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Over the road trucking is a hard, rough existence. The general public just does not understand the reality of the trucking life. People watch as the big rigs pull out onto the road ways and head off to some destination

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

known only to the professional behind the wheel. The life of freedom! No boss looking over your shoulder, and endless hours of traveling the country, enjoying the sightseeing aspect all along the way! The general public could no

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

Examples of combination products may in

be so wrong.

For most of the professionals in OTR truck driving, there is a constant, daily battle to be fought every day, never mind the weeks and sometimes months that go by without seeing their families. Forget about slee

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

ing in your own bed every night or just relaxing and watching a little television. Don’t think about having to eat out every day and showering in a truck stop. Give no thought to the fact that the American trucker runs down the ro

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

d fighting overcrowded streets on very little sleep, and is simply trying to do what we all are attempting to do: make a living.

The general public’s attitude for the most part, is that these trucks are a nuisance. I wish just once,

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

Combination pro

that the truckers would come together and shut down for a week. Let the gasoline supply go dry . . . let the grocery store shelves turn empty . . . let the retail stores have nothing to sell . . . let the restaurants be without food.

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

It would not even have to be a week. Within three to four days the United States of America would look like a third world country. The general public would be crying, “Bring back our truckers!” Fortunately, America’s truckers are

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

too compassionate to allow this to happen, but for them, I wish just once . . .

The saddest part of all, however, is not the ways of the general public. The professionals in the trucking industry come under attack by someone

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

ou would not even consider: their own employer. These are the trucking companies that brutalize these men and women on a daily basis. They will push them to run harder to ge

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

the freight to where it needs to be. And, as the truckers fulfill their duty, they receive no more benefit or compensation for their valiant effort. After running nonstop to make the delivery on time, their employer may now make t

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

em “sit” for two days, thus losing any extra miles they would have received. They are exploited constantly, and these exploitations are hidden in well disguised ad campaigns and perhaps simple bonus programs such as being “awarded”

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

Following aspects would a

ith a company jacket!

Over the road truck driving jobs pay by the mile. The average at present is around .32 cents per mile. If a driver is not moving, they are not making any money. The average pay for an owner operator is

dd to the challenges in developing combination products:

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

roughly .96 cents per mile. Just so the trucking companies know, you cannot make ANY MONEY working for .96 cents per mile! But, then again, they already know this. Truck drivers want to drive. Truck drivers want miles.

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

he #1 exploitation toward truck drivers lies with the trucking companies. They will promise miles, but then never deliver. They will give you just enough miles to keep you hanging on, but that is all the drivers are doing. Thei

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

only concern is the freight. These trucking companies are too ignorant to understand that without the driver, they have no company.

Driver retention is a major problem in trucking today. The average turnover rate today sits

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

at nearly 125%. There is one company that has a driver retention problem of 200%! The intellectuals that run the company can’t figure out why. I can help! Do you want to lower your retention problem? Here is a suggestion for

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

Professional from academic institutions, pharmaceutical industries, health care indust

ou: GIVE THEM MILES! Also, don’t just give them miles, but treat them with respect. Respect . . . another issue. Of course, I understand why the retention problem exist. There is more to the story. Sadly, many drivers are not aw

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

re of the “why.”

These drivers that have chosen truck driving careers take pride in their work and profession. Without them, our country and even the world as we know it, would crash. As you put in your 8-5 job and head home

.

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

for the evening . . . as you wrap up your five-day work week and enjoy your weekend off . . . remember the American trucker that is still out there . . . running . . . getting all of the items delivered, so when you go to the store wi

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

Companies that provide selfless information through particip

h your family, those items will be on the shelves. Because even though the trucking companies continue to exploit their own drivers, these same drivers will still complete their mission. It’s their pride. It’s in their blood

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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An expert commercial banker writes about some of the common issues with borrower who have successful businesses stifling their growth or creating more difficult borrowing positions by seeking to avoid or reduce income taxes.

The 7 most important things you need to know when hiring a bookkeeper, the gatekeeper of your money!

Promotions and advertising are the crucial part that business undertakes. This is the span of time businesses tell whether they were able to successfully introduce their products in the market. It is this period that they can evaluate how good their products had been for their clients.

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