E-Articles - Business

Yesterday I look at my calendar and saw that my newsletter was on my calendar for today. I wondered what I would write about.

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

By the end of the day, I had my topic. Back-up and Recovery System.

Are you prepared for a disaster? Around 2pm yesterday

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

Examples of combination products may in

I looked up from my computer and saw a reflection of smoke. I knew right away someone’s home was on fire. Thinking it was on

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

e of the homes behind me I stepped out my patio door. It was the house right beside mine that had caught fire. I immediately

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

went out front to find two members of the family in shock. I found out 911 had been called and no one else was at home. The

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

Combination pro

ire department was there within moments and started fighting the fire. I, like a lot of my neighbors, stood outside and watch

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

ed with sympathy as this single mother with five children lost everything they owned.

It always happens to somebody else, rig

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

t? Not all the time. One minute my neighbor’s house was on fire, the next, a whole opened up in their attic and the most ama

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

zing ball of flames shot directly towards my house. It was at that time I realized that I could also lose my home. I went in

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

grabbed my purse and my dog and was back out in the driveway. As I stood there I realized I didn’t follow my plan.

You see,

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

since I started my business I’ve had what I considered a good plan incase of fire, I’ve even written up a disaster recovery pl

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

Following aspects would a

an. My business and its equipment are insured separate from my homeowners. It will also cover any lost income I may incur.

dd to the challenges in developing combination products:

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

’ve burned copies of all my software and keep it off site along with copies of important business documents. I back up my ent

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

ire hard drive daily incase my PC crashes. I keep my calendar on my PC and sync it with my palm; I also keep a paper calendar

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

incase of power outage. Now, the plan was that on my way out of the house I would grab my external hard drive that is used as

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

a backup.

I stood there really hoping that my home would be saved and thinking I need a new plan because when push came to sh

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

Professional from academic institutions, pharmaceutical industries, health care indust

ove, my dog and purse were the only things on my mind. I was so shocked that after all that planning, my business didn’t even

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

come to mind.

Well, I was lucky; my home suffered only some exterior damage. My neighbors, unfortunately, lost everything ex

.

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

cept what was in their garage. Note: fireplace ashes stay alive at least a week after the fire burns out.

If you have not co

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

Companies that provide selfless information through particip

sidered what you would do to get your business back up and running incase of a disaster, I suggest now is a good time to start

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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