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The other day I was delivering some coaching skills training for a company when a

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

delegate asked me how she should coach the person who is an introvert and has litt

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

Examples of combination products may in

le to say.

This is the type of person when you start your coaching session by say

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

ing "How is everything going?" they just reply with "OK" and then the tumbleweed m

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

akes its way across the floor!

Overall, during a coaching session the coach shoul

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

Combination pro

d be doing around 30% of the talking and the coachee should be talking around 70%

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

of the time.

This is a challenge when you talk to someone who either does not hav

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

e a lot to say or who is naturally shy.

This is what I recommend:

After you get

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

the normal "OK" response ask this:

"On a scale of 0-10, with 10 being absolutely

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

perfect and 0 being the pits, where would you currently rate yourself?"

If the co

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

chee responds with a "7" that must mean that to have rated themselves a "7" they m

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

Following aspects would a

ust be comparing themselves to what a "10" looks like.

So the next response and q

dd to the challenges in developing combination products:

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

uestion to ask is:

"A rating of 7? That's great. What would a 10 look like to you

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

?"

Let them explain this and probe a little deeper.

What you are doing here is s

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

timulating a conversation by using an alternative method other than just saying "W

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

hat is going good right now?"

To someone who is naturally shy you are not going t

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

Professional from academic institutions, pharmaceutical industries, health care indust

o get a lot out of them by asking this question.

Then, the next steps would be to

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

ask:

"So you have described a 10. And you rate yourself a 7. What do you need to

.

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

do to bridge the gap?"

I hope you can see how powerful this method is?

And you

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

Companies that provide selfless information through particip

can use it on all types of people not just the shy ones - I use it all of the time

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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