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It’s interesting to hear the responses from executives when I ask them, “What are the characteris

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

tics of a good Leader?”

If I ask that question in a large room of executives, or even upper leve

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

Examples of combination products may in

l managers the answers will be all over the map, and many are conflicting.

A couple of the usual

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

answers are:

A leader is someone that empowers those working for him to make their own deci

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

sions.

A leader is someone who gives clear, direct orders, a take charge person that command

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

Combination pro

s his employees.

The first implies that we let the employees make up their own minds what to do,

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

and how to get the end result. The second implies that we’d better be somewhat of a micromanager

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

and tell everyone exactly what to do and how to do it.

Aren’t those somewhat conflicting?

Afte

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

r we have built a huge list, and almost always the RIGHT answer isn’t there, I’ll point out to th

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

em they have put several conflicting statements up there.

So, “If you had to narrow it down to j

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

ust one thing that defines a really good leader, what would it be?”

Out of all the years I’ve as

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

Following aspects would a

ked that question of executives, I believe only one time has someone even come close to the answe

dd to the challenges in developing combination products:

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

r. The answer is “A leader gets results.” I believe that the reason there were so many conflicti

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

ng characteristics is that most of what we put up there was “situational.” A good leader always k

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

nows when to use whatever tool according to the situation to get the results that are needed.

To

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

o many are stuck in one mode or the other because “that is the right way to do it,” such as “empo

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

Professional from academic institutions, pharmaceutical industries, health care indust

wering” employees. I’ll admit that is usually the best way, but there are employees that need a n

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

udge once in a while, that perform well when given step-by-step directions instead of guidelines.

.

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

Too many are focused on activities, and then get frustrated because they don’t get results.

A

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

Companies that provide selfless information through particip

good leader knows how to find the right tool, when to use it, and always delivers results.

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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