Advice You - Business

The Olympic Games are a global celebration of challenge, performance and achievement. Around the world, vie

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

wers thrill to see who takes home the Bronze, Silver and Gold.

I enjoy looking deeper, silently granting ‘

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

Examples of combination products may in

ersonal Diamond Awards’ to anyone who goes faster, higher or longer and achieves a ‘personal best’.

What w

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

ould the Olympics be like if we officially included the Personal Diamond Awards?

Imagine an athlete who wi

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

s the bronze medal as well as a Personal Diamond. How would that athlete react? How might the audience resp

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

Combination pro

nd? Would the bronze medalist begrudge the silver or gold medal winners? Not at all. Would the silver and g

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

old winners offer their sincere and heartfelt congratulations? Absolutely.

Imagine an athlete who wins no

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

edal at all, yet still achieves a Personal Diamond. Would he go home beaten and dismayed? Or elated by his

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

chievement? Would his compatriots be disappointed or encouraged?

Imagine an athlete who wins the gold meda

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

l with a Personal Diamond performance. How would the audience and athletes respond to that record-setting p

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

rsonal and global achievement?

Now think about your family, your company and your department. How might li

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

Following aspects would a

e around you be enhanced by granting Personal Diamond Awards?

Would others be inspired by recognition of t

dd to the challenges in developing combination products:

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

heir ‘personal best’ in service, sales, teamwork, speed or innovation? Would they be more willing, more eng

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

ging, or more helpful and encouraging towards others?

Now think about yourself. What personal bests are yo

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

aiming to reach today? Is it focus, attention, commitment, generosity, forgiveness, responsibility or rela

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

xation?

How would you feel about a Personal Diamond Award extended from those who know you well? How would

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

Professional from academic institutions, pharmaceutical industries, health care indust

you feel about a Personal Diamond that you recognize and award to yourself?

Key Learning Point

We perform

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

in the Olympics of our lives every day. Whatever the field of your endeavor or the circumstances you face,

.

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

your life deserves your very best.

Action Steps

The next time someone achieves a personal best, acknowled

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

Companies that provide selfless information through particip

e them with a Personal Diamond Award. They will feel stronger and more committed. You’ll feel terrific, too

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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