E-Folder - Business

Ooh, I love a good list! Especially at Christmas time. It just gets you feeling all warm and fuzzy and prod

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

uctive, doesn’t it? Unfortunately, most resolution lists read like a Martha-Meets-Oprah-Make-Your-Life-Reall

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

Examples of combination products may in

-Special instruction sheet. You know, stuff like “Always show you care with a hand written thank you note.

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

Use high quality, recycled card stock, and sign in calligraphy.”

Not exactly inspiring.

And as sticky sweet

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

as your nephew’s half eaten candy cane.

So, I’ve prepared a different kind of list, one that’s pure octane a

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

Combination pro

d 100% sugar free—with nary a saccharine euphemism in sight. The politically correct should step aside. The

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

rest of you should strap yourself in and keep your mouth closed—there’s gonna be some dirt flying.

Without

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

urther adieu . . .

Karri’s 11 Commandments for Entrepreneurial Success:

1) Sometimes you have to grit your

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

eeth and get the job the done when you really don’t feel like it. I have no solution for this except to prom

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

ise yourself a cold alcoholic beverage when you have finally finished the dreaded task.

2) Leverage your kno

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

ledge, not your time. There are limited hours in a day and just one of you. But the power of knowledge to g

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

Following aspects would a

nerate wealth is limited only by your imagination.

3) If you are not making any mistakes, you’re playing it

dd to the challenges in developing combination products:

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

too safe. If you are not learning anything from your mistakes, why are you even doing this?

4) Respond to a

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

l correspondence within a reasonable amount of time. In this age of depersonalization, it will not go unnoti

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

ed.

5) Follow up on every qualified lead. If you do not hear back right away, understand that most people l

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

ive harried lives and try again. If you still don’t hear back, let it go. It wasn’t meant to be.

6) In mos

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

Professional from academic institutions, pharmaceutical industries, health care indust

situations, it’s beneficial to everyone when you say what you think, unless you are not thinking.

7) Being

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

seful is more important than being right.

8) And integrity is more important than being honest.

9) Recogniz

.

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

e inefficiencies and remove them. If you can’t, outsource them.

10) There is more than enough wealth to go

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

Companies that provide selfless information through particip

round in this world. You just have figure out how to ask for it.

11) It’s never about price.

Happy New Year

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.e-folder.org.ua/article/44593/e-folder-Making-a-List-and-Checking-it-Twice--Resolve-to-Get-Your-Business-Mojo-On.html">Making a List and Checking it Twice: Resolve to Get Your Business Mojo On</a>

BB link (for phorums):
[url=http://www.e-folder.org.ua/article/44593/e-folder-Making-a-List-and-Checking-it-Twice--Resolve-to-Get-Your-Business-Mojo-On.html]Making a List and Checking it Twice: Resolve to Get Your Business Mojo On[/url]

Many Universities to propel their academic research programs faster will partner with government agencies and private enterprise and this makes sense because it is a great source of monies to help propel the university and the businesses and government to get brilliant minds who basically work for free as slave labor.

Is it possible to franchise your business? How can you decide if franchising is the right route to take for your business?

It takes commitment and an obsession about customers to win business. Over the years, my experiences have taught me that it is simple to create a customer-focused culture, but it certainly isn't easy. If a company gets it right, however, the customers and profits will be easy to attract and keep.

Tags

Links

E-Folder - Making a List and Checking it Twice: Resolve to Get Your Business Mojo On

Related Articles: