E-Folder - Business

One week after the recent announcement of heightened airport security I had to take a flight. I heard a

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

bout long waits going through security so I arrived at the airport two hours before my flight. Naturall

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

Examples of combination products may in

y, when one arrives with plenty of time, there is no one in line but if you arrive late it seems as if e

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

veryone in the world is going somewhere that day. I whisked through security and had plenty of time to

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

sit and observe. As much as everyone likes to complain about air travel I’m always in wonder that somet

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

Combination pro

hing as complex as an airport let alone the entire air travel industry, actually works as well as it doe

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

s.

So there I was, observing a microcosm of the air travel industry. A little while after I arrived, t

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

o crewmembers arrived. Little by little, other crew arrived. They introduced themselves to each other.

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

It was apparent that none of the crew had met each other before. Yet, as I boarded the plane, I was a

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

ware of how well they worked together as a practiced, coordinated team. Each knew what they were to do

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

and did their jobs as professionals.

While watching the teamwork in the cabin, I thought of how this co

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

Following aspects would a

ntrasted with some businesses I see where delivery of service is somewhere between adequate and chaotic.

dd to the challenges in developing combination products:

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

Realizing that these people work together all the time, the equation just doesn’t compute. Then I tho

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

ught, perhaps it does compute.

In the airline scenario, management knows they are putting together a cr

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

w of people who, in all probability, never or rarely work together. In order to insure that passengers

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

on every flight receive a high level of standardized service they must have systems and processes in pla

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

Professional from academic institutions, pharmaceutical industries, health care indust

ce that a well-trained crew can fit into or chaos ensues.

In a less structured business, systems and pr

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

ocesses are often verbal, not documented. Training is sloppy or non-existent. The business gets by bec

.

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

ause teamwork and standardized delivery of service is far less critical… until they start losing custome

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

Companies that provide selfless information through particip

rs to a better organized, more structured competitor. In this case, it is wise to think like an airline

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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The wrong entertainment can ruin an event and, worse yet, project the wrong image about your organization. The right entertainment creates a positive buzz among participants and a favorable impression about your company or non-profit.

Textile wastes are the materials which are either used textiles or excess materials which may not be directly usable for creating the main textile product. These wastes could be anything from basic yarns to used apparels. Textile wastes are in equal demand across developed as well as developing countries. Modified goods made from these wastes are sold in countries such as India, Pakistan, and Srilanka. Textile wastes are made to undergo a process known as recycling.

I recently read an article that said that business executives would benefit from using the risk analysis methods that financial advisors use. I remember a class in graduate school called Managerial Decision Making, and I learned about risk analysis and decision-making.

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