Subjects - Business

During the past 10 years I have had the good fortune to coach a number of good clients. About 17 percent of the ind

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

ividuals who have entrusted themselves to me have been Chief Executives or Main Board Directors of corporations wit

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

Examples of combination products may in

h turnovers counted in the hundreds of millions.

Coaching is like most other businesses in that the coach needs to

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

keep learning and progressing in order to stay up with the game. One of the most valuable sources of knowledge is

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

one’s clients.

This is especially true when you are coaching people who are already very successful. You notice wh

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

Combination pro

at they do and how they think and adopt some of their best traits into your coaching toolkit.

There is one really

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

noticeable difference between highly successful executives and those I would term “ordinary managers.” They are pre

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

pared to act and make changes in the way they behave. In other words they are not stuck in behavioural ruts.

When

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

you agree a plan of action, with clear, well defined goals with a good client, you can be sure that they will start

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

to implement it straight away.

And, importantly, they also go further than simply implementing their new strategy

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

; they can also be relied upon to keep behaving in the new way until it becomes a new habit. In other words they ma

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

Following aspects would a

ke it an automatic reaction to a given situation.

Their new habitual behaviour quickly replaces the old behaviour

dd to the challenges in developing combination products:

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

that was causing them problems.

I recently had first hand experience of how effective it is when you change a hab

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

it. When I stood on the scales on the first day of the new year I weighed 197 pounds. That was 41 pounds more than

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

the 156 pounds I weighed when I got married. So I decided then and there to trim off 31 pounds.

Now I knew from ta

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

lking to lots of people who had tried dieting that diets tend to be less than successful. So I decided to completel

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

Professional from academic institutions, pharmaceutical industries, health care indust

y change my eating habits. I adopted a new meal regime.

It was not easy, but it has worked. In the first 3 months

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

I have lost 20 pounds, so I am well on the way to my target.

Later today I will publish another article “Why Diets

.

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

Don’t Work And This Does” about what I have been doing. Basically I am still eating what I have always eaten - I j

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

Companies that provide selfless information through particip

ust eat less. The real secret is in how I control my mind. It is an important lesson I learned from my good clients

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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