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In terms of achieving and sustaining optimum performance levels within your team it is vital to recognise from the outset that effectiveness depends on the interaction of t

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

he following three factors;

• Task

• Team maintenance

• Individual Needs

In my view you must:

• Ensure, continuous task achievement

• Meet

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

Examples of combination products may in

he needs of the group

• Meet the needs of individual group members

The balance must always be kept in mind (though some compromise may be necessary)

Your own best cont

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

ibution to getting things done is ideally approached systematically. You must:

• Be clear exactly what the tasks are

• Understand how they relate to the objectives of

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

he organisation (short – and long-term)

• Plan how they can be accomplished

• Define and provide the resources needed for accomplishment

• Create a structure and organisa

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

Combination pro

ion of people that facilitates effective action

• Control progress as necessary during task completion

• Evaluate results, compare with objectives and fine-tune action and

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

method for the future

The following three-checklists relate back to our original three factors and highlight the thinking that is necessary here

Checklist 1: Achieving

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

he Task:

Ask yourself:

• Am I clear about my own responsibilities and authority?

• Am I clear about the department’s agreed objectives?

• Have I a plan to achieve th

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

se objectives?

• Are jobs best structured to achieve what is required?

• Are working conditions/resources suited?

• Does everyone know their agreed targets/standards?

•

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 the group competencies as they should be?

• Are we focused on priorities?

• Are those areas in which I’m personally involved well organised?

• Do I have the informatio

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

necessary to monitor progress?

• Is management continually assured in my absence?

• Am I seeing ahead and seeing the broad picture?

• Do I set a suitable example?

Check

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

Following aspects would a

ist 2: Meeting The Individual Needs:

Ask yourself if each individual:

• Feels a sense of personal achievement from what they do and the contribution it makes

• Fee

dd to the challenges in developing combination products:

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

s their job is challenging, demands the best of them and matches their capabilities

• Receives suitable recognition for what they do

• Has control of areas of work for whi

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

h they are accountable

• Feels that they are advancing in terms of experience and ability

Many questions stem from this about what people do, how they do it, how what they

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

do is organised and how they feel about it. It is worth thinking what you need to ask regarding your own particular team

Checklist 3: Team Maintenance:

To involve t

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

e whole team in pulling together towards individual and joint objectives, ask yourself, do I:

• Set team objectives clearly and make sure they are understood?

• Ensure sta

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

Professional from academic institutions, pharmaceutical industries, health care indust

dards are understood (and the consequences of not meeting them are understood and approved)?

• Find opportunities to create teamworking?

• Minimise any dissatisfaction?

•

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

Seek and welcome new ideas?

• Consult appropriately and often enough?

• Keep people fully informed (about the long – and short-term)?

• Reflect the team’s views in dealin

.

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

s with senior management?

• Accurately convey organisational policy to the team and reflect such policy in their objectives?

In Summary:

An analytical approach to

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

Companies that provide selfless information through particip

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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