Useful Advices - Business

Who is ‘they' in your organisation? Sales? Marketing? the Executive Board, Customers? Do ‘they' ever seem to be making your job harder to do? Do you ever hear stuff like (or catch yourself saying): "this job would be fine if it wasn't fo

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

r ‘them'!", "nobody tells me anything", "they move the goalposts all the time"?

It seems that we often fall into the trap of creating a ‘them' and an ‘us' - a ‘silo' mindset. It can kick in surprisingly fast! We have seen organisations

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

Examples of combination products may in

f twenty or so people who have divided themselves up into different functional groups, where ‘Sales' complain about ‘Operations', ‘Marketing' finger points at ‘Sales', the ‘staff' are suspicious of ‘management' - and everybody sits in th

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

e same room!

This mentality is caused by individuals' and groups' perceptions of each other - ‘them' - that over time start to appear to be the truth. Let's take a look at what's going on from some different angles:

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

rong>Who's in Your Team?

Who in your daily working life shares with you a commitment to your organisation's success? When you really think about it, do you share a common interest with ‘Sales'? Absolutely - admi

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

Combination pro

it! With ‘Marketing'? For certain. Your Customers? Yes, if your product or service adds value and meets their needs. Your suppliers? Almost certainly. Your competitors - aha! Possibly not. Here you just might meet some

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

one who does not have your best interests and those of your organisation at heart - though even here you may know of a few stories where competitors have a shared commitment in a joint venture.

Challenge yourself and those you hear talk

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

ng around you. It can't really be the case that all those departments, divisions, individuals and groups actually want the organisation to fold and you to fail! Something else must be going on.

What Motivates ‘

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

Them'?

Do you come to work to do a poor job, miss your targets, and make others' life difficult? Of course you don't. Why then would you ever assume, or allow others to assume that anyone else would? In our experience

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

he vast majority of people in responsible jobs are deeply committed to doing the best job they can every day.

To assume that anyone on your team (see 1 above for who is on your team!) would ever by deliberate action or conscious inactio

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

make your job harder and jeopardise the success of the organisation, is to show a deep lack of respect for that person. They feel that they are doing their very best to do a good job. If the results of their efforts don't work

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

Following aspects would a

for you, guess who is responsible for raising the issue and resolving it? A hint: it's not ‘them'!

How can I Sort it Out?

First, explore the questions in 1 and 2 above. It is best to get help from a coach or objective

dd to the challenges in developing combination products:

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

utsider: you are part of the problem and this bit can be like trying to do brain surgery on yourself!

Now you have an opportunity to resolve some issues and clear up the misunderstandings. Here's where to start:

Identify the ke

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

y player(s) and sit down face to face and talk

Take full responsibility for your past attitude to them and their contribution

Allow them to do the same in return - and listen without defending yourself

Have a g

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

od laugh together about the absurdity of it all!

Acknowledge them for their commitment to doing a good job and make it clear that you respect that they are doing it in good faith

Explain the impact of their actions 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

ecisions on you and allow them to explain why they do what they do - without arguing or defending your corner

Work together as equal partners to find a solution that works for both parties. You may not sort out

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

Professional from academic institutions, pharmaceutical industries, health care indust

the whole issue straight away, so make a commitment to keep meeting and chipping away at it until you have a solution which works for both of youYou'll need patience. It takes time to undo the habits of a lifetime and to resol

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

e problems which may have built up over months or even years. It takes time and creativity to build bridges and create trust especially when new processes and agreements don't immediately work perfectly. We're not talking here about ‘tro

.

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

ubleshooting'; we're talking about the conscious, complex and skilful process of making an organisation really work. It's about people working together in mutual respect to ensure that each gets a solution that works not only for his or

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

Companies that provide selfless information through particip

er own interests or group, but for the other individuals or groups as well. It's what we'd call partnership, and in true partnership, there is no ‘them'

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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A perfect combination of science and business in a single career is a pharmaceutical sales job. Let's say that you have a science background but want to get more into the business world with dollars and cents rather than microscopes and labs. Or let's say you have a business background but are completely fascinated with the science, particularly the medical healthcare world. Well, a great way to combine science and business is to work as a pharmaceutical sales representative...

English and French are at odds with each other again! EU official logo is chosen for the 50th anniversary of the Treaty of Rome and it is in English.

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Useful Advices - Are They With You or Against You?

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