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FINDING DIRECTION: An organization can’t succeed without direction. Direction means having clear goals and guide

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

lines; set goals and guidelines for staff to follow. When staff direction is needed, you must provide effective

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

Examples of combination products may in

procedures for everyone to follow. Have guidelines and goals firmly set to keep the gray areas to the absolute m

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

inimum. It’s up to you, to keep the departmental goals and that sense of direction so that it is not allowed to

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

be buried beneath the workload.

UNDERSTANDING AN ORGANIZATION’S DIRECTION: Successful leaders also understand t

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

Combination pro

he organization’s direction, and act along those lines. As a leader, you will also have to maintain a healthy fl

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

exibility within the organization. For example, one day you may attend a departmental meeting where the message

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

is, “Spend, spend, spend, new research is your major goal.” The next month you may get a memo from the CEO that

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

says, “cut 50% of your research budget in two weeks” .After having just re-directed your group, you must now ado

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

pt this new goal and create a lean and mean team that will strip excess expenditures to the quick. If you are a

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

good leader, you are also an informed leader. You should work hard to be a helicopter; always moving around in v

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

Following aspects would a

arious circles, hearing what’s what so that very little will come as a surprise.

GUIDELINES TO SET DIRECTION: -

dd to the challenges in developing combination products:

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

-Set goals and objectives for the organization. Ask, “What does the organization want to accomplish, when, and h

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

ow?” --Break down goals by department. This gives each sector in the organization a clear picture of their goals

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

. --Encourage staff to set annual goals and objectives. Next, have them break down their goals into monthly task

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

s, going as far as setting weekly goals. Work towards monthly or weekly goals isn’t always feasible, but within

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

Professional from academic institutions, pharmaceutical industries, health care indust

time, it will get easier. Set goals is the first step to meeting them. --Organize procedures. Every task has a p

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

rocedure. Write it down and include it in your procedures manual. Make sure every procedure has a clear set of s

.

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

teps and is accessible to staff. --Delegate. Give responsibility to those who earn it. Don’t make every little d

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

Companies that provide selfless information through particip

ecision yourself. Give staff responsibility with direction, and you give them greater confidence and competence.

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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