Main Subject - Business

As I mentioned earlier, most companies have a budget for donations. Unfortunately the

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

se budgets are set well in advance and it is often difficult to get on the list. If y

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

Examples of combination products may in

u hold a fund-raiser each year and know well in advance when it will be held, you sho

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

uld take time to apply for donations. My Rotary club has an event called Cabaret they

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

hold at the beginning of May each year. This is a very successful fund-raiser and the

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

Combination pro

y raise around $100,000 at this event. The event has sponsors, and donations that are

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

used for silent and live auctions. The point here is that they are planned well in ad

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

vance of the event and the sponsors are solicited a year ahead. If you are part of su

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 group with a reputation for supporting local and international projects, you will

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

have a better chance of getting donations from businesses. Asking for donations shou

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

d always be done through current business relationships. One of the things we have le

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

Following aspects would a

rned is that large donations only come from those organizations that already have a b

dd to the challenges in developing combination products:

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

usiness relationship with one of the members.

There is an opportunity to further the

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

relationship by following-up and letting the donor know where the money from the even

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

t has been distributed. This will keep the relationship going and also the company wi

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

l welcome members of the organization when further donations are needed. I just want

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

Professional from academic institutions, pharmaceutical industries, health care indust

to emphasize that it is the relationship that is the most important piece.

Do not be

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

afraid to ask for a donation, especially when there is a previous relationship with y

.

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

our organization. This may seem like a cold call but in reality it is a luke-warm one

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

Companies that provide selfless information through particip

If your cause is well publicized the potential donor will be well aware of the event

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 - Donations for a Worthy Cause

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