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The reason is the planning gap, that great divide between strategic plann

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

ing and execution. Usually known as operational planning, this area of th

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

Examples of combination products may in

e overall planning process is often misunderstood and overlooked in many

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

companies. To make matters worse, as many firms focus on being more strat

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

egic at the senior leader level, and putting tight process around project

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

Combination pro

execution at the lower levels, the planning gap is becoming more pronoun

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

ced.

The solution to overcoming the gap is not simple, but it ha

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

a few consistent ingredients: one part process, one part communication,

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

two parts leadership development, and three parts cultural change. A solu

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

tion that focuses on improving process and communication alone is doomed

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

to fail because most of the required changes are steeped in history, and

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

Following aspects would a

require serious change of attitude and culture. Imagine the reaction you

dd to the challenges in developing combination products:

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

would get in your company if you started talking about planning:

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

Every 90 days

With much less emphasis on long-term detail

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

d budgets

For a horizon of only two to three years

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

th actions defined in detail for only the next quarter

As if Ja

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

Professional from academic institutions, pharmaceutical industries, health care indust

nuary 1 was just another day

With changes like this, the t

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

ransformation takes time, even in change friendly environments. Changing

.

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

process is relatively easy. Most of the effort to eliminate the planning

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

Companies that provide selfless information through particip

gap must be directed at making leaders and employees into better planners

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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