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Grow Wisconsin is a new network of grant writers in WI who exemplify that collaboration begets success while reminding us th

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

at no matter how your grant defines profit, all grant proposals should be outline how you will measure results.

Only a year

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

Examples of combination products may in

old, Grow Wisconsin, is a group of 18 grant writers, who have been working with businesses and non-profits to bring in thous

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

ands of dollars to the State of Wisconsin. In a field that is saturated with non-profit executives and employees, this group

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

of grant writers is unique because most of them work for business firms and focus on for-profit grants. The majority of the

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

Combination pro

funding opportunities that they pursue are SBIR (small business grants from the federal Small Business Administration) and W

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

sconsin Department of Commerce support for Wisconsin businesses seeking funding.

Their for-profit position means that Grow

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

Wisconsin grant writers must include a strong commercialization, or sales, plan in their proposals. They cannot just offer t

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

build a product, they must also prove they can sell it. Non-profit grant writers can relate to this concept, as they try to

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

prove that programs will not only meet an immediate need, but also build a sustainable solution to the larger problem.

Gro

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

Wisconsin meets at customer facilities around southern Wisconsin and while the networking has been valuable to the members

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

Following aspects would a

of Grow Wisconsin, it will inevitably trickle down to benefit their clients.

Laura Ricci, a consultant and member of Grow W

dd to the challenges in developing combination products:

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

sconsin said, "These writers and consultants are seasoned professionals. Any firm competing for federal funds would be inter

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

ested in eavesdropping on their tips and tidbits. We can't and don't discuss particular clients, but we share all kinds of h

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

lpful hints and background information. At our last meeting, I caught suggestions that would save a start-up over $8,000.00

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

in set-up costs alone."

Their group is a fertile breeding ground for partnerships. Some of the members are technical expert

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

Professional from academic institutions, pharmaceutical industries, health care indust

in a particular field while others have spent years mastering the craft of grant writing. By bringing these various experti

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

se together in teams, they hope to not only improve the quality of their proposals for their clients, but also generate more

.

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

business for themselves. Certainly a win-win situation!

Anyone currently providing grant-writing services in Wisconsin is w

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

Companies that provide selfless information through particip

elcome to join their monthly meetings by sending an inquiry to info@growwisconsin.org. Their website is www.GrowWisconsin.or

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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Who would ever get into any venue (product launching, schools and family reunions, children's birthday parties) without bumping into a full scenario of colorful balloons in various shapes and theme?

They say advertising will help build your business and indeed Ted Tuner use to say; Early to bed, early to rise, work like hell and advertise. And the young Ted Turner meant it too. You see, Advertising Today Pays the Bills Tomorrow. Of course if you pay too much for advertising, which does not pull such as expensive Yellow Page Advertising or Yellow Page Advertising,

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