References - Travel and Leisure

"Are you enjoying your holidays here?" The waitress at the Park Cafe in Villach is very friendly as she serves the fabulously rich cake and st

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

rong coffee we ordered - with a glass of water by the way, which is typical for Austria.

People often address us as visitors, even when we're not - or maybe the

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

Examples of combination products may in

are right and we are tourists everywhere, except the place we grow up in. We lived in Cape Town for nine years until recently, and settle here in Austria's Cari

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

nthia now - but we are German.

How can they tell you're different?

'When in Rome, do like the Romans do.' I found that to be good advice in the past w

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

enever I travelled to places I hadn't been to before. Trying to blend in at airport customs in Jakarta is what you did when you arrived in Indonesia via Singapor

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

Combination pro

e from South Africa on a second, clean passport during the Apartheid years.

But does it work? Did the locals think I was born in Venezuela when I was in Caracas

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

I am sure I didn't pass for a local in Cape Town's Kayelitsha township, but a few kilometers away in Simon's Town nobody gave me a second glance walking down ou

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

r Waterfront.

Fact is that we're all different, of course - six and a half billion unique human beings on this planet, our fingerprints prove it; and it's not i

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

portant how far apart we are geographically - what matters is how close we are culturally. There's a difference, although there is a proportional relation.

If I

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

start yodelling in the middle of Hamburg, passers-by will stop and stare. In a small village in North Korea I would get arrested and put in an asylum for that,

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

ut anywhere in Austria, folks would smile and join in. Well, the way I yodel some of them might think I am dying and call an ambulance, but that's not the point.

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

Following aspects would a

The point is that others can tell very quickly that you're different first by the way you look, and then by the way you speak. Or write?

That's what I am tryin

dd to the challenges in developing combination products:

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

g to find out from you today : can you tell that I am German from the way I am writing this article? I publish COMPASS for subscribers on four continents (Asia d

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

esn't seem to be interested much) and I consciously try to choose a neutral style here.

Working in Public Relations, on other occasions I would use a different

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

approach for a particular purpose. When I lived in London in 1979/80 I sometimes played a little game with myself at parties : how long could I hide the fact tha

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

I am German by putting on as much of a British drawl as I could muster?

After a while, the best score I achieved was just under one hour if I remember correctl

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

Professional from academic institutions, pharmaceutical industries, health care indust

y - and it was either because of, or in spite of all that really good French red wine they offered there.

Now here in Austria, I spoke to a gathering of Germans

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

and Austrians last week and all of them, without exception, were amazed that I hadn't lost my northern German accent after 22 years in South Africa.

That's how

.

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

the waitress in the Park Cafe could tell we weren't Austrian, so we had to be tourists : not everyone wears Lederhosen here so we didn't look different, but I am

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

Companies that provide selfless information through particip

not one to keep my mouth shut for long.

We spoke differently. Do I write differently? Please drop me a brief comment and tell me what gives me away - or doesn't

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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Your first cold call is a daunting, if not downright horrifying task. You are about to pick up the phone and dial a complete stranger. For me, I kept wanting to know everything about this person, their company, what they looked like, how would they react, would they like me, etc before talking. It just isn’t possible to answer every question. At some point you have to pick up the phone and get it over with. So, how is the introverted cold call done?

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