Main Subject - Business

If asked to look at your work calendar for the week, the odds are pretty good that you have a few if not several meetings already scheduled. Now, if asked how you feel about attending some of those meetings, the

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

odds are even better that you may either roll your eyes, groan or mutter something under your breath. Sound familiar so far? Okay, that was the easy part.

Coming from a background of 20 years in the corporate

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

Examples of combination products may in

world, I can readily identify with attending a surplus of meetings. Additionally, I know all too well how employees come to "dread" going to meetings and clearly I fell into that category as well. But now in ret

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

rospect, I've come to learn a few things, as we often do once we step back and reflect. After reading this article, you'll have a better understanding of what causes meetings to break down-- (S.N.I.P.P.Y) syndro

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

me and an alternative (C.L.E.A.R. V.I.E.W.).

See if you can relate to any of the following statements:

1. Look, I've invested a lot of time on this idea and
if we can't move on it, I'll have wasted my

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

Combination pro

time.          Self-serving

2. We never get anything done in this meeting, anyway.   Negativity

3. We have to enforce this policy so people know right
    fr

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

om wrong. Insisting

4. Can you believe how domineering she is in th

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

ese
meetings--who hired her, anyway? Provoking

5. Given our roles in the company, I think it's obvious
that I shou

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

ld make the final decision. Power driven

6. If you would let others speak once in a while, it would
be helpful.

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

You statement

As human beings, it's easy for all of us to fall into any of these behaviors from time to t

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

ime. What's more problematic however, is being unaware of our behavior and the effect we have on others in the workplace. As we know, like the "common cold," our attitudes can be contagious. The reason for this

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

Following aspects would a

is something called the interaction cycle. The interaction cycle addresses how we interact with others and this impacts the quality of our relationships.

The key components of the interaction cycle inclu

dd to the challenges in developing combination products:

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

de:

a. Values/Expectations/Mindset: these form our initial impressions.
b. Selective Perception: a filtering function that only lets in what matches our initial impressions.
c. Fe

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

elings: a range of negative to positive thoughts triggered by our perceptions.
d. Action: our feelings ultimately influence our behaviors.
e. Reaction: others respond to us by the w

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

ay we act, so their behavior is in fact the result of what we send out.

What we know then is that behavior breeds behavior. Now, it's starting to make some sense as to why we and others act as we do. But,

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

the more critical issue is figuring out what can be done.

This brings us to a C.L.E.A.R. V.I.E.W. which is as follows:

C = Concentrate on the listener
L = Listen with the goal of und

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

Professional from academic institutions, pharmaceutical industries, health care indust

erstanding
E = Eliminate judgmental attitudes
A = Actively listen (paraphrase what you believe someone said)
R = Respect differences
V = Value input offered by oth

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

ers
I = I messages (describing someone's behavior and its effect on you)
E = Encourage participation from others
W = Work towards agreement (build on what others say and the

.

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

n add your input)

Wouldn't you rather have a C.L.E.A.R. V.I.E.W. than the S.N.I.P.P.Y. syndrome? Change is a gradual process; however with increased insight and the right tools, w

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

Companies that provide selfless information through particip

e can all make a contribution towards constructive group dynamics. After all, why dread something that we could ultimately look forward to?

Contact information: www.speech-matters.com; dale@speech-matters.com

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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Having the appropriate skill sets is not sufficient until and unless a person has the pre-interview preparation. IT is necessary to have an idea about the type of questions that may arise and the answer to the same should be a heart winning one and not merely blame or highlight a problem.

In the World of Franchising every thing must be documented as the relationships could go South and turn into litigation. It has not always been this way, however due to the number of attorneys trying to scrap the creme off the money flows in the industry it has become a constant legal game.

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Main Subject - Constructive Group Dynamics: How to Go from the S.N.I.P.P.Y. Syndrome to a C.L.E.A.R. V.I.E.W.

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