Useful Advices - Business

What’s a cosmic 2 x 4 you ask? It’s actually a phrase that’s been used in the ‘new age/ metaphysical’ world for the past 15 years or more. It refers to the lessons we learne

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

d the hard way when we didn’t listen to our intuition.

In the process of our intuitive development, we learn to listen more deeply and follow the guidance that comes from w

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

Examples of combination products may in

thin. Because conscious awareness is building during that time, whenever we choose not to listen and go against our intuition, the lessons learned seem twice as powerful 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.

d painful than if we had listened.

When it happens, it feels like a 2x4 hitting you right between the eyes. It’s especially powerful because ‘you should have known better

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

. These are lessons that are meant to get our attention either consciously or intuitively. It is infinitely preferable to have it come through the intuitive realm, then take

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

Combination pro

action upon it.

Choosing to ignore, or bypass your intuitive sense will have repercussions that can lead to self blame, resentment and red ink in the business world. Have

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

you ever sat in a business meeting and listened to a proposal knowing the entire time that it ‘felt wrong’ somehow, yet you didn’t say anything? Later you aren’t surprised

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

to watch the plan fail, thinking you should have said something when you had the chance before the company took a loss.

Intuition is like our inner guidance system or a GPS

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

We all possess intuition. We didn’t exactly come into this life with a set of operating instructions, however we do have an inner road map. Each time we have a ‘feeling’,

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

or what I call a ‘knowing,’ it’s a signal that we are on the right road and headed in the right direction.

Think about a time when you had a bad experience and you caught

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

yourself saying afterwards, “I knew I shouldn’t have done that! I had a feeling, but I did it anyway!” We’ve all had experiences like that throughout our lives. Generally it

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

Following aspects would a

’s something we want to ‘make happen’ or something we want really badly, so we ignore those inner feelings. Not listening to our inner voice can be detrimental to our well

dd to the challenges in developing combination products:

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

eing, and to our bottom line! It’s the repercussions of our inaction that I call the Cosmic 2x4.

Paying attention to your intuition is one thing, however acting on it is an

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

ther. Why do you think you have an inner guidance system? It’s not meant to sit on a shelf and look pretty, only being dusted off once in a while. It is meant to be used e

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

eryday.

Our lives require constant course adjustments or corrections, similar to the automatic pilot on airplanes. In order to stay on track and reach the correct destinati

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

n, we need to make constant small course corrections. This is where our inner guidance system comes in really handy! Just listening isn’t enough however. Taking action on

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

Professional from academic institutions, pharmaceutical industries, health care indust

he intuitive message is just as important. When we don’t listen, we steer off course. Usually those sort of off-road detours are very bumpy and filled with potholes. It’s a

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

lesson in learning.

The moral of this story is that cosmic 2x4’s are painful and avoidable.

Tips for working with your intuition:

1. Sort and distinguish Intuitive messag

.

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

s from the regular mental chatter that goes on in your mind.

2. As you actively acknowledge your intuition it becomes easier to recognize.

3. The more you listen to your

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

Companies that provide selfless information through particip

intuition, the louder the volume.

4. Trust your intuition will always guide you in the right direction.

5. Acting on your intuition brings rewards.

© 2005 Jaelin K. Reec

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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