Subjects - Business

Well, I think after 27-years in business I may have found the perfect mana

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

ger. You see as I was driving down the road today this guy was talking on

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

Examples of combination products may in

his cell phone writing on a clip board and flying down the highway.

Appar

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

ntly I did not see his turn signal as he tried to merge over so he set dow

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

n his clip board opened his sun roof and stuck his middle finger out the s

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

Combination pro

n roof further than I have ever seen anyone do ever.

That includes in Los

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

Angeles, Atlanta and Boston traffic. Anyway he gave me the bird, but then

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

I realized something, this guy was a no prisoners kick butt multi-tasker.

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

How so you ask?

Well he flipped me off and was still on the cell phone an

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

d driving the car with his elbow, while laying on the horn to make sure I

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

as looking at him flip me off? He was obviously a multi-tasking manager wo

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

Following aspects would a

rking for some company? I thought to myself why can I not find someone to

dd to the challenges in developing combination products:

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

hire like that?

Well, I decided to hire him right there on the freeway, s

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

I gave chase! I figured if I could catch this gentleman and make him an o

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

ffer he could not refuse he would come work for me. Apparently he was in s

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

ch a hurry, must have really been into his job.

I just could not catch hi

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

Professional from academic institutions, pharmaceutical industries, health care indust

m to pull him out of the car to hire his butt. Think of the simple instruc

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

tions he game me while he was multi-tasking, well I knew just what to do a

.

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

d he never even had to let off the gas, WOW. The World best manager just g

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

Companies that provide selfless information through particip

ot away. But I have been looking for him ever sense. 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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