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The best professional advice!

All of your possibilities from this moment, are located in your own personal expectations. All of your expectations are located in the very p

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

ersonal relationship you have with yourself. The relationship you have with yourself is the relationship you will have with others.

What matters most is how you see yoursel

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

Examples of combination products may in

f! Take very good care of the relationship you have with yourself at all times.

I was a member of Toastmaster International and in 1984 Caroline Sander RN introduced me to

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

the National Speakers Association. I went to all the local chapter meeting and to the National Conventions. The first meeting I attended, I felt a little uneasy about bein

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

g in this new setting. Billy Arcement came up to me and introduces himself from Donaldsonville Louisiana. Billy knew that I was uneasy about being at this meeting. He said,

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

Combination pro

“If you have a dream in your heart long enough, you have what takes to realize that dream. I never forgot those words.

Ginger Bondi was the president of our local chapte

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

r. Ginger was tough love. I listened and took notes of everything other speakers in the chapter said that I must do to convince people to hire my topics. I practice all of

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

these ideas.

I called Ginger Bondi and ask if I could come and speak with her. I told her that I did not want to do anything to hurt the speaking profession. That I wanted

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

to abide by the code of etitics of the National Speakers Association.

I shared with Ginger how I just signed a contract for a speaking engagement in Tampa Florida. This was

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

my first really serious paying engagement. I told her I was nervous that they would find out that I was just a Bicycle Shop Owner. This audience was to executives of the s

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

eel industry. Ginger said, “Knock it Off, Mike Marino; I want you to go to Tampa and just be yourself! If you go there thinking they are better, you will not do well. If y

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

Following aspects would a

ou go there thinking you are better than they are, you will definitely not do well.

You must go to Tampa and be who you are and allow them to be who they are, and you will do

dd to the challenges in developing combination products:

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

just fine.” I embraced Ginger’s advice. I did well and was privilege to speak with many of the other chapters in the steel industry after that.

The next best advice that

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

I received was from Michael Lebouf PhD. I was attending a local chapter meeting of NSA and everyone was sharing what it took to be a full time professional speaker. When i

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

t was Dr. Lebouf’’s turn to share he said, “Just be good!” If you are good, people will say she is good! He is good!”

Rick Phillips sales & staff trainer gave me this advi

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

ce. “Never beat a dead horse!” All good things come to an end and then something better begins. Get on a new horse to take you the rest of the way. Forward ever, backwards

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

Professional from academic institutions, pharmaceutical industries, health care indust

never!

All of this advice applies to any profession. Keep your dream in your heart. Be yourself, and be good at what you do. Never beat a dead horse. It’s over! What ar

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

e you going to do about it?

The room for improvement is still the greatest room in the world. You can improve on your dreams. You can improve on your relationship with yours

.

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

elf and others. You can improve on your proformance in your profession. You can get a new horse. It does not cost anything to think big. It pays to be good.

All advice tran

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

Companies that provide selfless information through particip

slates into the same thing. Take care of yourself. If you want to do twice as much for yourself, your family, your profession, community, take care of yourself twice as much

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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