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Jacob had sent his family on across the river Jabbok. Now he’s alone in the night with the river; this smooth talking, manipulating, deceiving Jacob. Here he stands in the dark by the ri

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

ver Jabbok; the river that runs in the darkness between the life he has lived up to this point and the new life that could lie on the other side in the land of Canaan – the Promised Land

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

Examples of combination products may in

All he has to do is cross it.

But to cross over into a new life is not an easy thing to do. It is not a simple process because before one can cross, unknown dangers may have to be face

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

and terrifying battles fought. This is what Jacob discovered. To cross over into Canaan was not just a matter of crossing a stream, because in the darkness a strange and mysterious Pres

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

nce arises. Ancient tales had it that rivers had spirits which had to be defeated before the river could be crossed. But when we read on in scripture we learn that the antagonist that ap

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

Combination pro

eared into the night to seize Jacob for a struggle that would last until daybreak, was not a river spirit, but the God of Righteousness forcing Jacob to his reckoning.

There comes a tim

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

e in our lives when every soul must give a reckoning by the river Jabbok. This Old Testament story is dramatizing the consequence that comes to every soul that has tried too long to evad

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

the truth about itself. The soul must wrestle with the mystery of existence and the reality of God to whom we must give an account. It is a time in our lives when we cannot manipulate a

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

yone or deceive anyone or con our way out of the situation because no one’s there but you and God.

Jacob is wrestling with the judgment of God flowing through his very core of being. To

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

orrow he has a date with destiny; he sees Esau whom he so easily degraded into an object to be used for his own advancement. Jacob saw his world shadowed by his guilt. Old memories awake

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

ed; old fears rose up from the past. All his betrayals, deceptions, lies and manipulations converged in on him in fateful battle.

Here, by the river Jabbok Jacob had to find the God wit

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

Following aspects would a

hin. He had to face up to himself and admit deep down that he did not deserve anything. He had to give up the pride that thought he could work out his own peace of mind by his own wits.

dd to the challenges in developing combination products:

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

acob had to struggle with himself to break through himself to the divine. Who will win?

We too must fight many personal battles with our inner selves by the river Jabbok. We cannot cros

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

over to the new life until we come to terms with ourselves and recognize ourselves for what we really are. Then we must make the decision as to which one of ourselves will win the battl

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

by the river Jabbok. Who will win when we see in one corner dirty, broken, bleeding, unsuccessful people crying out to be loved and in the other corner clean and bright and upward risi

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

g stars? Who will win when we hear Jesus’ voice calling us to deny ourselves, take up our cross and follow Him and Satan’s voice offering us power and wealth and prestige? Who will win t

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

Professional from academic institutions, pharmaceutical industries, health care indust

he struggle when a friend is in trouble or disgrace and to stand by him or her would mean that your own sweet reputation could also be tarnished? Who will win when power and status parad

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

before our eyes and tempt us to betray ourselves and others in exchange for recognition, adulation or a high office? Who will win?

Who will win as we and Jacob wrestle with the God wit

.

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

in our souls in the night beside the river Jabbok? Our true selves that were made in the image of God or the fragments of our selves that want to make idols of things like sex and power

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

Companies that provide selfless information through particip

nd money and recognition?

The Presence at Jabbok is stirring within us, calling us to wrestle with our depths until we find our true selves.

Scriptural Reference: Genesis 32:22-32(NIV)

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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