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As I was finishing a chapter on executive leadership and peak performance for my new book with Stephen Covey and Brian Tracy, I was asked to give a few examples of

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

my clients’ success stories. The more I got into developing the list, the more I had to work at condensing their stories - because we’re all unique. and it’s the be

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

Examples of combination products may in

hind-the-scenes details that are so fascinating. Sure, I can rattle off a list of clients and describe their “before” and “after” situations, but that’s not the 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.

tory that needs to be told. You see, a mere list misses the critical issues and full richness of the experiences these wonderful people faced during significant per

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

iods of their lives. So what do people need as they face significant challenges or critical periods of growth in their lives? Well, I don’t think you can effectiv

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

Combination pro

ely separate personal and professional issues; as a professional coach, I look at how the person functions as a whole. In that light, I’ll share with you a brief ov

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

erview of one of my clients’ stories, along with a few insights.

Bob H., a new CEO for a technology company, came to the Executive Roundtable to share in our best-

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

practices module. He was in an impossible situation, with an international board of directors made up of high-profile, wealthy venture capitalists. There was a noti

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

ceable leadership vacuum in the company; major decisions and key hires needed to be made to put the company into the black, but Bob was being micromanaged by his ow

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

n board and was intimidated by their wealth and status.

He needed to make some critical decisions based on his professional knowledge and ability - but he also had

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

a family to feed. Nevertheless, within a year he had implemented a new strategy, reformatting the board and getting its support; making those key hires and critica

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

Following aspects would a

l decisions that needed to be made; and had the company in the black six months later.

It sounds simple, but it wasn’t. First, Bob had to change his mind-set. He n

dd to the challenges in developing combination products:

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

eeded to fully understand the situation he was in. He really only had two choices: Make the tough decision to grow the company and risk getting fired, or start look

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

ing elsewhere to develop his career. That’s not easy for someone to accept. You may know it, and the client may know it, but that doesn’t mean they can hear it.

If

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

he accepted the status quo, the outcome was certain and unacceptable - a slow corporate death. Other options had been explored and failed, so in coaching Bob, it b

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

oiled down to understanding a major, bottom-line ground truth about leadership: A leader must have the vision and the courage to make the best possible decisions.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Of course, as his coach, I believed Bob had the professional ability to make it happen. Still, while I can get my clients ready to play the game, they have to play

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

it - after all, it’s their life. My job was to support Bob during this process by hearing what’s not said, and seeing what’s not visible. In Bob’s case, he needed

.

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

clarity in a complex situation. I knew he couldn’t take the needed steps until he changed his mind-set and fully understood his situation. Bob had to be ready to e

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

Companies that provide selfless information through particip

xercise his vision and make the tough decisions, and be ready to deal with the consequences. Once he realized that, and acted upon that realization, he got it done.

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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