Advice You - Business

Forecasting future sales is one of the most difficult areas for many companies. The challenge is to produce consistent and accurate advance information which can be used by production, stock

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

and service managers to plan for future demands.

In practise, much of the forecasting work currently undertaken is very random, if not haphazard guess work. It is based on highly subjective

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

Examples of combination products may in

eports of the sales people, often under short term pressure to predict acceptable levels of achievement in order to meet targets.

As a result much of the medium-to-long-term sales order foreca

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

sts are often made up of business projections based on nothing more scientific than optimistic guess work rather than on disciplined and realistic assessment of likely conversion of sales from

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

ndividual customers.

Companies spend thousands of pounds and hundreds of man hours on their annual, quarterly and monthly budgeting and forecasting activities.

Financial management techniques

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

Combination pro

and systems have developed apace in recent years but these have little input into the forecasting process, especially predicting short and long term sales.

The pressure for accuracy is growin

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

. Jobs, investment and expenditure depend on making the right assumptions and predictions. Too often companies fail to spot in advance negative trends or competitive activity which impinge on t

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

heir ability to win new orders.

Most forecasting, in the widest sense, is based on historic information with some allowance for highly subjective judgements such as the economic climate, trend

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

in the industry etc.

The Achilles heel of even the most significant business planning methodology is an almost uncritical acceptance of what the sales team predict as imminent or long term bu

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

siness opportunities and their value.

Companies put complex and time consuming reporting procedures in place to capture data but can be extremely uncritical of the quality of the information i

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

self which is provided.

Frequently the sales predictions - short, medium and long term - are highly suspect. They depend on the sales team’s personal, often highly subjective views, and often

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

Following aspects would a

reflect the pressure for ‘certain sales levels to be achieved’

Predicting the real chance of winning a particular order will change the closer the customer gets to placing the order. Two or th

dd to the challenges in developing combination products:

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

ee months ahead the sales men will report the order as ‘in the bag’, closer to, the odds will often be reduced or even discounted. There is no discipline or consistency in the process. Orders ‘

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

lost’ now will be replaced by ‘new’ opportunities conveniently two or three months down the line. These new ‘orders’ will be lost as the time for their confirmation gets closer. Thus, the organ

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

sation never has a realistic assessment of its potential sales.

What is missing is a management awareness of what is really happening to ‘vapour sales opportunities’ and a complete lack of sys

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

tem and discipline in predicting the real possibility of winning specific orders consistently. These ‘vapour sales opportunities’ represent unsubstantiated sales opportunities which can amount

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

Professional from academic institutions, pharmaceutical industries, health care indust

to anything up to half of the ‘pipeline’ business being reported to management from month to month.

Sales teams are relying on a base level of business coming in to cover up poor predictions a

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

nd to replace lost orders previously anticipated. This is one reason that organisations frequently fail to spot downturns or changes in their business environment.

The solution is a proper str

.

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

cturing of reporting procedures. Apart from eliminating unqualified business this process can help the organisation be more responsive to real business and focus on genuine problems and opportu

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

Companies that provide selfless information through particip

nities which the process identifies.

Much of this procedure can be computerised. It is a complex process and requires consistency, minimising the scope for human fallibility and changeableness

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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