Cases - Business

How would your business operate if half your work force were out sick? Would your business continue to function if several of your top key employees died? How many employees are cross-trained in other positions?

A r

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

ecent study showed the threat that most preoccupies the world's business leaders is a global influenza pandemic. This is why you need to start asking these questions now so your business can be prepared for a possibl

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

Examples of combination products may in

bird flu pandemic. A bird flu pandemic will not discriminate. Everyone from the janitor to the CEO would be affected. Worst-case scenario could leave millions sick and any where from 5 million to 1.5 billion people

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

ead around the world.

The World Bank, which has estimated that a bird flu pandemic lasting a year, could cost the global economy up to $800 billion. The economic toll on the world economy will be catastrophic. There

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

would be major economic losses due to worker absences and interruptions in supply and delivery chains. Even a ?mild? pandemic would have lasting effects on your business. Because a global flu pandemic is such a threa

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

Combination pro

, current business and disaster response plans may not be adequate to deal with it. What steps should you start to take now to prepare?

As with any worst-case scenario you should be aware of the risks and have a con

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

ingency plan in place before you need it. By planning now you will help keep your business running, your employees safe and head off possible legal issues. Some of the steps you may want to consider are:

Establish a

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

pandemic coordinator or team with responsibilities for preparedness and response planning. Provide current avian influenza information to all employees. Identify and make available information on community resources.

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

Identify key essential areas and current employees responsible. Cross-train other employees in those areas so they are able to fill in for sick employees. Have written documentation for those employees filling in fo

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

others.

Identify key suppliers and alternative sources for critical materials and supplies. Increase raw material inventories to keep production going for several months. Plan for ?just in time? inventory shortages

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

Products and inventory from Asian countries may not be available if Asian factories are shut down due to illness.

Play "what if?" What if Joe in accounting was out sick for a month? Or Sam in IT died? Who could fil

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

Following aspects would a

l in, how would the business run? It is estimated that between 30-60% of the workforce will be out sick.

Maintain a healthy work environment. Encourage hand washing, offer hand sanitizers, consider quality air purif

dd to the challenges in developing combination products:

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

ers. Limit face-to-face contact with employees and customers. Limit large group meetings, shared workstations and public events. Limit or eliminate non-essential business travel. Make use of conference calls and vide

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

conferencing.

Review employment policies to see if you can require employees to stay home if they are sick. Establish new sick time policies. Check employee agreement clauses for business closure plans, hours of wo

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

k and position changes. Establish policies and procedures for sending staff home, staff leaving work on their own, unauthorized absences and returning to work. Plan to offer additional sick time pay or wage and salar

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

advances to staff unable to work. Plan for family member illness, community quarantines, school/business and public transportation closures.

Offer telecommuting options to as many employees as possible. Offer flext

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

Professional from academic institutions, pharmaceutical industries, health care indust

me and other creative job options.

Back up essential files off site, provide access to a network of key employees.

Establish a communication plan for employees and business contacts. Include key contacts and tracki

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

g for employee status. Employees will be hungry for up to date information about their business, jobs and co-workers. Good communication with your employees is essential to avoid rumors, panic and misinformation.

To

.

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

encourage employees to stock up on food and supplies for an extended home stay, purchase supplies for them in bulk to take advantage of discounts, offer the savings to employees. Or offer them a SAM?s Club or Costco

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

Companies that provide selfless information through particip

embership at no charge.

Taking these steps today will help your business be prepared for a possible bird flu pandemic, survive for the duration and return to business as normal faster than those who are not prepared

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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