Advice Pool - Self Improvement

The prayer of Serenity asks for ‘courage to change the things we can,” most of us spend our lives in a state of denial regarding what we can change

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

. We seem to refuse to accept the things we cannot change, (reliving them constantly) while abdicating the responsibility TO CHANGE the things we

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

Examples of combination products may in

can.

WHAT DO I MEAN?

Early in my 9 to 5 career, while I was searching for a sense of direction I had my first taste of office politics. At this

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

time I was not equipped to manage this and as a result I was eventually fired. No reason was ever given to me – other than this is not working out

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

– and legally none was needed as I lived in a “right to work state.” Now to say I was depressed and confused would be an understatement – after a

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

Combination pro

ll I had met ALL my goals and quotas even earning record bonuses – unheard of before (this it turns out what the problem – but I am getting ahead o

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

f myself.) so I knew I was not underperforming.

I eventually discovered the “real” story and it is the typical one of the mediocre 10 year veteran

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

being rattled by the new kid and decided to make sure I did not get promoted over her. She did such a good job, that I was told to leave as I was

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

seen as “anti-team.”

THE MORAL OF THE STORY….

I spent about a year replaying this injustice over and over – despite the fact I had found a better

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

paying job with a substantial pay increase. My mind was filled with this toxic energy; I was on the hamster wheel.

Until I discovered the power

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

of acceptance and realized how important it was in turning my life around. It is without a doubt the first step on the ladder up to emotional and

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

Following aspects would a

financial greatness. Do not confuse acceptance with inaction, I am not saying we accept wrongs and do nothing (in my case my legal options were no

dd to the challenges in developing combination products:

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

n-existent, but I became determined to achieve GREATNESS.) What I am saying is to accept the unpredictable nature of this existence, that our most

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

difficult moments are our best teachers.

Charlotte Joko Beck says it this way: “…we have to face the pain we have been running from. In fact we

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

need to learn to rest in it and its searing power to transform.”

We cannot transform our attitudes and consequently our relationships, career, fin

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

ancial futures – and in a larger sense our world until we stop wasting energy resisting what is. Only then is our unique GENIUS IS RELEASED.

So g

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

Professional from academic institutions, pharmaceutical industries, health care indust

oing back to my story, my firing was the first step to the wonderful life I have now. I would not have achieved financial success with out having

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

my “cage rattled.”

TOOL KIT

• It is no coincidence that all the great religions teach about the power of acceptance/forgiveness – It is the first

.

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

step to transformation.
• Nothing in your life will change, as it did with mine unless YOU see your problems as a source for growth and GREAT

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

Companies that provide selfless information through particip

NESS.
• Time and energy are wasted consistently reliving the injustice.

OpTimize your attitude and your life, career and finances will follow

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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