Advice You - Business

Fear is a very powerful emotion. When we live in fear, even of the unknown, there is a tendency to isolate, exert control and be on the defensive. It drains our e

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

nergy and creates exhaustion.

The majority of coaching conversations I am having these days are about this fear generated by a struggling economy. Worry

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

Examples of combination products may in

over business progress, finding a job, salary and bonus eliminations, increased job performance expectations have taken over people’s mindsets thus decreasing moti

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

ation and focus for themselves and their business.

While no one has a crystal ball to know exactly what will happen with the economy, you do have the key

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

s to move through this time by the actions you take to minimize the fear and maximize your choices. Following are three key tips on how to refocus and regain motiv

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

Combination pro

ation during a challenging time:

Key Tip #1 Go Back To The Basics

What are the critical items you need to do to maintain positive movement fo

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

ward in your career and in your life? What can you take charge of? There are critical items that you need to focus on day in and day out in whatever your work eff

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

ort is about. If you are unemployed, there are critical items. If you run a business, there are critical items. What are they? Identify, simplify and take action

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

Tip From The Coach: Think of this also in your personal life. What critical items do you need to have happen in order to maintain joy and relieve st

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

ess? Is it time with family? Time to golf? What critical items do you need that may have been ignored due to your focus on fear?

Key Tip #2 Define An

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

d Honor Your Genius Work

In Ernest Oriente and Judy Feld’s book Smart Match Alliances, they describe genius work as “Genius work is the highest and best

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

Following aspects would a

use of your time. When you do your genius work- the activities that produce the greatest results in the shortest period of time for you – the struggle ends….fast.”

dd to the challenges in developing combination products:

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

What is your genius work? What is the work you do that suspends time and delivers the greatest results? Define it, honor it and spend the majority of y

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

our day doing it.

Tip From The Coach:
To define your genius work answer the following question: What three areas of focus and corresponding act

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

ivities that would constitute the best and most valuable use of my time today? (Note: For additional information on Genius Work and the Smart Match Alliance syste

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

send me an e-mail with “genius work” in the subject line.)

Key Tip #3 This Too Shall Pass

Because there is no crystal ball, we cannot predi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ct when this economy will take a positive, sustained turn. However, history proves that it will turn. It has always done so; there is no reason to think it will n

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

ot do so again.

Tip form The Coach:
History also shows that YOU have been through challenging times in the past and moved through those times as w

.

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

ll. Perhaps it has not been the economy but other life events. Identify for yourself what life challenges you have faced in the past and how you have navigated th

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

Companies that provide selfless information through particip

e uncertainty. That should give you clues as to your ability to face this current challenge AND specific things you could do to make the process less painful.

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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Part 2 of 2- RJ Baxter discusses the 7 strategies that he used to double his business for two years in a row!

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Accounting outsourcing services has become mandatory for the over-burdened accounting firms who need to outsource their work at any cost. In fact, outsourcing firms complete the work in very less time compared to the in-house staff. It's like a boon for all those organization that are unable to handle their accounting work.

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Advice You - Staying Motivated In A Struggling Economy

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