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One of the topics I am asked to deliver frequently for my clients is how to get people who c

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

ome from different areas of the organization to work together effectively. These people also

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

Examples of combination products may in

may have different education levels, experience, agendas, time with the organization, and va

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

rying roles.

It is not an easy task to get two people to work together effectively, let alo

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

e a group of people who may not see each other on a regular basis and must communicate via t

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

Combination pro

elephone, memo or email.

There are a number of issues that must be taken into consideration

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

when orchestrating a group of diverse individuals to work together toward a common goal, obj

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

ective or mission.

Some of these are:

1. Managing individual creativity
2. Managing t

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

e individual need for appreciation, recognition or acceptance.
3. Dealing with individu

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

al ego needs, power struggles and/or group politics.
4. Pulling together a group that m

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

y have very busy schedules - with travel, different work shifts, vacation time and general t

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

Following aspects would a

me off.
5. Leading the group toward a group goal rather than a variety of individual on

dd to the challenges in developing combination products:

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

es.
6. Managing the natural conflicts that will develop as a result of different person

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

lity style interaction.
7. Keeping the group or team motivated knowing that motivation

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

is an individual and very personal issue.
8. What to do with the team when it must disb

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

nd for whatever reason.
9. Indoctrinating a new member into the team process after the

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

Professional from academic institutions, pharmaceutical industries, health care indust

project is well underway.
10. Sharing information in a timely and equal basis for all m

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

mbers of the team.

Any of these can be difficult to administer. Team leadership requires: f

.

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

inesse, tact, skill, patience, courage, a firm hand, good people skills, outstanding sales s

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

Companies that provide selfless information through particip

ills, ego control, judgment, effective communication skills, and planning – lots of planning

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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Are you really taking advantage of one of the major assets in your company? Employees have the capability to provide significant input to formulating solutions to some of the most difficult operational problems facing many businesses. Unfortunately, there are few companies that actually have a systematic approach to utilize this potential untapped resource.

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