E-Folder - Business

I have spoken to several business owners recently who have said to me that they would like

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

to position the company for sale within the next 3 to 5 years. All of these businesses w

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

Examples of combination products may in

ere financially strong with revenues in excess of $3 million a year.

After speaking with

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

them for awhile, each of them made another interesting comment. They said that they were

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

not interested in growing because they would then have to hire and manage supervisors and

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

Combination pro

additional employees and that would be too much trouble. It would also cause them to lose

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

touch with their customers, which gave them a competitive advantage in the area of Custom

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

er Service and Quality Control.

I asked each of them how much the company would be worth

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

without them being there. They all agreed that it would be worth less than their financia

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

ls indicated, because they were the company. My next question; "So if you go away for a l

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

ong period of time, what would happen to the business?" Again the answer was basically th

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

Following aspects would a

e same, "It would begin to lose money."

Can you see the problem here? How can these succ

dd to the challenges in developing combination products:

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

essful entrepreneurs position their business for sale if all of the Goodwill is positioned

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

on their shoulders? It will be very difficult at best.

So, I respectfully suggested to

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

each of them that they were not doing themselves a favor by staying so close to the busine

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

ss. It was imperative that they start today putting processes in place to allow others (Y

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

Professional from academic institutions, pharmaceutical industries, health care indust

es, they may need to hire supervisors and more employees) to run the business. This was n

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

ot going to happen in just a few months. It could in fact take the entire 3 to 5 years to

.

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

reach this objective.

If you intend to sell your business and make what it is worth, don

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

Companies that provide selfless information through particip

't get caught with the goodwill in your court. Give it to the business.

To Your Success

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/44702/e-folder-Good-Goodwill.html">Good Goodwill</a>

BB link (for phorums):
[url=http://www.e-folder.org.ua/article/44702/e-folder-Good-Goodwill.html]Good Goodwill[/url]

Formulating a series of well-thought out questions in advance of the interview will not only help you draw out pertinent information form the interviewer, but also demonstrate your intelligence and sincere interest in the position at hand.

Today’s businesses require regular updating of skills, with global competition and emerging technologies on the rise. With customer demands and expectations also on the high level, businesses require their mangers to have good project management and technical skills.

Do you monitor the results of your strategic plan? Is that monitoring constant and consistent? The failure to monitor the progress of the plan dooms many plans within the first few weeks.

Tags

Links

E-Folder - Good Goodwill

Related Articles: