Digg It - Business

This subject pertains to the traveling team that invades offices or businesses that are not living

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

up to expectations. The dreaded moment when corporate sends in their team of so called experts to F

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

Examples of combination products may in

X the problems. I have repeatedly seen these so called teams of experts come into locations only 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.

leave it worse then it was when they arrived.

I was visiting with the leader of one of these so ca

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

led teams recently and was appalled by his planned course of action. After quite a bit of discussio

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

Combination pro

n the leader asked “The Specialist” for some tips. First let me tell you his opening strategy. He p

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

oudly went on to inform me that since no one knew his appearance he was going to hide and hang arou

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

d and find out all the mistakes they were making and then inform them it was going to be his way or

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

the highway. He spoke very confidently.

The obvious problem that “The Specialist” has with this ri

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

ght off the bat is that I prefer to catch people doing things RIGHT! What I recommended to him was

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

erhaps he should take another approach…for example, why not positively introduce himself, let every

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

Following aspects would a

ne know there was a clean slate and establish a great relationship with everyone. I suggested that

dd to the challenges in developing combination products:

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

fter everyone trusted him and realized that he was not a hatchet man, they would feel more comforta

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

ble. Then as the first few days progressed he could gradually slide in his changes. Instead of bein

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

afraid of massive change, the employees would be much more receptive to change.

I have done this

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

ountless times, in fact I even take it further and meet with the individual employees and let them

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

Professional from academic institutions, pharmaceutical industries, health care indust

now that I was there to advance their career and if there was anything I could do to help them I wo

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

uld be glad to. This approach works wonders, and the results are staggering! Instead of blowing eve

.

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

ybody out and having to build from scratch, you have done what was expected of you and that was FIX

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

Companies that provide selfless information through particip

the problems.

You in fact have endeared people to you and dispelled the notion of being an INVADER

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.diggit.org.ua/article/20674/diggit-The-Invasion.html">The Invasion</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/20674/diggit-The-Invasion.html]The Invasion[/url]

Small and medium sized business owners are often confronted with cash shortages within their business. Frequently this problem is resolved through obtaining a bank loan or extending overdraft limits. An alternative approach for the business owner to take is to extract early value from the business receivables through invoice factoring.

Whenever I talk about buying businesses I tend to get a lot of questions about distance. How far away should a business you buy be? Should it be in your backyard? Should it be in another city? Another state? Another country? In other words, they want to know if distance plays a factor in the success of a business they buy, and what do I think about it?

Tags

Links

Digg It - The Invasion

Related Articles: