Cases - Business

I've lost count of the number of times I've heard people complain that they can't pu

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

rsue job X because they lack experience, and they "don't have transferable skills."

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

Examples of combination products may in

Poppycock. Everybody has transferable skills.

The reason people think they don't i

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

because they're mixing up two very different things. They're mistaking transferable

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

skills for transferable experience.

Transferable experience is usually direct. It

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

Combination pro

llows you to say, "I've done this particular job (or part of this job) before." If y

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

ou haven't, then you really don't have directly applicable experience. That's where

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

most people give up and stay stuck.

They forget that many skills aren't necessarily

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

job specific. Sure, if you have experience with a particular software program, or pi

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

ece of machinery, or work process, those are specific skills. Think more broadly, th

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

ugh.

Skills are skills are skills are skills.

If you've got management skills, you

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

Following aspects would a

certainly exercised them in a particular setting (say, a retail store). But you pro

dd to the challenges in developing combination products:

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

bably had to deal with many of the same things other managers in other industries ha

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

e to. You had to handle personnel issues, scheduling, maybe inventory management, et

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

c. In a sense, all managers share certain tasks and roles. There are differences of

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

ontext, but there are lots of commonalities too.

And therein lies the secret to mak

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing your skills transferable, or at least to making them sound that way on a resume.

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

Just remember one rule of thumb: Focus on the commonalities.

All skills have at le

.

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

st some transferable component or flavor to them. I can't even name a skill that doe

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

Companies that provide selfless information through particip

sn't have at least some transferable component. Not one.

Copyright (c) by Roy Mille

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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Cases - Yes, You DO Have Transferable Skills!

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