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You have probably heard it said the Holy Spirit is like a cloud; a fog; a ghost or even a wind. As we all know, it is as hard to explain what or who the Holy Spirit is as it is to explain what wind is. Obviously, the wind is somethin

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

g we cannot see, But, we can feel the wind so that leads us to try to explain it by talking about the effects of the wind and what it does all around us.

I have spent many fun-filled hours in wind-related activities such as: sailing

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

Examples of combination products may in

boats, flying airplanes and soaring in hang gliders. As a result, I have become quite familiar with the effects of the wind. I know many of the ways the wind can affect whatever vehicle I’m in. Of course, it is always up to me as

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

he one who is in control of the boat or plane to adjust the sails or wings properly to make the best, most practical and safest use of that wind. I must, through training and experience, learn to make that unseen and uncontrollable w

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

ind became my servant.

When I feel the wind on my face, I know it is there and I know in which direction it is blowing. The wind can be soft and gentle or it can be wild, and strong! Then, it is up to me to learn what the wind is “t

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

Combination pro

lling” me so I will always be the one who is in control of the airplane or sailboat I am in. That’s when I have to make a choice: I can either “fight the wind” or yield to it. When I try to fight the wind, it does not work. I never

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

win that battle. But, when I relax and go with the flow, I’ve found I can; always find ways to make progress toward my goal. For example, when in flight, in a light aircraft, in a strong, rough and bumpy wind, I will choose to head

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

my fragile airplane to the sanctuary and safety a nearby airport. Or, when in a sailboat in stormy winds and rough seas, I will steer toward a protected harbor where I can drop my anchor and know I’ll be safe. In these ways I find I

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

ake control of the effects of the wind but I can never actually control the wind.

As Christians, we sometimes try to explain the Holy Spirit as being a person who lives in us where he affects our lives much like the invisible wind.

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

(See Acts: at Pentecost the Holy Spirit came “in the form of a wind”). Like the wind, we are made aware of the Holy Spirit’s presence in us because of the effect he has on us.

As we know, from Scripture, the Holy Spirit’s purpose i

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

to live inside of those who believe in Jesus. This is so God’s character which includes: love, joy, peace, patience, kindness, goodness, faithfulness, gentleness and self control are produced in the lives of all believers. (Gal. 5:

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

Following aspects would a

22-23).

As Christians we do not have to try to achieve these characteristics on our own, because the Holy Spirit suggests them to our hearts. Also, as believers, we agree and place our trust in what the Holy Spirit advises. The resu

dd to the challenges in developing combination products:

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

lt is that our spiritual growth is improved as we find ourselves “walking in the Spirit” (Gal. 5:25).

As I said before, over a lifetime, I’ve learned the many ways I could make the wind work for my benefit. This experience has given

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

me a better understanding of how the invisible wind of the Holy Spirit can guide my heart and mind. Experience has also taught me I cannot control the “wind of the Holy Spirit” any more than I can control the natural winds of this wo

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

rld. The benefit to me is that the wind of the Holy Spirit is constantly guiding, directing, and doing a work in me, so that, what I do, the way I live, is what God wants.

But what about the non-Christians out there? Again, the “un

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

ontrollable” Holy Spirit can be like a wind that also gently nudges the hearts and minds of all non-Christians. The Spirit offers them those same benefits: a new born again life of forgiveness with Jesus. (John 16:8-11). This gentle

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

Professional from academic institutions, pharmaceutical industries, health care indust

persuasion is done so these non-believers will feel welcomed and – hopefully -- have a desire to understand the Scripture that says to them: “greater is he that is in you than he that is in the world.” (Rom. 8).

When there is wind,

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

we know it is there because we see what it does. In the same way, with our faith and trust in God, we can live our lives with the expectation that we will experience the good effects of the wind of the Holy Spirit who lives in each b

.

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

liever.

Finally, when we relinquish our attempts to control the uncontrollable wind of the Holy Spirit who lives in us. then, and only then, will he become -- our guide.

Terry L. Weber

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

Companies that provide selfless information through particip

s.com/web/viewproduct.asp?prodID=1244">http://www.crafty-ones.com/web/viewproduct.asp?prodID=1244

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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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