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As a small business owner, I am constantly looking for ways to network with other professionals

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

and business owners in my area. I enjoy the interaction between entrepreneurs, inventors, owne

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

Examples of combination products may in

s, and business-minded people. It is a thrill, in fact.

In my never-ending quest to meet other

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

, I visit and participate in countless business networking and referral groups. One in particul

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

r set me off to the whole idea; the group will remain nameless for obvious reasons. Perhaps I h

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

Combination pro

ve been sheltered, my favorite group meets at a local coffee shop and we have a very relaxed me

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

ting and generally find a topic that suits a majority of the group. The “rules” are simple: sho

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

up. That’s it. We do have an expectation that each person will purchase their own coffee if th

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

y chose to order, but this does not pertain to the group itself. This structure, or lack there

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

f, matches my personality wonderfully.

I recently visited a group and almost felt overwhelmed.

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

Every person who entered the room was quick to make their way to me and introduce themselves, a

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

Following aspects would a

lmost as if it were required. I later found out that it was required; moreover, any member of t

dd to the challenges in developing combination products:

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

e group that was guilty of not introducing themselves was fined – as in monetarily fined.

I ob

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

ained a copy of the bylaws of this particular group, while I understand the importance of struc

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

ure, rules, regulations, and such, the thought of having a 35+ page bylaw booklet seemed a litt

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

e excessive.

I took it all in stride; I later found that to be a member of that group would co

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

Professional from academic institutions, pharmaceutical industries, health care indust

t nearly $900 a year after quarterly membership fees, dues (separate from membership fees), fin

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

s, and the weekly breakfasts. This fact struck me as very odd, especially when the group’s miss

.

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

on statement includes making money for its members.

Have I been sheltered? The thought of simp

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

Companies that provide selfless information through particip

y sitting around a table with 6 other business leaders sounds appealing to me.

More to come ..

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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The keys to effective improvisation are the same as the keys to success in just about any other area of life, including business.

As a retired entrepreneur I was recently reflecting how I had always felt that our company needed to out innovate our competitors. In fact I spent countless hours considering how to be more efficient and use our machinery to make more money in less time and give us the edge over the competition.

Are you throwing around the word 'accountability' and no-one is catching it? This article takes a look at what practical steps you can take to improve the chances that people will be accountable for the goals they are responsible for.

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