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I have been fascinated over the years by the debate, research and discussion about leadership and management. Increasing

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

ly there seems to be a focus on the differences between leadership and management and it seems to me that this has devel

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

Examples of combination products may in

oped in part because of deficits in one or the other.

Most of us would like to become, or to think of ourselves as, str

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

ong leaders. There is something appealing about the idea of creating and pursuing a vision and influencing others to sup

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

port the necessary transitions. True enough, if it wasn't for good leadership, nothing would change or improve.

However

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

Combination pro

, not as many people seem to be as drawn toward being a good manager. Maybe I am misreading the "climate", but managemen

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

t is often associated with the mundane, the routine and a whole range of "left-brain" activity for which the kudos are f

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

ew.

There appears to be a perception that one can be a leader or a manager, but not much acknowledgement that those ski

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

ll sets can reside in the same individual. I believe this is an erroneous view.

My view of leadership and management is

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

that they do require different skill sets, but must co-exist in order for any change to occur effectively. It is like a

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

hand and a glove. Put together they make a great partnership.

I came across a short, but interesting,article at

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

Following aspects would a

="http://www.teamtechnology.co.uk/leadership-basics.html" target="_blank">http://www.teamtechnology.co.uk/leadership-bas

dd to the challenges in developing combination products:

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

ics.html which acknowledges the importance of both leadership and management.

In part, the article states:

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

uote>Leadership without management ...sets a direction or vision that others follow, without considering too much how th

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

e new direction is going to be achieved. Other people then have to work hard in the trail that is left behind, picking u

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

p the pieces and making it work...

Management without leadership...controls resources to maintain the status quo or ens

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

Professional from academic institutions, pharmaceutical industries, health care indust

ure things happen according to already-established plans...there is no new change, no new direction - the referee is con

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

trolling resources to ensure that the laws of the game are followed and status quo is maintained...

Leadership combined

.

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

with management ...does both - it both sets a new direction and manages the resources to achieve it.

Lets

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

Companies that provide selfless information through particip

have respect for both leadership and management and view them as partners in effective change and improvement processes

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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