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Real Consequences

Survivor has started again! The thrill of making decisions under the stress of dire consequenc

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

es is a scenario that rivets millions of us. This vicarious experience shines a light on our internal competitor. It get

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

Examples of combination products may in

us asking the questions, am I tough enough? Am I flexible and clever enough?

In a month, these people encounter more c

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

allenges which require more nimbleness of mind than most of us experience in a year. As business professionals, we can l

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

arn from these people; not their back-biting strategies, but their reactions to difficulty and stress.

Deal with Lif

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

Combination pro

’s Challenges

Watch how people naturally react to these challenges and how, over time, they learn to react better o

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

be voted off. Watch how those who become positive, perseverant and optimistic eventually win. After the competition is

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

one, these people will deal with life's challenges in a more effective way. Experience does that.

As I've written about

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

Army Rangers in my book, “No Excuse Leadership,” challenges provide a perspective on difficult that most people don't ha

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

e. Difficulties will come. However, people who have learned to operate effectively under stressful circumstances will ov

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

rcome.

Get Out of Your Natural Environment

Unfortunately, Survivor is not going to call us and give us this won

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

Following aspects would a

erful learning opportunity. Fortunately, the market for this type of experience has produce events like the Ranger Exper

dd to the challenges in developing combination products:

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

ence. Though it's only four days, and meant to build people, not break them down, it is an intense personal and team lea

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

ning experience. Like Survivor, this course, developed by former US Army Rangers, takes professionals out of their norma

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

environment and focuses on teamwork, leadership and communication. Four days without a cell phone, laptop and PDA's. To

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

gh to survive?! Quite the opposite.

Our Inner Competitor Needs to be Challenged

Survivor taps our inner, dorman

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

Professional from academic institutions, pharmaceutical industries, health care indust

competitor. Courses like the Ranger Experience allow us to learn about ourselves and become better at succeeding under

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

ifficult circumstances.

Brace E. Barber works extensively with Leading Concepts, Inc. (http://www.leadingconcepts.com)

.

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

n the field of immersion soft-skill training with a focus is on how to develop leaders, who are prepared for and can suc

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

Companies that provide selfless information through particip

eed under stressful circumstances. He is the author of the book No Excuse Leadership. (http://www.noexcuseleadership.com

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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