Answers - Finance

Some time ago I attended a seminar where participants were told to burn some money; a reasonably-sized amount of money. You should have heard the gnawing and gnashin

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

g of teeth in that room! Step right up, folks, and light it on fire. Come on now. It’s only money.

Some people, likely less adept at saving than others, actually ru

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

Examples of combination products may in

hed forward in an attempt to show how money had no hold over them. There was a principle in there somewhere. Not sure what it was.

Others cowered into the corner, r

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

efused to take out their wallets, looking for the exits. It does seem reasonable to me to avoid torching cash. After all, you’ve worked hard for it. Put in years wor

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

h of work and put off many luxuries to accumulate what nest egg you have. Burning it would somehow seem to indicate a crack in the psyche.

But what if I told you th

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

Combination pro

at many people are geared right up to burn tens of thousands of dollars? Oh, they’re not going to march forward to the front of some hotel ballroom and pull out stac

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

s of cash from a briefcase and toss them all onto a controlled, indoor bonfire. Nope. That’s dramatic. Their method is much harder to picture, but let’s try and crea

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

te a vivid picture nonetheless.

Imagine a retired widow or widower. Or, perhaps, a senior single person. A person who is finished working, and has been enjoying the

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

fruits of their savings. They have accumulated several hundred thousand dollars in their RRSP, which has since been transferred to a RRIF. They receive income from t

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

his RRIF. Let’s say it has $400,000 in it.

Like most of us, this person does not want to think about their own demise. Their focus is on their grandchildren, perhap

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

. Hobbies. The garden. Other things. They are, of course, surprised when they die, and even more surprised when they get a box of popcorn and a front row seat for th

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

Following aspects would a

e posthumous show called ‘distribution of your assets’.

Let’s go straight to the grand finale, shall we? In this last part of the show, the contents of the person’s

dd to the challenges in developing combination products:

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

RRIF are put in an over-sized briefcase, sawed in half, and one half is tossed onto the gigantic bonfire known now as the Canada Revenue Agency. Let me explain…

The

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

proceeds of an RRSP or RRIF can roll, tax-free, to a surviving spouse without any tax consequences. In our example, however, there is no spouse to roll the proceeds

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

to. As a result, the full amount of the RRSP or RRIF comes into income in the year of death. What happens when you get a sudden influx of cash? Say, $400,000 worth o

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

f cash? Well, first of all it will put you in the very highest tax bracket. Second, you’re taxed. (Hence the idea of just sawing that over-sized briefcase in half an

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

Professional from academic institutions, pharmaceutical industries, health care indust

tossing one half on the bonfire.)

Not convinced. Okay, forget the bonfire idea. Instead, half of the briefcase contents, $200,000 in our example, are put into a bo

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

x, tied up with a nice red ribbon and hand delivered to … the Prime Minister. Like that better? Hmm.

Well, at least now you know what happens when you die. There’s

.

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

big fire. There’s gnawing and gnashing of teeth. People rushing for exits. And a few, good people, are sitting there calmly because they planned ahead, or had alrea

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

Companies that provide selfless information through particip

dy gone through all of this at some weekend seminar.

Strategies do exist to avoid the erosion (torching) of your assets when you die. Talk to your financial advisor

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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