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As a young employee I was transferred to work in an office tower in downtown San Francisco. I wasn’t the only person to arrive in this new office space – the group had changed significantly due to reorganization and many of us were working together for the

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

first time.

My boss, the Marketing Manager, asked me to help him with some unusual projects. First, I organized an ugly tie contest. Next, we created a puzzle where everyone told me their fantasy identity (who they would be if they could be anyone) and I

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

Examples of combination products may in

created a quiz. People had several days to try to figure out who was who. This culminated in a party and the revealing of all the secret identities (and prizes for those who had done the best guessing).

Along with many other events, we eventually institut

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

ed the first casual Friday in this company (hey, this was 1987).

At the time I knew what was happening and why it was important to the development of the culture in this organization. But I didn’t understand it the way I do now. . .

For a whole variety of

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

reasons, organizational culture is important to the health or viability of any organization.

It is one thing to know something is important. It is another thing entirely to know what to do about it. This article will give you some specific things you can

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

Combination pro

do to act on the importance of your organizational culture.

Get help. Wherever you sit in the organizational structure or hierarchy you can impact organizational culture in a positive (or negative – but why would you want to do that?) way. Admitted

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

ly, if you are in a position of leadership, it might be easier, but we can all have an impact. But we can’t do it alone. Form a team of like minded, interested and enthusiastic people, and get them on board with developing and enhancing your culture.

G

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

et a vision. Get your team to discuss the current culture. Define the parts of the culture that are already great and need to be supported. And honestly determine where the culture could use some polishing. Then create a vision of the culture you want

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

to create, taking into account the entire current picture –the warts and the beauty marks.

Get strategic. Your team will recognize that this is important – you’ve picked people who already understand that and you have developed a deeper understandi

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

ng as you created a vision of a desired future culture. Help everyone understand - the team and organizational leadership – that this isn’t a band-aid, quick fix; but an ongoing, strategic intention to build a more attractive culture that fits the needs of

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

he organization.

Get people excited. Chances are your culture team will be excited. If not, get them excited! Help the team recognize that not everyone else in the organization is going to think that these efforts are worthwhile immediately. Reme

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

Following aspects would a

mber that enthusiasm is contagious. Do what you can to keep the enthusiasm of your team high. If their excitement falters, remind them of the vision they created to re-invigorate them.

Get a champion. That person may be you, or it may be someone e

dd to the challenges in developing combination products:

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

lse on the team. In my case, I took on an alter ego of the “phun phantom.” While a moniker might not be necessary, a point person, whether anonymous or not, is important. Culture change is like any other change – it requires champions. The champion needs

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

to be someone who is passionate about creating the new culture. As in my case, this might be a perfect role for a young energetic person, but don’t assign the role. The best champions will rise up and “select” themselves.

Get started. Yes, I have

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

listed the first five suggestions in a chronological order. But that doesn’t mean you can’t so something today, as soon as you finish reading this article or right now. You already know some things that need to change in your culture, so role model one of

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

hem starting immediately. Maybe your first step is to invite a couple people to lunch that you think might want to be on your team. Whatever your first step is – do it.

Get momentum on your side. Any change will have a greater chance of success wit

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

Professional from academic institutions, pharmaceutical industries, health care indust

h momentum. Don’t form your team today if you don’t think you’ll be able to get them going quickly. Don’t think of this something that can be done in a couple of weeks. A single event that you hope will permanently change the culture - won’t. In fact, it

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

might have the opposite effect entirely. Get started but be committed to building momentum and staying with it. It will be one of the most rewarding efforts you and your team will ever engage in.

I haven’t given you specific cultural events to try. Why?

.

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

Because I don’t know what kind of changes you want to create. In my case we were trying to create higher levels of camaraderie and more fun in the workplace. You may have that and may want to enhance your culture in completely different ways. You and yo

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

Companies that provide selfless information through particip

ur team will figure out what to do. This list is meant to help you figure those things out for yourselves.

These seven things are by no means a complete list – but they are a great place to start. And getting started is the most important next step of all

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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Out of everything I do I get the most enjoyment from speaking and teaching. Maybe it’s the old stand up comedian in me, but nothing feeds my addiction like standing in front of a room of entrepreneurs talking about the ups and downs, the ins and outs, the do's and don'ts of business.

There are many different ways you can be trained for an mlm business. You can select whatever training is good for your time schedule.

A good business plan has ten key components. Providing a comprehensive assessment of each of these components is critical in attracting investors. This article discusses the first five components.

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