Useful Advices - Business

WRITING A BUSINESS PLAN
- Common mistakes to avoid -

- Unbelievable Financial Projections
Whether you’ve omitted key figures such as salaries or whether the numbers you

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

’ve forecast are outrageously high, this area is one to be very careful with. A business plan will need to include everything from break-even projections to proposed return on inv

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

Examples of combination products may in

estments to cash flow forecasts, and somebody in your team will need to be able to discuss these issues confidently.

- No credible Evidence of Demand
Is the idea or product

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

needed? Wanted? The business plan needs to demonstrate this need in order to justify the business proposition.

- Lack of a Viable Opportunity

A business plan must describe a

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

opportunity and explain how this opportunity can be exploited profitably. The Plan must also

Show how what is required will be delivered.

- No Clear Marketing Plan
It’s ea

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

Combination pro

sy when drawing up a plan to forget the basics about how the customers are going to be accessed. The business plan must include a comprehensive and credible analysis of how the co

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

mpany intends to secure access to their target market in a cost-effective manner. In this era there are thousands of web sites that are available to help market but how to get not

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

ced in amongst the others is easier said than done. Knowing who the customer is and how they buy is essential, but identifying them and accessing them can be challenging and costl

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

y.

- Poor Cash Flow Management
It is pivotal to a business’ success that the differences between cash and profit are recognised. If this seemingly minor but in reality major

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

, area is overlooked the result can ultimately be insolvency.

- Cash Flow Management
When writing a business plan it is easy to overlook the most obvious - “What is the mai

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

purpose of this plan?” Once the primary objective of the plan has been ascertained, it will be easier to ensure that the key requirements of the reader are met.

- Overestimatio

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

Following aspects would a

n of Revenues

What constitutes 'excessive' is subjective, but the numbers will need to be justified. If it becomes apparent that the figures are

fantasy, the author will los

dd to the challenges in developing combination products:

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

e all credibility and therefore potentially jeopardise any confidence the potential investor might have in the

plan.

- Business Plan Inconsistencies

A business plan must be

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

consistent throughout. It is sensible for one person, if possible, to write the plan as this helps eliminate the

possibility of inconsistencies.. Similarly anybody presenting th

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

plan must present a coherent delivery.

- Competitors? What competitors?
It is a common mistake to downplay any competitors in order to promote the idea or product. There ar

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

e always competitors to everything, even if it is only for the finances. It makes more sense to acknowledge your competitors rather than ignoring them and as stated in the previou

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

Professional from academic institutions, pharmaceutical industries, health care indust

s tips, honesty is the best policy.

- Don’t Rush!!
The business plan MUST be right when it is submitted, with the contents accurate, clear and spelt. B business plans usuall

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

need to be completed by a certain date and it can be easy to rush to get things ready to submit. If this happens the result does not do justice to the proposal. Top tips include:

.

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

-

The plan is printed on good quality paper;
Tables and Charts have been edited to ensure they are formatted correctly;
The plan has been edited down to a digestible

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

Companies that provide selfless information through particip

size (Addendum can be provided on request).
The Plan has been independently proof read by someone not involved;
The presentation should be a true reflection of the plan

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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