Useful Advices - Business

Step IV: Recap the Conversation

Your prospect has been talking for a while.

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

You’ve been taking notes and developing needs, providing solutions and listen

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

Examples of combination products may in

ing to their concerns. That’s why you want to take this opportunity to recap

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

what you’ve discussed to this point. I would suggest the following, “ Jim,

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

know we’ve talked about a lot of things going on in your business. I just wa

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

Combination pro

nt to confirm your 2 biggest concerns are ______ and _____.

You want to recap

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

for a few reasons:

1. They need to agree these are their biggest problems.

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

his is the type of problem that will require immediate action.
2. Maybe y

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

ou haven’t heard their biggest problem. If you haven’t, now is the time for y

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

ou to find out what ‘keeps them awake at night’.

If they have agreed on their

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

problems, you now need to know when they would anticipate making a change. “D

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 time frame in mind for making this change?” is a perfect question

dd to the challenges in developing combination products:

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

to ask. You can’t try to close someone who isn’t expecting to make a purchas

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

e for 12 months.

You also need to know who else might be making this decision

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

You can’t close someone who isn’t at the meeting. A good question to ask he

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

re is, “If you were to move forward with this purchase, is there anyone else

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

Professional from academic institutions, pharmaceutical industries, health care indust

who needs to be involved in the decision? This is also something you should a

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

k before you ever agree to meet with a prospect.

You’re now ready for the mos

.

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

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

Companies that provide selfless information through particip

a target="_new" href="http://www.susanadamshome.com">www.susanadamshome.com

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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