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Last year provided us with one of the best investment returns in recent

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

memory, a pleasant surprise to most of us. Now would be a great time t

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

Examples of combination products may in

o rebalance your portfolio and reposition the gains that you made last

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

year.

No one knows whether the stock market will go up or down from it

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

’s current high. We are however certain that it will not stay at this l

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

Combination pro

evel. When the market provides you with gains it is always a good time

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

to rebalance your portfolio, don’t wait for the market to go back down

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

to contemplate whether your investment allocation was too risky.

Do yo

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

u know how much money you have in stocks versus bonds; international ve

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

rsus domestic or large company stock versus small. Why are your investm

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

ent allocated the way they are and is that still appropriate?

There ar

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

Following aspects would a

e many questionnaires available to help you determine your investment m

dd to the challenges in developing combination products:

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

ix.

Once you have determined your allocation mix you need to keep up w

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

ith it to make sure you rebalance it regularly. Most 401k plans have so

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

me sort of automatic rebalancing that will keep you allocation in line

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

for you. I suggest that you set up auto balancing 2 times a year. If yo

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

Professional from academic institutions, pharmaceutical industries, health care indust

u have automatic rebalancing that does NOT mean you can completely igno

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

re your allocation, you need to review it at least one a year to take i

.

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

n to account personal and stock market changes.

Simply remembering the

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

Companies that provide selfless information through particip

old adage SELL HIGH and BUY LOW doesn’t help, you need to take action.

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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