Subjects - Business

Back when I was a grade school kid, a couple of times each semester the fire alarms, announcing a fired

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

rill, would shriek. We would all jump up from our desks and march, single-file to our appointed spot o

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

Examples of combination products may in

tdoors. The goal of those fire drills was to teach students how to react if a disaster struck; instead

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

f the chaos that would occur when hundreds of kids try to escape from a burning building. A safe, orde

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

ly evacuation would certainly reduce the number of casualties.

In recent years sudden, unforeseen, dis

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

Combination pro

strous events have devastated populations around the globe. Terrorist attacks in New York, London and

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

adrid, tsunami in Asia, and hurricanes along the gulf coast have all cost individuals, businesses, even

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

whole geographic regions dearly.

I’ve seen a number of recommendations to help people prepare for dis

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

sters in various media, but every business has to prepare for a disaster also. If a disaster never hit

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

you, be thankful, but if one does occur the business should be able to reopen afterwards if you have s

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

ent just a little effort on contingency planning.

Naturally your planning should include redundant off

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

Following aspects would a

premises backups of all computer files to insure you will be able to resurrect inventory records, bank

dd to the challenges in developing combination products:

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

ccount records, tax records, accounts receivable, accounts payable, human resources, training manuals,

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

tc. It is also vital to be able to connect with your staff in case of an evacuation or natural disast

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

er. A business that is well prepared for disasters should be able to connect with personnel using mult

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

ple methods – cell phone, land line, email, and all the staff should know how to connect with managemen

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

Professional from academic institutions, pharmaceutical industries, health care indust

so the business is able to continue after order is restored. .

All the above plans are not worth the

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

aper they are printed on unless the disaster plan is updated and practiced regularly, just like those f

.

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

re drills we endured as kids. The fire never hit my school and a hurricane may never hit your business

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

Companies that provide selfless information through particip

but if you have periodic fire drills you will be well prepared and confident the business will survive

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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Subjects - Have Fire-Drills to Survive Chaos

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