Digg It - Business

A man is driving his sports car along his favorite winding road on a beautiful autumn day. He’s enjoying the colorful scenery and the exhilaration of the wind on his face. The car is a fine piece of machine

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

ry as it handles the bends and curves like slot car on a track. His Z3…red is his pride, and it is his joy.

The day is, well, perfect. All of a sudden around the bend coming at him is a Volvo. The driver i

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

Examples of combination products may in

clearly upset with a frustrated look on her face and is even more surprised by the man in his car she now needs to avoid. As she passes by the man she maintains her lane and shouts out to the man, “Pig!”

I

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

n his anger and disbelief the man does a hazardous U-turn and catches up to the woman. He pulls up along side her and yells at the top of his lungs, “Cow!”

Extremely satisfied with himself he turns the car

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

round and resumes his leisurely drive and as he rounds the bend sure enough he hits the pig. Another version of this story has him rounding the bend and sure enough there is a policeman and he gets pulled ov

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

Combination pro

r for speeding, but we found that version a bit disrespectful.

Of course the moral of this story has to deal with how help can and is often perceived as threatening. The woman was doing everything she could

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

under the circumstances and the man took it as an attack on him.

Once while golfing I remember a golfer behind us yelling and waiving a club. “I hate being pushed” I said, “We’re maintaining a good pace”.

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

So I shout back, “Relax, we are playing as fast as we can…just chill out!” When we made the turn he approached us and I was preparing for a verbal confrontation. Imagine my embarrassment when he gave me bac

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

k my 7 iron I left back on the sixth fairway.

Why do we sometimes think the worst in folks when they may be trying to lend assistance? In both of these scenarios there is a direct correlation to the uncerta

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

nty of a situation and how our misunderstandings impact trust or the lack thereof. The driver was uncertain as to why the woman would say such a thing and I was uncertain as to why these guys were shouting a

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

us on a golf course. Distrust is a direct result of uncertainty.

Let us take this subject to a plain higher. Direct feedback is also one of those perceived threatening things and conflict is a form of dir

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

Following aspects would a

ect feedback. Unfortunately everyone thinks conflict is a nasty word. It’s not; at least it doesn’t have to be.

The fact that we disagree with one another, even for a split second, makes us think different

dd to the challenges in developing combination products:

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

y about our position, even if we still strongly disagree. Open disagreement in team meetings is how we are able to get many points of view on a subject. Unfiltered and passionate dialogue provides construct

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

ive sessions in which teams air different points of view. Healthy means passionate, yet respectful. These dialogues must remain professional and not get personal.

So what happens when I push back a bit, pa

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

sionately state my point of view and still my ideas are not being used? What a waste of time, right? Wrong! Just because we are heard doesn’t guarantee our ideas and thoughts will be used. In fact they oft

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 are not. We sometimes find that we strongly disagree with the decision being made and you know what…that’s alright too.

We don’t have to agree but we do need to be on board. Once we leave that conference

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

Professional from academic institutions, pharmaceutical industries, health care indust

room all of our actions, decisions and behaviors need to be in alignment with those decisions. We don’t have to agree, but we do have to commit. It is this lack of commitment that impacts the way we hold t

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

ams and team members accountable.

In closing we need to come back full circle. So, why don’t teams have passionate debate in meetings? It’s a lack of trust. Trust that we can be unguarded in our thoughts,

.

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

opinions and positions. We are creating a culture of “bobble heads” and we are taking part in “bobble head” meetings. And this is why most of us hate going to meetings. There’s no excitement and very litt

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

Companies that provide selfless information through particip

e interest unfortunately.

We can sit through a three hour movie, but we can’t stand the thought of another 30-60 minute meeting. Why? What is it that every movie has in common? It’s an element of conflict

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/45734/diggit-The-Man-The-Woman-and-The-Pig.html">The Man, The Woman, and The Pig</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/45734/diggit-The-Man-The-Woman-and-The-Pig.html]The Man, The Woman, and The Pig[/url]

What was the recipe for success that global companies used to get where they are today? When you go and buy a product that is globally known, do you ever stop to think that the company was once a small business operated by someone looking to make a difference, like you?

A logo design, commonly known as a logo, is the graphic element of a trademark or brand, set in a special font or arranged in a particular but legible way. The color, shape, typeface, etc. of a logo should be distinctly different from others on the market. It is a graphic representation symbolizing one’s organization. It is designed for instant identification and can appear on company letterhead and advertising material, and is a way an organization can easily be recognized.

Are leadership skills all that important in order to grow your Career? Not only are they important, but in most cases they are crucial. Organizations require three competencies in order to survive and go on to thrive - they are a reason for existing, a means of administrating itself, and leadership. Without leadership your team will be without direction - and so will your career.

Tags

Links

Digg It - The Man, The Woman, and The Pig

Related Articles: