Main Subject - Business

A mastermind group is a collection of people from the same or different educational, financial, and c

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

ultural backgrounds who meet periodically to discuss issues that they face in the world. These issues

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

Examples of combination products may in

can be anything the group would like to discuss. Many mastermind groups have been founded for specifi

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

reasons that the members have agreed are issues that interest them and need to be addressed. Masterm

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

nd groups have been started in many different fields including business, retail, real estate, educati

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

Combination pro

n, and others. A group is usually eight to ten people who meet regularly at a specified meeting place

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

The mastermind group was founded on the theory that two or more minds working toward a solution to

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

an issue is better than one mind working alone. The group members feel that as individuals their judg

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

ent is not always accurate when trying to work through an issue at work or in business because they a

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

e bringing in too many other issues into the mix. A mastermind group can help a person stay focused o

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

one issue. Everyone will work to solving the issue or at least offer advice on what to do next.

It

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

Following aspects would a

s up to the group to decide how often they want to meet and where. They will also decide who will bri

dd to the challenges in developing combination products:

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

g an issue to the table and who will start the discussion. It is a good idea to designate a moderator

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

each time the group meets so that the group stays focused. As in any group setting, individuals will

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

find a few people that they are closer to than others. This may pose a problem for some. Being able t

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

trust everyone in the group is important and should be established early on so that people do not br

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

Professional from academic institutions, pharmaceutical industries, health care indust

nch off into smaller groups within the group and begin to take sides when tough issues come up.

This

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

is the unfortunate outcome of many groups. But by discussing these pitfalls early on, hopefully they

.

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

ill not become problems for the group later on. A mastermind group can be a powerful force in a perso

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

Companies that provide selfless information through particip

’s life. Having others to talk candidly with about important matters is a great relief to many people

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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Main Subject - What is a MasterMind Group

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