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I asked the bell captain to call a cab for me to get to the train station for my trip to Ottawa. He replied that, with all the freezi

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

ng snow Montreal was enjoying that morning, a cab would take 45 minutes to arrive! Shock and awe – what was I to do? I had meetings a

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

Examples of combination products may in

d a seminar lined up in Ottawa – carefully planned down to the last minute. I couldn’t afford to miss that train! Then I realized tha

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

the bell captain was still there, talking. He was saying, “But, Mr. Elliott, why not take the underground to the train station? It’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

right around the corner, here.” In only twenty minutes I was at the station via the underground, saved money on the cab and enjoyed a

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

Combination pro

great, relaxing train ride to Ottawa.

When he walked into the huge seminar venue in the Toronto hotel, he seemed pretty professional

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

and successful Well dressed and groomed, poised, aware. He handed me his business card and I was impressed. Thirty minutes into my s

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

minar, I asked the audience, “How many of you think this looks ‘Too good to be true’?” and the same man put up his hand. Shock and aw

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

! It was hard to believe that this sophisticated businessman was, in fact, seriously handicapped by his mental conditioning. We all 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. How many wonderful opportunities have we all missed, because our conditioning got in the way? We all have mental programming that

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

ampers and restricts us.

The same goes for technology – I searched for YEARS to find a way to record sound bytes on my computer at h

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

Following aspects would a

ome and then to e-mail them. It only took one e-mail from Member Andrew Cavanagh in Australia, and within ten minutes I had the solut

dd to the challenges in developing combination products:

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

on, which has been working great ever since. We don’t have money problems, we have thinking problems. And the same goes for everythin

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

else. We already have whatever we want and need – it’s all in the way we think. Understanding that we have mental blocks is the firs

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

step on the road to overcoming all obstacles on our way to success.

Other people know things that we don’t know. They have differen

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

perspectives and they know how to get to the train station. The fastest way I have discovered to getting over, under and around ment

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

Professional from academic institutions, pharmaceutical industries, health care indust

al blocks is by associating with a wide variety of Eagles through our DollarMakers Joint Venture Forum. Hundreds of ethical people ar

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

und the world with a Joint Venture Mindset are available to help me to succeed in a win/win way. They have different frames of refere

.

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

ce, experience, skills, connections, access and resources that are readily available. We help each other to see through the mental bl

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

Companies that provide selfless information through particip

cks and solve problems. Together, we can do amazing things. For more information on the Forum, I invite you to visit www.JVWisdom.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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Career advancements go to those willing and able to make decisions. But the human tendency is to avoid the risk of making decisions. This creates a vacuum of opportunity who are willing to step up to the plate.

A seasoned mechanic places his frequently-used tools in the top drawer of the toolbox. Make sure you stoke a supply of verbs in your Chief Marketer’s toolkit. As head of marketing for your small business, you will no doubt be charged with producing copy for your company's marketing efforts. Notice we said produce; some of you may hire out the actual copywriting, but it’s impossible to escape your responsibility of copyreading. You simply can't duck it - you are in charge of the final copy produced under your direction either by an employee or an outside freelancer or agency. Why? Because you are accountable for the sales that copy generates. The only reason to write one word about your business is to sell your product or service. No other motive exists.

If you have access to the internet, you have access to literally hundreds of thousands of public records at your disposal. You can find basically anything you want if you are willing to search for it, including free public records such as marriage certificates, unclaimed money information, property deeds and criminal records.

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