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Buying a car can be rather complicated, as the whole process tends to be somewhat mysterious. It’s often hard to know if you’re getting a g

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

ood deal or not, even as the salesman claims that he’s selling you the car “at invoice.” Leasing a car is much the same way, except that th

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

Examples of combination products may in

e terminology is different and you don’t get to keep the car. You’re still going to spend a lot of money, though, so it makes sense to be a

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

well informed about leasing as possible.

For most consumers, leasing makes less sense than buying. When you buy, you have a tangible prod

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

uct that you can resell later or trade in for a new one. With a lease, the only thing you are buying is the right to use the vehicle for a

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

Combination pro

while. If you don’t drive a lot or if you just like having a new vehicle every couple of years, leasing may be a good choice for you. Befo

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

e you get involved, here are some things you may wish to consider:

The money factor – This is the equivalent of an interest rate on a c

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

ar sale. The money factor, in order to remain mysterious, will be presented as an odd number with a lot of decimal places. To convert it t

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

o an approximate interest rate, multiply it by 24. The money factor, like just about everything else in a lease, should be negotiable.

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

The amount due at signing – The size of the check that you have to submit when you sign the lease can be sizable. You’ll hear a lot a

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

bout low payments in the commercials, but little (except in the fine print) about the amount you have to pay upfront. That will include tit

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

Following aspects would a

le fees, license fees, deposits and a reduction in the capital cost that will reduce the size of your monthly payments. Ask about this ahea

dd to the challenges in developing combination products:

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

of time; you don’t want “sticker shock” when you see the total.

Duration of the lease – Make sure you understand how long the le

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

ase will last. If you want a car for three years, make sure the lease isn’t for 24 months.

What happens at lease end? You may ha

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

ve to pay, or you may get to walk away, or you may have the opportunity to buy the vehicle. The end of lease situation is spelled out in th

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

document; make sure you understand it before you sign.

Total mileage allowance – The lease will stipulate how many miles you may

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

Professional from academic institutions, pharmaceutical industries, health care indust

drive over the course of the lease; you will have to pay a per mile charge if you exceed that. The per mile fee can be excessive, so make

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

sure that the number of miles that you are given matches your driving expectations. Keep in mind that the mileage amount and the per mile 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

e is negotiable.

Each of these things can be an expensive nightmare if you aren’t prepared for them. Leasing a car is different from

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

Companies that provide selfless information through particip

buying one and you need to understand that long before you sign your name on the contract. Otherwise, you could be in for an expensive ride

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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