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Imagine the following scenario; Ten years ago you decided to quit your job and start your own company. For ten years you worked hard, made sacrifices, and it pa

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

id off in the end. One of your first employees, a loyal, hard working employee has been by your side the whole way.

Things were going great. Until about eight

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

Examples of combination products may in

onths ago.

All of a sudden, clients whom you had worked for for years were not returning your calls or e-mails. Then, sales from your online products site star

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

ed dropping dramatically. One day, out of the blue, that long time devoted employee did not show up for work, nor would they return any calls.

What you did not

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

know was that employee who you trusted with your life had spent the last eight months intercepting / reading all your e-mails, installing monitoring software on

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

Combination pro

your computers to watch everything you do, contacting clients without your permission with the explicit purpose of feeding them false information. The employee

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

as downloading all proprietary code for you online products store, setting up a duplicate site on another server, and taking orders for those products.

In ano

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

ther recent case, an employee of an institute of higher learning was threatening to blackmail the executive staff. They had been notified that any action taken

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

gainst the individual would result in loss of large amounts of critical data and negative publicity. We were hired to determine the validity of the threat and

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

to collect evidence for possible legal action. What we found was quite disturbing. The suspect employee had installed logic-bombs throughout the organization

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

network. These logic-bombs required specific action be taken every 48 hours by the suspect employee. If the employee did not perform a specific task within t

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

Following aspects would a

e allotted time, for instance, if he / she had been terminated, the logic-bomb would execute. There was much more to this story and none of it was positive.

dd to the challenges in developing combination products:

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

ou have just been the victim of corporate fraud
------------------------------------------------
But how could this happen to you, and by someone who you

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

trust? It happens more frequently then you know. If you can gather enough evidence and convince the District Attorney to take action you might only have to spen

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

d $20,000 to $50,000 to sue this person. On the other hand, if you can't get the District Attorney involved, it may cost you hundreds of thousands of dollars,

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

and you won't know what the outcome is until it's all over!

A Few Things You Can Do
-----------------------
These are not fictional stories and everyone

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

Professional from academic institutions, pharmaceutical industries, health care indust

is equally at risk for such an event. Make sure you have strict controls and guidelines to keep your business safe. Any proprietary information, whether it b

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

code, sales information, client lists, or financials should be well guarded. Obviously this information must be shared with others in your organization, but

.

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

t can be done so with audit trails. As a business owner you should know who has access to what, when, and how.

The objective of this article is not to make peo

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

Companies that provide selfless information through particip

le paranoid; its purpose is to promote awareness. Most people / employees are law abiding and productive, but don't make the mistake of letting your guard down

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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Each year the advertising industry magazine called Advertising Age nominates the very best advertising and marketing campaigns in corporate America. Of course the consumers are not stupid and many times they can guess who is going to win.

Not long ago I was hired to provide executive coaching for the CEO of a medium-size company. The Board of Directors hired me because they were concerned about the CEOs “ability to get things done.” There had been complaints and even some hard evidence that important responsibilities remained incomplete. Before my first meeting with the CEO I was told that he had the education, experience and desire to be highly successful. Nonetheless, too many projects, tasks, assignments, problems and opportunities somehow didn’t get his attention, thus remained incomplete.

Attention bosses and assistants: Here's how to protect your valuable time, avoid ambushes, and create a good impression.

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