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Subscribing to the old adage “two minds are better than one”, mastermind groups employ the use of like-minded people who come together to challenge one another, create and implement objectives, and to brainstorm ideas in order to support each other in the pursuit of

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

a common goal. Like rungs on a ladder, each member of a mastermind group aids and sustains the others in his or her climb towards their objective.

Mastermind groups were formerly introduced by Napoleon Hill, an American author and one of the first pioneers of the

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

Examples of combination products may in

“self help” genre. His book “Think and Grow Rich” is one of the best selling of all time. Hill states that mastermind groups are “the coordination of knowledge and effort of two or more people, who work towards a definite purpose, in the spirit of harmony.”

Althoug

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

h Hill may have been the first to coin the term “mastermind group” these kinds of assemblies have been in effect throughout the existence of humanity. Socrates’ academy fits the definition as does Jesus and his twelve disciples. The Great Pyramid builders would als

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

o have been a mastermind group. Using the skills of architects, astronomers, mathematicians, scientists, designers and a force of four thousand general laborers, these builders used the strengths of many to reach their famous and impressive goal.

In the early 1700’

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

Combination pro

, Ben Franklin purveyed one of the most socially relevant mastermind groups of that time. Commonly called the Leather Apron Club and officially termed the Junto, this group of young men who had no financial or social advantages, met weekly to discuss subjects such a

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

s philosophy, morals, economics and politics. It was comprised of enterprising tradesmen and artisans who adhered to the belief that each of them had something to teach and to learn. The group was in effect for forty years and eventually became the American Philosop

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

hical Society, the works of which are still evident today. The group was responsible for the implementation of the first public library, volunteer fire departments, the first public hospital, police departments, and even paved streets.

In the early 1920’s, six men

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

in Chicago (later referred to as the Big 6) formed a group that met once a week over dinner. At the time their names would have been unimportant, today we know that each of them went on to be hugely successful; thanks largely in part to the company they kept, provin

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

g that like-minded, goal-oriented individuals can radically influence each others success. The members included Charles Wrigley (the owner of the Wrigley chewing gum company), William Hertz and William Ritchie (the founders of the Yellow Cab Company), Albert Lasker

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

the owner of the Lord and Thomas Ad Agency (which was at that time, the largest ad agency in the world), John R. Thompson (the owner of a chain of successful lunch rooms) and Andrew Carnegie (who amongst other impressive endeavors, founded and owned the Carnegie Ste

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

Following aspects would a

el Company, a business that was worth millions). These men adhered to Napoleon Hill’s belief that “When a group of individual brains are co-coordinated and function in harmony, the increased energy created through that alliance becomes available to every individual

dd to the challenges in developing combination products:

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

brain in the group.”

Other mastermind groups include Presidents and their advisors, Bill Gates and Paul Allen, Walt Disney and his brother Roy, and Steven Spielberg and George Lucas. Being famous however, is not a prerequisite; consider a group of students studying

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

together for finals or a board of directors meeting.

Organizing a mastermind group is relatively simple. The key factor is to establish a protocol before the group is formed. Ask yourself what it is that you would like to achieve and then turn your attention to th

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

e people who you believe can help you attain that goal. Each member requires his or her own personal or business mission to accomplish and, the time in which to devote to that objective. Each person’s participation is essential, whether the members meet in person or

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

via telephone or on line. Peers give feedback, brainstorm new possibilities and set up accountability guidelines that keep the meetings focused. In addition, it is important that the participants trust one another implicitly in order to create an environment that is

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

Professional from academic institutions, pharmaceutical industries, health care indust

safe and non-judgmental. Gary Ralston, a senior business consultant at Ralston Consulting in Ohio says, “Trust deepens as the group forms. Confidentiality, like a water-tight bond, is the most important part of mastermind groups.”

Mastermind groups come in all for

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

ms and sizes. Consider the largest mastermind group of all. It has 1.2 million members in the Unites States alone and more than 2 million worldwide. Founded by two men, Bill Wilson and Dr. Bob Watson in Akron, Ohio in 1935, the organization consists of more than 105

.

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

,000 groups who adhere to the same set of guidelines and principles in order to reach a common goal. The members share their experiences with one another in the quest to solve their common problem. The goal? Sobriety. The group? Alcoholics Anonymous.

Perhaps the st

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

Companies that provide selfless information through particip

rength and potential of mastermind groups can be summed up best through the words of well-known cultural anthropologist Margaret Mead. “Never doubt that a small group of thoughtful, committed citizens can change the world. Indeed, it is the only thing that ever has.

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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