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Although the specific guidelines for each foundation vary, most foundations are looking for the same kind of information to help them evaluate your request for funding. Check out these top

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

tips from the foundations when you sit down to prepare your next proposal.

Follow the guidelines
First, be sure to follow whatever guidelines the foundation has provided you. If the

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

Examples of combination products may in

foundation requires a specific cover letter or application form, be sure to use it—this makes their job easier and it shows that you’re serious about your proposal. (There’s a good chance

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

that your proposal will not be read if you don’t use the appropriate form, so don’t ignore this basic but critical step.) Keep your reader in mind at all times, and help out by providing

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

subheadings for each section of your proposal. Pay close attention to any page limits described in the guidelines, and be sure to submit all materials on time!

Get right to the point

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

Combination pro

Describe the specific goals and objectives of your project in a clear, concise summary, and do it right at the start. Don’t wait until the middle of your proposal to say what you want. T

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

his will probably require your project officer to go back and read from the beginning again. Clarity and concision—in defining your need, proposing a solution, and describing how the found

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

ation can help—is the best way to start a proposal.

Represent your organization
Tell the foundation the mission and history of your organization—but do so briefly, in no more than a f

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

ew paragraphs. Your goal here is to build credibility, describe the nature of your programs, and demonstrate your record for making positive change. Be sure to provide the essentials here

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

, too: your location, size, budget, etc. How are you different from other organizations that do similar work?

Identify the problem
Your goal here is to demonstrate the importance of

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

the problem and to show that your organization can provide an innovative solution. Since you can’t assume that the funder knows anything about your subject area, convey the essentials as

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

Following aspects would a

clearly and convincingly as possible. Use both quantitative and qualitative evidence: include meaningful data as well as testimonials from your clients to tell the story of your project.

dd to the challenges in developing combination products:

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

Identify clear and assessable goals
When you describe how your organization will tackle the problem, be as specific as possible. What are your goals, how will you reach them, and how

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

will you measure your success? Include everything you’ve done already, such as research, planning and collaboration.

Name other sources of funding
Funders want to be a part of succes

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

sful projects, but they seldom want to be the only funding party. Be sure to describe all other funding sources in your proposal, including in-kind contributions of goods and services, mat

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

ching funds, etc.

Sustainability
How does your project provide a new approach to an existing problem? What is the project’s long-term vision? How will it be supported after the gran

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

Professional from academic institutions, pharmaceutical industries, health care indust

t funding runs out? These are questions that your funder will likely be considering. Try to address them in your proposal.

Assessment tools
How will you measure the success of your

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

project? Describe your assessment tools, including what data you’ll be collecting, who will gather it, and how it will be evaluated.

The foundations are your resources
Applying for gr

.

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

ant funding can be a trying process, so it’s important to be patient and persistent. The foundations want to help you, so don’t feel bad about asking questions when you’re putting your pro

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

Companies that provide selfless information through particip

posal together.

You know your organization, you know your clients, and you know the importance of the work you do. Keep these tips in mind, and good luck with your next round of proposals

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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