Digg It - Business

It is easy to get caught up in the bloodshed and threats to our security, no matter where in the world we live. However, being American can be doubly difficult since the fall of the Berlin Wall and the tragedy of 9/11, where as the world's only

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

Superpower we are caught up in every web of tragedy that the world spins.

And with the knowledge that terrorists aren't weaker since the wars in Afghanistan and Iraq but instead are growing stronger, evidence Hezbollah's ability to destroy an

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

Examples of combination products may in

Israeli ship and strike its third largest city by missile, the fear that danger sits on our shores and laps at our coastal communities is real and growing.

So, what is an American business person to do? I speak specifically to the business per

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

on, because as a consultant and a business person that is my work community but most important, we wield a great deal of influence and power and how we use that power is critical to not only economic but also to our very survival.

I don't pret

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

nd to have either political or military answers to the current world state of affairs, but I think that my five decades as an American political activist (including serving a brief time as a paid lobbyist), my eight-years military experience, a

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

Combination pro

d my 30-plus years business experience, may offer a learned point of view.

In these troubled times, I believe we business people have a responsibility to ourselves, our clients and customers, our friends and family, our country and the world t

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

o do the following:

Continue to grow our businesses. Our clients and our customers need good products and services at a fair price and that provide good value not only for their basic needs but for their growth. The world economy needs

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

to stay strong no matter the states of politics or war. And our families and communities need life's essential gifts to stay strong, which come from the earnings that we make and reinvest in our businesses and our communities.

Do not be

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

ome conservative in our business practices, which ultimately hurts business growth and profits. Invest in growth and innovation; take calculated risks; understand and employ the appropriate best practices.

Seek outside knowledge and adv

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

ce from every source--including business peers, our employees, business books and articles, and business experts--to ensure our businesses look outward, avoid the trap of doing only that which is familiar and traditional, and employ forward thi

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

king to avoid getting stuck in the past.

More than ever, give back to our communities and extend those communities beyond our local boundaries. During times of stress, we need to help those organizations that do good. In the end, it is

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

Following aspects would a

good for business and good for our communities. When people are given a hand up, after all, they become consumers and better citizens.

Do the right thing. Pay taxes owed, keep corruption off our doorsteps and keep excessive greed at a d

dd to the challenges in developing combination products:

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

stance. (Greed drives Capitalism, even though we are loathe to admit it, but excessive greed indicates an inherent personal weakness and leads to corruption.) The economy and our neighborhoods need businesses driven by values so that we enhance

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

our credibility, especially in times of fear. Credibility and trust must live within us, if we are to maintain hope in each other.

Treat everyone with respect and dignity, especially our employees. In these days of merger and downsizing

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

many are but one paycheck away from desperate times. They need to be able to count on us, if not for a job then for the truth and fairness.

While remaining focused on our businesses and our lives, stay current in world affairs. The fam

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

ly of (wo)Man requires an educated and informed populace to protect us from ourselves. And freedom calls us to act before it is too late, which means we need to know when our leadership in both the political and economic arenas are required, so

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

Professional from academic institutions, pharmaceutical industries, health care indust

that we can step in and raise our voices up for the good of all.Whether we like it or not, business persons are recognized as leaders: We have power and we must use it for the betterment of society. Too often we are seen as using tha

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

power badly (think Enron). We must use that power instead to take an active role for the good of our neighbors or it is power wasted. That good begins within our own businesses and as we grow the good spreads outward.

The world is a scary pla

.

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

e, and North Americans are more vulnerable than ever before in the history of the world. As business people we can use our power to work to alleviate some of the pain and fear or we can choose to be insular and safe and hide behind a veil of ig

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

Companies that provide selfless information through particip

orance that says "world affairs are none of our business."

Lewis Green is the Founder & Managing Principal of L&G Business Solutions, a management consulting firm focused on helping businesses grow using marketing and sales strategies.

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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Digg It - A Word about War and Fear and the Role of the Business Person

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