Main Subject - Business

"It is a terrible thing to look over your shoulder when you are trying to lead and find no one there." - Franklin D. Roosevelt

Persons accepting promotion from individual contributor to leader often do not realize the extent of the change. All

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

too often they assume that they will be doing basically the work as before except that they will now be ‘in charge’. In reality, a major change in responsibility is occurring. The new leader requires a different set of skills, attitude and behavi

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

Examples of combination products may in

rs. When we asked seasoned leaders what they wished they knew then that they know now, this is what they said:

1. Research your new job. Find out all you can about: the company (if it is one you have not previously worked for);

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 department you’ll be working in; your new job responsibilities; the history of the position; your predecessor and his or her approach to the job; and your new subordinates – if you don’t already know them. Also learn the purpose of your departm

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

nt, team or unit – what work is being done, what is the current state of play; your boss and your boss’s boss expectations and if you have customers, what their expectations are.

2. Start planning in advance. Form at least a te

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

Combination pro

tative plan - it will be harder to plan once you are in position. Think about what you want to achieve and how you would like to develop yourself to match the demands of the job. Reflect on your strengths and weaknesses – how can you deploy your p

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

ositive qualities and experiences to advantage and compensate for your limitations. Above all, don’t depart too dramatically and quickly from established practice.

3. Get to know your team. Meet with your team first together

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

nd then individually. Don’t skimp on time – these first meetings set the stage for building a productive relationship. Listen carefully, eliciting information about the work and about them as individuals. Consider leaving the team with a question

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

to reflect on: “What should I do or not do to help you perform your job effectively?”

4. Focus on important relationships. Introduce yourself to customers (internal and external); suppliers, and the people who make up the profes

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

sional network surrounding your job. Get to know your boss immediately. Find out such things as: the frequency of status reports (daily vs. weekly vs. monthly); the amount of information (just give me a quick update vs. a 5 page report); and the

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

esired mode of communication (email, voice mail, face-to-face).

5. Identify likely standards of performance. Observe, listen and note what is acceptable and what is not in your new environment. Within a few weeks you should ha

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

Following aspects would a

e some ideas of what your staff expects of you. Identify the criteria by which your boss, your peers, and your customers will judge you. Be honest with yourself – can you meet those standards? If not, what do you need to do? Consider who could h

dd to the challenges in developing combination products:

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

elp you and what the price might be.

6. Power up your people engine. Make a point of noticing and showing appreciation when someone puts in extra time and effort. If you are aware that another team member wanted or expected to g

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

t your job, acknowledge the fact. Express the hope that you can work together on a friendly basis and say that you look forward to his or help.

7. Don’t be the lone ranger. Lead by involving team members. Listen to what they a

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

e telling you, especially if the team has been working together for a long time. They probably have a better sense, then you as the new manager, of what is going on, what needs to be done, and where the sand traps are.

8. Set an example

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

. Demonstrate strong personal commitment to achieving your department’s or unit’s or team’s goals. Build warm, friendly relationships rather than remain aloof. However, there is a fine line between being friendly and being a pal. When yo

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

Professional from academic institutions, pharmaceutical industries, health care indust

put on the manager’s hat, your role changes. You want respect first and then hopefully being liked.

9. Take stock regularly. Take time to reflect on your progress at the end of your first week, your first month, and your fir

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

t quarter. Identify issues that require immediate attention, and ways to deal with them, before they grow into big headaches. The pattern of behavior you set in your first three months will be extremely hard to change later. As a new leader, yo

.

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

ur primary task is to listen and learn.

10. Discover the leader in you. You can't make sense of your role as a leader unless you know yourself first. Look to others for guidance but be true to who you are. "Leadership is a mat

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

Companies that provide selfless information through particip

er of how to be not how to do it. In the end, it is the quality and character of the leader that determines performance and results", according to Frances Hellelbein of the Peter Drucker Institute.

Make sure you become a super not blooper leader

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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Before we get into the problematic issue with the current state of the American work ethic; I wish to apologize in advance for my bluntness and comments in this article. Now then about the American work ethic, it is lacking in many regards and I wish it were not so.

Well actually no it's not usually but it can be far better if you know what to expect and how to manage your new business. Every new business owner starts off, full of hope, excitement and enthusiasm. How do you make sure that you are not on of the 80% of small businesses that fails in the first few years?

Profit magazine ran an article that compiled management advice quotes from leaders of Canada's fastest growing companies. The quotes were just randomly posted on the pages without stating the name of the person that said the quote. This is fitting because these were great quotes, motivational, without regard as to who said it; they are spoken by Canadian business leaders and managers but they are universal and apply to business throughout the world, including The U.S.A.

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