Main Subject - Business

William came back from vacation. He walked into the office and was told that there was an envelope and a silver colored cardboard box on the safe for him. He opened the envelope. It was a form letter con

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

gratulating him on thirty years of service. In the box was an award pin in honor of his thirty years. William’s supervisor just dropped everything off on his way through town, while William was on vacati

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

Examples of combination products may in

n. No personal effort was ever made to thank William for his dedication. No handshake. No phone call. Not even an email.

William took the envelope and box and threw them in the trunk of his car where th

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

ey remain. I asked him why he didn’t take them out. He responded, “I don’t even want to touch them. They make me feel dirty.” William is not a problem employee. He knows his job and has never been counse

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

ed. Each day he comes to work and does his job without supervision. His supervisor works in an office over one hundred miles away. Most companies would be thrilled to have employees that take no supervis

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

Combination pro

on. Many companies recognize that motivated employees are an important part of the work team. Some companies show care and concern for their employees. Some have too many cracks that let recognition oppo

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

rtunities slip through.

The company William works for is not a small company. It’s a national company. You would recognize the name. Recognition can be one of the easiest things to accomplish. It lets p

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

ople know that their work is appreciated. Lack of appreciation is a slap in the face.

William says, “Just when I think I can’t think any less of the company and management, they come up with something n

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

w and my opinion is lowered again.” William didn’t have long to wait – just a couple of months.

On a Wednesday, William reported to work and was told to call about a large luncheon in a nearby city to h

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

onor all employees with thirty years of service. The president of the company was even flying in to speak and honor those dedicated employees. People were coming from hundreds and thousands of miles away

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

Nice. Right? The event obviously took planning and coordination. William was told on Wednesday afternoon. The big deal special luncheon was on Friday, less than two days notice. Somehow, William was ove

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

Following aspects would a

looked . . . again.

William tried to act like the events didn’t bother him and that he wouldn’t have gone even with more notice. In reality, he was depressed. “In my mind I saw the silver package in my

dd to the challenges in developing combination products:

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

trunk and just kept thinking about wasting thirty years of my life,” he confessed.

There is no happy ending to this story. As a matter of fact it got worse. Adding insult to injury, later that day Willi

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

m didn’t collect enough from a sale and finished up with a shortage at the till . . . which he had to pay.

In a USA Today article, A snub really does feel like a kick in the gut, writer Maggie Fo

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

says, “The feeling is familiar to anyone who has been passed over in picking teams or snubbed at a party – a sickening, almost painful feeling in the stomach.” Maggie was writing about social distress.

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

A study has been done with functional magnetic imaging that proves that the brain reacts to rejection and snubbing in the same way it reacts to physical pain. The study was published in the October 2003

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

Professional from academic institutions, pharmaceutical industries, health care indust

ssue of Science.

“A social snub and a big-toe stub can generate a similar response in the brain, suggesting emotional and physical pain are more closely related than was previously thought

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

”
-- Anna Salleh ABC Science Online

While no one in today’s business world condones physical violence, it’s amazing what stress and pain can be inflicted by managers who are ill-equipp

.

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

ed, ill-advised and ill-prepared to deal with social interactions and situations in the workplace. William should have been recognized for his thirty years of service. He wasn’t. He should have received

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

Companies that provide selfless information through particip

ositive reinforcement for his dedicated work. He didn’t. A few kind words could have soothed hurt feelings. Kind words never came. Recognition motivates. Thoughtlessness produces just the opposite affect

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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