Main Subject - Business

Many times in my work as a grant writer and consultant, I am asked by my clients to contact a foundation about potential funding. I am happy to do this; it is part of my job and it helps for me to directly ask the quest

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

ions that will effect what I write in the grant proposal, but I sometimes wonder if the client isn't missing an opportunity by making that connection directly.

By the same token, when I am first meeting with a potentia

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

Examples of combination products may in

client, they often ask me if I have good connections with any local foundations. I do, I say, but then I think to myself that my connections are irrelevant; it's their connections that matter.

This all bring up the qu

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

stion of whether or not having a connection inside a foundation is more important than what you put in your proposal. Whenever I teach grant writing or nonprofit fundraising planning I am asked about this common assumpt

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

on, and whether or not it is true.

It is completely wrong, I tell my students, having connections won't get you funding. Except in those situations where it does. Let me explain further.

Connections mean nothing
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

I can't even count how many times I have submitted an un-invited grant proposal to a foundation based only on my research, without having even one phone conversation or email exchanged between us, and had that proposa
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
fully funded.

On the other end of the scale, I have been in situations where a well-known foundation was wining and dining my co-workers and me, toasting us and what a great partnership we had, only to pull our fundin
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
two months later because of a "change in priorities."

The bottom line here is that it doesn't really matter how many friends you have on the inside. If your proposal is well written and clearly identifies how it is in
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
line with the funder's priorities you will be successful. If your proposal is not what the funder is looking for, or it simply isn't clear what you want to do, you will fail. The best connections cannot save a lousy pro
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
osal or one that is completely outside the guidelines.

Relationships are everything

What I wrote above does not mean that you shouldn't try to cultivate good relationships with your funders. The same courtesies
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
and attention you put into your individual donors should be shown to your foundation and corporate sponsors as well.

While you can be very successful only submitting un-solicited proposals, you are always playing a num
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
bers game. There are more good nonprofit projects and program proposals than there are charitable dollars to go around. You will receive your fair share of rejections along with the funded grants.

Where good relationsh
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
ps will help you is when it pays off in trust. When a decision is close, being known as a reliable nonprofit that meets its goals and is easy to work with can make all the difference.

Even better is when that relations
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ip pays off with the foundation approaching you for a proposal before you approach them. While even an invited proposal is no guarantee of a grant, it does start you out on much better footing.

But it is up to you to b
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ild that reputation and that relationship through dependability and good communications. Respect your foundation officer's time and only call with important questions, not just to gab or to complain, and be sure to than
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
them for their time. Likewise, be available when they call you with questions about your programs or to find out what your issues are. Submit your reports on time, using the format they provide, and don't ask for any s
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
ecial favors or extensions.

Conclusion

Getting back to the clients who have me make their foundation calls; they're not doing anything wrong by outsourcing that job, but they are missing a chance to get to know
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
their funders better.

As for the clients who ask about my relationships as a pre-requisite to hiring me: my relationships can only go so far. For long-term funding they need to build long-term relationships, and those
.

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
ust be made from within the organization, not from an outside contractor.

To those students of mine who are new to the nonprofit sector and the world of grant writing, I say, don't despair. Build your resumes first, wi
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
h well-written proposals and successful programs, be yourself and be professional, and the relationships will develop in good time.

To all of them I say, remember, connections mean nothing: relationships are everything

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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Main Subject - Foundation Relations: Is It What You Do or Who You Know?

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