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Last Minute Grant Proposal Improvements

There comes a point where you never want to look at your grant proposal again. You have spent weeks working on it and the fast-approaching

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

submission deadline that once filled you with fear, now makes you elated. You are ready to send it off and take a long weekend. Not yet! Stay dedicated enough to make the followi

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

Examples of combination products may in

g last minute improvements and set your application apart from those that were sent off in haste.

1. Hide it from yourself. After reading the same proposal repeatedly, you

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

eyes gloss over typos and your mind hears what you wanted to say - not what you actually wrote. Take as much time away from it as you can, even if it is only a few hours. When yo

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

u come back to it, your perspective will be fresh and you will easily pick up on details that you previously missed.

2. Reread the RFP and application guidelines. You shou

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

Combination pro

d know these almost by heart because they are in essence, the treasure map. Grant makers often tell you exactly what they are looking for through their outlined priorities and goa

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

s. Be sure you have clearly stated how your project will help accomplish these. Also, look for specific instructions about formatting (e.g. margins, page length, font, number of c

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

opies to submit) and follow them.

3. Ask a friend for honest feedback. Find someone who is unfamiliar with the project because they will read it like a grant reviewer woul

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

: without any prior knowledge of your work. After they have finished reading, ask them to sum up your project out loud. If they cannot, go back and clarify the parts that stump th

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

m, because these are mostly likely the parts that will stump a grant reviewer too.

4. Write your goal in two sentences. Unlike objectives, your goal is a lofty ambition; a

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

answer to the question, “How do you want to change the world?” Write your goal on a post-it note and stick it next to your computer screen. While doing final edits, ask yourself

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

Following aspects would a

if you have weaved that goal into all the activities of your project.

5. Add cited research to your needs statement. A needs statement should be backed up by persuasive pr

dd to the challenges in developing combination products:

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

of. Someone making the case for a problem with homelessness and states, “64% of students who fail a class at Palm High have been homeless at one time” is more convincing than he w

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

o writes, “homelessness is a problem at Palm High.” To prove that you are not making up statistics (like I just did) cite your sources in a footnote.

6. Add page numbers.

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

Reviewers almost always work in groups and appreciate being able to reference certain pages when discussing proposals.

7. Add white space. Chances are you have so much to

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

ay about your program that you have already considered changing margins, single spacing, and using 10-point font to cram as much text into your document as possible. Please don’t.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Grant readers will appreciate an application that is not only succinct and specific, but also easy on the eyes.

8. Deliver it in person (or let FedEx do the same). Even if

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

you have enough time to send it by mail, seeing the grant transferred from your hands to the safety of the hands of the Foundation will prevent any middle of the night panic atta

.

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

ks. The signature that FedEx requires is the second best thing. If you must submit electronically, print out your confirmation screen or email.

Congratulations! You have not only

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

Companies that provide selfless information through particip

finished your proposal and sent it out into the world, but by making the easy improvements above, you can enjoy that long weekend without having to worry that you missed something

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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