Advice You - Business

Lynn Visson's "Wedded Strangers" identifies differences in work ethic between Russians and Americans:

“

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

Americans, with a work ethic, grew up knowing they would have to work hard to get a job. For Russians, u

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

Examples of combination products may in

der the Soviet system, the government found them a job or they got a job through personal contacts.”

“U

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

nder the Soviet system, the idea was to get away with as little work as possible, as there were no pay r

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

ises. There was no real threat of getting fired either. Working hard just led to more work.”

“For women

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

Combination pro

in the Soviet Union, the workplace was a place to gossip, sell each other clothes, and exchange tips on

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

where to get consumer goods.”

“To Russians, Americans are time obsessed. To Americans, time is money. 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

Russians, relationships are more important than time.”

Lynn Visson's "Wedded Strangers" talks about f

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

rther distinctions between Russians and Americans:

“The worst thing a Russian can say about you is that

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

you are dry. Meaning that you are cold and logical. Outpourings of emotion in private life are balanced

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

by extreme restraint in public life.”

Russians smile when there is something to smile about – for examp

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

Following aspects would a

e, when they are with their family and friends and the vodka is flowing.

Russians have what is best des

dd to the challenges in developing combination products:

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

cribed as a dry sense of humor. They make jokes that are very sharp or witty. They can be also be very s

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

rcastic. They make humorous comments that require intelligence and a keen understanding of a situation t

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

be funny.

The Russian delivers his joke or funny story with a serious expression on his face, while ev

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

eryone else bursts into laughter. If he laughs with the others, it spoils the joke.

Lynn talks about di

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

Professional from academic institutions, pharmaceutical industries, health care indust

ferent perceptions of time:

“Being late is part of the Russian makeup. Being late was a way of showing

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

ontempt for the system and of asserting self. To Russians, appointments are guidelines.”

“Americans do

.

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

one thing at a time. They value short-term relationships and take deadlines seriously. Russians do a var

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

Companies that provide selfless information through particip

ety of things at one time, they value long term relationships, and they are flexible about appointments.

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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