E-Folder - Business

Not long ago, I read an interesting statement on a Blog about entrepreneurs and their business

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

planning. You see, when I give speeches to MBA students, they seem totally clueless in the WOTS

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

Examples of combination products may in

analysis as the business consultant blogger indicated. Of course they are young and wet behind

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

he ears, but they ought to know what is going on.

It seems that the MBA students do "set up a

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

ake company" business plans and think this is good enough in the real world. One company I star

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

Combination pro

ed had a 400 page business plan, which of course was abbreviated to 40 pages down to two + two

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

(executive summary and outline). But we had "ALL" the information to back it up.

Indeed if you

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

want to win you have to know "Everything" about "Everything" in the industry, competing subsect

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

rs, trends (real trends, not the BS) and all the realities and created realities surrounding th

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

future endeavor. If not you cannot finish first and Vince Lombardi would not approve.

I recen

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

ly met a gentleman working with some new advances of old aerospace technologies wishing to take

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

Following aspects would a

it to a whole new level. I sent him some "Trade Journal" online newsletters and he basically s

dd to the challenges in developing combination products:

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

id yes, but we are looking for 50 million dollars and this is not important information? Says w

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

o?

In that very trade journal were co-partnering companies, vendors, banks catering to the ind

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

stry, investment bankers, etc. Besides that, you need to know this information anyway. You have

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

to know what you are talking about. Not only to secure funding, if you need it, but simple to i

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

Professional from academic institutions, pharmaceutical industries, health care indust

nsure survival.

Thus the business blog post hits home and it is something I too have noticed o

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

t there, too bad really. More entrepreneurs wish to skate by, rather than hitting a home run. W

.

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

thout the practice, observations, knowledge and insight, they somehow think they deserve to win

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

Companies that provide selfless information through particip

on BS alone? I wish it were not so, unfortunately this is what I see - Interesting topic indeed

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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All borders for denim jeans seem to be down these days. Denim jeans are everywhere. They are on the designer catwalks, home collections and on accessories. Price barriers have been broken. There are umpteen numbers of finishes and washes. From embellishments, to destroyed, distressed and ultra low-rise jeans, designers are coming out with limitless possibilities with denim jeans. The market too seems never to bottom out.

You know those big Human Resources Policies & Procedures manuals that all big corporations have? The ones govern your code of conduct during your workday? Those rules were made to be broken. That is, if you decide to work for yourself and become an entrepreneur. Otherwise, you'd get fired for breaking the HR rules.

I truly believe that every individual in the whole world is potentially only five or six contact steps away. This 'five or six degrees of separation' shows that even an entire population of over five billion people is still highly accessible. However, for practical purposes , we don't necessarily want or need to meet millions, or even thousands of people in different organizations, age groups, religions, professions, culture or places. We are just looking to develop a network that will eventually provide us with additional business. Ideally therefore, we need some kind of filtering or research system that will help us to build a set of relationships of high quality, or a strong network that can find people and resources both efficiently and effectively.

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