Main Subject - Business

This articles relates to the AlphaMeasure core competency Culture and Climate. AlphaMeasure defines climate as the effect an organization has on the employees, while culture ref

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

ers more to the acceptable behaviors, attitudes, and habits of the organization as a whole. Knowing and understanding workplace culture and climate leads to a better understand

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

Examples of combination products may in

ng of what factors are influencing employees. In relation, the level of service your customers receive is almost always influenced by the culture and climate of your organizatio

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

n. This competency can be especially insightful if your organization is experiencing customer service related issues or problems working together internally.

A Tale from the

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

Corporate Frontlines: An Employee's Perpective on Culture and Climate. This short story is part of d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

">AlphaMeasure's Tales from the Corporate Frontlines.

When large, multinational corporations acquire medium-sized, locally-oriented businesses, huge shifts in the cultu

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

re and climate of the workplace can occur.

I experienced such a shift while working for a prosperous company with a rich local history and plenty of prestige in the community.

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

hen I started there, years ago, the culture was very friendly and laid back. This may have been due to the fact that although an eastern company, it was owned and directed by a

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

larger west coast entity.

The culture and climate was relaxed and friendly. Occupants of executive row could be seen mingling with "regular employees" at company functions, whi

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

h were many- the bill nearly always footed by the company. They recognized employees and their families by name, and were regularly spotted in offices, hallways, and the cafeter

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

a, catching up with fellow workers, and enjoying themselves. Morale was high, along with productivity and profitability. It reminded me of working for a family business, even th

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

Following aspects would a

ough 500+ people worked in the building.

Then came the sale. At the first of many employee meetings, the details of the huge corporate transaction, of the kind so common these

dd to the challenges in developing combination products:

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

ays, were outlined. This new parent company turned out to have a climate and culture exactly the opposite from what we were used to for years.

Change didn't occur overnight, bu

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

t gradually the shift began. Then it washed over our little company like a tidal wave. Executive row was walled in like a fortress, and its occupants stayed inside. We were barr

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

ged by memos, new rules, more rules, dress codes, building regs, vacation regs, holiday changes, work process changes, changes for the sake of making changes (or so it seemed to

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

the employees), layoffs, restructurings- the climate became tense and chaotic. Morale suffered, as well as productivity.

Eventually, things worked out. Communication between va

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

Professional from academic institutions, pharmaceutical industries, health care indust

rious levels of management improved, understandings were reached, and the company survived and thrived again. But I always wondered---couldn't someone have done something to mak

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

the shift easier and smoother? With sales, mergers, and acquisitions so common these days, there has got to be a better way. It seemed to me that if a little consideration had

.

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

been given to the radical climate and culture changes involved, the company could have handled the transition more smoothly, to the benefit of everyone involved.

This article m

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

Companies that provide selfless information through particip

y be reprinted provided it is published in its entirety, includes the author bio information, and all links remain active.

2004 - AlphaMeasure, Inc. - All Rights Reserve

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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