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The precise start is always difficult to pin down. Typically trouble is not recognized until slipping revenues and eroding profits span two or more calendar quarters. These are difficult problems and catch many managers unprepared to deal with

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

the rapidly deteriorating situation. These problems are symptoms of many underlying problems. These underlying problems are often unrecognized or simply overlooked as the financial slide gets worse.

What causes a good company to go bad? It c

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

Examples of combination products may in

an be anything or any combination of things that began the all too quick slide into financial trouble.

Way posts on the journey include nervous bankers, demoralized employees, defection of competent players and strained resources. The tempera

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

ture is rising faster than revenues and profits are falling. Denial and fear of fault finding become the driving forces.

A survival threatening crisis is significantly different from years of running a business in good times and bad. Sadly, 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

n a crisis situation decisions tend not to be made. Unfortunately for the business, failure to act is a default decision to do nothing. This is often the most expensive decision of all. Suddenly marketing, sales, production and accounting all

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

Combination pro

have different agendas, views and are going in different directions..

Given the nature of market forces and change, every enterprise is as vulnerable to trouble as it is to the lure of success. Assigning blame at this point will do nothing to

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

alleviate the problems: you won’t even feel better. The blame game can clearly wait. Post mortems reveal the causes of death after the victim has already died. Remember, it may not be your fault, but it is your problem.

Okay, so blaming some

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

one does not cure the problem. What to do?

Ask yourself these four questions:

1. Is the business viable?

2. Is there a solid core business which can be salvaged and form the foundation for the new, restructured business?

3. Is there signif

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

icant cash on hand, or available sources to fund the turnaround through recovery?

4. Is management capable of leading the new business? If you can answer yes to each of these questions, then a seasoned Crisis Manager can help. The CM offers

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

a new set of eyes, skills and understanding of troubled situations to independently evaluate the enterprises’ circumstances and quickly must face a series of questions that existing management may never have asked:

• What is the purpose of th

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

is project (or business)?
• Should it be saved?
• If so, why?
• Are those answers valid?

Problems that occurred over time will not be solved overnight. A successful turnaround requires months, even years of hard work. The Cr

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

Following aspects would a

isis Manager is a change agent, a catalyst in this process. Ultimately the success or failure of the turnaround rests upon the various stakeholders: owners, management, employees, suppliers and lenders; all of whom must be dedicated to turning

dd to the challenges in developing combination products:

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

the business around.

The Crisis Manager focuses on stabilizing the situations threatening the immediate survival of the company (e.g. calling bank loans, negative cash flow, death of the CEO.) In addition, he will quickly assess the root cau

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

ses of the enterprises poor performance so limited resources (time and financial) can be marshaled to best effect. Once the chaos is stabilized, he business gains much needed breathing room to implement corrective actions and begin the turnaro

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

und.

The ability to develop and implement a Recovery Action Plan designed to stop the fiscal bleeding and begin corrective actions and restructuring necessary for a successful turnaround is the Crisis Manager’s next task. In the event manage

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

ment is temporarily unable or unwilling to function under the current stress, he may also act as the interim CEO.

The Crisis Manager acts in an interim role for periods lasting from three to fifteen months in small and mid-cap companies. He a

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

Professional from academic institutions, pharmaceutical industries, health care indust

ssumes the CEO, CRO (Chief Restructuring Officer) or general manager role for the period of time necessary to guide the company though restructuring and recovery. As part of the CM’s responsibilities he will coach existing management, add new

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

players to supplement the management team and, where necessary, replace managers.

In many cases existing management is one of the causes of the crisis. Rarely is this intentional. In order to stop the bleeding and steer the company towards re

.

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

covery it is often necessary for an experienced crisis manager to take the helm. The duration of this role depends upon many factors, only one of which is the ability of the existing management to adapt.

Changing conditions, new technology, e

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

Companies that provide selfless information through particip

tc. may not be ‘fair’ but they are facts of business life. The keys to yesterdays successes often become the locks barring today’s need for growth. Adaptability and prompt recognition of the need for outside assistance are the keys to survival

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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Most of the businesses these days borrow money either in short terms or long terms basis. The majority of cash flow statements illustrate the increase and decrease of the earnings of the short term debt only. It does not report the total amount that are either borrowed or paid. On the other hand, when illustrating a long term debt, the total amount and the reimbursements of the long term debt must be indicated in the cash flow statement on a yearly basis. The figures on these cash flow statements are illustrated on gross not net figures.

Postcards are valuably known as a material that represents a business. It conveys a message that makes clients turn their heads even without the existence of a personal representative.

Pune is one of the chief industrial cities in India and has been contributing steadily to several small, medium sized industries and offering jobs to more than thousands of people every year.

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