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1) No one asks her to participate.

Olivia always comes prepared to be part of the

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

action. She wears her best fur, fluffs up her whiskers, and sharpens her claws. But

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

Examples of combination products may in

people treat her as if she's just a cute little pet. As you might expect, she feels

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

mad when the other attendees ignore her. So she takes a nap.

2) It's difficult to

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

ap.

Usually, the big talkers speak with loud voices. While this seems to scare the

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

Combination pro

other attendees into silence, it still makes it hard to sleep. She especially disli

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

kes jokes because they cause an outburst of laughter, and that jolts her awake. Cer

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

ainly, no one likes to be awakened by a loud noise.

3) They don't take breaks.

Ol

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

via detests lengthy marathon meetings that go on and on without a break. She wonder

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

if any of the people in these meetings were ever shown how to care for their basic

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

comfort. When I suggested that she ask them to set up a litter box, Olivia curtly t

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

Following aspects would a

old me that she prefers a little privacy.

4) The attendees behave like mice.

Ever

dd to the challenges in developing combination products:

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

cat knows that if you want to catch something, you have to watch it. But people in

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

meetings have an attention span that would embarrass a mouse. They dart and dash ab

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

ut nibbling on everything without focusing on anything.

5) They drop what they cat

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

h.

Cats know that once you catch something, you bring it home. After all, that's w

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

Professional from academic institutions, pharmaceutical industries, health care indust

hy you caught it. But people drop a decision (or useful idea) and rush off to talk

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

bout something else. They don't even play with it. Olivia wonders if they know that

.

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

they caught something.

So what are your meetings like?

Would Olivia want to atten

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

Companies that provide selfless information through particip

one?

By the way, you can meet Olivia at: http://www.stevekaye.com/staff-olivia.ht

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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