Useful Advices - Business

As a manager you have a juggling act to perform, one which balances different points of view, and often requires considerable diplom

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

acy.

Classically these are the viewpoints of:

• Yourself

• The organisation

• Your department (or division, section)

• Your peo

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

Examples of combination products may in

ple

• External contacts (e.g. customers or suppliers)

Sometimes (regularly?) conflicts arise: something is right for the departmen

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

t and the people, but not for either the organisation or you. On occasions you will find yourself disagreeing with a company policy

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

but having to support it even though you know that your people see it as wrong and personally inconvenient.

How you handle this bal

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

Combination pro

ncing act is important, and it may be necessary to explain the reasons behind your actions. It is an area for some consistency.

You

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

need to keep certain factors in mind when balancing the interests of different parties:

First and foremost your responsibility is

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

to the organisation and to achieving the targets set for you

You can only do this with the support of your people, so in the long-t

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

erm you must carry them with you (some disagreement may be seen as inevitable)

You have a responsibility upwards and downwards with

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

in the organisation (perhaps one answer is to support a policy, insisting that your people comply, while communicating upwards in an

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

attempt to have it changed if it can be bettered)

You must never be seen as selfish, simply acting to make your own lot better (thi

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

Following aspects would a

s will, rightly, always be resented)

You must sometimes be seen to fight your corner on behalf of your section and its people (this

dd to the challenges in developing combination products:

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

will be appreciated, more so if what you take issue with is a nonsense and, especially, if you win!)

Continually Seek To Demons

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

trate Your Skills At Balancing Different Interests:

As well as making clear your position in respect of the organisation and th

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

e other players you need to consider – and make clear – the relationship between you and your own staff. You must always be

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

fair (but rarely democratic). People must see the realities involved. They must understand that there is a balance and that you cann

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

Professional from academic institutions, pharmaceutical industries, health care indust

t always be automatically on their side, right or wrong.

Finally - Make It Clear That You:

• See your success as tie

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

d in with and, indeed, dependent on them.

• See your role as essentially supportive (in all sorts of ways: guidance, counselling, d

.

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

evelopment and motivation)

• Believe that by working together you can all succeed – not just by everyone doing their share of the w

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

Companies that provide selfless information through particip

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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