Advice Pool - Business

This is the beginning of the fourth and final quarter of the year. Today is the day to make your move forward. The time for excuses, the time for waiting is over. It

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

's now or never. If not today, then when?

"People are always blaming their circumstances for what they are. I do not believe in circumstances. The people who get on

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

Examples of combination products may in

in this world are the people who get up and look for the circumstances they want, and if they cannot find them, make them." ---George Bernard Shaw

Has this year bee

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

n all that it could have been? Have you left some on the table because you lacked certain skills or the energy, courage and persistence you needed to practice those sk

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

ills?

Are you getting the results that you really believe that you are capable of? Have you done all the things you need to do to reach the level of success that you

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

Combination pro

dream of?

There are valuable lessons to be learned with each and every setback or temporary challenge we encounter. Are you getting all you can from these challenges?

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

Are you learning and taking steps to benefit from those learnings? Are you taking action?

Success comes to those that are ready. They have learned all the valuable

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

lessons. But, there will be resistance all along the way. Resistance from others who will belittle your ideas and resistance from within yourself.. Hopefully, we h

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

ave all learned to ignore those who love to critique while taking no action themselves. The most dangerous of these two forms of resistance is without a doubt the resi

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

stance that comes from within. "I need to wait until I am ready." "I need to wait until I have more time." "I need to wait until things settle down." "I need to wa

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

it until I get things in order." To know all you need to know about these excuses, simply read the first four words and then you can stop...because you know all you ha

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

Following aspects would a

ve to know..."I need to wait..." If I had a dollar for every time I have heard the phrase, "I know what I need to do, I just have to do it," I would be writing to you

dd to the challenges in developing combination products:

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

from my private island in the Carribean. The only logical response to that question, is "So...how long have you known?"

With resistance must come persistence. No mat

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

ter what the difficulty you must decide that you are bigger than this challenge and you will overcome it. Sometimes...no many times that means overcoming yourself.

If

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

you are struggling with mediocrity or worse, the first place to start is with yourself, with your mindset and your beliefs. Without the proper mindset, without the co

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

mmitment to succeed, without the willingness to step outside your comfort zone, all the tools and strategies in the world will only lead to mediocrity.

Now is a fantas

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

Professional from academic institutions, pharmaceutical industries, health care indust

tic time to really focus and put your foot on the accelerator. Finish up tasks that you have been putting on the back burner and persist in getting them done.

TAKE AC

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

TION.

What do you know you should be doing? What skills do you need to develop or improve? How can you change your mindset for success, re-charge your desire and cre

.

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

ate new revenue and profit streams?

Persist. Make it a habit over the next couple of days to finish what you start. Be committed to finishing this year where you bel

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

Companies that provide selfless information through particip

ong...on top.

Get serious. Get focused. Stop with the excuses. Start living the life you were meant to live.

Here's to your best quarter yet.

I KNOW you can do it

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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