Advice You - Business

Do you call yourself a solo professional and have you launch

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

ed your consulting business? Are you sure you are the solo p

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

Examples of combination products may in

rofessional that you profess? So many people are not the pro

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

fessionals that they claim to be out there. How can I make s

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

ch an unprofessional comment you ask?

Well first you are ri

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

Combination pro

ght because anytime you yell; The Emperor Wears No Clothes,

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

then you are no longer one of the group. That behavior is so

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

unprofessional indeed. Okay so now I ask you the question; w

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

hen you hear or see BS in your industry do your bring it to

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

the attention of the Industry, your customers, vendors, netw

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

rk and associates?

If you do you are not a professional sol

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

Following aspects would a

o or otherwise, so stop pretending to be a professional when

dd to the challenges in developing combination products:

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

you are obviously a major renegade. Is being a renegade in

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

the industry bad?

Well, sometimes you will find fewer clien

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

s, but if you stick to your guns over time you will find peo

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

ple trust you more and your advice and you will not only end

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

Professional from academic institutions, pharmaceutical industries, health care indust

up rocking the industry, you will evoke change and fear in

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

ll the others who are the True Professionals. Isn’t it funny

.

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

everyone is running around pretending to be a professional

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

Companies that provide selfless information through particip

when in reality it is a negative word? Consider this in 2006

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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Advice You - Professing to be a Solo Professional?

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