Digg It - Business

First some answers on a not so serious note:

1. Make an estimate, 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

hen multiply by 2, divide by 0.134263 and take the square root after

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

Examples of combination products may in

adding Pi times the estimate times 12.345

2. Use a dart board and g

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

t some friends together to change the numbers to very high 8 figures

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

The one person that hits the same estimate range on the dart board

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

Combination pro

times is the closest to the estimate.

3. Take a wild swing and at

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

he end of the report, cite the analyst firm IMTSU 2006 (I Made This

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

tuff Up).

There are 3 portions to the cost of resolving the options

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

backdating issue:

1. Tangible costs - Regulatory fines and expense

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

- Internal investigation fees - Audit investigation fees - Docum

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

ntation & restatement fees - Back tax dues and penalties and intere

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

Following aspects would a

st - Share holder lawsuits: Settlement fees, Defense fees

2. Intan

dd to the challenges in developing combination products:

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

ible costs - Market capitalization loss - Employee turnover (not e

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

sy to guesstimate, but rest assured there will be some) - Internal

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

external communication expenses - (If delisted): stock appreciatio

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

opportunity costs

3. Variable expenses - Reduced revenue from cus

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

Professional from academic institutions, pharmaceutical industries, health care indust

omer becoming nervous about purchasing products

For the 3 companies

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

we have worked with estimating $100 Million for a $3-5 Billion marke

.

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

capitalization in Tangible costs alone is on the average side.

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

Companies that provide selfless information through particip

arget="_new" href="http://blog.vangal.com">http://blog.vangal.com

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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Digg It - Estimates on How Much Companies Will Spend to Resolve the Options Backdating Issue

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