Advice You - Business

In corporate life, at least, change is not only the ‘only constant’ but also frequently the bogeyman. You know that it’s necess

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

ary, but (“oh my god!”) how are you going to get people to go along with it, even welcome it? The underlying assumption is that

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

Examples of combination products may in

people are going to resist it. So you design your change management programs with all the necessary touchy-feely content as we

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

ll as the hard systems and physical changes.

However, there are situations where people adapt remarkably quickly, without ‘hel

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

’. For example, when you join a new company, they have a way of doing things that is undoubtedly different from the way you hav

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

Combination pro

e been used to. But what do you do? You do your damnedest to adapt to this ‘alien’ new way of doing things. Whatever thoughts y

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

ou may have had during the first few days about the oddness of the place are very soon displaced in your desire to become a use

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

ful part of your new environment. In the process, you have made all sorts of changes to yourself without pain: you have a cup o

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

coffee at 10, not as soon as you get in to work; you attend meetings that run into lunch, where before you had a strict lunch

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

break; you complete your meeting notes the day of the meeting, instead of the day before the next one. And that’s just the smal

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

l stuff. Now you are working for a new boss, with new colleagues and new people to get to know. This could all happen if you we

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

Following aspects would a

re already an employee and just got ‘reorganised’. In this case would your actions and reactions be the same? Probably not!

So

dd to the challenges in developing combination products:

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

what is the difference that makes change easy in one situation but not in another? Surely it is in the mind of the individual.

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

In one situation they have everything to gain and nothing to lose. In the other they might come out worse off. In the first cas

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

e, they made the decision for themselves and had worked out in advance what it was worth to them. In the second case, the decis

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

ion was made for them and the reasons for the change did not specifically have their personal interest in mind. The instigators

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

Professional from academic institutions, pharmaceutical industries, health care indust

of the change were looking for benefits to the organisation not to individuals. The first is self-centred, the latter is organi

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

sation-centred. Being a cog in the machine is fine when we’re a ‘big wheel’ but not so fine when you are a smaller one that may

.

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

have to whir faster. The fear is not unfounded, either. So often many people involved in corporate change do find themselves n

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

Companies that provide selfless information through particip

ot fitting any more.

The fear of loss is greater than the fear of gain. When there is nothing to lose, change is not a problem

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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Advice You - Change Is Not Always Difficult

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