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It just happened that September 1st, 2006, was a Friday. (And for those interested in historical trivia, September 1st, 1939, the day W

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

WII started, was also a Friday.) Why am I talking about it? Because September is a rollover month for many futures contracts, including

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

Examples of combination products may in

very popular stock index e-minis and whenever a rollover month starts on a Friday, a rollover day is on the first Thursday and not on

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

the second one as is usually the case. I thought that pointing this out merits some attention.

Here are some other facts about the rol

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

lover and expiration days. The latter is always on the third Friday of a rollover month. For the instruments we are most interested in,

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

Combination pro

that is e-minis of the futures contracts traded on the Chicago Mercantile Exchange (CME) and the Chicago Board of Trade (CBOT), the mo

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

nths in question are: March, June, September, and December. There is a single contract letter associated with each month and, in the sa

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

me order, it is: H, M, U, and Z.

When we switched to the September 2006 contract on the rollover day, which happened to be on Septembe

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

r 7th, we switched to trading the U contract. The rollover day is the day most traders start trading the new contract, which also means

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

that the trading volume shifts from the old contract to the new one. That does not mean that you have to switch to trading the new con

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

ract on that particular day as you can still trade the old one until the expiration day, but doing so on the rollover day makes a lot o

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

Following aspects would a

f sense. Otherwise, the longer you stay with the old contract the more your trading is going to be affected by the volume which is gett

dd to the challenges in developing combination products:

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

ing poorer and poorer the closer we are to the contract expiration.

Interestingly enough, December 1st 2006 also fell on a Friday and

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

so again the rollover day was on the first Thursday of the month and not on the second one. You can easily check it using any online ca

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

lendar. While this might look like a coincidence, it actually is not. There are some deeper reasons why this is so and can happen only

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

to these two contract months. What this means, in particular, is that even if a March rollover day happened to be on the month's first

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

Professional from academic institutions, pharmaceutical industries, health care indust

Thursday, the next rollover would never be on the first Thursday in June. The same is true for the June-September sequence. In fact, us

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

ing the calendar, we find out that June 1st, 2007 falls on a Friday and thus the month's rollover day will be on the first Thursday of

.

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

June. However, the next rollover day is on the second Thursday in September 2007.

You can learn why this is so from a very interesting

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

Companies that provide selfless information through particip

Wikipedia article. Just visit this site and find out what it has to offer on "corresponding months." That will explain this regularity

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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