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On February 20th, I returned from St. Augustine, Florida, where I attended the 7th Annual M

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

eeting of The First Tee (www.thefirsttee.org and was a featured speaker on Strategic Thinki

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

Examples of combination products may in

g and Planning. It became clear from the reception and comments I received after my power p

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

oint presentation, that I had accomplished my goal of sensitizing the attendees to the bene

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

its of strategic thinking and planning and getting many of them to commit to starting the s

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

Combination pro

trategic planning process soon after they returned home. I selected a few slides from my po

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

erpoint and have listed the information below that I shared with them.

Strategic Thinking

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

allows proactive thinking beyond your current activities and traditions deals with change p

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

sitively by responding to it effectively involves making decisions that consider changes or

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

anticipated changes in the environment. Strategic Thinking is not a one shot deal a box o

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

tricks or bundle of techniques a quick fix to solve immediate problems

What Are The Benef

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

Following aspects would a

ts of Strategic Thinking & Planning?

Strategic thinking and planning empowers you to influ

dd to the challenges in developing combination products:

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

ence rather then be influenced; clarify or redefine your role and your target group; deal p

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

sitively with the inevitable change; address critical issues you are facing; find innovativ

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

e ways to achieve goals; decrease crisis management; give continuity during changing times

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

r when there is new leadership; use resources efficiently and effectively; anticipate issue

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

Professional from academic institutions, pharmaceutical industries, health care indust

s and develop policies to meet future needs; gain commitment and bring your group together

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

o work on common goals.

Do you have a strategic plan? Do you consider yourself and your te

.

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

am to be strategic thinkers? Are you realizing the benefits listed above by using strategic

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

Companies that provide selfless information through particip

thinking and planning? If you are not, maybe your competition is using these powerful tools

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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Do you hesitate to bring up tough issues, because you aren't sure how to resolve them? Do you dread talking with your boss or co-workers about controversial topics, because you know the result won’t be good? Do you get stressed out just thinking about a difficult conversation you need to have? Is your organization suffering, because managers and employees don’t know how to talk about challenging issues without ending up in arguments that have unsatisfactory outcomes?

Be prepared to field questions that the audience will ask and want to know. Brainstorm ahead of time for possible questions, scenarios, and answers. There will always be someone who asks the tough questions. If you are the expert, you are expected to know the answers. Obviously, if you don't know the answer, you should not make one up. If the question is way out of line, you can say you don't know the answer. But what do you do when your audience expects you to know the answer and you don't? How do you save yourself from losing credibility?

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