Main Subject - Business

Thinking of the bigger picture, of the success of the organization, this has the potential of being the most important and the most dangerous attribute in this series of Managing Your Team.

Perhaps it's human

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

nature, maybe it's all to do with power and influence - there can be a tendency to accept, without question, statements made by those in a position of power or those we regard as experts in their field.

Within

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

Examples of combination products may in

your organization, you'll know 'the rules'. You'll know what can be said, what can be questioned and who can be questioned. I've been there and have to say that I didn't always get it right.

I can only hope

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

that your organization believes in the real practical value of empowering individuals to develop and add value in an open and structured environment.

Even if it's not, the purpose of this article is to...

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

Ask you, as team leader, to create and maintain the team environment within which openness is encouraged, and all team members feel enabled and safe to question statements made and conclusions reached.

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

Combination pro

Allow them to take a risk

Why is this important?

From the day we discovered the world was round to landing on the moon, from the quill to the laptop - where would be today if nobody question

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

ed, if nobody challenged, if nobody felt enabled to take a risk?

I am not suggesting we create a free for all. The emphasis still needs to be on adhering to the agreed ground rules and following a structured,

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

systematic approach. Having said that, as leaders of our team, we can lead by example - we can get into the habit of presenting facts and supporting data not opinions. We can remind the team how successful we

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

/ they have been by following a behaviour of fact driven, data supported problem solving/decision making.

Give real examples to support argument, especially if you have examples of disastrous outcomes when de

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

cisions were based solely on opinion. This behaviour sets clear expectations in the minds of our team members.

Everyone benefits, you, the team, the organization, the customer.

Why should this behav

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

iour be encouraged?

It's likely some team members will be reluctant to question other team members or authority figures

They may actually think it's rude to do so

Perhaps the presen

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

Following aspects would a

ter is so confident and dominant, this causes the reluctance to question

Team members may believe that they need data before questioning others (is that fact or opinion) - they don't!

Perhap

dd to the challenges in developing combination products:

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

s team members have tried to challenge someone before and the outcome was less than positive or comfortable (I've been here too).

How do we manage this behaviour?

Boring as it may be to some, when

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

the team is in the forming stage, set it as a ground rule that whenever the team leader, a team member, or a guest speaker gives a presentation or simply provides information, all statements are based on fact

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

which is supported by data and not merely someone's educated opinion or hearsay.

Of course there will be times when this is not possible but that's the whole point of encouraging an open approach and a risk-fr

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

ee team environment - bottom line - if there is a lack of data, the statements or decisions can be challenged constructively and through that challenge, the team reaches consensus before moving on.

"Con

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

Professional from academic institutions, pharmaceutical industries, health care indust

structively" means we are challenging the statement in oder to get a positive outcome and not attacking the individual personally, for example...

"If we accept what you have said as feasible, what data can

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

you provide to test it?"

"Tell us how you can prove that those last statements are true"

"That idea sounds really good. Given there is not a lot of supporting data, what can we do to help justif

.

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

y running with it?"

"What data do we need to provide that verifies the conclusions are based on fact and not opinion?"

Note that a lot more information will be forthcoming when we ask open, searchi

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

Companies that provide selfless information through particip

ng questions, for example...

What's the difference between "can you provide data?" and "what data can you provide?"

Managing Your Team (Part 10) will look at Why Assumptions Are Dangerous

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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Venture capital is a possible source of funding for new relatively unproven enterprises that appear to have promising futures. However, such money is often hard to come by.

Does it seem like the road to creating a successful business is filled with roadblocks?

Having formed your Commercial Cleaning Services Company one of the most difficult aspects of running it that you will encounter immediately is in getting your quotes correct. Correct from the point of view of the cleaning company in covering all its costs in doing the clean and making a reasonable profit, whilst pitching it at a level which is still attractive to the potential customer.

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Main Subject - Managing Your Team (Part 9) - Is That a Fact or Just an Opinion?

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