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The headlines are scary. “Bankruptcy is at all time highs!”

Well, that may be, but you don’t need to be one of those stati

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

stics.

I know your situation might be dire and in some rare cases, bankruptcy may be the only way, but in most cases, it pr

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

Examples of combination products may in

bably is not the answer.

DON’T GET SCARED INTO BANKRUPTCY

The number one reason why people file Chapter 11 is not because

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

hey have to, but because they think there is no alternative, that it’s the only way to escape the pressure and pain of their

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

situation; to eliminate debt.

THERE IS ANOTHER WAY

It’s time to start thinking differently. No, I mean REALLY different.

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

Combination pro

Look, if you are considering filing for bankruptcy and the creditors are breathing down your neck with harassing calls on a

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

regular basis, it’s time for some serious action right?

TAKE CHARGE!

My debt advice to is, don’t get angry, just get serio

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

sly organized and start taking control of the situation. Your absolute top priorities should be the following;

1) Food & w

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

ter (essentials only)
2) Shelter (mortgage or rent)
3) Clothes (the essentials)
4) Utilities (electric

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

ity, phone, etc.)

Everything else is secondary. Come up with a budget, track every dollar, cut all expenses that aren’t in

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

the list above, stop spending on credit. You get the picture, right? This is your own personal debt elimination program.

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

Following aspects would a

f you have to sell stuff, sell stuff. If your situation is bordering on the repo man coming to take your car, big-screen TV

dd to the challenges in developing combination products:

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

or whatever, why don’t YOU sell it and take the proceeds instead.

WORK WITH THEM!

Work with the creditors. Send them a co

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

py of your budget and tell them exactly how much they are going to get. Forget the minimum payments or whatever they tell y

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

u they want. You are going to pay them, BUT ON YOUR TERMS.

Be smart, polite and patient. Don’t be rude or disrespectful.

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

Plan and communicate with them regularly and most will cooperate.

Just be diligent with the money you do have. Cancel the

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

Professional from academic institutions, pharmaceutical industries, health care indust

ell phones, turn off the cable TV, do what needs to be done and you can eventually come out ahead. There’s no quick fix her

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

e, but you can have debt elimination without bankruptcy.

I know it’s tough, but you need to be tougher. Be creative, get a

.

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

vice, take help from others and be realistic. If you have to visit the local food bank or sign up for food stamps, do it.

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

Companies that provide selfless information through particip

won’t lie to you, this road is hard. But the difficulty in the short term is well worth it. Hang in there! YOU CAN DO IT

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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