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Cholesterol is like the calibre of staff. LDLs are the dysfunctional staff and the HDL the good ones cleaning up the mess left by the LDLs. The human body requires some chol

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

esterol to function properly. These cholesterol – “good” (high density lipoprotein or HDL) and “bad” (low density lipoprotein or LDL) ones – are found in all cells which help

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

Examples of combination products may in

o carry fats in the body.

Similarly, in every organisation, there are two categories of employees. There are the “bad cholesterol” employees as well as the “good cholesterol”

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

employees. Those in the first category, the “bad cholesterol” are not natural self-starters and they require prodding by some external forces from the environment before

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

hey are compelled towards achieving certain goals.

Too much of bad cholesterol can increase the risk of heart attack and stroke, as the bad cholesterol slowly builds up in

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

Combination pro

he walls of the arteries that feed the heart and brain. Eventually, their vital supply of blood, oxygen and nutrients are cut off.

In the corporate context, the heart attac

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

k would be synonymous with a company suddenly waking up one day and finding that it has lost all its competitiveness. Usually the stroke or heart attack suddenly deals a l

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

thal blow on their victims without any warning signs.

The “good cholesterol” employees are intrinsically motivated from within. They are intelligent, high achievers and w

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

ill exercise initiative and assume responsibility towards achieving the goals. They are able to attain the goals even though the external circumstances may not be favourab

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

e or supportive of such actions. The “good” cholesterol carries the “bad” cholesterol away from the arteries and back to the liver, where it is metabolised from the body,

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

hus minimising the clogging of the artery walls.

The “good cholesterol” employees have a high level of internal energy or “qi” which propels them forward despite the extern

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

Following aspects would a

al difficulties. The danger of not establishing the desired corporate culture is that it will not only fail to spur the “bad cholesterol” employees towards achieving the d

dd to the challenges in developing combination products:

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

sired corporate goals but may even deter and demotivate the “good cholesterol” employees from doing so.

One way of perpetuating good cholesterol is to ensure that you have

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

good genes and cloning at the recruitment stage. This is why Bill Gates of Microsoft hires the best, brightest and highly motivated of the new university graduates, mainly

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

the “good cholesterol” personnel. He creates the environment where these individuals can thrive. As the critical mass of “good cholesterol” employees work in concert to sh

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

re experience, stimulation and knowledge, the energy level “qi” shoots up. This also raises the contribution levels of the “bad cholesterol” employees and gets the whole c

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

Professional from academic institutions, pharmaceutical industries, health care indust

ompany all motivated and charged up.

Another way is to develop good cholesterol by training or exercising. Some people are not able to do their jobs well because they are

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

not adequately trained for the purpose. Good training and development programmes like exercising increase the “good cholesterol” employees and reduce the dysfunctional perso

.

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

nnel.

To further foster the “good cholesterol” performance, your staff incentive scheme should be consistent in rewarding the good employees and penalise the bad ones. Thus u

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

Companies that provide selfless information through particip

derstanding the facts about “good and bad” cholesterol employees will help take better care of your corporate health. It will help you avoid a corporate heart attack or stroke

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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