Useful Advices - Business

"The mighty Amazon begins as a mere icy trickle from an Ande

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

s glacier.

As the Amazon surges across the torrid wilderness, hundreds

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

Examples of combination products may in

of tributaries pour their waters into it. Torrential rains swell the flo

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

od. Now, the Amazon is no longer a river; it is, instead, a moving inlan

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

sea that drains nearly half of South America.

So great is the river's

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

Combination pro

power that even when it reaches the Atlantic the Amazon refuses to die.

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

It floods the ocean with fresh, muddy water for up to 100 miles offshore

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

"
- David Reed

Should your company's training efforts b

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

e any different? If there is not a training program in place, yet, you c

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

ould be the "icy trickle" that starts one, or demands one. As more and m

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

re people take part in business training their ideas make the program mo

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

Following aspects would a

re and more viable. A great business training program, like a river, can

dd to the challenges in developing combination products:

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

change the course or direction of a company.

A training program can be

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

very modest. A person loves a self-improvement book and loans it to a c

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

-worker. A person is skilled at presentations shares their expertise. An

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

other person knows people who would be happy to come in a share their su

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

Professional from academic institutions, pharmaceutical industries, health care indust

ccess stories. A training program is really based on teamwork.

Think ab

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

ut your company and co-workers. List their needs. Ask questions. Talk to

.

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

managers. Become enthusiastic about training and share your passion.

I

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

Companies that provide selfless information through particip

f an icy trickle can grow into a mighty river, so can a training program

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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