Main Subject - Business

Many church youth groups plan bake sales to support their programs, summer camp or mission trips. Everyone likes cook

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

ies and cupcakes, so why not have a bake sale? While a bake sale might sound like a good idea, here are 7 reasons why

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

Examples of combination products may in

may not be the best idea.

1. Bake Sale Item Prices - Bake sale items are typically priced quite low. After all, you

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

can only charge so much for a little zippy bag of cookies. Prices generally range from 50 cents to $10 for a cake. S

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

o unless they give an extra donation, each person who makes a purchase is contributing a very small amount.

2. Impos

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

Combination pro

sible Volume - Considering the low price point of items, your church youth group would have to do a lot of baking to

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

come up with enough items to generate a good income at the end of the day. With baked goods it’s just not possible.

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

3. Potential Funds Raised –Unless you only need to raise $100 or less your group is not likely to reach it’s goal wit

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

h a bake sale. Why would you spend so much effort on something that produces so little results?

4. Too Much Work - A

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

nyone who’s ever baked items for a sale (and I have) knows how much work it is. It may take all afternoon to bake a f

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

ew dozen cookies and cupcakes. At best your hard work will fetch the organization $10-20. Was it really worth it?

5.

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

Following aspects would a

Perishable Foods – Baked goods need to be sold the day of the sale. If bad weather, a low crowd or something else th

dd to the challenges in developing combination products:

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

warts the bake sale, you can’t save them for later.

6. Too Many Fundraisers –Because bake sales generate such a low

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

amount of income for the group, it becomes just one more fundraiser people are asked to participate in. After awhile

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

even people who support your group will get tired of being asked.

7. Divides Your Efforts – Because your church yout

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

h group is spending time on the bake sale, it is taking time away from fundraisers that could be more profitable. Why

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

Professional from academic institutions, pharmaceutical industries, health care indust

not focus all of your efforts on one or two fundraisers that will produce much more results?

Instead of wasting tim

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

e with a bake sale, find a fundraiser that is the best match for your church youth group. An effective fundraiser is

.

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

appealing to a wide majority of your supporters, brings in the most amount of money compared to the effort and doesn’

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

Companies that provide selfless information through particip

t cost more than is appropriate.

There are a variety of great fundraising ideas… bake sales are just not one of them

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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