Digg It - Business

The Blind Men and the Elephant

It was six men of Indostan
To learning much inclined,
Who went to see the Elephant
(Though all of them were blind),

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

That each by observation
Might satisfy his mind.

The First approached the Elephant,
And happening to fall
Against his broad and sturdy side,
At

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

Examples of combination products may in

once began to bawl:
“God bless me! But the Elephant
Is very like a wall!”

The Second feeling the tusk,
Cried, “Ho, what have we here,
So very ro

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

nd and smooth and sharp?
To me ‘tis mighty clear
This wonder of an Elephant
Is very like a spear!”

The Third approached the animal,
And happening

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

to take
The squirming trunk within his hands,
Thus boldly up and spake:
“I see,” quoth he, “the Elephant
Is very like a snake!”

The Fourth reach

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

Combination pro

ed out an eager hand,
And felt about the knee.
“What most this wondrous beast is like
Is mighty plain,” quoth he;
“’Tis clear enough the Elephant<

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

r> Is very like a tree!”

The Fifth, who chanced to touch the ear,
Said: “E’en the blindest man
Can tell what this resembles most;
Deny the fact who c

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

an,
This marvel of an Elephant
Is very like a fan!”

The Sixth no sooner had begun
About the beast to grope,
Than, seizing on the swinging tail

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

> That fell within his scope,
“I see,” quoth he, “the Elephant
Is very like a rope!”

And so these men of Indostan
Disputed loud and long,
Each i

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

his own opinion
Exceeding stiff and strong,
Though each was partly in the right,
And all were in the wrong!

John Godfrey Saxe (1816-1887)

Well you a

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

re now probably wondering whether you have signed up for a poetry course or one about management and management planning. Replace each of these wonderful men of Indos

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

Following aspects would a

tan with a member of your team. As a way of explanation let’s look at a management team made up of the CEO, CFO, CTO and all the other C’s. Each comes to the table wi

dd to the challenges in developing combination products:

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

h many years of experience and study behind them. They come with a thorough understanding of their role in the company but a limited understanding of the other C’s ro

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

les.

Now imagine your revenue is on a downward trend and you have come together to try and reverse this trend. Each member will see the problem and solution from the

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

ir own familiar position. You will sit around and argue long and hard about how to tackle this problem. If each took a tour of the ‘elephant’ and tried to understand

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

ach part and how each part makes the whole then it might become clear that the elephant has a thorn in his foot and therefore can’t walk to get his food and water and

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

Professional from academic institutions, pharmaceutical industries, health care indust

so is becoming malnourished.

Understanding each part of the elephant and how they come together to make the whole is what Peter Senge calls ‘systems thinking’ and i

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

s one of the five disciplines that make a learning organization.

We are not saying that the CFO needs to go and get a marketing degree and work in marketing. But if

.

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

ach member of the team listens and tries to understand the whole ‘elephant’ rather than stating their position more and more firmly, then the team has more chance of

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

Companies that provide selfless information through particip

reaching a true understanding. The team has more chance of fixing the problem and achieving success.

Open your eyes and see the whole ‘elephant’ for what it truly is

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.diggit.org.ua/article/23399/diggit-The-Blind-Men-and-the-Elephant.html">The Blind Men and the Elephant</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/23399/diggit-The-Blind-Men-and-the-Elephant.html]The Blind Men and the Elephant[/url]

The U.S. has pioneered slip sheets and has used them for many years. However, the dominance of the supermarket sector in some European countries may be forcing the change there also.

Pay policies and programs are one of the most important human resource tools for encouraging desired employee behaviors and discouraging undesired behaviors.

Are you looking for simple ways to increase your income without making a major investment? One small way to begin doing this is by becoming a reseller or affiliate for peripheral services that you believe in and already use on behalf of your clients.

Tags

Links

Digg It - The Blind Men and the Elephant

Related Articles: