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Recently my wife and I went to pay a visit to our Financial Planner. We scheduled

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

the meeting to in order to get a detailed picture of our financial situation. We w

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

Examples of combination products may in

ent into the meeting with our financial records and excitement. After he asked a n

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

mber of questions about our assests, our professions, salaries, plans, etc. he fou

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

nd that we could combine our debts into a nice Mortage Equity Loan. Then he crunch

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

Combination pro

d the numbers and spun off some facts and figures.

At one point in the conversati

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

on he actually said and I quote "we're practically giving money after." This is wh

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

re I started to get an uneasy feeling. Then he went on to compliment my wife telli

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

ng her that she looks like Nicole Kidman. I was not too pleased because well she w

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

s still blushing, and he was eager to get us to start filling out the loan applica

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

tion. I told him that we will think about it and get back to him.

After the 1 hou

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

Following aspects would a

r meeting, I found myself not trusting our financial advisor, because although the

dd to the challenges in developing combination products:

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

plan to combine our debts (- school loan, parent's loan, and mortgage) it would be

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

a poor choice at this time. He wanted to take our equity and increase the amount

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

f time we would be paying off debt. He told us - don't pay off your debts, you're

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

gonna need that money, instead get another loan to combine your debt into one paym

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

Professional from academic institutions, pharmaceutical industries, health care indust

nt.

Basically this deal is good for the bank and not good for us, so we've decide

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

d not to take his advice at this time. This brings me to my original question- Who

.

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

can you trust with your money? How do you know which CPA are really working for yo

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

Companies that provide selfless information through particip

ur best interest, versus working for their own best interest, they are in business

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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