Advice You - Finance

Do you need money for your small business startup or charitable project?

A grant, either from the federal or

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

state government or a private foundation may be the answer. The federal government alone has $400 billion t

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

Examples of combination products may in

o give away. Unfortunately, you can’t just call them and ask for a check in the mail – each grant applicatio

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

n will need a written and well thought out proposal. Check out the resource page at the end of this article

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

for links and advice on where to apply and procedures to follow.

Follow these guidelines in writing your gra

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

Combination pro

nt proposal for a good chance of success:

1. Put your self in the reviewers shoes. What is he looking for

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

in your proposal? What information does he need? What format does he prefer?

2. Follow the instructions.

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

It may seem obvious but many, many grant proposals are rejected because basic instructions were not followed

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

. Read and follow any directions.

3. Looks for funding that matches your mission or circumstances. Don’t

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

try to change your needs to match the grant. Find the grant that matches your needs.

4. Do some research o

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

n the funder. This is particularly important for private foundations. What is the purpose of their grant an

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

Following aspects would a

d what do they want to achieve?

5. Always include a summary or abstract even if not specifically asked for.

dd to the challenges in developing combination products:

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

This covers the project and its aims in two or three paragraphs. It can be part of the proposal or in a cov

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

er letter. Include key points to explain the objectives of the project.

6. Review and edit for spelling an

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

d grammar. Have somebody else review. Then a third person. Nothing will put off a reviewer faster than slo

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

ppy grammar or bad spelling.

7. Be innovation. Be creative. Stand out from the crowd.

8. Learn from the

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

Professional from academic institutions, pharmaceutical industries, health care indust

rejections. Ask for feedback from the reviewer if you can. Learn from your mistakes and improve your metho

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

dology.

9. Don’t give up. Even the best baseball batting average is close to 0.3. This means that they mi

.

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

ss 70% of the time. You will fail as much as this, if not more. Keep trying.

For a list of grant resources

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

Companies that provide selfless information through particip

and links visit: http://365money.info/grants.php

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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Advice You - Writing Successful Grant Proposals

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