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The latest series in "The Apprentice" features 2 distinct group of candidates. One group, who ar

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

e only high school graduates are termed as "Street Smarts" by Donald Trump whereas, the other g

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

Examples of combination products may in

oup are all college educated with some having MBAs and advanced degrees. They were termed as the

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

"Book Smarts".

What was revealed at the start was that the "Street Smart" group were mainly en

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

repreneurs and had a net worth 3 times more than the "Book Smart" group!

What this goes to show

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

Combination pro

is that you do not need a college degree to be an entrepreneur and rich. In fact, having a coll

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

ge degree may be more of an impediment to being a successful entrepreneur.

Why is this so?

Fo

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

r one thing, entrepreneurs cannot be conformist and stick "by the rules" and college somehow ten

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

s to train people to stick "by the rules". Entrepreneurs will always come up against obstacles

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

and will have to find ways around these obstacles, many times, unconventionally.

College tend t

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

make graduates think in a similar fashion, hence, they tend to be highly trained clones with no

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

Following aspects would a

personality. Entrepreneurs however know that they need to have their own USP, or "Unique Selli

dd to the challenges in developing combination products:

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

g Proposition" to be successful and being entrepreneurs, will find or create their own USP to ma

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

ke a success of themselves.

Entrepreneurs know that they need to think out of the box and crea

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

e a niche for themselves as they do not have the resources to fight the big boys on their terms.

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

For college graduates, there is always the choice of going to work for one of the big corporat

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

Professional from academic institutions, pharmaceutical industries, health care indust

ons. For entrepreneurs, failure is not an option as they would not get very far in a big corpor

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

ation without a college degree.

This is not to say that all college graduates are not entrepren

.

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

ur material but that in most cases, getting a college education may not be the best route to bei

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

Companies that provide selfless information through particip

ng an entrepreneur as the education system is designed to produce workers and not entrepreneurs

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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Answers - Street Smarts Vs Book Smarts, What Does It Takes To Be An Entrepreneur

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