Useful Advices - Business

There is much talk today about ethics in business - as there should be, but there should be more than talk; there should be a high moral code

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

for all executives who are responsible to both their customers and their shareholders.

I have been the president and CEO of one publicly owne

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

Examples of combination products may in

company and also was president of another that was responsible to customers who traded equities. This carries a high responsibility to all co

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

cerned. You have to be more than worried if you do something wrong because you will go to jail. You must have the desire to try to always do y

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

ur best for everyone who works for you as well as all the customers or investors that deal with your company.

Ethics is supposed to be either

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

Combination pro

black or white, right or wrong, but today it is many shades of grey. If any company does shady business you can be sure it starts at the top

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

nd filters down because the president is the one who sets the example for the actions of the entire company. This is as true for actions of ou

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

elected officials as it is for corporations or individuals. We have had some pretty sorry examples of that in Washington.

Each time there is

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

a new scandal the public seems less disturbed. The recent disclosure that mutual funds have been allowing hedge funds and other large traders

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

to take positions after the closing bell is a brutal example. Maybe investors are not aware that someone is writing checks on their account. T

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

is is stolen money that is no different than a guy with a gun holding up a 7-11 store. Yes, the one difference is that the mutual funds have a

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

Following aspects would a

lowed millions of dollars to be siphoned off from those to whom they owed a fiduciary relationship. The fund manager is a crook and deserves j

dd to the challenges in developing combination products:

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

il time. He just took the money with a click of the computer keyboard and that was his weapon. White collar crime deserves the same punishment

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

as the guy with a gun.

When you give a brokerage company, a mutual fund or any financial institution your money you expect, in fact, you dem

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

nd, that they treat you fairly within the rules of the industry. When you are short-changed you should not accept it.

Because of the huge amo

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

nts of money available and accessible to people in the financial industry it is easy to understand how they can be tempted into criminal actio

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

Professional from academic institutions, pharmaceutical industries, health care indust

s. That is why all publicly traded companies are required to have their books audited annually. Lately we have seen that even these audits are

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

tainted.

Investors rely upon the numbers set before them in order to make decisions about owning stock in a company. If the information is d

.

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

shonest a proper decision cannot be made.

Today we are seeing another type of corporate officer being created. He is called the Governance Of

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

Companies that provide selfless information through particip

icer. It is his job to see that the company maintains high ethical standards. I applaud this action and hope he cannot be seduced by big bucks

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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