Cases - Business

Who would expect that watching a fifty year celebration for Larry King wou

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

ld get me thinking about the attributes of great coaches, sales profession

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

Examples of combination products may in

ls, clients, consultants, you name it. The other night while watching La

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

ry being interviewed by Katie Couric, Katie asked Larry what makes a great

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

guest. His response got me thinking. Larry said they have PASSION; they

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

Combination pro

are able to clearly ARTICULATE what they do; they have a CHIP ON THEIR SHO

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

LDER and they have a SENSE OF HUMOUR.

Larry named a few examples, such as

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

Frank Sinatra, who had all four attributes, and Jimmy Hoffa, who by the wa

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

lacked a sense of humour. Go figure! I started to think about all his g

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

uests and who was the most engaging of them. True enough. They were all

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

assionate about something, clear and easy to listen to, funny and edgy all

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

Following aspects would a

at once. This really struck a chord with me. I know that all the named a

dd to the challenges in developing combination products:

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

tributes are highly valued in coaching relationships for example.

Your co

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

ach should exude passion and commitment where your success as a client is

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

oncerned. Your coach should help you achieve laser like clarity and demon

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

trate laser like clariety as well; your coach should be slightly edgy and

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

Professional from academic institutions, pharmaceutical industries, health care indust

y that I mean having the gumption to call it like it is; and your coach sh

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

ould be able to laugh with you and not take themselves too seriously. You

.

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

know when I think of Larry’s description of the great guest, it seems so s

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

Companies that provide selfless information through particip

mple and somehow it’s such a gem. Thanks for sharing Larry. And Congrats

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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When starting up a business, there are some important legal matters that you’ll have to deal with, no matter how much you’d love to just dive in and get started.

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