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Recent incarnations of The Apprentice featured some very unusual people. While I’m sure they were chosen to spice up the show, none of them seemed to possess the skills or expertise needed to compete on that l

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

evel. If the show was supposed to be all about people vying for a mega-management position with the Trump Organization, these were candidates with the wrong stuff for that much-coveted spot. While the show and

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

Examples of combination products may in

more conventional candidates may not have benefited from the antics of these bizarre applicants, serious viewers can certainly profit from their mistakes and eccentricities.

Apprentice 3 gave us the amazing

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

Danny. Looking like a leisure suit hippy, this guy loved to strum the guitar and sing. He had a gimmick, but couldn’t seem to consistently deliver the goods as part of a team. Apprentice 4 introduced the often

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

incomprehensible and seemingly ineffectual Markus. He became an outcast in the competition having proved to be uninspiring and frustrating to colleagues during various tasks. But my personal favorite was Bren

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

Combination pro

t from Apprentice 5. Here was a guy who loved to tell everyone about how much he would bring to the table. However, he didn’t work and play well with others and became known more as a big eater than a heavywei

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

ght performer. To challenge him was to face a verbal barrage and witness his own special brand of temper tantrum.

When it came to working as part of a project team trying to successfully complete a challengin

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

g task, these characters forgot all about FLEXABILITY. As The Donald has often demonstrated, you don’t have to compromise to be flexible. You just have to be willing to try a new approach, consult others with

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

more expertise and go with the flow when you see that it benefits everyone involved including you. Instead, Danny, Markus and Brent became obstacles of their own creation. Each decided that every task would be

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

approached from the standpoint of their own philosophy and methodology. This made them appear as unyielding and incompetent, even though all three had achieved a measure of success within their chosen careers

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

.

Another important lesson to be learned from these three eccentrics is that being UNCONVENTIONAL is not always desirable when you‘re faced with a tough project and rapidly approaching deadline. In order to t

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

Following aspects would a

hink outside of the box, you have to know what’s inside. That means being familiar with time-proven techniques and procedures that have worked for others facing similar tasks. It also means being intellectuall

dd to the challenges in developing combination products:

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

y prepared. People with a passion for success will equip their mental toolbox with a willingness to learn and the ability to be consistent, intuitive, flexible, creative, decisive, unpretentious and motivated.

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

If we judge them by their contributions to each task as Trump did in the boardroom, we see that Danny, Markus and Brent failed to exhibit evidence of these qualities which can help produce outstanding project

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

team members and excellent leaders. While seeking to be his Apprentice, many candidates who compete on the show end up fired because they fail to follow the example set by Trump.

While most people think of D

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

onald Trump as the ultimate Entrepreneur, he is also an astute businessperson. While he leads with authority and has no trouble getting his point across, Trump also inspires people with success and motivates t

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

Professional from academic institutions, pharmaceutical industries, health care indust

hem with opportunity. When it comes to moving his business empire forward, he doesn’t just think about making money. Trump is always looking for new opportunities to make more money by providing the very best

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

product or service to those who can afford it. With his name boldly emblazoned on and associated with everything he does from a business standpoint, Trump has to insist on a superior level of quality. As a suc

.

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

cessful innovator, The Donald is second to none.

The Apprentice unashamedly presents the good, bad and ugly of people competing in the workplace. It’s a fantastic opportunity for success-driven individuals to

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

Companies that provide selfless information through particip

learn the ABC’s of business behavior. If there is one vital lesson to be extracted from that aspect of the show it is that being eccentric isn’t a bad thing, as long as it doesn’t make us own our worst enemy.

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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