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Have you ever sat in a meeting where everyone is busy giving their point of view and trying to prove why they are right? Where no one is actually listening or trying to understand other individuals’ points of view. The alternative meeting format is wh

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

ere everyone listens to and agrees with the meeting leader. No one contributes or adds ideas, they are just compliant.

In my experience most meeting are either one or the other. But when you think about it, what is the point of most meetings? Meeting

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

Examples of combination products may in

s are usually held to make decisions. The outcome that most people would want from the meeting is that the BEST decision is made, not that any decision is made, or another sub-committee is formed but that a decision that delivers results is made. Then

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

we move on.

So as we hustle from meeting to meeting being very busy, achieving nothing in the way of measurable results, we land up with yet another sub-committee. All because we have lost the art of dialogue. So, the question is; what is the differ

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

ence between dialogue and discussion?

DISCUSSION – Discussion is the way that most people communicate. During discussion we present our ideas and everyone analyzes and dissects them from their different points of view. The purpose of discussio

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

Combination pro

n, though, it to make sure you win, or that your point of view is the one that is accepted. During the discussion you will support your idea and give your points more strongly until, eventually, others agree with you. You want to prove that you are ri

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

ght, and the most knowledgeable, as does everyone else in the discussion. Great! With everyone trying to win the argument, no decision is ever made and we eventually need to form a sub-committee to decide. Or the CEO, or team leader, uses his or her d

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

ivine autocratic right and decides for the team.

DIALOGUE – Dialogue on the other hand is an exploration of ideas. It is not a new form of communication but is the way the ancient Greeks and many so called ‘primitive’ societies are seen to exp

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

lore ideas. During dialogue everyone works together contributing towards the idea. Remember the team is greater than the sum of the parts; therefore more is achieved from the dialogue as each person’s ideas add to the last. In a dialogue no one is try

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

ing to win. They are trying to learn and create. They suspend their individual assumptions and explore ideas and issues. It is a free flow of ideas where participants continue to think and watch themselves think. The great physicists Heisenberg, Pauli

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

, Einstein and Bohr described the conversations they had with each other. As we know from history their conversations (dialogue) changed traditional physics because what they could achieve as a group exceeded what each could do as individuals. Interes

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

Following aspects would a

ting? So who is ‘primitive’ now?

How do you get your team to dialogue? There are 3 conditions needed:

Everyone must suspend their assumptions. Dialogue comes to a grinding halt when someone digs in their heels and says “this is the way”. They n

dd to the challenges in developing combination products:

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

eed to suspend their assumptions to really see where the truth lies. Suspending ones assumptions is not easy, as often they are so deep seated that we don’t even know that they are assumptions! Instead, we take them for being the truth.

Tea

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

m members must be thought of as colleagues and equals. If you manage to think of others as colleagues you will interact as colleagues. Team members will feel less vulnerable and less likely to either want to dominate the discussion or not say anything

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

at all. Thinking of everyone as colleagues can be difficult in a hierarchical workplace environment. Can an individual in authority come down from their lofty position and talk to everyone else as an equal or do they like their elevated position and

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

pontificate wildly?

There should be a facilitator. A facilitator can help ensure that ALL assumptions are suspended. This means questioning statements and beliefs as they are mentioned. They are also important in keeping the dialogue moving

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

Professional from academic institutions, pharmaceutical industries, health care indust

. As a team gets better at dialogue the needs for a facilitator is reduced.

You are closer to achieving dialogue when your team meetings are filled with questions. Questions indicate an attempt at understanding. Sit back in your next meeting and

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

see how often a question is asked. No questions = no dialogue.

Teams can enter dialogue if everyone knows what is expected of them in advance and if they truly want the results created through dialogue. Dialogue is playful conversation and everyone

.

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

must be willing to play with new ideas. Who says you can’t have fun and grow at the same time?

I hope you can achieve dialogue in your teams. Since we became aware of the difference and have been trying to practice dialogue we have really had some am

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

Companies that provide selfless information through particip

azing insights into our business and what we do. We have achieved a whole level of new understandings.

Who knows, maybe there is something amazing that your company could achieve if you all just put your heads together. 1 + 1 = 3 makes a lot of sense

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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