the killer and where most grant seekers fail.

Here are a few tips for writing your grant proposal:

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

1. You may understand your business or concept inside out - but the person reading your proposal doesn't. Explain your idea clearly and in detail. Have at least two other people O

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

TSIDE of your organization read the proposal and then ask them questions about your concept. If they cannot explain what you are trying to do - chances are the grants committee won'

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

either. And they won't fund what they can't comprehend.

2. The proposal must flow smoothly from beginning to end. As a result, the proposal just doesn't make sense. To avoid this

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ituation, start with an outline that clearly follows each step of your plan...then expand each point as needed to fully explain your business plan. Then - give the finished proposal

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

to someone outside the field of education to read before you submit it. This will help you to identify parts that needed to be clarified.

3. If you want your proposal to be taken s

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

riously - show the funding committee that YOU take it seriously by carefully proofing it for spelling, typing and grammatical errors. Take time to have at least two people proofread

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

your proposal before you submit it - and then read it again yourself to make sure!

4. Don't estimate costs and funding needs for the proposal rather than taking the time to resear

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

h and evaluate the actual expenses. In a grant proposal, guesses just won't make it. If a grant reviewer suspects that your financial sheet is not accurate - you just lost the grant

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

Find out exactly what kind of computer system you are going to need and exactly what the cost will be, then spell it out in the proposal exactly!

5. Make sure that your goals and

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

bjectives are clearly laid out and specific. If you say "I want this grant so that I can help the community" you won't get nearly the credibility as you would by saying "This grant

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ill allow us to buy 2 new computers, and create 2 part-time paid staff positions in an area where jobs for high school students are very difficult to find."

6. Give yourself enough

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

time! Don't throw the proposal together in order to meet the deadline.... it shows. A good proposal package takes time to assemble and research properly. If you really want the mone

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

- then spend the time to put it together correctly, without shortcuts.

7. Every grant has rules and directions that must be followed EXACTLY! If you want your proposal to be read

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

and considered, read and re-read the directions. If it says that the grant MUST be submitted via the online form - don't even bother to ask if you can fax it in. Unlike employment a

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

plications where it sometimes pays to be "original", grant committees have rules in place for a specific reason, and they expect them to be followed to the letter. To do otherwise m

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

y mean that your application will be disqualified before it ever gets read.

8. Make sure that your proposal is what the funder actually finds! Don't assume that just because there

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

s a significant amount of money available, that they will fund just anything - the truth is that funders are often VERY specific in what they are looking for (and sometimes a bit od

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

, but that's their choice!) and will rarely deviate from their "category". You may have the very best purple widget in the world - but if the grant is only for the producers of RED

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

IDGETS - you won't get the grant!

Grants are hard to find and competitive - so put together the very best proposal possible and prove that you are the one that should get the money

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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