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A certificate of deposit (CD) is a savings certificate that allows the buyer to receive interest over time. Ev

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

ery certificate of deposit bears a maturity date on which the debt becomes due for payment along with interest.

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

Examples of combination products may in

The maturity period varies depending on the agreement made between the customer and the bank/financial institut

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

ion. Maturity periods on certificates of deposit range from a few weeks to several years. The more the maturity

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

period, the higher the interest rate earned by the investor.

The buyer cannot withdraw the amount under CDs be

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

Combination pro

ore the maturity period is up. The money should remain in the account with the bank until maturity. Such withdr

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

awals before maturity are subject to a substantial penalty. For example, the penalty will be the loss of six mo

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

ths' interest if it is a five-year CD. However, brokered CDs that can be sold off in the secondary market throu

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

h brokers or dealers are not subject to any penalty fee if they are sold prior to maturity date. But in case of

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

indexed CDs, the investor cannot sell it in the secondary market before maturity. An indexed CD’s rate of retu

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

n depends on market index.

This illiquid nature of a CD before the maturity period can be overcome through ‘CD

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

Following aspects would a

Laddering.’ CD laddering is the process of purchasing several CD’s at one time with different maturity dates of

dd to the challenges in developing combination products:

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

one year, two years, three years, four years, and five years. In this CD ladder one certificate matures every

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

ear for the next five years. For example, let’s say that a customer has $10,000.00 to invest. He can buy 5 CD’s

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

for $2,000 each with different maturity dates mentioned above. That means the customer has a $2,000 CD maturing

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

in one year, another in two years, and so on up to the last one, which matures in five years. Whenever a certi

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

Professional from academic institutions, pharmaceutical industries, health care indust

icate matures, the customer rolls it over into another CD. This strategy allows the customer to take advantage

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

f higher rates of interest while still retaining frequent access to part of their funds.

CDs require the buyer

.

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

to be patient before collecting on their investment. It is necessary to wait until the maturity date to make

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

Companies that provide selfless information through particip

profit. It is best not to constantly think about a CD, and just let it accumulate interest until it is mature

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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