Advice You - Business

You settle down to watch the movie. Aliens have landed – everybody panics and waits for the hero to arrive with a plan to save the planet. Until someone screams, “But

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

he’s on annual leave this week!” We all hope that somebody, somewhere will take care of whatever disasters affect our workplace – fire, flood, burglary etc. Somebody, somewh

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

Examples of combination products may in

ere must be getting paid to sort all that out, right? Well hopefully. But you too have a big part to play.

If someone in your business is working on a business cont

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

inuity plan they will have started by identifying what the biggest threats are to the most important things the business does. For example if the main building is getting old

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

and prone to power cuts, leaks etc but also happens to house the reception desk, the team that organises customer deliveries and the payroll people…well, there better be a p

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

Combination pro

lan. The continuity planner will go through the options:

Buy a new building
Renovate the old building
Separate critical teams out into differen

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

t buildings

Have an alternate location where teams can work if something goes wrong

All of the above will have cost and hassle implications. But here’s

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

where you come in. There may well be a plan out there that says in certain circumstances you need to work from home or in another building miles away. The important thing is

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

that you are aware of your role in the business continuity plan. That you know what to do – even if it’s just wait at home until your manager contacts you. (This assumes your

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

manager has your up to date contact details and this little bit is an important part of business continuity planning.)

Planning for and dealing with emergencies is difficul

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

t for two reasons:

#1. “Sods law” This states that when something goes wrong it will be in the early hours of a Sunday morning or that the person who could most easily fix i

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

Following aspects would a

t will be on holiday.

#2.Secondly, emergencies always have unexpected knock-on effects. (eg. vandals start a fire so the police close off the road. The fire brigade arrive b

dd to the challenges in developing combination products:

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

ut can’t get through the security gates because the manager with the keys is stuck in traffic - because the road has been closed off..etc etc)

Again here is where you come i

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

n. The planners and heads of departments can see the big picture, how teams and departments link together across the business. What they don’t have is knowledge of the detail

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

Why some equipment really is essential and others not, why trying to do something at a different time or in a different place simply would not work. They need advice from st

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

aff that do the job about what will work. So raise any concerns you have about potential threats and look for holes in the business continuity plans.

Another crucial area bu

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

Professional from academic institutions, pharmaceutical industries, health care indust

t one which is easy to overlook is dependence on suppliers and subcontractors. It is not good enough to tell angry customers “well it was contracted out to them and they let

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

us down”. The business needs to know that suppliers and contractors have continuity arrangements. Again it is you who has the day to day experience of dealing with external p

.

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

roviders and you know how well they cope when something goes wrong at their end.

So at work tomorrow find out about the business continuity plan. Ensure you know what part y

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

Companies that provide selfless information through particip

ou need to play and check whether you think the plans will actually work. (Unless the Earth really is destroyed by an alien space fleet which means you can have tomorrow off.

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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The art of Networking is a key ability for any type of entrepreneur. Networking can bring you important information as well as give others important information about you.

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