Main Subject - Business

You find them in all spheres of society – in cubicles, on the shop floor, on the sports field, in the marching crowd of protesters, as huge as in the CEO-chair, yet as small as on the nursery school playground. They are the minority group of people impacting on the majority of society – whether positive

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

or negative – but they are of one breed: the leaders. However, the real leaders – those who make it to be examples in the business bestsellers – have one particular commonality that is easy to spot: MATURITY. Maturity developed by the ability to make sense out of hardships while average people merely

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

Examples of combination products may in

endure them. Maturity developed by the ability to comprehend the limitless abstract more than the average majority merely understands the limitation of the concrete. Maturity developed by the insight that people always have significantly more to offer than spreadsheets and checklists. Maturity developed

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

by the ability to manage oneself first before leading others. These are the real leaders…

Mature leaders deal in intangibles

Communication. Perception. Future. Vision. Dreams. Risk. Body language. These are the conceptual elements found in the minds of the leaders – the nutrition of their mental p

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

ocesses. They don’t fear the complexity or insecurity of the abstract as they have developed the ability to give structure to the unstructured. Even more – they have the extraordinary ability to convert complexity into simplicity, because they know that implementation depends on clear understanding.

T

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

Combination pro

hat’s why leaders give much attention to intangibles – making sure that in every cubicle there is an understanding where the company destiny lies; that all company communication installs trust in the people and that everything translates into implementation.

Leaders not only deal in intangibles – they r

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

eally understand them. In addition, they ensure that the complex and symbolic become understandable, inspiring and implementable.

Mature leaders manage themselves before they attempt to lead others

A few daily disciplines: Choosing the difficult right over the easy wrong. Self-understanding. Emotion

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

l intelligence. These are the inherent attributes found in the core of the leaders’ character. These days Emotional Intelligence is the buzz word in the business world and one can describe it as the ability to recognize and manage one's own feelings and the feelings of other people, as well as the abili

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

ty to energize oneself. The fact that mature leaders should manage themselves before they attempt to lead their people is summarized well by Tony Blair: “I do not seek unpopularity as a badge of honour, but sometimes it is the price of leadership and the cost of conviction”.

Leaders understand that t

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

hey can’t have a handle on other people if they don’t have a handle on themselves. Dr. Daniel Goleman, author of Working with Emotional Intelligence, emphasizes that superior leadership requires a combination of both emotional and technical abilities. IQ is merely the entry point into any new position,

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

ut it doesn’t guarantee outstanding leadership. For any leader the ultimate competitive advantage is emotional intelligence. As Tom Crane (“The Heart of Coaching”) puts it: “My behaviour determines my emotions; my habits develop my behaviour; my will dictates my habits; my character directs my will.”

L

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

Following aspects would a

eaders even know their own limitations before others have to point it out. Wisely they then surround themselves with people that can compliment both their strengths and weaknesses. They have the emotional intelligence to know that no one is indispensable and to keep their own ego’s in check.

Mature lea

dd to the challenges in developing combination products:

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

ders follow a human asset approach

Leaders must teach themselves to lead their human assets with the same zeal that they devote to their financial assets.” To do so, leaders will have to become life long students of human nature and clearly understand what makes people tick and what makes them stick. As

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

the old saying goes: “If I say that I’m a leader and no one is following me, I’m not a leader, I’m merely out for a walk!”

Mature leaders don’t push – they motivate; they don’t control – they coach and evoke commitment; they don’t dictate – they inspire; they don’t prescribe – they stimulate creativity

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

and empowerment. Above all, mature leaders bind themselves emotionally to their followers by means of the most vulnerable element of all – trust. They affirm the faith of their followers.

Leaders don’t compromise personality and principles but they vary their styles to be culturally flexible. They in

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

fluence rather than control and build core competency amid diversity. Mature leaders possess the invaluable mindset that no academic institution can ultimately provide – that of the daily coaching, teaching and mentoring of their people.

Mature Leaders leave footprints

Leaders leave something behind.

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

Professional from academic institutions, pharmaceutical industries, health care indust

They live for that. That’s why they start a new assignment by asking: “What would be my number one regret if I had to leave without achieving it?” And then they sacrifice personally to live up to this legacy.

They don’t just merely leave an organization with sound financials and market shares. No, m

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

ch more – they leave behind newly developed leaders, sustained influence, a culture of learning and development and lasting values. Mature leaders live out their highest calling and leave behind intrinsically motivated people, who continue to multiply themselves into more mature leaders.

Mature Leaders

.

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

recognize their expiry dates

Everybody has an expiry date. A mature leader has the insight to see it coming and still feel secure about it. When they get to that corporate crossroad, they do not shy away from knowing what to win, what to lose or what to trade. This is normally the point, where they c

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

Companies that provide selfless information through particip

an stay and hold the company hostage to their ego, or move on to give newly developed leaders the opportunity to change things for the better and lead the organizations to new heights.

Mature leaders know when to lead, when to follow and when to get out of the way. Immature leaders just go off like milk

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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New Sarbanes-Oxley laws can be troublesome to manage. These regulations may seem cumbersome in some cases, but are designed to protect companies from fraudulent practices.

One example of this is the company software used. Many futures brokers require that their clients download their software, which should be able to give them access to real-time market stats and much more. The first step is finding out if such a program is used. Then, you may want to learn more information about it.

Companies that traditionally wholesale their goods to commercial markets are finding a niche in retail sales, selling their wares to individuals over the Internet.

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