E-Folder - Business

Imagine what your life would be like if you had the flexibility to work when you wanted to, rather than being stuck in a 9-5 business environment. How would it feel to get out of the r

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

at race and have more time to enjoy more free time?

I've been coaching a lady for the past year who originally was the manager in a financial services practice. Mary had been with thi

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

Examples of combination products may in

business for several years and found that over time her energy and vitality had been drained out of her.

She would leave work at the end of each day, sometimes at 5.00 p.m., other da

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

ys at 7.00 p.m. She was often exhausted from all the pressure of looking after a team of 15 people and also having to keep the owner of the business happy.

Mary found that at the end

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

f each day all she wanted to do was go home and relax. She had spent all her energy at work and there was nothing left over for her personal life. Her health suffered as well as her re

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

Combination pro

ationships, both with her husband and her friends. She used to be a happy-go-lucky person and now she was snappy and miserable to be around.

Mary found that the environment she was wo

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

rking in was negative and sapped her energy. The culture was one of 'just get on and do the work'. There was no people development and rarely any professional development. The business

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

owner thought it was enough that he supplied employment for his staff. He wasn't interested in investing any time or money into them. His attitude was "Why waste money? If we train the

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

m, they'll probably leave any way." What he didn't realise was he was creating an environment that ensured his people would do the barest minimum of work and any excuse to slacken off,

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

they would take it... and they would more than likely leave anyway.

After all, he didn't care for them, why should they make an effort to help his business.

Anyhow Mary finally took

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

he plunge and left to go into business for herself. Now this wasn't a quick decision. It took time for her to work out what she enjoyed doing and also if it was going to provide her wi

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

Following aspects would a

th the income she desired. She also needed to ensure that she could have time for a life. Just because someone decides to go into business for themselves, doesn't mean they'll be able

dd to the challenges in developing combination products:

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

o enjoy both. That's very evident with many small business owners.

Also for the business to be successful Mary had to learn how to have the mind-set of a successful business owner and

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

not that of an employee. She needed to learn new skills and some of those skills included how to be organised and manage her time effectively, setting up systems and sales and marketi

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

g.

This was a huge step from being an employee all her working life and then going out on her own. Coaching had given her the confidence that she could get out of her situation and in

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

ect passion into her life.

We were recently reflecting on how far she had progressed over the past year. She's now driven, motivated, and has heaps of energy to learn and grow. She ha

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

Professional from academic institutions, pharmaceutical industries, health care indust

s now become a participant in her life, rather than a spectator.

Mary is so much happier. She stays away from negative influences which drain her and now has a passion for life. You c

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

n hear it in her voice.

When she was employed she was so lethargic and took forever to get things done. Now she's a productivity powerhouse, nothing can stop her.

How's your working

.

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

environment? Is it positive and uplifting or negative and draining? It's never too late to change. You probably spend most of your waking hours at work, so if you're not enjoying it, t

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

Companies that provide selfless information through particip

en do something to change it. Your life is in your hands... if you want to keep it that way then take action.

Have a great week

Lorraine Pirihi Australia 's No. 1 Productivity Coac

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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Exporters of coffee found a new place where the merchandise earns its price hike. New York City, the location of most coffee shops in the world, is said to be the place where coffee's price will increase over 20% in the forthcoming months. The beans will most likely outstrip other important merchandises to exporters like silver and copper.

Some easy invention ideas you can take and call your own. No intricate mechanics or complicated plans here.

In the last article Part 4a published on [June 01, 2006 08:10:51 pm], I have shared how several tools are used in the IMPROVE PHASE. I have covered how to use Benchmarking and Cost Benefit Analysis. In this issue, I will cover some of the problem faced by team members when they use these two tools.

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