Main Subject - Business

Back, (maybe I should say "way back") in the '80's, as a senior manager in Hewlett Packard Ltd.,UK, I was regularly asked to give talks to groups from both the public and private sectors.

The most common

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

themes were People Development, Performance Appraisal, Continuous Improvement and "Managing Change"

I suppose it would be fair to say that my 'presentations' and discussions were somewhat animated wi

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

Examples of combination products may in

h a great deal of walking about and mingling with the audience. So much so that I could not get comfortable with overheads and tended to use two flipcharts on which I could prepare key messages on one and take n

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

tes on the other especially when important points were made or questions were not answered fully.

It would also be fair to say that after a while the talks became routine and I always welcomed a challeng

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

ng group with whom we could have a lively discussion instead of a one-way presentation.

The Question That Almost Threw Me

On one occasion, I had just been introduced and had given a brief ov

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

Combination pro

erview of the session to a group of around a couple of hundred members of the police force, when this sergeant in the front row piped up...

"What gives you the right to talk about managing c

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

ange?"

Wow! Did that stop me in my tracks.

Slowly walking over to the flipchart, I'm thinking how do I answer this one?

There was only one thing for it! Flipchart pen in

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

hand, I turned, looked at the sergeant and said:

"Well, let me see" as I started the list

Left home at sixteen

Father died when I was twenty one

Mother died a few

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

ears later

Engaged three times

Went through very difficult and painful divorce

Married twice

Moved from Scotland to England (Serious change situation!!!)

Almost b

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

ankrupted

Promoted within the department

Promoted to a different department function

"All I can say, sergeant, is that any one of the items on the list can be a significant

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

change situation. Certainly some may be perceived as more serious than others but all change situations need the appropriate due care and attention, especially when they involve others"

W

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

Following aspects would a

ile we continued with the discussion following the rest of the presentation part, it became clear that there was a general perception that change or the management of it wasn't a problem for companies such

dd to the challenges in developing combination products:

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

as Hewlett Packard compared to the public sector.

I had never worked in the public sector and, therefore, wasn't prepared to comment other than to summarise by making the following key points...

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

Yes, we were looked after. Yes, we did have an excellent working environment. Yes, we did have a superb range of benefits. However all of that would pale into insignificance if a change situation wasn't

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

managed properly.

What do I mean by properly?

Before talking about it, make sure we understand it

What is it?, Why is it?, When is it?, Who is effected by it?

Difficult

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

as it may be, do not leave staff to find out on their own

If effected by the change, think it through, what does this mean to me

Plan its implementation, who needs to be involved

Wha

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

Professional from academic institutions, pharmaceutical industries, health care indust

needs to be communicated, by whom and by when

Avoid any attempts to B.S. It will ALWAYS be recognized

Absolutely no question is trivial. Give it due care and attention

If you ask a

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

question, listen to the answer before passing judgement

Don't listen to rumours and, certainly, don't start them!

As always, a lot easier said than done. But, there is one thing for sure,

.

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

ny change situation will always be less controversial, more readily acceptable, and definitely managed a whole lot easier as long as people DOWN and UP the organization Communicate, Communicate, Communicate
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

This introduction hopefully sets the scene for a series of follow up articles which will look at change and transition in greater detail.

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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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Main Subject - What Gives You The Right? - An Introduction To Managing Change

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