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Toronto busted through last season and broke up the stranglehold that the Pin-stripes and Bean Towners have had in the Ame

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

rican League East Division by bumping Boston out of their reserved second place spot. The Jays did it with quality startin

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

Examples of combination products may in

g pitching. Sadly, Toronto’s success appears to be short-lived as losing Todd Lilly will not allow the Jays to bloom again

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

in 2007.

I don’t mean to sound down on the Blue Jays because they are a good team which would win several other divisions

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

in baseball, but there is a very fine margin for error in the elite AL East. Right handed ace Roy Halladay has helped spe

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

Combination pro

d up Toronto’s progress over the last few seasons. Adding A.J. Burnett and Ted Lilly to the mix had the Jays’ starting rot

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

ation emerging as tops in the division. But instead of picking up another guy to shore up the staff some more, the Jays lo

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

st Lilly to a handsome sum in Chicago. That loss puts a lot more pressure on A.J. Burnett to perform this season to pick u

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

some of the slack. Another 10-8 year is just not going to cut it.

The Jays cannot afford any kind of a drop off from fir

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

st basemen Lyle Overbay or Troy Glaus who were brilliant last season in their first year with the team. We won’t have to w

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

rry about Vernon Wells who continues to increase his superstar status with each swing of the bat. Or will we? He just sign

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

Following aspects would a

ed a mega deal and sometimes this can result in a down year. I remain optimistic as the young Wells doesn’t appear to have

dd to the challenges in developing combination products:

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

reached his potential.

Jays backers finished way in the money last season. The boys north of the border have produced wi

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

ning seasons for their backers in four of the last five seasons. This season won’t match the success lining the pockets of

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

2006 supporters, but it should still produce profit for Jays enthusiasts. The Jays won’t be quite as good this season wit

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

the loss of a solid starter, but because the go under the radar compared to the Yankees and Red Sox, the Jays will show b

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

Professional from academic institutions, pharmaceutical industries, health care indust

etter value than these higher profile teams.

It wasn’t a big shocker when the Blue Jays jumped into the number two spot i

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

n the AL East last season. It will be in 2007. Toronto still has enough talent to leave the Devil Rays and Orioles in the

.

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

ust, but the Red Sox and the Yankees will be tough fish to fry. Toronto is a team which has made great moves to put a soli

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

Companies that provide selfless information through particip

d team on the field, but it just isn’t enough in a division which houses two of baseball’s best teams year in and year out

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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