Subjects - Business

"The winds and waves are always on the side of the best navigators." — Edward Gibbon, English Historian

Leaders

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

look beyond the current situation – beyond what is to what could be. That's why leadership is all about change.

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

Examples of combination products may in

It's why leadership is action, not a position.

Growing our leadership is also a dynamic process. It begins at t

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

e center of our being and develops in multiple directions, each represented by the timeless leadership principle

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

described in The Leader's Digest. This "hub and spokes" model is the basis for The CLEMMER Group's Leadership W

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

Combination pro

eel.

Each part of the wheel corresponds to an area of leadership. At the hub of the wheel, we have the vision,

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

alues, and purpose with which leaders effectively focus their teams and organizations on the core of their being

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

(Chapter 2: Focus and Context).

Leaders also take initiative and do what needs to be done rather than waiting f

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

r "them" to do something (Chapter 3: Responsibility for Choices).

Leaders are authentic and lead by visible exa

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

ple, fostering openness and continuous feedback (Chapter 4: Authenticity). Leaders are passionate and build str

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

ng commitment through involvement and ownership (Chapter 5: Passion and Commitment).

Leaders lead with heart an

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

Following aspects would a

d rouse team or organizational spirit (Chapter 6: Spirit and Meaning).

Leaders grow people through strong coach

dd to the challenges in developing combination products:

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

ng and continuous development (Chapter 7: Growing and Developing).

Finally, leaders energize people by building

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

strong teams, inspiring, and serving (Chapter 8: Mobilizing and Energizing).

The wheel model provides a metapho

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

for situations faced by an organization. For example, just as a wheel's weight-bearing ability depends upon the

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

strength of its hub, so too does the strength of an organization's hub (or core values) determine the weight of

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

Professional from academic institutions, pharmaceutical industries, health care indust

he performance and change issues that it is able to carry.

The wheel also represents the circular nature of lea

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

ership – there is no beginning or end. Each of the supporting leadership principles around the outside of the Le

.

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

dership Wheel are interdependent and interconnected. If our team or organization develops all the leadership ski

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

Companies that provide selfless information through particip

ls, the wheel is well-rounded. If it is deficient in one or more of these skills, the ride may be a little bumpy

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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Subjects - Steering our Leadership Wheel

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