Main Subject - Business

An Executive Summary is a more finely tuned version of your full blown Business Plan. Some people get the two documents confused and others use the two terms interchangeably. There is no special set of rules for preparing either document al

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

though most people would probably agree that the Executive Summary should be contained in your Business Plan.

You want to attract potential investors, so a short, direct, targeted version of your Business Plan works best. Besides, you shou

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

Examples of combination products may in

ld be a little protective of your business plan. Don’t just send it out to everyone, especially if it contains confidential, proprietary or trade secret information. The Executive Summary is a good way to get your “story” out there to locat

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

e venture capital financing without sending people your full blown Business Plan.

A good stand alone Executive Summary should be 8-10 pages long, whereas most Business Plans are about 25 to 35 pages long. Here is an outline of a bas

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

ic Executive Summary:

Company Description
Mission Statement
Products and/or Services
Financing Requirements
Use of Proceeds
Management Team
Competitive Analysis
Financial Forecast
Exit Strategy<

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

Combination pro

blockquote>

Here's an important drafting tip: START OUT STRONG. The first section that an investor reads is your Company Description section. You need to make an impact on the reader, grab their attention and make them want to read every word of

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

your Executive Summary. The best place to start is right at the top with your Company Description. Check out How to Make Your Comp

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

any Description Stand Out for some great pointers.

Mission Statement. The Mission Statement should be a short statement of your company business and what it intends to accomplish as a goal. For instance, an internet service provider b

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

usiness might have the following Mission Statement:

“NetSky Holdings, Inc. (Symbol: NKYH) is an internet service provider (ISP) focused on acquiring other ISPs and consolidating all of their operations to achieve economies of scale.

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

NetSky’s goal is to be recognized as one of the most profitable ISP consolidation enterprises in the ISP field.”

Limit your Mission Statement to 1 or 2 sentences in length. The two key points you want to convey to the reader are your

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

confidence and the goal you are seeking to achieve. Strong and powerful statements are good because they show your business drive, but remember to keep it real. Don’t put price projections in your Mission Statement. For instance, do not say we exp

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

Following aspects would a

ect to generate $10,000,000 in gross sales during our first year of operations. There is a separate section of the Business Plan for your Sales Projections.

Financing Requirements. When you write about your Financing Requirements carefully

dd to the challenges in developing combination products:

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

plan out your breakdown based on (a) your use of proceeds, (b) a careful analysis of the revenue you feel you will generate and (c) over what period of time you feel you will be able to achieve the all important “net profit”.

(a) Use of Proceeds

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

. There is nothing wrong with micromanaging the money you expect to raise. In fact, if you are seeking $2,000,000 to buy equipment and sell widgets and you state the following:

Equipment $ 500,000
Salesmen $ 300,000
Advertising/Mar

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

keting $ 200,000
Materials $ 300,000
Working Capital $ 500,000
Overhead $ 200,000

TOTAL $2,000,000

Then you probably won't get any financing. Your numbers are too general and don't show any real thought and detail

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

to the whole process. Investors like a Management Team that can micro-manage expenses.

It is a good idea to sufficiently detail your use of proceeds in the Executive Summary. Investors will appreciate the detail, research, time and

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

Professional from academic institutions, pharmaceutical industries, health care indust

effort you have put into preparing the use of proceeds section. They will see you did your homework, researched your numbers, carefully analyzed the matter and were prepared. I cannot stress the importance of RESEARCH and PREPARATION enough

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

.

(b) Estimated Revenue. You don’t need to state your estimated revenue in this section. You actually break that down in the section entitled Financial Forecast. But keep in mind that what you put down later in your Financial Forecast will direct

.

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

ly impact what you are asking for in this section. For instance, if your estimated revenues show a net profit in 18 months, it is not a good idea to base your Financing Requirements on 12 months.

(c) Time it will take to be Profitable. Again, you

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

Companies that provide selfless information through particip

don’t have to actually state that in this section. However, it has a direct relation to your estimates that will appear in your Financial Forecast section and will probably come up in questioning by investors. So think ahead, think smart and be prepared

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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