Advice You - Business

The position of Finance Director (FD) in business is generally held in high esteem and in many instances the role is considered to be second to the Chairman/Managing Director.

The position affords the incumbent the opportunity to become actively involved in

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

all aspects of the business in order to facilitate good planning and reporting practices. On occasions this high level cross-functional activity may not be enjoyed or even welcomed by the Finance Director’s peers.

Whilst it would be expected that large

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

Examples of combination products may in

organizations would appoint a full-time Finance Director, there are many reasons why such an individual may not be employed by many small and medium sized businesses.

There are situations that are most suited for engaging a Finance Director and these includ

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

The owner losing control of the business – not knowing how the business is performing – no management accounts – no cash management
Rapid business growth without a senior financial professional to assist in setting a robus

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

t strategy and plan for the future

Businesses that absorb all available cash with increases in working capital potentially restricting growth and capital expenditure.

Established businesses with poor profitability and/or with an unacceptable

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

Combination pro

ash generative history.

Businesses facing external pressures to make financial improvements to satisfy personal or corporate commitments from banks or investors.

Business owners that plan to exit and seek help to maximize the business value.

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

i>In the above situations the small business owner may gravitate back to the work with which he/she is most comfortable or to the work that is necessary to meet the immediate business demands. This action is taken at a time when the business may be becom

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

ing more complex, undergoing change and potentially be at greater risk of failure. In such circumstances the services of a Financial Director are essential to maintain the good management and success of the business. Affordability is one key reason why a full

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

time Finance Director may not be employed in the small business. However, the cost of a full-time FD may be prohibitive but it does not eliminate the need for a person to fill the role. In addition there may not be sufficient work to actively engage a full-ti

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

e finance director, what then are the options?

Consider the appointment of a Part Time Finance Director.

An increasing trend amongst small and medium sized business owners is to appoint a Part time Finance Director, albeit the person may not be formally app

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

inted to the board – thus becoming a virtual FD.

The part time FD will only work sufficient time to discharge the commitments of the position; this then represents a significant saving against employing a full time person. Typically one to three days e

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

Following aspects would a

ach week would be worked which would be a cost effective solution for the small and medium sized business owner.

Would the role of the part-time Finance Director differ from that of a full time person? No, the responsibilities of the position; be it part-tim

dd to the challenges in developing combination products:

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

or full-time would be the same; only the time worked would be different.

The part time FD would become conversant with the business, take responsibility for accounting, cash management and advise and report on the financial performance of the business.

How

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

ver, a virtual or part time Finance Director would provide several advantages including:

Containing costs. The financial skills required in the business would only used when the business needs them.
Usually experience

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

d in different business sectors and different sizes of business. This would provide the opportunity for the part time FD to transfer the skills, best practices and knowledge gained in one industry to another.

Offering the business owner

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

g>unbiased and independent opinions.

Freeing-up management time to enable other specialist functional directors to concentrate their work in areas most beneficial to the business.

Providing in

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

Professional from academic institutions, pharmaceutical industries, health care indust

ut into the strategic decision making process.

Advising on general business matters.

Adding credibility of the business to third parties, particularly banks, finance providers and other professionals

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

Consulting with auditors, solicitors and other professionals on behalf of the business.

Ensuring good management and accounting practices are implemented and compliance with statutory requir

.

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

ments.What traits should the part time Financial Director possess? It will be important for the business owner to be able to work with and trust his part time FD. In addition the Finance Director should demonstrate an interest in the business and be

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

Companies that provide selfless information through particip

willing and able to transfer his knowledge and skill into the business. The part time Finance Director should become an integral part of the management team and take responsibility for and be accountable for his/her actions and at all times act professionally

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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Corporate kits, or sets of documents that are used to track and enter information for the purpose of registering a new corporation, can be applied to wholesalers. Wholesale prices are less than retail, as it involves high volumes. In the wholesale market, quality is key. The customer looks for good quality at competitive prices. Corporate kits includes the corporate seal, printed or blank minute books, by-laws, printed stock certificates and receipts, stock transfer ledgers, government forms, and a padded 3-ring binder with matching slip case.

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