Useful Advices - Business

Learn the Rules

"Whoever gossips to you will gossip about you." ~Spanish Proverb

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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

What You Write or Say. Assume that anything you write or say will be read or heard by everyone in the company. E

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

Examples of combination products may in

-mail makes it easy to respond emotionally. Before you respond to an irritating e-mail, take a minute to calm down,

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

then, write the e-mail. If you have a tendency to send harsh messages, save a draft and review it sometime later to

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

nsure the tone is business appropriate.

A corollary to this principle is Happy Hour - don't go! There is a h

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

Combination pro

uge risk of saying something you shouldn't say, getting out of control, or just being in the wrong place at the wron

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

g time. You should stay out of office politics. Don't say anything bad about anyone, ever.

Arrive Early and Leav

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

e Late, but Not Too Late. You want the reputation of a hard worker, but not one that can't get their work done.

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

his principle also applies to taking work home. Over the long-term, you want to have a life outside of work. Maintai

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

ning a work/life balance will keep you engaged in your job; therefore, more productive.

Find Out What Your Boss

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

Wants and Deliver. Regardless of your personality, relationships, or good looks, you must be productive. For you

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

Following aspects would a

r boss, it means doing what they want, no matter how silly it may seem to you. For example, I had a boss that wanted

dd to the challenges in developing combination products:

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

to know how many Dairy Queens between Dallas and Houston served a particular yogurt.

Always say, "Yes!" to a reques

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

t from leadership. For your boss, there are ways to provide better solutions without damaging the relationship.

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

"Always do more than is required of you." ~General Patton

Give People Credit. Don't take credit for your

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

self. This is important for a variety of reasons. First, you need people to help you get things done. Second, when p

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

Professional from academic institutions, pharmaceutical industries, health care indust

ople recognize people who work for you, you get the credit as well. Third, it's the right thing to do.

Conc

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

lusion

When It Comes to Your Career

1. You're Responsible
2. Remember Who You Work For
3. Learn

.

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

the Rules

As Bill Karnes put it, "Eagles don't flock; they fly alone. And eagles soar above the rest of their w

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

Companies that provide selfless information through particip

orld. So, too, do people who start things, who lead groups or who otherwise set themselves apart from the crowd."

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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Useful Advices - A Career Built on Character - Part 2 of 2

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