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May and June are the big months for graduations, be it high school or college, and I find it interesting how students today take it for granted. True, most understand that it m

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

arks a passage from one stage in their life to another, but most do not seem to grasp the significance of their diploma and what it represents. First, it certifies you have lea

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

Examples of combination products may in

ned a specific curriculum, but more importantly, it means you possess the faculties to learn, that you can be taught; two important attributes employers are looking for. They a

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 not so much interested in what you have learned in school as much as your ability to learn and adapt, which is what the diploma represents. Regardless of your degree, most em

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

loyers are going to spend a period of time debriefing you and then teach you how to do things in the manner in which they want things done.

High School students in affluent ar

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

Combination pro

as of the country tend to believe they have a right to go to college. I don't care how much money your family has, going to college is not a right, it is a privilege, one you s

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

ould be thankful for. And I do not believe college is the right path for everybody; some would be better off in a trade school or perhaps a stint in the military where they mig

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

t learn some organization and discipline. Like our colleges and universities, both trade schools and the military are honorable institutions and represent a viable avenue for y

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

ung people to pursue.

What I tell students departing for college is that it is most definitely not the same thing as High School; that it is now THEIR education, and, as such,

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

they have every right to hold the professors accountable for getting the education they are paying for. Frankly, I think every college professor should offer their resume and c

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

edentials to every student on the first day of class so they know what they are buying. Some college professors do not like this. What they fail to remember is who the customer

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

Following aspects would a

is here. But I digress.

When I graduated from Junior High School in Chicago years ago, I received a diploma in cap and gown. I don't believe such diplomas are given out anymor

dd to the challenges in developing combination products:

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

(in fact, most schools have gotten away from the term "Junior High School" and now refer to it as "Middle School"). Years ago, during the Depression, a Junior High School dipl

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

ma was very much prized as it was as far as someone could go before having to go to work to help support the family. Back then, a High School diploma was prized at the same lev

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

l as a College diploma is today. The point is, a diploma is nothing to be taken for granted as it is a representation of your credentials in today's society.

I recently met a

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

id who dropped out of his Senior year in High School, simply because he felt he was too cool for school; he felt he had enough street smarts to get him by in life. After a few

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

Professional from academic institutions, pharmaceutical industries, health care indust

inutes of talking to him, I knew exactly where he was going in life, nowhere. This is a prime example of someone who is destined to attend the School of Hard Knocks for the res

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

of his life, and grouse about it for years to come.

But if you have graduated, don't think this is the end of your education. You will be learning lessons for the rest of you

.

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

life. Our schools and universities do nothing more than train your mind to learn. That is their mission. This does not belittle the diploma they will hand you. After all, it i

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

Companies that provide selfless information through particip

a reflection of not only you, but your parents and teachers as well. So treat your diploma with respect; be proud of it; go ahead, frame it. And "Welcome to the jungle."

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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