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Before you do anything, have the likely expectations of your people in mind. They will tend to define a good manager as one who:

• Is positive and enthusiastic

• Has vision (sees the longer /broader view

• Achieves

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

their own goals

• Is well organised

• Making good – objective – decisions

• Delegate appropriately

• Provides good – honest – feedback

• Is fair and has no favourites

• Is open-minded and curious

• Listens (an

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

Examples of combination products may in

is available to listen)

• Knows and takes an interest in staff

• Encourages/supports staff development

• Communicates well

• Shows confidence and gives credit

• Keeps people informed

• Acknowledges own mistakes

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

weaknesses

• Shares experience

Similarly, people will have firm views on the type of manager they do not want. Those, for example, who:

• Put themselves before their people

• Fail to set clear object

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

ves/priorities

• Don’t appear to care about the team (a loner)

• Are secretive (or late informing)

• Procrastinate

• Are unapproachable

• Are not honest, open and fair

• Fail to consider people’s feelings

• Let

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

Combination pro

their personal workload prevent team maintenance

This list and the preceding one could easily be extended and will be influenced by factors that are especially important in your job, organisation or function.

Ma

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

e it your business to discover what is most important to your people.

New Post – New Employer?

Throughout your planning and progress you need to tailor your approach depending on whether you are moving p

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

sitions within your current company or moving to a new one.

• Existing employer. Keep in mind that people know you. Your position relative to others will – must – change. You have to create a suitable distance

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

between you and others, and not allow existing relationships (and friendships) to dictate the way things work. At the same time you are (still) part of the team, and how this manifests itself needs consideration. Bewa

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

re of being arrogant. Do not throw the baby out of with the bath water – old alliances can help.

• New employer. The learning curve you face is inevitably much steeper. Beware of acting (or even of giving a vi

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

w) before you have sufficient facts.

Always match your approach to the actual circumstances and be realistic about the situation you are in

First Things First:

Day one as a manager: a great deal to co

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

Following aspects would a

sider if you are moving into a new situation. You should:

• See your new manager early on: confirm your role and priorities and set up communications procedure between you both, especially to make clear how yo

dd to the challenges in developing combination products:

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

check things during the first few days.

• Arrange introductions to other key people: if your work involves contacts with others (another department, people on the same time level as you, etc), make sure you k

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

now them and begin to cultivate a relationship from the word go.

• Meet your own staff: (more of this anon).

Once again, remember that you only get one chance to make a good first impression – especial

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

y in a new environment. This may be a clich?, but it’s true. So, consider the details and get them right. For example:

• Be sure to arrive on time (or a touch early)

• Look the part (think about what you wear)

M

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

et The People:

Make a point of speaking to everyone on day one. If this is not possible (for example, someone may be away) set a time for an initial word. This can be informal (just a word at their desk) or in yo

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

Professional from academic institutions, pharmaceutical industries, health care indust

r office or meeting room. It needs to do various things.

• Act as a personal introduction

• Clarify, briefly, how you see their role (or how the other person sees it)

• Dispel any immediate fears the team member ma

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

y have

• Answer any immediate questions (or say when they can and will be answered)

• Begin to show you as the kind of manager you want to be

Ask questions and canvas opinion from the team about how things are goin

.

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

, what might need change, challenges for the future, etc

And Finally:

Keep these exchanges positive. Do not be afraid to put things on ice for the moment but be specific – “I can’t answer that now; give me

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

Companies that provide selfless information through particip

a day or two and I will say something about that when the whole team gets together”.

Keep notes – and keep promises made during such conversations.

Copyright © 2007 Jonathan Farrington. All rights reserve

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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No mater how you think your team works, deep down leaders and workers both care about the fairness of the decision making process. In order for there to be buy-in, peace and support in your team the decision process must ultimately be perceived as fair

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