Advice You - Business

I got married just shy of two weeks ago in Roswell, Georgia. The wedding and its surrounding events were the best days of my life, filled with a million sparks of light, love and warmth.

The problem

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

is, well I'm having trouble going back to work.

I love my job to the core, but after weeks of being surrounded by family and friends, assembling centerpieces and just being, I'm struggling with sitti

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

Examples of combination products may in

g at my desk and caring about e-mail. I long to return to the land of happy wedding bliss, dancing around a proverbial Maypole and hanging out on the couch with a dear friend.

Eventually I got back t

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

o work and did as much as I could. But after a few hours I daydreamed, tried to fight it off, gave up and ended up on the sofa watching Everybody Loves Raymond. To make matters worse (and here's the c

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

ltural stuff for those who were wondering) I berated myself for being lazy.

"You should be doing more!" I told myself. "Think of how much you could be achieving. Get back to work! Volunteer more! Wri

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

Combination pro

e more articles! NOW!"

This tirade went on for awhile until my professional training kicked in. I flashed back to living in Nepal for a year. I saw Nepalis closing up their shops to drink tea with ne

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

ighbors; I saw how sitting by the lake chatting with family did not diminish them; I saw how being with each other improved their quality of life.

In Nepal, the amount you achieve does not equal how

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

orthy you are as a human being. Perception of achievement is partly cultural. What a relief.

All over the world, work and quality of life get balanced in different proportions. This happens even with

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

n your own culture (think of the man or woman whose children come before working overtime, even in a work crisis). Challenges can arise when two cultures come together from opposite ends of the spectr

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

um.

For example, a recent U.S. client of mine acquired a company in the U.K. The biggest source of frustration for both was the gap in work vs. life balance. The U.S. side believed in 24/7, Blackberr

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

es on vacation, and weekend work. U.K. employees often left right at 5:00 pm, refused to work weekends and resented their new U.S. headquarters for infringing on personal time. Neither side saw the lo

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

Following aspects would a

ic of the other's set of rules.

So what do we do?

The first step in successfully blending work vs. life balance is to define culturally loaded statements that cause judgment and resentment. For exam

dd to the challenges in developing combination products:

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

ple, what is "a sense of urgency" or "a good work ethic"? Different cultures define these terms according to their own values and priorities. Each side can discuss how they view these concepts as obje

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

tively as possible to increase understanding, thus moving away from the "lazy vs. hardworking" mentality.

The second step for success is to identify the areas of flexibility. Where can each side shar

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

the burden, compromise or change procedures? In the example above, the U.S. staff could learn to cross-train more thoroughly, provide better rationale for overtime and limit weekend work. The U.K. st

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

aff could learn to openly discuss their needs with management, offer more flexibility and compromise when possible in crisis times.

The third step for success is to learn which elements of each cultu

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

Professional from academic institutions, pharmaceutical industries, health care indust

e could benefit the whole. For example, people in the U.S. often wonder how European countries allow such long vacations (four to six weeks is standard). The answer is planning. Vacations are planned

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

nto the budget at the beginning of the year, as is rigorous cross-training. Aren't planning and cross-training elements that can help any organization? Looking at how cultures around the world do busi

.

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

ness, including balancing work and the rest of life helps elevate the whole organization.

There is no magic solution to work vs. life balance in a global setting, but recognition is a grand start. Ir

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

Companies that provide selfless information through particip

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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