Top Adding - Computers and Technology

All responsible businesses today protect themselves from financial disasters via insurance policies structured to recoup loss of revenue should the unexpected occur. But an

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

insurance policy can’t restore lost customer and other business data, and that’s often the most expensive loss of all.

A couple of years ago, when a business acquaintance fi

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

Examples of combination products may in

st told me about his company’s decision to switch from media-based data storage (tapes, CDs, zip drives) to utilizing the services of an online data backup company, the first

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

thing that came to mind was a nightmare that had occurred in my business back in the mid- to late 80s. “Disaster” was definitely the word for it – and our protection against

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

the fallout from it was practically non-existent.

Sometime after the end of business on a Friday, some pipes burst in the suite of offices right above ours. Throughout the

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

Combination pro

eekend, untold gallons of water crashed through the ceiling unrestrained and uncontrolled, so that by Monday morning it looked as if a tidal wave had washed us. Unexpected,

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

o say the least, on the 14th floor of a building in the middle of town.

As is the case with most executives it was my habit to be the early bird to the office, and the sight

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

that greeted me when I unlocked the door is forever burned into my brain. Our carpet was soaked through with three to four inches of water. Our furniture was all but floati

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

g through our suites – and even the pieces that remained stationary were soaked through and ruined. All the phone lines were shorted out. And I didn’t dare flip any light s

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

itches….

Worst of all, though, was what I saw when I went to inspect our small, fledgling IT area. Absolutely everything in the room was thoroughly drenched and dripping wa

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

er, from our server to the file cabinets housing tape backups to the PCs on the desks. We had, just several months prior, begun the arduous task of moving our client and oth

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

Following aspects would a

er business data from hard copies onto an electronic storage system – and I can still hear the one word that echoed in my head as I surveyed the damage: Gone.

Our insurance

dd to the challenges in developing combination products:

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

olicy covered the financial losses – but nothing could reimburse us for or replace the staggering amount of vital data lost to the flood. Because this was in the 80s and IT

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

departments were just beginning to be considered in small businesses, the learning curve was steep and expensive when anything out of the ordinary happened. Online data stor

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

ge services didn’t even exist in those days. Our entire repository of crucial data had been on those tapes and on that server – and we lost almost all of it.

The first less

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

n my company learned from our flood was that we needed physical, off-site storage for our organizational and customer data. That’s how we handled backup and storage for many

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

Professional from academic institutions, pharmaceutical industries, health care indust

years following that event – but while that was a great deal safer than storing our data on-site, there was nothing to guarantee our storage site wouldn’t ever experience suc

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

an unexpected disaster, as well.

I never once fully stopped worrying about it – until I learned about online data storage and backup services. Today, my company utilizes b

.

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

th an on-site tape backup and the services of a remote, online backup system. Our in-house tapes are mostly used for monthly backups (thus saving wear and tear on the tapes a

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

Companies that provide selfless information through particip

d maintenance on the hardware) and we use an online data and storage service for daily data backups. We’re fully covered, now – and our data is as safe as it possibly can be

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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