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It's not the first time I have been facilitating a workshop or group session and as early as the first break, other members of the group have asked me to deal with someone who is dominat

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

ing the session.

How often have you been in a similar team setting and said to yourself...

"Why don't they shut up for 5 minutes? They're talking through a hole in their whatsit!"

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

Examples of combination products may in

What can make the situation worse? Those that just love to hear themselves talk...

Quite often are only repeating what someone else has said.

May not have the authority

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

to speak.

May not have the expertise or any experience in the particular subject.

Even when not talking, are not listening - they are too busy thinking about what to sa

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

Will inhibit other team members from participating

Whatever you do don't stop for breath. The slightest pause, even natural quiet times that occur in meetings are reg

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

Combination pro

arded as opportunities for the dominating team member to talk some more.

Seriously, these situations can be tricky. We want the whole team or group to participate in a balanced<

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

/b> (not necessarily equal) way.

Moreover, depending on the team session, or team project, some team members may have more experience and expertise than others and we may need to depend on

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

their expertise to move forward.

This dependency in itself can lead to another type of challenge which is covered in Managing Your Team (Part 4).

Leaving this dominating is

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

ue unresolved can definitely harm the overall effectiveness of the team. Over time, other participants will either attend team sessions reluctantly or find a "very good reason" not to atte

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 at all. This will greatly damage the sense of team worth and teamwork.

What can make it tricky is that we want to deal with this without alienating the dominating participant -

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

they are a member of the team and still have a valid and valued contribution to make to the overall success of the team and, therefore, their participation still needs to be encouraged.

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

Following aspects would a

>So, how do we lead dominating team members?

If it's a team meeting, group session, or project meeting for example, give everyone a chance to prepare. Using meeting managem

dd to the challenges in developing combination products:

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

nt best practice, all participants are given the agenda in advance, asked to prepare their inputs depending on the subject matter. Team members will all also note that each of them have be

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

en given a certain time slot and a certain amount of time to give their inputs. It's up to the team leader or facilitator to ensure the agenda is adhered to. We all do that anyway, rig

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

ht?

Play to their strengths. Recognise that a team member may have more experience and expertise than others and their inputs are valued but also emphasise that all team inpu

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

ts are important.

We discussed "reluctant" participants in Managing Your Team (Part 2). So, without pointing the finger at "dominating" participants, it could be worthwhile runni

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

Professional from academic institutions, pharmaceutical industries, health care indust

g a team session which specifically discusses team participation, balance of participation, reaching consensus on the 'rules'.

For those of you unfamiliar with the term gatekee

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

ping, as team leader it well within your power to address the issue in situ by, for example, thanking the dominating team member for their contribution and emphasising that you w

.

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

ould like to get inputs from other team members.

Use one of my preferred techniques - Brainstorming or another where you get members to write down their ideas, say top three, and

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

Companies that provide selfless information through particip

then in a structured way, invite each team member to share their ideas with the rest of the team.

Managing Your Team (Part 4) will look at Disproportionate Amount of Influence

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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