Advice You - Business

No two grants are exactly the same. The geographic locations of the applicants vary. Some grants are international, some are national, and some are local. The application deadlines vary. Some grants are offe

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

red annually, while others are offered quarterly. The number of times that you can apply may also vary. You can apply for some grants several times, yet some grants will only fund you once. Despite these dif

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

Examples of combination products may in

ferences, you can significantly increase your chances of securing grant funds from various types of funding sources by adhering to the following guidelines:

1. Be sustainable. Sustainability is one of the m

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

ore recent buzz words in grant writing. In the past, some programs were dependent upon the same funding sources year after year. This was unfair to new applicants for the same funding sources because the fun

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

ds were being monopolized by older organizations. It also allowed organizations to become overly dependent upon a single funding source. Some funding sources now require applicants to describe their plan of

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

Combination pro

sustainability. In other words, “How will you sustain (keep your program running) if we never fund you again?” Will you train others to implement your program at their own location (for a fee)? Will you open

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

a business related to the services that you offer?

2. Be able to inform the world about the results of the project. This can be done by your organization or an outside PR agency. If you don’t inform the e

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

tire world about your results, at least inform your community. This doesn’t have to be expensive. In the past I have done all of the following and more: distribute a newsletter (online and hard copy), join a

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

n association and share at the meetings, place press releases on my website, post flyers throughout my community, and sending emails to our business partners, past and present clients, and personal friends i

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

nforming them of all current events. Funders want the world to know about them and about the good work they’ve helped you implement.

3. Be willing to collaborate. There are many reasons that funders would p

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

refer that you collaborate. One: Collaborating increases the likeliness that you will not stray from what you said you would do in the grant application. Two: There will be more people working together to ac

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

Following aspects would a

complish the tasks. Three: More clients will be served by the program. You will also benefit from collaborating because: you will have someone else helping you to recruit participants for your program, you w

dd to the challenges in developing combination products:

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

ill have someone else evaluating the effectiveness of your program, and someone else will share the burden of securing resources for your program. If you choose the right organization to collaborate with, it

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

can be a win-win situation. Additionally, it could double or even triple your profits.

4. Be prepared to assess the program’s effectiveness. Evaluations help both you and the funder. It is important that y

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

u assess the strengths and weaknesses of your programs so that you can operate at your full potential and make any necessary changes. Offering anything less than your best is unfair to both you and your clie

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

nts. Remember, a lot of agencies are competing for those funds. Therefore, funders want to ensure that they have chosen the best applicant. Outstanding results could lead to an increase in funds offered to y

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

Professional from academic institutions, pharmaceutical industries, health care indust

our agency.

5. Grammatical errors. I am a witness. It is difficult to notice mistakes in a 5-30 page grant application once you’ve read it several times. If possible, have someone proofread your application

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

before it’s submitted. Use spell check too! I have seen some organizations make very careless mistakes on their grant applications. When possible, put your application away for a day or two before reading i

.

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

t again.

Many grant seekers have excellent program ideas. However, they are still denied funding because of the aforementioned issues. Often this causes them to become discouraged and they do not reapply. K

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

Companies that provide selfless information through particip

eep applying until you are successful. There is money available. It is waiting for you. I have made many of my dreams come true using funding supplied by the generosity of others; I invite you to do the same

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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