Useful Advices - Business

For entrepreneurs who are looking for an angel investor to help them with their capitalization needs, one of the most difficul

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

t things to do is to actually meet with an angel investor and present his or her business plan. However, there are a number o

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

Examples of combination products may in

f things that an entrepreneur should bear in mind with regard to angel investors so that he will not have to worry too much ab

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

out what will happen during the meeting.

Before the meeting

One of the first things that entrepreneurs should bear in mind i

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

that even before an angel investor agrees to meet with him or her, the angel investor probably already has an idea of who he

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

Combination pro

or she is. This is because of the fact that angel investors make it a point to "screen" who they meet with, and, as much as po

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

ssible, they want to be introduced to entrepreneurs by a trusted friend or relative so that they would have a "reference." Th

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

s is because they want to meet with entrepreneurs whom they can have confidence in and trust.

If an angel investor is a famil

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

y friend or was introduced by a friend or a relative, it would be good to hold a "pre-negotiation meeting" before the big meet

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

ing by inviting the investor to gatherings or parties. This is because doing so can allow the entrepreneur and the investor to

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

get to know each other better before the meeting, which can also serve as a good opportunity to make a good first impression.

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

Following aspects would a

During the meeting

During the big meeting, an entrepreneur can build on the first impression that he has made by coming to t

dd to the challenges in developing combination products:

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

he meeting prepared to effectively present his business concept and to answer any questions that the investor may have. To be

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

able to do so, he or she must prepare a good business plan and bring some very important tools like a calculator, which can he

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

p him assess his business needs given the different options he would be presented with during the meeting. In case the invest

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

or agrees to invest, it would be a good idea to draw up a letter of intent. However, if the investor is a friend or a close fa

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

Professional from academic institutions, pharmaceutical industries, health care indust

mily friend, a simple verbal agreement and a handshake would suffice before the papers are prepared.

To help relieve some of

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

he anxiety that an entrepreneur goes through in looking for an angel investor, there are a number of ways by which he or she c

.

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

an make the meeting with an investor more pleasant. Some of these include holding a "pre-negotiation" meeting and preparing we

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

Companies that provide selfless information through particip

ll for the meeting in order to leave a good impression with an investor and increase the chances of signing an investment deal

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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