Useful Advices - Business

Years of experience have taught me there is no such thing as “Business Ethics”. If a person isn’t ethical in the rest

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

of their lives, their business ethics aren’t worth the shoe leather they’ve worn out either.

I stood beside a State

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

Examples of combination products may in

Representative at college graduation recently, and heard him tell a gentleman shaking his hand that he had the utmost

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

respect for the President of the college, because he knew who her friends were and they all had good solid “Business

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

thics”. I raised an eyebrow and continued a conversation with another friend nearby. It was my third College Graduat

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

Combination pro

on this year.

At a high school graduation, I listened to the Valedictorian say, “Your values for living all of your

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

ife will follow wherever you go.” At another graduation, an honorary graduate stated, “Who you are today will be ref

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

ected every day of your life, by what you become tomorrow.” At another function, celebrating the accomplishment of o

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

der students, those who were returning to school after being part of the work force for many years, I heard yet anoth

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

r speaker say, “Your life is marked by dates, one at the beginning, and one at the end, with just a dash in between.

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

A short little dash reflecting who you were, what you accomplished, and the values you held. How important will your

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

Following aspects would a

dash be?”

As I reflect on these comments, I look back at my own life. Every choice has a consequence. I know, beca

dd to the challenges in developing combination products:

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

se I’ve made a few bad choices, along with the good ones. As I look back, I often realize the choices I made that did

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

’t turn out so very well were often made with the influence of other people, so I have to look back further. This br

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

ngs me back to the comment by the State Representative, about knowing the President of the College’s friends.

Someti

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

es, our choices of friends are the first bad choice of many. We are judged by the company we keep, and ultimately we

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

Professional from academic institutions, pharmaceutical industries, health care indust

pay the consequences of the choices we’ve made, influence by the company we keep. That’s a bit redundant – but extre

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

ely true. If you desire to be ethical, you live an ethical life, and you choose ethical friends.

What do your friend

.

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

and your choices say about you?

If personal fulfillment is your goal in life, ethics may appear to be unnecessary.

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

Companies that provide selfless information through particip

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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