Useful Advices - Business

Do you like skating on thin ice? Do you leap before you look? I thought not. As an investor you make careful assessments before putting in your hard earned money. Yet you may be missing

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

an aspect that can mean the difference between success and failure. The ability of a business to cope with disaster.

No doubt you perform the usual checks; financial audit, assess the

; 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 and evaluate the market. All well and good but meaningless if the business cannot survive what life throws at it. Let’s leave tornadoes and terrorism for the moment and think abo

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

ut the mundane disasters that force thousands of businesses into oblivion. The weekend leaks, the staff that suddenly quit, the suppliers that only supply excuses. The neighbouring busi

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

ess from hell. The equipment that breaks when the big contract is due.

Some people still believe that insurance will make it all okay. The more battle weary among us know that when the

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

Combination pro

insurance cheque finally arrives it cannot mend a ruined reputation, it won’t make disgruntled suppliers agree to supply again and it won’t stop competitors pouncing on misfortune.

At

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

this point I could bombard you with the oft quoted statistics. Along the lines of "..one in five businesses suffer a major disruption every year blah blah". I won’t bother. Harsh as it

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

ounds who cares what disasters befall other businesses? You need to ensure that your investment is safe. Besides which if you want to worry just read any newspaper and imagine the busin

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

ss tragedies unfolding behind the big accident, the crime scene, the protracted roadworks or the boom in the Asian economies.

So the wise investor seeks a resilient business. A busines

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

s that says "yes we got flooded at the weekend...but we have arrangements to work elsewhere, back up equipment in place and our staff know how to re route orders. It is not a problem".

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

uch an operation brings to mind a spider’s web. Bits can break but it still works. As opposed to many businesses which are more akin to a house of cards.

How do you start assessing how

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

Following aspects would a

well a business has prepared to cope with disruptions? Such discussion often goes under the banner of "business continuity planning". However this is a term that has suffered from over

dd to the challenges in developing combination products:

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

association with the IT side of things. (Borne out of the Y2K issue.) A more holistic approach to assessing business resilience will cover what the business is doing to protect and plan

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

for disruptions to all its key resources. Some examples being;

People – is their knowledge captured or does it leave with them?
Information – are copies usable and

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

ecure?

Telecomms – if the phone line was cut how will customers reach you?

Reputation – if the media wanted answers what would you say?

Premises – what

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

happens if the access road is blocked?

Equipment – have you tested using the alternate kit?

Of course business continuity planning is not all gloom and wringing

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

Professional from academic institutions, pharmaceutical industries, health care indust

of hands. The resilient business has the satisfaction of telling customers about how they will deliver come hell or high water. "Oh and by the way, what have the competition said in tha

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

respect?". Imagine throwing that card on the table to tip the negotiations.

Speaking of negotiating tactics, a wise investor who uncovers concerns about the resiliency of a business c

.

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

an can add a whole dimension to the deal talks. It goes without saying that the amount you invest must reflect the level of risk you are taking.

As an investor you can bring many thing

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

Companies that provide selfless information through particip

to the table. Next time go armed with the right questions and an appreciation of the importance of business resilience. So that whatever decisions you make, avoid investing in disaster

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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Earned value (EV) is one of the most sophisticated and accurate methods for measuring and controlling project schedules and budgets. EV has been used extensively in large projects, especially in government projects. PMI is a strong supporter of the EV approach because of its ability to accurately monitor the schedule and cost variances for complex projects.

Chances are that in today's volatile world of work, you may one day be let go, downsized or made redundant. You can wait for the moment to blindside you, sending you into despair and frustration. Or you can prepare for it, even anticipate it, and use that moment as a turning point for your future.

Do you want to achieve success? Learn quickly. Don't let any one or anything steal your dreams. Dream big and make them come true. You can do it. Don't let anyone tell you different.

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Useful Advices - Are You Investing In Disaster?

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