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Do you know when I heard “Don’t take it personal?” That was the day that I went to a major computer convention and came back to my office in tears. Seeing

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

my misery, my boyfriend, decided to take me to lunch. As I was relating the incident about how I approached a salesman at the convention concerning technic

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

Examples of combination products may in

al product information, and without looking up, he told me to come back tomorrow - with my husband. My boyfriend calmly said those words, “Ah, don’t take it

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

personal!”

How could I not take it personal, after all, I’m an expert in my field and I’m told to bring my husband. I wasn’t even married. Now as my boyfr

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

iend was about to wear his lunch, he asked me a question.

“What can this guy do for your business?”

“I needed some information,” I replied.

"Can you get t

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

Combination pro

hat information from another source?” he inquired.

“Yes, but he didn’t have to be rude to me.” I complained.

“Well you see,” he slowly explained, “there wa

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

nothing in it for him. He’s been at that little booth all week and was probably rude to everyone - soooooo don’t take it personal.”

That little business s

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

ecret was hard for me to learn. The trick is to think of excuses for people. When the computer salesman rolls his eyes as you ask an excellent computer que

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

stion, just think to yourself - he just doesn’t know the answer, poor guy. When you’re trying to get that point across to your co-worker and they have a gla

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

ed look, just think, maybe the baby kept them up all night. Get creative and make up a list of excuses you can laugh at, and then use them.

Sometimes it’s

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

fun to just go along. Once, I was working on a computer at a real estate office. The computer was in the front office just inside the door at the reception

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

Following aspects would a

ist’s desk. The receptionist went down the hall and left me alone in the office. As I was working at the computer, a guy came in followed by a group of pe

dd to the challenges in developing combination products:

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

ple. As he past the desk, he snapped his fingers and ordered coffee to be brought to the boardroom. I started to tell him that I was the computer consulta

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

nt, but didn’t get two words out of my mouth when he barked “Just do as you’re told.” I could have gotten upset, but that day I said to myself “What the hec

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

k? They are paying $55.00 an hour.”

Therefore, I got up went down the hall and found the coffee room. I proceeded to locate a tray and cups, filled about s

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

x cups, found cream and sugar, and started back down the hall. Since I didn’t know where the boardroom was, I had to ask the nearest person and without ques

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

Professional from academic institutions, pharmaceutical industries, health care indust

tion, she pointed the way.

I calmly walked into the room, went to the head of the table where the guy was sitting and served him the first cup of coffee. W

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

ithout looking up, he muttered.

“Thank you.”

“Well that’s probably the most expensive cup of coffee you’ve ever been served.” I replied.

Then he looked u

.

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

and questioned me. “You must be new?”

I smiled and continued. “No, I’m the computer consultant and on the clock at $55.00 an hour.”

I promptly left the r

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

Companies that provide selfless information through particip

oom while the laughter roared on. He didn’t apologize to me until two weeks later, quietly outside in the parking lot.

###

Gina Novelle (copyright 12-2004

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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