Advice You - Business

When grant-seeking organizations conduct a diligent search to find funds for their programs, hundreds of possibilities are likely to arise. If using a re

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

source like the Foundation Center database, there will be detailed information about foundations’ and corporate funders’ priorities, past grant awardees,

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

Examples of combination products may in

pplication criteria, and funding limitations.

Pay close attention to this information. Searching for the appropriate funding source for your programs and

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

projects is a skill right up there with effective writing, when it comes to winning grant money.

Why is the search so important?

Many fledgling nonprofi

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

s envision multimillionaires waiting to dole out thousands and millions of dollars to every worthy 501(c)(3) organization. They assume a well-written gran

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

Combination pro

proposal will speak for itself and for their needs. How many of us have received email assuring us of the thousands of government dollars available to pr

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

ctically anyone willing to make a small investment?

There’s way more to that story. I’ve learned three very important facts about grant seeking—and belie

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

e me, they are facts:

* Any money that’s available is slated to make a difference in specific areas.

* Every funding source stipulates its funding prior

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

ties and criteria for grant making.

* Writing a grant that isn’t a match for those priorities is a waste of your time.

Your organization’s challenge is

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

o conduct a search so wide and deep that you finally hit on a funding opportunity that seems like it was issued just for you. The mission, projected outc

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

mes, and focus areas should all seem tailor made for your program. Once you believe you’re on the right track, take additional precautions by remembering

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

Following aspects would a

the following:

* Note the range of funding available to applicants. For foundations, check how much money was awarded to what kinds of organizations. I

dd to the challenges in developing combination products:

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

ABC Foundation gave $275,000 to a well-known agency with national impact, don’t expect the same amount for your community-based tutorial program that ser

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

es 40 children.

* Stay within the funding range established. If the awards are from $250,000 to $650,000, don’t write a proposal for $75,500 believing yo

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

r program is a bargain. Funders know the scope of services and kinds of outcomes that can be expected with a particular level of support. If they intend

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

to make a major impact, they’re looking for larger projects. There are reasons for setting such parameters.

* Take the instructions seriously. If funds

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

Professional from academic institutions, pharmaceutical industries, health care indust

re targeted for women’s health, don’t stretch it and write for children’s medical issues. One might assume that a funder that cares about women will, no

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

oubt, care just as much about children. But, in grant writing, making assumptions is a liberty one can’t afford to take.

The bottom line is, your progra

.

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

and organization is designed according to your mission and vision. Funding agencies’ philanthropy is aligned with their mission and vision, as well. Sin

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

Companies that provide selfless information through particip

e time is a valuable commodity—for you and for the funders, take the time to conduct a thorough search so a majority of your grant writing efforts pay off

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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