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Senior executives are usually senior executives because they have been promoted over

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

the years as recognition of their performance...their operational performance. In a

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

Examples of combination products may in

dition, most succession planning looks at developing individuals that are exceptiona

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

l operational thinkers, not strategic thinkers.

Once at the VP level or higher, the

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

e employees must affect more change and more influence on the organization to merit

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

Combination pro

heir compensation and responsibilities. Organizations cannot afford to pay executive

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

compensation to great operational managers. Senior leaders must drive the future di

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

ection of their firms to survive, compete, and reach ever-higher levels of performan

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

ce. In particular, CEO's should be the embodiment of their organization’s vision and

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

strategic direction. The only way to do so is by operating on a more strategic basis

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

Two key ingredients are essential to elevate senior leaders to this more strategic

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

Following aspects would a

level: better strategic skills, and a greater investment of time. In addition to a

dd to the challenges in developing combination products:

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

yriad of leadership and communication skills, CEO's and other senior leaders must ex

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

plicitly build the skills necessary to be better planners. These are tough skills to

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

develop, and although there may be some place for limited formal training, job relat

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

d experiential training is the most effective way to pick up this important skill se

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

Professional from academic institutions, pharmaceutical industries, health care indust

t.

So how much time is enough? CEO's should dedicate 60%-80% of their time to plann

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

ng and strategy. Divisional level VP's should dedicate 50%-75%. This includes any ac

.

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

tivities that will better position the company for the future, as opposed to operati

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

Companies that provide selfless information through particip

nal activities that focus on the past, and just getting through the rest of the week

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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You may not get promoted quickly to your desired position - promotions are highly competitive and you need to prove yourself (often over and over) to reach the top. This is possible only through hard work, motivation, confidence and your initiative for learning new skills and accepting challenges.

The first and the most appealing advantage of outsourcing deals with cutting the costs for the experienced labor force from abroad. An Indian offshore IT specialist would be much happier earning from 300 to 500 hundred dollars a month working for an American company than for a local firm earning even less. Both the American employer and the Indian specialist benefit from the situation. Quite a clear advantage of outsourcing.

So, how does one protect himself and his commission when he's showing a prospective buyer around? He Csalts the record! I first heard this term from an attorney who was explaining to me how important it is to document your dealings in great detail. I specifically recall his using the Clintons as an example of people who have mastered this art.

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