Advice You - Business

I’ll never forgot the time I called my father from the restaurant I owned to tell him that I found my calling and was going to pursue a career as an author and speaker. His response was less than enthusiastic. “What the he_ _ are you going to do that

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

for,” he said. “That will never amount to anything. It’s a load of junk. Just focus on your restaurant.” I hung up the phone and thought two simple words “Thanks Dad.”

Believe it or not, I didn’t get angry at him for saying this. I knew he was just o

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

Examples of combination products may in

ne of many negative people; I call Energy Vampires, that I would have to face on my journey through life. Unfortunately energy vampires don’t just exist in our families but they also lurk in our businesses, social organizations, churches and neighborh

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

ods. They are real. They are everywhere. And they will suck the life out of our goals, dreams and plans for success if we let them.

If you're like most people, it has happened to you. You were talking to someone and before you knew it, they drained t

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

he life right out of you. You looked for fang marks on your neck but they were nowhere to be found. Then you realized Energy Vampires don't have fangs. They have other means to suck your energy. Here are a few:

Negative comments -"Did I tell you how

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

Combination pro

much I hate my life and work? Did I tell you what so and so did to me? Did I tell you why nothing goes right?"

Dream snatching - "You can't do that. You’ll never succeed at that. Are you living in fantasyland? You should do this instead."

Shrinking

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

evices - "What is wrong with you? Can you do anything right? Why did we hire you anyway?”

Team Destruction – “We’ll never make it. It’s Joe’s fault. Everyone is clueless.”

In other situations the words may be less harsh but the result ends up being

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

the same. Once an Energy Vampire starts sucking the air out of your tires it’s difficult to move. Don't let this happen. Realize that life is like an energy bus and the people you surround yourself with on your ride through life have a huge impact on

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

how far you will go. Create a positive and successful ride by following these simple rules for the road that will take you to the places you want to go.

-Post a sign that says, NO ENERGY VAMPIRES ALLOWED. Pete Carroll, football coach of USC says he 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

esn’t allow negative energy in his locker room and you shouldn’t allow negative people on your bus.

-Realize that some people are going to get on your bus and some people won't. That's ok. The people that get on were supposed to get on. The people th

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

at don't were probably meant to get on another bus or perhaps they would have ruined your ride. Don't take it personal. Just keep on driving with your vision focused on the road ahead. If you waste your energy thinking about the people who didn't get

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

Following aspects would a

on your bus that means you'll have less fuel to pick up the people who want to get on.

-As you drive just keep picking up people along the way who want to get on your bus. Eventually you'll have a filled -standing room only- bus with great energy.

-

dd to the challenges in developing combination products:

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

rive at your own speed and don't compare your success to other buses.

-During your ride, you will have many people get on and many get off. Don't take it personal. The people who get off may have to get on another bus. Or perhaps they will make room

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

for someone special who is supposed to get on.

-Have fun and enjoy the Ride. You only have one ride through life so you might as well enjoy it. The goal in life is to live young, have fun and arrive at your final destination as late as possible with

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

a smile on your face.

A few years later after that “not so positive” discussion with my Dad he called me up on my cell phone. I had just finished my first appearance on the NBC Today Show and he excitedly said, “Your mother and I just watched you and

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

your book really made a difference in those people’s lives. We’re so proud of you. We always knew you could do it.” When we hung up I just laughed. He didn’t even remember being an energy vampire. What changed I wondered. What made the difference? And

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

Professional from academic institutions, pharmaceutical industries, health care indust

then it hit me. We’re all driving our bus. We have the best seat and the best vision for the road ahead. Not everyone will see what we see. They are limited by their own vision, doubts and fears. They think that dreams were meant for others but not f

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

or people like you and me. But we know better and in our knowing we understand that every driver will be tested on their journey. Every driver will encounter negativity, naysayers, roadblocks, flat tires, fear and self doubt. No one goes through life

.

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

ntested but the answer to these tests is positive energy. And the ultimate rule for the road is that our vision, positive energy and certainty must be greater than anyone’s negativity, fear and doubt. Positive energy consisting of vision, optimism, tr

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

Companies that provide selfless information through particip

ust, enthusiasm, purpose and spirit makes the difference. When we fuel our life, work and team with positive energy we will surely enjoy the ride of our lives….and keep the Energy Vampires off the bus or even better convert them to positive passengers

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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Sanitizing is the process used to rid or reduce the number of microbes (microorganisms) on the surface. Sanitizing cannot be accomplished until surfaces are clean.

The small business can benefit from an effective Yellow Page ad. I should know. I sold those ads for 25 years and now pass on my knowledge.

It is common for organisations to undertake projects, however most do not employ full time Project Managers and it is common to pull together a project team to address a specific need. While most people are not formally skilled in project methodology, taking a role in a project team can be an excellent learning opportunity and also enhance a person’s career profile. To that end, this article aims to give an understanding of project management methodology and how it underpins most formally run projects.

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