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John F. Kennedy said, "Lofty words cannot construct an alliance or maintain it; only concrete deeds do that." Partnering and alliances are the terms used to describe mutually beneficial relationships. Partnering is the business paradigm for the next millennium. Relationships are the 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

orner stone of any successful business. Outrageously Successful Relationships (OSRs) are the conduits for successful business growth. More people in business today should make the smart decision and make daily Relationship Bank Deposits, the concrete deeds Kennedy spoke of in 1963. You m

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

Examples of combination products may in

ust make deposits before you can withdrawal.

Throughout my adult life, people have recommended that I should work harder. Some have suggested I work smarter. My choice is the latter, to work smarter. Business is getting more complex, seemingly by the day. Both you and I should continual

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

ly seek additional solutions to our daily business challenges. Partnering with others to create alliances for various reasons is my answer to the idea of working smarter.

First on my working smarter list is to develop a personal Mastermind Alliance. Mastermind Alliances, also known as s

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

rategic alliances for individual development, can assist you in eclipsing your competition. This holds true for both your career and your enterprise. I belong to a geographical mastermind alliance, called Gold Coast Speakers, which consists of other professional speakers and consultants.

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

Combination pro

We started meeting early in 1989 and continued to get together about once a month or so. This is a confidential environment where each can share their gifts and receive counsel on important business, career and personal issues. I do not believe I would have survived in my speaking care

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

er without this relationship. The members of my mastermind alliance are some very special and giving people. The group consists of not more than a dozen members that are geographically close to one another, this allows us to regularly meet. We rotate from home to home, each member having

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

the opportunity to host a meeting. We make it simply for the host by ordering delivered pizza.

Another mastermind alliance success story is the Downtown Palm Springs, CA breakfast club. A couple years ago I interviewed Tim Ellis, general manager at the Riviera Resort & Racquet Club in P

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

alm Springs. The interview was for an article about Palm Springs’ strategic alliance with other California cities to draw tourists to the state. He told me about his downtown Palm Springs mastermind alliance. It consisted of general managers from seven other deluxe hotels, the conventio

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

n center director and the owner of the aerial tram. They meet every Wednesday and rotate member locations weekly. They discuss issues uniquely important to the hospitality business in downtown Palm Springs.

I recently spoke with Tim. He is no longer at the Riviera. He started his own c

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

mpany, Lathom Hotels. Tim bought one hotel and leased another. The hotels both feature suites with full kitchens. He started his company to serve a neglected niche in town, long-term retired guests. He told me that much of his success comes from the networking relationships in the break

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

Following aspects would a

fast club. He said that he could not have picked up and done the same thing in another town. And yes, he still belongs to the alliance.

There are five personal core values that I believe are necessary for your Mastermind Alliance members to possess. They are trust, tolerance/ understan

dd to the challenges in developing combination products:

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

ding, cooperation/growth, caring/commitment, and synergy/mutuality. Use these values as your guide when making member selections. Too often I've heard people talking marriage but really acting one-night stand. This behavior is what I call cotton candy partnering. Like cotton candy, it lo

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

oks good and tastes great but disappears in seconds. These are definitely not concrete deeds and not the type of members you'll want in your Mastermind Alliance. In contrast, integrity partnering is what allows synergistic solutions, the concrete deeds.

Use your group as a sounding boar

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

for ideas you might have missed, to uncover unnoticed pitfalls in your plans and various other important areas that offer you value. In the group of which I am a member, we spent an entire year dedicating each meeting to individual members for dealing with their specific issues. Wow! It

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

was powerful to have several people focus their energy and attention to a single member's issues. Giving energy can be as powerful as receiving it. I learn when I am being helped with my issues and when others are helped with theirs.

To make this kind of alliance relationship valuable

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

Professional from academic institutions, pharmaceutical industries, health care indust

for all involved the giving or Relationship Bank deposits must be frequent. Additionally, all the members of the alliance must be committed to the alliance itself. When this happens the alliance becomes a living entity and begins to evolve in it's own direction. While this might seem odd

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

I have regularly found it to be true.

Inherent while building Mastermind Alliances, you will notice both benefits and pitfalls. The benefits of alliance relationships usually outweigh the pitfalls. Be careful and methodical in the search for Mastermind Alliance partners and in the elem

.

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

ents of which the alliance will operate. Remember Caveat Pars (Partners Beware), as the road to successful alliance partnering has roadblocks, land mines and quicksand pits. Knowing how to select the right alliance partners and making good selections is truly a concrete deed, of which K

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

Companies that provide selfless information through particip

ennedy spoke. Make your relationship Bank Deposits and you will surely develop Outrageously Successful Relationships (OSRs) with your Mastermind Alliance group members.

To access helpful additional information from Ed Rigsbee at no charge, please visit www.rigsbee.com/downloadaccess.htm

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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