Digg It - Business

As a freshly promoted sergeant in the British Army, I was thoroughly enjoying the status and perceived power of my new position. Part of my job was to conduct the morning parade at which I had to inspect the junior soldiers to make sure that they were &

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

ldquo;All Present & Correct”, (clean uniforms, shiny boots, faces freshly shaved and hair well trimmed.)

In those days the regulations stated that a beret had to be worn tilted to the right and with the cap badge directly over the left eye. 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

e young Private, lets call him Smith, enjoyed looking 'cool', by wearing the badge in the middle of his forehead, and with both sides of the beret tilted. After having corrected this several times, I started to get a bit annoyed. He would turn up wearin

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

it correctly, but as soon as the parade was over, he would re-adjust it to his own style. This irked me tremendously, and I became determined to teach him a lesson. I ordered him to wear his steel battle helmet instead of the beret. This of course caus

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 him to be ridiculed by his peers, but I was absolutely sure that I was “doing the right thing”.

For whatever reason, this soldier must have been just as determined as me, and at every opportunity, he would revert to his favourite style, a

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

Combination pro

d the war of wills continued. The crunch came one day when I sent a Lance Corporal to bring Private Smith to the guardroom where I was on duty. The corporal came back with the message that Smith “would be down later”. Feeling that my authori

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

y was being challenged, I re-dispatched the corporal, with two other soldiers, to bring the Private to me “under escort”, and immediately.

When they returned soon afterwards, I stood Smith rigidly to attention and gave him the biggest dress

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

ng-down imaginable. I verbally assaulted him by ranting and raving about how useless he was, what a waste of space and so on. I was so intent on making sure that Smith learned his lesson, and so certain of my own Rightness, that I forgot that here stood

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

another human being. Eventually I paused and looked more closely at the man. And there, while he stood stiff as a pole, trickling down his cheek was the saddest little tear that I have ever seen.

In those days incidents of this type were not uncommon,

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

nd were often used to effect “good order and discipline”. Thirty years on I can now say that the person who learned most from the episode was me.

During my later years in industry I haven’t seen a conflict quite so dramatic or one sid

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

d. I have certainly witnessed hundreds of examples of similar polarisation however, where both parties dig deeper in to their respective positions. This has often been to the detriment of not only themselves, but the environment in which they work. Pola

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

Following aspects would a

isation can start with a simple difference of opinion, leading to a perceived insult. Resentment can build, and the virus can spread. Other people can become involved, and before long the rivalry has poisoned the whole workplace. Sometimes “it&rdq

dd to the challenges in developing combination products:

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

o; is ignored, and lies festering just below the surface. Work proceeds ‘as normal’ but tasks are carried out unwillingly and without enthusiasm. Once again, the whole workplace can become infected. When this atmosphere is detected by custom

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

rs, trade drops off and pressure increases as fear of layoffs emerges. The downward spiral continues as this dry rot eats away at morale. The go-getters find employment elsewhere, and those who stay feel trapped in an environment that they have come to

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

oathe.

Prevention is better than cure is the old adage. How much better would it be to nip this dry rot in the bud, before it really takes a grip? Can it be done? The answer is a resounding YES.

The whole idea of Management has become subject to some

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

ntense scrutiny over the last few years and the notion of Leadership has emerged to take its place. Traditionally management has been about task allocation with minimal input from the person actually doing the job. “Fix this” or “Proce

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

Professional from academic institutions, pharmaceutical industries, health care indust

s that” and “Come back when you’ve finished”. Leadership on the other hand tends to be more like “This is what needs fixing, how do you propose to go about it?” People nowadays seem to have an innate aversion to being

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

managed, but they don’t mind so much being led.

If you see yourself as a Manager, with all the implications and trappings of POWER, perhaps you should ask yourself how your subordinates see you. When you allocate a task to a staff member, does he

.

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

leap to it immediately with zeal and enthusiasm? Or with a grunt of acquiescence? How does he like to be ‘Managed’? To help with your answer, how do YOU like to be ‘Managed’?

So how does Leadership help prevent the dry rot previ

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

Companies that provide selfless information through particip

usly mentioned? There is enough evidence around now to indicate that where a worker has been involved in the initial planning of the task, and helped to define the Goal, he is more inclined to OWN the job, and carry it out with greater conscientiousness

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.diggit.org.ua/article/45623/diggit-Empower-or-Overpower.html">Empower or Overpower?</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/45623/diggit-Empower-or-Overpower.html]Empower or Overpower?[/url]

Success as an event and meeting professional has never been more challenging, due to increasing competition and higher demands to meet business objectives. If you feel a little overwhelmed, you’re not alone. Merely projecting a veneer of confidence isn’t an option. So what can you do?

Everyone is talking about small businesses. In 1993, when it was allowed, more than 90,000 new firms were registered by individuals. Now, less than three years later, official figures show that only ...

Tags

Links

Digg It - Empower or Overpower?

Related Articles: