Advice You - Business

Leadership coaching is of critical importance in this age of speed and instant results.

10 years ago, coaching a leader on the basic elements of leadership was viewed as unnecessary.

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

After all, everyone knows this stuff, right? But we now live in a time where even the Wall Street Journal carries a regular column entitled Executives on Trial. Poor leader

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

Examples of combination products may in

ship is so prevalent in our society that we are less likely to blindly trust a leader anymore.

This leadership void didn’t happen overnight. It’s been occurring for quite a while.

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

Like anything else in our culture, it has gone through various stages of acceptance. It’s very much like comparing an R rated movie of 20 years ago to an R rated movie today. The ol

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

er movie seems tame in comparison. The standards haven’t changed that much but our perceptions sure have. We tolerate much more than we did back then. The same holds true for our l

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

Combination pro

eaders’ behaviors.

Virtually everywhere you look today there are concrete signs of eroding leadership. It’s frustrating to see, and it’s easy to feel that all we can do is complain.

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

But there is something we can do. We’re coaches!

We are like teachers – we influence the future by doing what we do best – coach. And in the world of leadership coaching there ar

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

e many opportunities to help.

Before you begin carving your niche to coach leaders, here are a few things you will want to consider:

1) Are you in full integrity? Do your ac

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

ions match your words? Do you keep the promises that you make to yourself? Integrity is a funny thing. You can’t measure it exactly but you sure know when it’s not there. So befor

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 you begin advising and coaching on the merits of integrity, be sure that you have your own house in order. In other words, be honest and truthful with yourself. Be a model of inte

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

grity for you first. When you model integrity, life gets a lot easier and your leadership coaching is more authentic.

2) Do you have a clear and focused program to follow? Y

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

Following aspects would a

ou don’t need to create a workbook or write a business plan, but you do need a path for your clients to follow; something that guides them through a process. It could be identifying

dd to the challenges in developing combination products:

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

basic steps that you verbally guide your clients through. Whatever that process is, define it, map it out, and then communicate it to your clients. A well defined process will keep

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

you on track with your clients and will also provide them with something they can stay focused on.

3) What’s your message? What do you stand for in the area of leadership?

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

This is not your opportunity to get on a soapbox and preach, but you still have to have a clear overriding purpose. Something that defines your brand of leadership coaching that mark

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

ets you and what you stand for. To coach leaders well – very, very well – you need to have a strong view of what a leader should be. A generic message won’t do; it’s got to have an

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

Professional from academic institutions, pharmaceutical industries, health care indust

dge to it. Now here’s the challenge – have an opinion but keep your judgments out of it. The leader isn’t seeking your approval. He or she will focus on your message and act on it,

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

if it resonates with them or inspires them. So what’s your message?

These are 3 easy-to-implement leadership coaching strategies to help you improve your leadership coaching. Work

.

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

on them and change the world – one client at a time. There is no magic formula here, only tried and true actions that have consistently produced results.

Leverage your leadership c

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

Companies that provide selfless information through particip

oaching strengths and talents, and grow and prosper along with your clients.

There are additional ways to develop your leadership coaching business. Visit our web site to learn more

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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