Main Subject - Business

The challenge of managing difficult managers can be rather daunting, especially when you inherit them! If they are your own born and bred, then hopefully they would have evolved in

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

to great managers!

Experience shows that difficult managers are difficult because they are angry and frustrated about something or somebody (even themselves - especially whe

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

Examples of combination products may in

e they are, or have become, a square peg in a round hole of a job), so the steps to take are these:-

Always a first is to build great relationships with your people. T

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

is involves protected one-to-one time, where they feel valued. Get to know them. 'Getting to know the name of their dog' has a good feel to it! Get them talking about anything and

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

verything that is important to them - this deflects the 'difficult' bit and creates a common place for you to communicate. It also builds all those things like trust and valued-nes

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

Combination pro

etc.

Get really clear on standards for all of your managers and get them involved in the process. Itinerant trouble-makers usually fall in if the majority do. Do the sa

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

me with personal objectives based on their best skillset, not their worst. It's easier to get success from things folks are good at then waste energy on things that are very tough

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

or them (in fact, frankly, they are in the wrong job).

Ensure that everyone complies with these standards consistently and fairly and be flexible if they don't work. It'

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

OK to be a bit tolerant, though only in the 'how' things are delivered as long as the outcome (the 'what') really happens.

If these measures don't work, it's time to ge

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

emotional (no. not tears!). The phrase, 'I need your help...' is a great way to go - as is 'I wanted to tell you how I felt after...'. Both are EQ dialogue, aimed to find out what

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

s wrong and how you can help. If the push back is to 'stop hassling them', then the groundwork you did with the standards proves it's worth.

After the discussion above,

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

Following aspects would a

is the 'escalation'. Most people actually want to feel that they are doing a good job - and if they can't, it's time to get a life and move on. This tough discussion will be a lot

dd to the challenges in developing combination products:

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

asier if you've followed the previous steps and it will also mean that you are more protected against criticism. So now is the time to get tough with whatever formal procedures you

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

organisation has. In different countries this will vary, but it requires tenacity and consistency on your part. But, what usually happens, is that folks realise you are serious an

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

move on themselves.

If they are resilient, go down your formal disciplinary route carefully, but do it! There is a moment when you can say, 'This isn't going to get any

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

easier, how can I help you resolve this...?' Be firm. clear, fair, resilient, tenacious and ultimately realise that their behaviours are where they are going wrong, not them as peo

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

Professional from academic institutions, pharmaceutical industries, health care indust

ple. Truthfully, you are doing them a big favour - one which others may well have not been prepared to take on - and that did these people a disservice.

Goodness knows

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

hat some folks have experienced in their lives before they got to us - some are redeemable, some are not - sadly, that's life and we can't be responsible for anyone else, after all

.

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

it's tough enough being responsible for ourselves. And difficult managers are ultimately no different than anyone else - so this can be used elsewhere.

This is do-able and

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

Companies that provide selfless information through particip

you will benefit from the experience (though some days you might curse a bit!). You deserve the peace of being able to work constructively with all of your people, whoever they are

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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It’s okay to take your job seriously, to be a stickler for professionalism, and sure it’s wonderful to take your responsibilities seriously. However, you have to be a bit careful when you allow your job to become your LIFE...

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