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In the mid 1960's I was working with Post Tension concrete projects in the southeast United States for Noble Concrete, Inc

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

. Many of our large projects would be stressing ring beams for dome concrete buildings. Domes exert a large lateral load

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

Examples of combination products may in

on the walls of the buildings upon which they set. The ring beam is what holds the walls from falling outward from the we

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

ght of the dome.

In concrete construction there is usually a large safety factor built into the construction in the way o

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

extra steel bars. Post Tension concrete is a little different, too much of a good thing can cause trouble.

The design e

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

Combination pro

gineer will note on the plans how much tension is required and suppliers like Noble Concrete would bid on the jobs and the

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

make the shop drawings showing the placement and size of the cables required.

We got the contract of a church dome in Ja

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

ksonville Florida and all was going well. When the concrete had been poured and reached the proper strength I loaded up t

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

e stressing equipment and headed south. Our time on the construction site for a job like this is usually no more than a c

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

uple of days and this one could be completed in less than a day. Of course there is always the problem with the Unions.

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

hey insist on having one of their people do the work. However, they never have anyone trained in this type of work. We g

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

Following aspects would a

ive them a call and they send us a couple of workers, we tell them just to stand there and watch and we complete the job a

dd to the challenges in developing combination products:

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

fast as possible.

We were making our second trip around the ring beam bringing the stress up in stages to prevent damage

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

o the columns. I had planned on connecting to each cable four times during the stressing procedure. Suddenly there was a

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

arge pop and all that I could see were workers scrambling down off the building!

We stopped the stressing and inspected t

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

e columns for cracks. I also climbed to the top of the support for the dome and checked the top of the form. We had rais

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

Professional from academic institutions, pharmaceutical industries, health care indust

d the dome about one inch off the top of the form. The columns were pulled into the point that one of them had cracked!

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

got on the phone to the engineer and asked him what we should do next. His reply was "is it holding up the dome? Then yo

.

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

r job is through." He had over designed the ring beam just as he over designs when using steel bars and if he was aware of

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

Companies that provide selfless information through particip

what would happen, which I doubt, he did not warn us. We relayed the information to the contractor and packed up for home

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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When these events take place and it involves high profile persons, one begins to wonder what on earth makes them do such things. Clearly, it is not because they are not aware of such consequences. And it would not be their lack of intelligence...

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