Advice You - Business

My 9 year old son loves to play the board game Checkers. At one time playing against

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

him was a snap, because he didn’t really understand the concept of the game, he only e

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

Examples of combination products may in

joyed the family time together sharing an activity. However, after much practice and

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

graduate student of “Checker Camp” directed by his father, he became an expert player

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

The once short checker game became a long competitive checker tournament. One evenin

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

Combination pro

g as I was losing horribly, my son asked me why I had not been focusing on the game.

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

replied that I didn’t feel the need to do such strategic thinking and planning. His

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

esponse became my mantra: “It is a waste of time to make a move without a plan or stra

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

egy because the consequence will almost always = loser. Always play to win”!

Do you

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

play to win or are you satisfied with the results from minimal effort and persistence?

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

Do you plan your day? Is there blocked time on your daily schedule for action items?

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

Following aspects would a

o you have a big picture goal with small reachable daily tasks that will lead you to t

dd to the challenges in developing combination products:

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

e bigger picture? Are you spending your days confused about what to do next? Do you

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

operate from a strategic action plan?

If you responded NO to any of the above questio

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

s, stop wasting time and play to win.

Incorporate these strategies in you routine

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

o win:

► Always Plan Your Day, Preferably The Night Before

► Deve

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

Professional from academic institutions, pharmaceutical industries, health care indust

op A Strategy To Get The Results Want

► Visualize The Big Picture

► Comp

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

lete Daily Bite Size Tasks

► Stay In The Present, Focus Only On The Work At Han

.

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

► Rejoice In The Small Accomplishments

► Create A Successful Environmen

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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Five key ethics questions that individuals in business or working for organizations should ask, whether at the executive, professional or managerial level. George F. Franks, III is the founder and CEO of Franks Consulting Group - a management consulting and leadership coaching practice based in Bethesda, Maryland.

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