Main Subject - Business

In the 1974 multiple Oscar winning movie “Network,” the character Howard Beale, a network news anchor

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

played by Peter Finch loses his mind on live TV after learning that he will be fired. He states tha

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

Examples of combination products may in

t he is “madder than hell and I’m not going to take it anymore!” He exhorts his TV audience to think

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

about the awful, unfair things they are tolerating in their lives and “go to your window, open it, an

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

d shout it over and over” until pretty soon, seemingly everyone in Manhattan is standing at their ope

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

Combination pro

windows shouting it out at the top of their voices!

I was reminded about that scene recently when a

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

businessperson told me about some of the frustrations he was having at work and the difficulty he 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

having with them. When he is in one of these situations he acts like an ostrich pretending it doesn

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

t exist or go at it like a linebacker on a NFL football team and hit it full force. Perhaps, I sugge

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

sted, there are alternatives to these polar opposites, as each can have disastrous consequences to th

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

people involved and to the company.

Putting one’s head in the sand, the classic response of the ost

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

Following aspects would a

rich, just denies the problem which, unfortunately, will not go away by itself and will probably get

dd to the challenges in developing combination products:

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

worse. Attacking the problem with great ferocity usually breeds anger, resentment, and may elevate t

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

e situation to the point of outright hostility (think “going postal?”). There has to be, and often i

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

s, a better way.

The better way is to just talk about the issue in a non-confrontational, but busine

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

slike atmosphere – person-to-person using neutral, non-emotional language with a goal of clearly defi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ning the issue and discussing how to best resolve it. When (or if) agreement is reached a method of

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

future monitoring should be discussed to insure that resolution is permanent. If agreement can not b

.

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

reached, alternatives should be discussed before emotions flare, people get disciplined (or worse) a

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

Companies that provide selfless information through particip

nd then fling open those windows and shout until the veins in their neck explode - not a pretty sight

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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