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I met and coached a CEO recently and he confided in me that it can be lonely at the top. He is recognized throughout his organization as a wise and competent person. H

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

e is there to bounce ideas off of, is running the company, having regular management meetings and retreats and is managing the hiring and firing of the company.

The bi

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

Examples of combination products may in

distinction that came out of the coaching when to be formal versus informal. It’s a great lesson to learn.

Being folksy and informal is part of the American way. It’s

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

down home, “Bill Clintonesque” and fun and lively. I teach charisma which shows a person how to have the ability to switch on the personality when it’s needed. This p

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

rticular CEO felt a bit taken advantage of by one of his managers. They became good friends and golf buddies and slowly the friendship was mirrored in the boardroom. Sl

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

Combination pro

ightly, ever so slightly, the formality wore off around the other managers and the CEO became more like one of the guys and not like the leader he once was.

We discuss

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

d that every human has basic needs and one is the need to be loved and admired. Those needs need to be filled, but the question is, by whom? Does a leader need to be l

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

oved by those he leads? Does he need to be strict or a lovable teddy bear type to be effective? What about you? Can you ask yourself: When should I act formal, if ever,

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

and when should I act informal, if ever?

Certainly, each person has the right to answer those questions by themselves but the truth is that in most circles, being comp

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

letely folksy won’t garner the type of respect that a person needs in order to maintain respect for ones work. Structures, protocols and guidelines can help a person wh

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

has the tendency to be down to earth in their personality, seem more formal in work. Without those structures, the “feel” is a bit loosey-goosey and not all that cred

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

Following aspects would a

ble.

I’ve gone through my own formal versus informal game recently. I’m new in a community and am building a PR, coaching and communication business. I’ve got one of t

dd to the challenges in developing combination products:

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

hose gregarious, fun and lively personalities so that’s fun when I’m socializing. I’ve realized though that in business, that personality is best left on the shelf unti

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

I’ve proven my effectiveness in business. I have found that it’s best to be effective first, and have fun later. I’ve even decided that because I’m in the community wi

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

th friends AND potential clients, to save my gregariousness for close friends and family. It’s a choice that I’m making for the good of my business. And business is my

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

priority and responsibility right now, not just having fun all of the time.

Try it on yourself. Imagine yourself with your mate’s work associates. How do you want to b

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

Professional from academic institutions, pharmaceutical industries, health care indust

e seen? What about with the President of the US? How would you act with him or someone else you greatly respect? Now, imagine yourself with your best friends and your p

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

tential best clients? How is it that you want to appear and act then?

Monitoring our own behavior sometimes is a difficult thing to do. As humans we want to tend to m

.

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

ake ourselves right all of the time and any critical look at our actions are somewhat hard to take. However, this is the best way to grow, and to improve relationships,

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

Companies that provide selfless information through particip

our image and our business, by looking at ourselves.

The old saying goes, if you want to grow your business, grow yourself. What have you done to grow yourself lately

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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