Advice You - Business

Today I had a long discussion with one of my clients who never managed to write a business plan and use

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

it for control. Why the hack do you do your book keeping when not using it?

I try to convince the guy

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

Examples of combination products may in

now for over a year to come to a meeting and plan his company - a business plan meeting is like playing

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

in the sand box. You build up your plans till you find a way you want your company in one year from no

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

and you document how you will reach this goal.

Because of this "playing" with your company’s numbers

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

Combination pro

you get a better feeling where the money is coming from, which profit centre is bringing you the most p

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

ofit. And you will find the activities that are eating up your profits.

So back to my client - it is n

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

ow over a year ago that I first saw that his profits get less and less. SO I called him and told him it

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

would be necessary to take a look at what he is doing - something is wrong.

But guess what his answer

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

was? "I have no time for such a meeting - there is so much work i have to do in my company"

After a ye

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

r of hard work (he still has so much work) and a year of calling him on a regular basis reminding him a

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

Following aspects would a

nd telling him about his financial key figures- he is deep in debt. And I don't think he will manage to

dd to the challenges in developing combination products:

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

make a turn around.

Now you will ask me “why do you tell me this stuff”

I am always asked the same qu

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

estion by my client: "Why do you tell me about the financial stuff, I have so much work and my revenue

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

s great"

I just want to remind you that revenue isn't the stuff that buys you your house or pays you y

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

our car - it is profit that counts - and you have to take time to do a planning and review of your fina

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

Professional from academic institutions, pharmaceutical industries, health care indust

ce otherwise you may end up in the same situation as my client - working hard every day - and in the en

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

d there is nothing left but a lot of debts.

So take out your time management tool and set an appointme

.

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

t for yourself when you will take your financial statements and review them and write a business plan f

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

Companies that provide selfless information through particip

or the next year. And don't forget to review your plan every 3 months - controlling if you are on track

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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