Digg It - Business

Business leaders today at all levels in organisations are facing more stresses and tasks than at any time in t

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

he past. Even though we have more tools at our disposal to manage these tasks we are also bombarded with more

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

Examples of combination products may in

information and data to process than ever before. In this environment it is all too easy for leaders to make m

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

stakes and in most instances staff are patient and forgiving of these honest slips.

However, there is one are

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

a where staff are not willing to compromise. This is the area of management versus leadership. Under stress we

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

Combination pro

may forget that there are times to lead and times to manage, and slip into management mode when dealing with o

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

ur teams.

If you or your team are experiencing "people issues" look for this rule of thumb:

Manage th

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

processes and the procedures - but - Lead, guide & teach the people.

If there are prob

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

lems, check if your leadership team is confusing managing with leading.

It really is that simple - not that e

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

sy - but certainly that simple.

A truly effective leader has a genuine concern for the success of those he le

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

ads, treating all staff members as individuals, giving credit, and ensuring that he is making his people look

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

Following aspects would a

good.

I had the opportunity to meet with a very effective leader recently. He recounted a story to me of an i

dd to the challenges in developing combination products:

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

cident in his organisation where there was some doubt as to whether the drinks cabinet in the meeting room sho

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

uld be locked. A member of his management team proceeded to padlock the cabinet - just in case. When this lead

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

r found out, he succinctly pointed out that the organisation has a value of trusting its staff, and then even

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

more succinctly requested the removal of the padlock!

A great leader keeps the objective out in front as a vi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ion, as simple as possible. He is always promoting understanding, always acting as a role model, living the or

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

ganisations values, walking his talk. He gets out of the way of his people so that they can get on with their

.

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

ork, and achieve their goals

An effective leader will make the difference between success and failure in an o

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

Companies that provide selfless information through particip

rganisation. Great management processes and systems will support leadership, but are never a substitute.

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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Digg It - Get Results Through Leading Instead of Managing

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