Advice You - Business

Part 1

A few weeks ago I attended a seminar sponsored by Independent Solutions Insurance Inc (Edmonton) entitled “Seminar On Disaster Preparedness”, during this seminar I heard stories from individual company owners w

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

ho told us of their misfortunes and how they coped with their crisis. In both cases these crisis were caused by accident, however, a potential catastrophe nonetheless. These individuals told their stories about how t

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

Examples of combination products may in

ey had to deal with their traumas from onset through to completion. From listening to these stories, it quickly became clear to me that there were similarities; was their insurance coverage adequate, how long could th

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

eir companies survive, without being operational, do they have adequate funding to start operations again, could they find suitable temporary business accommodations, employee morale and retention to name but a few.

I

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

is clear to most entrepreneurs that starting any new business involves risk and risk is one of the reasons, many of us are entrepreneurs. There is a certain thrill in taking the gamble and making a business work. Ma

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

Combination pro

y entrepreneurs however, do not consider instituting measures to manage the inherent risk of doing business. While taking a risk and winning is fun, prudent business owners take care to minimize their risk, just as yo

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

u would in any other type of business venture in which you are involved. We call this being “risk intelligent”; one needs to have a continuous process of analysis and communication as an integral part of any business.

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

So, What Are The Risks

Every day we are exposed to many risks which can cause a financial loss. Fraud, Accidents, property damage, illness and death are all risks we have to consider. However, other risks, such as

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

he possibility of being sued or becoming disabled and unable to work, are also important. We each have to decide how we will protect our vital assets should a risk become a reality.

RISK; is anything that threatens t

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

he ability of a corporation to accomplish it’s mission. A corporations mission is to earn profits by selling it’s products and services.

What Can Be Done

Appropriate contingency planning strategies protect against c

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

tastrophic losses, regardless of the cause. A company needs to adopt a risk aware culture, identify their risks and put in place a plan which will mitigate their losses. This plan needs to incorporate the entire risk

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

Following aspects would a

of the organization, separating your external risks from your internal exposures. This process can be achieved by completing a risk threat analysis which basically outlines your assets and the threats posed against t

dd to the challenges in developing combination products:

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

hese assets. A more comprehensive analysis can be obtained by hiring a professional consultant who can guide your through the process and assist in the education of staff and preparedness of your organization. A basi

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

analysis will break down your company into four parts; people assets, property assets, income assets and goodwill. Once we have identified the risks posed against these assets, we can then begin to formulate a plan o

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

action which will deal with the risks identified and have that plan written into the companies policies and procedures in order that all members of the company can familiarize themselves with their individual responsi

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

bilities.

In the event a disaster takes place and you have failed to plan, you are planning to fail in the management of a disaster, the consequence of your actions could be catastrophic to your organization. Ottawa’

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

Professional from academic institutions, pharmaceutical industries, health care indust

commitment to fighting white collar criminals and unnecessary corporate failures, introduced the Westray Bill. This bill is designed to protect organizations from fraud and the negligent acts of owners, directors and

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

managers. Watch out for part 2 of this series of articles when we look at a risk analysis in greater detail and discuss some basic internal controls. Future articles will include topics relating to corporate occupati

.

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

onal fraud, preventing industrial espionage, money laundering, corporate security in the millennium and investigating corporate thefts.

Marwen’s Contingency Planning; is a discipline that enables people and organizati

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

Companies that provide selfless information through particip

ns to cope with uncertainty by taking steps to protect it’s vital assets and resources. We recommend, just as you would walk around your car checking for defects, occasionally you should do the same with your business

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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The objective is to beat the competition and make money. Everything a business organization does should be focused on that simple objective, with interpretation through various Vision and Mission Statements. However if we take a survey of how our organizations spend our energy, often that objective is lost in a web of internal politics and positioning. Of course competition is normally good – regardless of whether it is internal or external – to the point we do not lose focus on company objectives as the ultimate outcome of our competition.

Postcards are said to be the economical way of reaching out for clients of different places. It serves as a valuable tool that you can have for your business campaign, promotions, advertisements, greeting cards, coupon cards, invitations, advertisements and business reply.

When you think about ways to gain repeat business from your customers, you probably turn your thoughts to marketing efforts such as advertising, public relations and other means that will allow you to repeatedly be seen. However, without one particular element included in your plan, your efforts to entice customers to buy over and over will fail.

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