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The note from the Dean’s Office read – “Please appear at my office at 2:PM – promptly”. It was hand signed, Dean Reppy, Law School.

My face flushed, I felt a knot in my stomach, and coughe

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

d to clear the broken glass from my throat. It was a sure-thing this was not an invitation to be editor of The Law Review.

Two recent exams came back with failing grades. The freshman year

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

Examples of combination products may in

is the hardest, they said. No joke – in college I was a star, here it was impossible to keep up with the daily reading assignments.

The mental movies in my mind’s eye began broadcasting de

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

th-and-destruction. My father freaking-out, mom sobbing in the kitchen.

My fianc?e, she was returning my ring. The climax of my movie was me - sweeping the floor in my dad’s candy factory

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

– for life!

The Meeting

I pushed open the door and sat where he pointed.

“Son, have you considered the plumbing industry? The money is good and you would not be discombobulated by examin

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

Combination pro

ations proving your ineptness.

Would you prefer to resign or wait for the inevitable?”

I heard my voice thunder – “I want another option. There is more to me than two failing tests. Uh, s

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

rry for yelling.”

“Sonny, did you know Albert Einstein said, “Insanity is repeating the same actions, expecting a different result!” You have two-months to finals – what will change?”

I h

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

ard my voice pipe-up, “I am signed up for an advanced speed reading course that will triple my reading speed and double my memory. Evelyn Wood guarantees I will read, comprehend and memoriz

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

three case studies in the time it takes me to half-finish one now.”

“Never heard of her – how long does her witchcraft take?”

“Must be synchronicity – two-months, and my first class sta

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

rts tomorrow night,Dean Reppy. I won’t disappoint you, my family and fianc?e. Did you know that President Kennedy’s White House staff took her course?”

“Nice rebuttal sonny. You are certai

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

you would not rather lay pipe – it is a noble and honorable occupation?”

“Dean Reppy – if I do not ace my finals, I will withdraw from school immediately. I was in the top ten percentile

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

Following aspects would a

at college, give me a last chance.”

He nodded and pointed to his door. Now I had to sign up for that damn speed reading course.

Studying or You Snooze, You Lose.

In the first week I was

dd to the challenges in developing combination products:

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

onvinced that they had stolen my $150 and offered gobbledygook in return. If I was a slow reader before, they taught me to absolutely dread opening a book. I practiced without hope, and I w

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

as not disappointed.

The second week of practice using my peripheral (side) vision, and a pacer to underline the sentences – something strange occurred.

I timed myself reading a law case,

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

finishing it and answering the ten questions, in half the time it ordinarily took. Maybe the improvement was plain old studying – I doubled my daily hours hitting the law books.

I tried it

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

a second time with a Torts textbook. This time I was 55% faster – 450 words per minute instead of 200 wpm, and I got 9 of the 10 questions correct. It got better the following week.

The

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

Professional from academic institutions, pharmaceutical industries, health care indust

inals were a cinch; I aced each and every one of them, with time to spare.

In my senior year came the Bar examination – the whole enchilada for lawyers – it was a like a 3rd grade test to

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

me – passed both halves on the first-crack. Yes, really! Even Dean Reppy smiled and congratulated me.

Endwords

Well, that’s the story Jerry. Oh yeah, soon after graduating I invested and

.

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

became one of Evelyn Wood’s partners. The program graduated two-million, including the White House staffs of four U.S. Presidents – Kennedy, Johnson, Nixon and Carter.

Funny – I never lear

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

Companies that provide selfless information through particip

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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