Main Subject - Business

A man drives down the highway each day on his way to work. On Monday he gets a flat tire. Like anyone else, he takes his lumps, changes his tire, and moves on.

One

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

month later, almost to the day, the same darn thing happens. Just his luck. Only this time, its raining and he is forced to return home after changing his tire bec

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

Examples of combination products may in

use he had gotten his new suit filthy in the process.

Convinced that he's hitting a string of rotten luck, the man buys a good raincoat, and develops a faster rout

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

ne for changing his tire (not bolting his spare down in the trunk, keeping his tools out and available, and keeping the raincoat close at hand). Next month, almost

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

s predicted, same thing happens. Only this time, he gets into a fender bender trying to get over to the right shoulder to repair the flat. Talk about the life of Jo

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

Combination pro

!

Nevertheless, it doesn't take long for him to go back to the well for another creative solution. No more wrecks trying to change a flat tire- nope, not for this

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

uy. He's figured out that its always the right front tire. In response to this keen observation, he's now decided to always ride in the left lane so that if (sorry,

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 mean when..) he gets another flat, he can more quickly glide over to the shoulder, avoiding risk of accident on his way to another speedy tire change. He also de

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

ides to keep his speed lower than normal so that if (when) another blowout occurs, he's not endangering too many people. That is, until a highway patrol officer pul

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

s him over for clogging up the left/ passing lane of the freeway. Back to the drawing board he goes.

One of these days, that poor guy is going to figure out that i

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

might just be his wheel alignment that is causing the problem. But not this time. Instead, like many of us, this man is trained to react to symptoms rather than ta

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

Following aspects would a

ing the time analyzing the root cause.

A big problem with our performance measurement systems is that they provide us too much information on symptoms, and not eno

dd to the challenges in developing combination products:

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

gh feedback on our core system breakdowns. Does your management system tell you when you tire has gone flat? Does it measure the speed with which you change the tir

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

? Or does it alert you that your vehicle is pulling to the left, outside of its normal control limits? The former is clearly reactive, responding only to a plethora

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

of symptoms. The latter is proactive, and will lead your more quickly into a mindset of real problem solving.

I've seen this play out all too often in the workpla

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

e. Take a call center, for example, whose performance management focus is on getting better at average speed of answer, abandon rate, cost per call, and the many ot

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

Professional from academic institutions, pharmaceutical industries, health care indust

er indicators that are all too common in that industry. But how many companies look at the volume of calls per customer served? Is it higher than it should be? What

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

if we do something to reduce the VOLUME of calls in the first place. Ahhhh....now we're getting somewhere. Would you rather reduce the cost per call by 10% (somethi

.

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

g that I guarantee you is envied by EVERY call center manager out there), or eliminate the call entirely by fixing the process (something that is valued by every SH

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

Companies that provide selfless information through particip

REHOLDER out there!).

Reactive or proactive? Symptom or problem oriented? Activity or process focused? What approach does your performance management process favor

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 internet has flourished into a money making source with a plethora of ways to make money over the past several years. There has been much debate online over whether paid surveys can actually earn you money. While it is possible to make some extra cash, don’t plan on making a living off of paid surveys. More and more people are turning to the internet so they can work at home as oppose to going to their 9-5 job, but taking paid surveys certainly won’t fulfill this desire.

Sooner or later, the interview invitation is going to say you are required to give a presentation as part of the selection process. And like most people you may dread having to do it. Here's how you can overcome those interview presentation nerves.

One form of burnout comes from too much effort and idealism that blocks the necessary process of fitting into the established pace of the workplace and lasting for the long haul.

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