Main Subject - Business

The world of business is changing dramatically. There was a time in corporate America when employees were closely connected with their employers – when they h

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

ad a sense of corporate loyalty. This is seldom true today. The reason? The old psychological contract between employer and employee has been broken.

There

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

Examples of combination products may in

were reasons for breaking the psychological contract - heavy competition, cost pressures, having to do more with less - all of these have impacted most corpor

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

ate cultures resulting in staff reductions, and higher demands on remaining staff with little or no recognition of their efforts. The result is that employees

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

are ready to leave on short notice for what they perceive to be better opportunities. And the most likely to leave are those who are contributing the most to

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

Combination pro

the business.

Some employers brashly say they will simply replace these employees – there are many available candidates out there who could do the job better.

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

This attitude is one of the main factors driving these employees to leave. And employers making such statements may not realize that they cause employees to

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

leave mentally long before they leave physically – these employees simply disengage.

What is the cost to the business of employee disengagement? One way it

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

can be measured is in declining productivity. People can be working longer hours but accomplishing less because they are no longer committed to results. The l

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

ights are on, but nobody’s home.

So what can employers do? Fire them all? They could, but what would happen to the business as a result? What would be the

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

cost of replacing them? There’s a more effective way of addressing the problem. Employers can hold up the mirror and take a good look. The person in the mir

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

Following aspects would a

ror is responsible for breaking the psychological contract. The good news is that he/she also has the power to craft a new contract.

Most disengaged employee

dd to the challenges in developing combination products:

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

s truly don’t want to leave. The corporation is like an extended family to them, although a dysfunctional one. They want to be members of the corporate family

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

. The trouble is that most corporate families today are codependent. They operate within an outdated paternalistic (or maternalistic) paradigm of family.

In

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

terestingly, the family relationship paradigm has changed over the last fifty years. Successful families today are no longer paternalistic. They are partnersh

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

ips, with mom and dad as senior partners and the teenagers as junior partners. Everyone is expected to perform activities that contribute to the success of th

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

Professional from academic institutions, pharmaceutical industries, health care indust

e family’s goals. There is mutual respect, support and recognition of success, both individually and collectively. The senior partners recognize that the jun

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

ior partners will eventually go off on their own, and they assist the junior partners’ development so they can achieve their highest potential.

Employers migh

.

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

t consider successful families as a model for rebuilding their corporate families, assuring goals and roles are clearly defined, members’ contributions are rec

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

Companies that provide selfless information through particip

ognized and rewarded and independence is encouraged.

The world of business is changing. Employers can re-engage employees to make this a change for the better

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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