Main Subject - Business

Imagine This!
I am going to have to ask you to use your imagination a bit. Picture a middle-aged male, 6 feet tall, long, wavy blond hair, about 185lbs. Now fo

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

r the fun part, he is dressed in a yellow tutu, a tiara adorns his head; he has a magic wand in one hand, a megaphone in the other and a toothbrush in his mouth.

For the

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

Examples of combination products may in

record, the picture you have conjured up is me. So why the picture you ask or maybe it is more like why and what the…? The picture was taken at an event called the Avon Br

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

ast Cancer 3-Day. In this event over 3000 people walked 67 miles from Leominster MA to Boston. You heard it, 67 miles in 3 days on 2 feet. My wife and I had walked it the

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

first year and for the next two years we joined the crew of 500 or so volunteers that supported the walkers. Our crew team ran a pit stop; our goal was to provide treats,

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

Combination pro

luids and moral support for the walkers. As you might have guessed our team theme was tooth fairies. Sometimes you have to step outside of your comfort zone and adopt a le

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

ss serious approach. At the end of those three days, despite the benefit of that megaphone I had no voice left. Let me tell you, it is some challenge to keep people charge

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

d when they are physically and emotionally worn. Let’ s face it, these people walked for a lot of reasons. Some of them are breast cancer survivors themselves, others are

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

alking in honor of loved ones lost to or still battling this devastating disease. For me, it was in memory of my Mom who had breast cancer yet died of other causes and a d

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

ear friend who at the time was battling the disease and who ultimately succumbed, this past year.

Don't Be Sad
But this is not a sad story; in fact this exper

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

ence was the most life-changing of my time on this earth. Each of my three years participating in this event I was fortunate to be amongst amazingly selfless people. To sa

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

Following aspects would a

y I was humbled does not come close to describing the feelings that surged through me. The tears flowed freely as did the joy, the cheers and the hope. There is no place I

dd to the challenges in developing combination products:

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

would rather have been, no experience that would have satisfied me more profoundly. I discovered strength and passion in me I had no idea existed, not to mention what I l

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

arned of so many others.

Business Is First and Foremost About People
OK, so what does this have to do with business anyway? Well, here are my thoughts. A busi

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

ness is first, about people; employees, clients, the public at large, and so on. The common denominator in business is people. Yet, when we get caught up in running a busi

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

ess (or for that matter being in business) it’s easy to lose our appreciation for those people upon whom our business depends. That is not something we can afford to do. M

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

Professional from academic institutions, pharmaceutical industries, health care indust

y 3-Day experience taught me a lot about how I look at myself and at others.

Take a Walk Alongside Yourself- You Will be Amazed
You have heard the old adage ‘

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

walk a mile in my shoes’. How about walking a mile alongside yourself? What would that be like? Take a close look at your day to day. How does it feel? What would it be li

.

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 to be your own employee, a client or even your boss? Do you know yourself this well? If you do I congratulate you as I suspect you are in the minority. If you do not, my

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

Companies that provide selfless information through particip

challenge to you is that you start the journey. When you do, you will be enriched in ways you cannot imagine. I know; it took me three days and 67 miles.

Start walking..

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.mainsubjects.org.ua/article/3089/mainsubjects-Take-a-Good-Look-at-Yourself-and-Grow-Your-Business.html">Take a Good Look at Yourself... and Grow Your Business</a>

BB link (for phorums):
[url=http://www.mainsubjects.org.ua/article/3089/mainsubjects-Take-a-Good-Look-at-Yourself-and-Grow-Your-Business.html]Take a Good Look at Yourself... and Grow Your Business[/url]

Positioning yourself as a thought leader in your area of expertise through presenting and speaking is a tremendous way to build your brand and extend your reach to new clients. Discover seven strategies to enhance your effectiveness as a presenter.

This is the perfect topic for the first month of a brand new year! Staying late started innocently enough: “If I just stay a little later today, I can catch up’ on this work I haven’t been able to g...

Tags

Links

Main Subject - Take a Good Look at Yourself... and Grow Your Business

Related Articles: