Useful Advices - Business

Imagine the horses all lined up at the gate in the last Kentucky Derby. Successful businessmen/women are just li

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

ke thoroughbred horses. They must practice, run like the wind and sometimes be driven to make it first through t

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

Examples of combination products may in

e line. Like a horse race the majorities are losers and only a few are Triple Crown winners.

We know that the m

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

jority of horses are not of the quality and disposition to ever be entered at the Kentucky Derby. Some might act

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

ally run in their local races but are not skilled enough to go beyond their home town. The vast majority of hors

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

Combination pro

es will be used for nothing but manual labor and the occasional ride through the farm.

Business men/women are m

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

ch like horses. The majority of people will only work for a living, a few might become small town business owner

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

and a select few will play in the chance to win millions of dollars. What makes these thoroughbreds different t

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

en the rest of society is their ability to continually improve on their skills.

Good business people have Stree

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

t Sense. They know what type of skills they must work on, they know where their weaknesses are, and they keep pr

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

cticing until they are the best. In other words, they have the ability to keep working and improving their skill

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

Following aspects would a

until they succeed despite their odds.

Imagine yourself as Street Sense in the 2007 Kentucky Derby. Calvin Bor

dd to the challenges in developing combination products:

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

l rallied the older horse Street Sense to win the Kentucky Derby with 2 & ? length in the 133rd running of the $

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

2,000,000 pot. He rose from the 19th position and challenged himself to the lead.

The owners of Street Sense di

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

not one day throw the horse onto the track and yell “run! run! run!” Like many of us Street Sense would have fa

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

led and most of us would have understood why. Despite knowing that an untrained horse wouldn’t do very well we w

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

Professional from academic institutions, pharmaceutical industries, health care indust

nt to beat ourselves up daily because we are not successful.

Street Sense had to practice, become knowledgeable

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

about its surroundings, and had to overcome its weaknesses. People in the world of business must do the same th

.

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

ng. For example, if you aren’t very good at sales you may need to study, practice and learn as much as you can a

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

Companies that provide selfless information through particip

out sales. The key to success is to be reflective about your abilities and be open to the possibility for change

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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Useful Advices - If You Were A Horse Would You Win The Kentucky Derby?

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