Main Subject - Business

Every entrepreneur should have a business mentor—someone who’s been through everything that they’re going through and can share their wisdom. Wheth

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

er he knows it or not, my business mentor is none other than former Enron Executive Ken Lay. For many, he might not make the most obvious choice of

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

Examples of combination products may in

a mentor, with his track record of lying, cheating, and stealing his way to success, but that is precisely why this choice is so appealing to me.

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

As his first duty as my business mentor, Ken (Mr. Lay to the rest of you) can grow my social network. This guy knows everybody—likely because he’s

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

aid most of them off at one point or another. He can introduce me to people who will come in handy when I need to get out of felony conspiracy char

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

Combination pro

ges. This is just one of the many valuable aspects of our business mentoring relationship.

I can trust Ken to be my business mentor, because he kn

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

ws that if he makes one false move the government will be on him like white on rice. Much like the old saying that the safest time to fly is the da

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

y after a crash, I feel like the safest day to have Ken as my business mentor is right after a huge financial scandal that covers the television, n

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

wspaper and radio waves for years, and gets used as water cooler fodder even now.

Furthermore, he’ll be my business mentor for free—unlike many on

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

line services that try to charge for business mentoring services, Ken just got away with the biggest scandal in business history. Thus, he doesn’t

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

eally need my money, because we all know that he has a few million stashed in a bank somewhere overseas. I get a free business mentor, and he gets

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

Following aspects would a

to pretend that he’s still somebody special—it’s a true symbiotic relationship.

But, one of the most important reasons that I choose Ken as my bus

dd to the challenges in developing combination products:

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

ness mentor: he’s already made every mistake in the book, so I can utilize his expertise in steering me away from potential business disasters—like

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

billion-dollar financial scandals, or particularly “creative” bookkeeping practices. Also, as my business mentor—should the need arise, Ken can po

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

nt me in the direction of a good lawyer to get me out of any particularly sticky situations.

Since Ken doesn’t have anything better to do right no

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

w than be my business mentor, I can’t see any reason why he’d decline the request. After all, it’s not like he’ll ever be hired at another company

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

Professional from academic institutions, pharmaceutical industries, health care indust

orth a hill of beans, so be may as well use his spare time to promote entrepreneurship in the global community. By being my business mentor, Ken ca

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

n pay off his debt to society, one lie at a time, all the while keeping me from heading to prison.

So, it’s easy to see why Ken Lay makes the best

.

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

business mentor ever—I don’t even see any other choices. So, over the course of our business mentoring relationship, I’ll expect him to help me wit

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

Companies that provide selfless information through particip

h some creative math, then help me to tuck that creative math away where no pesky FBI agents can find it. Like I said—a true symbiotic relationship

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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