Advice You - Finance

Most diseases including cancer and heart problems are easier to cure if detected early. Similarly, most sick companies can be turned around

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

if the problems are discovered early. Sick companies need to be placed urgently into the intensive care units as the normal treatment regi

; 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 is ineffective.

Unfortunately, owing to denial, ego or pure ignorance, many sick companies do not seek help till it is very late. Trouble

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

d businesses usually try to conceal their problems from others for obvious reasons – the creditors may stop their loans, suppliers may stop

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

supplies, employees may jump ship etc. However, like sick people, sick company need to seek urgent help. They need to engage specialists to

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

Combination pro

facilitate the restructuring programmes and to face the new harsh realities before it is too late.

Much like human health, more businesses

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

are also destroyed by neglect than any other causes. This is why regular health check is vital to prevent any unexpected health problems,

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

detect them early so that appropriate remedies can be administered. The traditional accounting methods such as balance sheets and profit and

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

loss statements only capture the measurable financial aspects of the company at a certain point in time. Furthermore, the real financial h

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

ealth of the company can be masked by deliberate accounting irregularities as in cases at Enron and Worldcom. By the time the sickness is

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

isibly evident in the company’s accounts, it may already be too late to take corrective action to reverse the situation. Oftentimes, when th

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

Following aspects would a

e accounts show red, the company is extremely sick or suffering from haemorrhage. There are many other non-quantifiable financial factors

dd to the challenges in developing combination products:

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

hat may impinge upon the health of the company. These may include high staff attrition, low morale or an incompetent CEO.Usually, there are

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

ample warning signs or symptoms of impending trouble. However, these warning signals are often ignored or suppressed; hence the onset of a

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

crisis comes as a surprise.

Early detection of business problems is vital to sustaining a company’s growth, manage the crisis effectively a

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

nd to contain the economic distress. Business problems rarely occur suddenly. Most problems develop over a long period of time due to a seri

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

Professional from academic institutions, pharmaceutical industries, health care indust

s of financial, legal, operational and strategic errors or miscalculations that went largely ignored or undetected by management. Some obv

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

ious examples that a company is heading down the wrong course include persistent operating losses, high key staff attrition, loss of moral

.

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

and market share.

It is important to pre-empt any problems from arising by looking out for warning signals. Therefore, a proverb that says

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

Companies that provide selfless information through particip

: “The superior doctor prevents sickness. The mediocre doctor attends to impending sickness. The inferior doctor treats the actual sickness.

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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