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The architecture of your corporate capital formation strategy should be engineered by design and not something that is evolved to

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

by default over time. However all too common is the enterprise that organizes itself improperly out of the gate by making the wron

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

Examples of combination products may in

g choice of entity, issuing the wrong type, class and amount of stock, seeking equity investments either from the wrong sources or

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

at the wrong time, utilizing the wrong form of debt financing and the list goes on…

I conducted an informal pole not too long ago

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

with the goal being to try and understand how entrepreneurs choose to organize their companies. The following five questions were

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

Combination pro

posed to a group of bright, successful and sophisticated entrepreneurs and the answers received ranged from the sublime to the rid

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

iculous, to the very enlightened. The answers displayed below are representative of the most common responses:

1. How did you sel

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

ct the your entity structure? “I asked my accountant which form of entity to use and he said that a Sub S would be the best choice

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

for minimizing my tax burden.”

2. How did you organize your capital structure? “My attorney just told me to issue 100 shares of

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

ommon stock.”

3. What was your capital formation plan? “I had a little cash saved up and I figured once I had been in business fo

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

r a while and established some revenue I’d get a bank loan.”

4. What was your valuation strategy? “I didn’t really have a valuati

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

Following aspects would a

on strategy…I thought it would take care of itself at the right time.”

5. What was your exit strategy? “I didn’t really have an e

dd to the challenges in developing combination products:

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

it plan per se, I just thought I’d survey my options when the time was right and see what produced the best return.”

The truth is

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

I’ve seen companies make all the wrong choices in their formative stages and yet still do well. However these companies that have

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

succeeded in spite of themselves had the luxury of having the time and the money to reengineer their business at a later date. The

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

sad reality is that most companies don’t have the time or the capital to unwind critical mistakes in their strategic financial pl

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

Professional from academic institutions, pharmaceutical industries, health care indust

ns.

My advice is simple… Do not fall into the trap of working with a small “mom and pops” accountant or attorney; rather seek out

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

the highest caliber professional advisors when developing your corporate financial plan. Time spent in the development of a sound

.

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

strategic financial strategy will help your company secure capital at the best terms, rates and conditions thereby allowing your c

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

Companies that provide selfless information through particip

ompany to scale by leveraging the lowest blended cost of capital into the best valuation resulting in the highest return on equity

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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It is a common knowledge that women are receiving lower wages than men do. The reason for that is cultural barrier; it also has to do with the general attitude toward women in the workplace. The sexual discrimination resulted in the feminism movement all over the world.

Your resume is your sales letter. It may not get you the job. But it must get you an interview. The resume should be written to arouse the interest of the employer so that you get your appointment for an interview.

When the time comes and you are ready to market your idea, most likely you will turn your attention to large companies for help. After all, you are telling yourself, these huge, large corporations are experienced in invention marketing and will take care of my idea; they have unique domain knowledge and the expertise necessary for me to succeed. Without much ado, you take your idea and knock on the door of big conglomerate. You are asked to explain your idea and provide business plan. By the end of the day you are told to stay patient and wait while the big boys are taking care of you. You wait weeks and months; keep telling yourself that the phone may ring any day now. Unfortunately nothing happens until you give in – you call first and told that your idea was too non-commercial...

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