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Recently, I was in Klang, Malaysia for my Internet MLM business.

Klang is famous for 'Bak Kut Teh' which literally translates as

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

"pork bone tea" and consists of pork ribs in a broth of herbs and spices boiled together with pork bones for hours. Additional i

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

Examples of combination products may in

ngredients may include mushroom, lettuce, and tofu.

Klang, widely believed to be the home of bak kut teh, is famous for her ma

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

ny bak kut teh restaurants. What I can say is that it's delicious, tasty and mouth-watering...even as I write about it now :-)

Y

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

esterday morning, I drove to church supposedly 20 minutes away from the hotel I stayed in Klang.

Though I am a Singaporean stayi

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

Combination pro

ng about 400 km away, I've been to Klang on several previous trips and was confident of driving around...

However, as I gunned d

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

own the highway, I took a left turn to exit and after several minutes, found that I am into some place totally unfamiliar.

Then

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

I quickly used my secret tactic:

I did a 'U-turn'

... and head straight back to the highway, hoping to find the right exit.

H

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

owever, the road connected straight across and I ended at the other side of the the highway. I kept driving and after several min

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

utes, it dawned on me that I am hopelessly and desperately lost.

The church service begins at 10.30 while my watch showed 10.40

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

already.

I had to pull over to a side road and used my 2nd secret weapon:

No kidding this time. It's a thick, tattered and tor

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

Following aspects would a

n street directory of the entire Klang Valley I carry in my car for emergencies such as this.

After several minutes of thumbing

dd to the challenges in developing combination products:

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

through the pages, I found my way once again and got there in time to attend most of the service.

And thank God I received an i

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

mportant lesson here...

When I was totally lost, I wanted to call my friend at the church to give me directions but I realized o

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

ne thing:

There's no way he could help me.

Because I didn't know where I was. In fact, I had to spend several minutes just to l

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

ocate where I was, flipping through several pages of the street directory.

And then, I had to know where my destination is. Aga

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

Professional from academic institutions, pharmaceutical industries, health care indust

in, I had to locate that in the directory.

Once I knew where I was and where I was going, I had to figure out how to get there.

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

So, do you know where you are in your Internet MLM business? Meaning... do you know what are your strengths and weaknesses? Are

.

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

you more efficient online or offline in promoting your MLM business?

And, do you know what is your destination? What do you wan

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

Companies that provide selfless information through particip

t to achieve? Long term? This month?

Last but not least, do you know how to get there? Do you have a strategy? A winning formula

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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