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In a recent paper circulated by leading Canadian automotive analyst Dennis DesRosiers, he pointed out that t

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

ransportation costs and uncertainty about long delays at the Detroit/Windsor border crossing were pushing au

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

Examples of combination products may in

omotive manufacturers and suppliers away from the region – a drain that’s already clear in southwestern Onta

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

io and southeastern Michigan. He added the following points and ideas:

Development follows infrastructure

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

Vehicle assembly plants and parts plants are making a geographic shift away from Detroit and Windsor and tow

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

Combination pro

ard the Sarnia-to-Fort Erie corridor

This shift affects employment, population, tax revenue and economic vi

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

ality in southeast Michigan and southwest Ontario

The automotive sector in Michigan and Canada is now more

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

ligned along an east-west corridor starting in Sarnia and ending in Forth Erie, rather than a north-south co

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

ridor starting in Windsor and ending in eastern Ontario

Commentary

As most everyone knows, the automotive

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

industry makes manufacturing decisions multiple years in advance. As has been stated by the automotive indu

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

try (e.g. CAPC report), increasing transportation costs and uncertainty about the reliability of the Detroit

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

Following aspects would a

Windsor border crossing are great negatives for the region. The industry has mitigated these negatives by r

dd to the challenges in developing combination products:

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

vising where products are produced and suppliers located. The risk here is that these changes may progress

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

at an ever increasing rate given the current market loses and financial pressures the industry faces.

Autom

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

tive companies and their suppliers are moving along this corridor, bypassing Windsor and Detroit. The corri

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

or gives them access to suppliers in New York and central Ontario as well as nearly direct access to Chicago

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

Professional from academic institutions, pharmaceutical industries, health care indust

via I-69. Also, the CN high-capacity rail tunnel in Port Huron makes shipping of parts and finished vehicle

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

s easier.

One example of this movement is Toyota’s recent announcement that places its new assembly plant f

.

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

r the RAV-4 mini SUV in Woodstock, Ontario, between London and Hamilton, right along this east/west corridor

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

Companies that provide selfless information through particip

This plant location hedges Toyota’s bets by allowing it to use the Windsor/Detroit if the border gets fixe

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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