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The CEO for 2006 through to the new millennium is less about traditional education and more about being plugged into quantum physics and the information highway

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

in combination. With so much distraction today the only thing left to do is turn your brain off regularly (stop thinking) and let yourself re-connect to the univ

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

Examples of combination products may in

rse. WISDOM!

The obvious keys to CEOism in the 21st century are; Ability to outsource effectively, strong interpersonal skills, KNOW YOUR NUMBERS- Always!- Busi

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

ess is all about numbers! Creating a passionate vision, Keeping the goals that lead to that vision in sight at all times and measuring your progress towards them

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

, realizing it is a moving target in today's economy.

Then we have our traditional 4 pillars:

Revenue
cost control
productivity

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

Combination pro

maintaining leading edge

Ok at a 70,000 foot level we have it covered...... RIGHT?

Now lets get into the not so documented elements of a successful 21s

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

century CEO!

Let's start with SELF- yep self- made up of mind, body, spirit- all needing to be fed constantly- regularly with positive energy-experiences. The

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

body- good nutrition, exercise, emotionally stable surroundings, the mind regular stimulation with positive knowledge- a reasonable stable social conditioning (u

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

bringing), the spirit- ah there is the tricky one- no I am not talking about religion- nor am I condemning it.

What I am speaking of is your connection to the s

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

urce, the universe, the place that you enter when you are really quiet or have experienced something extreme that takes you there. Your ability to willfully take

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

yourself there is key- the information age, constant information feeds of one sort or the other dampens, even blocks our ability to just Know what to do

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

Following aspects would a

.That intuitiveness that our great ancestral forefathers and mothers possessed. We all have that in us, some are more in touch with it than others. You can not a

dd to the challenges in developing combination products:

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

cess it through traditional personal development methods, you cant search for it- if you do- it will elude you!

yah i know sounds a little voodoish, but it IS o

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

e of the absolute key "Success " elements that define the CEO of the 21st century!

I am not suggesting that personal development is not necessary- it is, we inh

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

abit this bag of skin and it needs to be fed- see mind, body, spirit above.

So the core competencies of this this new CEO for the 21st century are; Connected to

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

source (universe)- spiritual development through shutting the brain down daily for periods of time, passion, personal development- mind, body- strong trusting p

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

Professional from academic institutions, pharmaceutical industries, health care indust

rsonal, business- partnerships, suppliers, clients and community relationships. A strong sense of maintaining integration between these relationships.

Lastly Fi

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

nancial stability through self mastery- not letting your ego convince you that buying things, or being associated with certain people, or situations is you!

Thi

.

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

might not sound as concrete as a college education (feeding the the mind is important-see above) but being able to shut it off so you inherently just Know
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
m>- IS SO KEY! If we have to lets label it - let's call it - Wisdom!

There you have it- sounds too simple! Its the true challenge of the CEO of the 21st century

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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