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Physicists tell us that energy cannot be created or destroyed and that all masses already have large quantities of energy stored in them. Vast amounts of energy exist in any

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

organisation. However, the organisation’s energy is dormant waiting to be harnessed and released by the correct stimulus.

Organisations also have the potential to tap a specia

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

Examples of combination products may in

kind of energy that is released when the staff take on risks and challenges. People experience this energy in the form of exhilaration, enthusiasm, vitality and a sense of u

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

rgency. This charged-up one’s entire being creating the desire to excel, to win, and to belong.

The creation of corporate energy involves everyone in the organisation. Every e

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

ployee has a part to play regardless of location and division. It springs from something deep inside each person, which causes them to work enthusiastically, with their heart

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

Combination pro

s and heads as well as their hands. Corporate energy drives employee commitment to rendering superb service. They must be empowered to change the course of events for the b

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

tter if necessary. When the vitality of an organisation’s people is focused and applied collectively, almost anything can be accomplished.

Corporate energy not only fuels orga

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

nisations to grow spectacularly during good times but also grants them the inner strength to endure and survive the bad. It is garnered and unleashed when a few people at the

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

top echelon demonstrate consistent leadership that are visible to their people. Today, in most large companies, half the available energy remains untapped. Effective leaders

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

act as the catalysts when they provide the proper stimuli. But the catalytic role in high-performance organisations is not restricted to those in the top management. The real

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

magic happens when leaders ensure that the catalytic agents are dispersed throughout the organisation. However, if the initial impetus is missing from the top, it will be pre

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

Following aspects would a

vented from generating energy in the organisation. A chain reaction can start in a single division, branch or work team.

What organisations need most to triumph in today’s fas

dd to the challenges in developing combination products:

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

-paced marketplace is people who possess skills that empower others; leaders who know how to inspire workers to aggressively seek out and seize opportunities that will enable

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

their organisation to surpass the competition; leaders who can help others visualise potential solutions, not just problems; people who motivate others to rise above the sta

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

us quo, envision greater possibilities and constantly propel the organisation toward a preferred future.

Senior managers often unwittingly diffuse instead of aspire, confuse r

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

ather than inspire. Successful organisational performance seems to go hand in hand with people being active and having fun at work. Many managers genuinely believe that when

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

Professional from academic institutions, pharmaceutical industries, health care indust

mployees are having fun at the job, they are goofing off. Unfortunately, they believe that their role is to keep everyone tightened up.

An interesting measure of corporate e

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

nthusiasm and energy is the parking lot. In an organisation where there is a lot of energy, the parking lots are full even on weekends. The employees are so charged up that t

.

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

ey continue to come in even on the weekends and stay up late and come in early on the weekdays.

Eventually, we do not need to have the knowledge of Albert Einstein’s quantum p

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

Companies that provide selfless information through particip

hysics knowledge to understand how to unlock the atomic energy in the corporate world. Each one of us can in our own little way be the catalyst to ignite the corporate energy

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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