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Leadership is a lost art especially when it comes to leading organizational change. Go on Amazon and there are a ton of books written about leadership. I could write one maybe ‘Everything I know about leadership I learned in the Marine Corps in Vietnam’. It’s true! A

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

nd nothing changes faster than the battlefield. But leaders today don’t get it. They think leadership is a position. I’m in charge so you follow. It’s not happening, especially during times of change. I’ve learned a few things that have worked and a few that don’t in

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

Examples of combination products may in

my thirty plus years leading people. The one thing I know for sure is that you must engage the ‘whole’ person. Each one of us brings three things to the party, our hands, our head and our heart. Let me explain.

For starters, each one of us brings our hands; that is

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

ur skills to the job. If we work at McDonalds they have pretty much idiot proofed their processes and the skill required is to show up. If you’re a builder you hire people with carpentry skills, a trucker and you hire truck driver skills and so on. For us in Vietnam,

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

as a Marine sniper, it was our shooting skills. Many leaders and organizations don’t get this at all. During times of change understanding true leadership is important. You need the skills of your people, that’s for sure, but oftentimes you make changes that render t

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

Combination pro

e current skills useless.

The next part of the person a leader must engage is the head. The head represents a person’s intellect; their engagement to think and problem solve and bring more to the job than just skills. When I worked at Compaq Computer in the mid-nine

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

ties they hired a lot of intellectual people who brought their heads to work because that is the business we were in. Engaging the head is of the utmost importance during times of change. You need all the help we can get. But as leaders, do we engage their heads in t

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

eir work or allow them to just be involved to the minimum? It’s a choice but during times of change especially it will make all the difference.

The third and most important element a leader can engage is a person’s heart, their passion. This can’t be bought, it must

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

be led. In the early days of Compaq, or any start up for that matter, the hearts of the people are engaged from the excitement of the start up. Great leaders keep the engagement of the hearts because of their leadership, not because of the start up. But during times

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

f change you tend to lose their hearts, their passion because everything is different. Be aware … this is a big deal.

During the Vietnam War came the world’s first massive use of helicopters. With the advent of the helicopter came leaders who now commanded from abov

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

instead of on the ground. The fact that your commander was in a chopper and not hooking it out next to you brought about a lot of distrust and anger, resentment over the fact that your leader didn’t know the same thing you knew about the battle. They often commanded

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

Following aspects would a

our hands and demanded our heads but were far from our hearts.

Yet we had one Colonel, his name was Masterpool, who we would do anything for. Why? Because Masterpool tapped our hearts and our passion, he didn’t just command. Once while out on a long operation where

dd to the challenges in developing combination products:

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

the fighting was heavy we were forced to march, at night, to a nearby base because helicopters were unavailable. Colonel Masterpool was on the ground the whole time, marching with us, encouraging us by walking up and down the column of weary Marines telling us we’d h

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

ve steaks at the mess hall when we returned. And at 0100 when we arrived he rousted the mess crews from a deep sleep and demanded steaks for his troops. We would have followed him anywhere because he tapped our very being with his leadership. He tapped our hearts.

T

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

e three parts representing the whole person must be engaged to get the most out of your organization and to successfully drive change in a reasonable amount of time. Think about Gandhi for instance. He inspired an entire country with his leadership although he never

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

eld an elected position. Gandhi’s leadership brought down the British Empire and he never held an official position. Why, because he engaged the whole person, not just one or two of the parts. He led by example and people knew they were important to him.

The foundat

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

Professional from academic institutions, pharmaceutical industries, health care indust

ion of this concept was borne on the battlefields of Vietnam as a Marine sniper, with two consecutive years in the Vietnam War, and is still applicable today. We were highly trained in marksmanship and that was our skill. We were highly trained in tactics, given incr

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

dible support troops and trusted to complete our missions. We were allowed and expected to use our intellect. Then we were part of an outfit with a strong and proud history, with outstanding leadership above us and while our country wasn’t behind us, our Corp was … w

.

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

had passion. Over half of our sniper outfit volunteered for more time in country than was required? I stayed 24 months, another of us 34, one 31 and many 18 months. It sure wasn’t because of the money; I think they paid me $270.00 a month with hazardous duty pay. No

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

Companies that provide selfless information through particip

it wasn’t the money; it was because of our passion to serve the man next to us, our Corp and to be the best at what we did.

To succeed at change when everything is confusing, leaders must engage the passion in their followers by engaging the whole person.

Ed Kugle

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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While women are still a minority in the corporate realm, many companies are encouraged to adopt Harry Klemfuss’ idea to recognize the importance of women in the office. In recent years, special products have been developed in order to recognize the hard work that women contribute to Corporate America.

The number one mistake made by applicants is not addressing selection criteria / KSAs at all (we'll save that for another article!) but for those who do address criteria, a common theme emerges, and unfortunately there are generally more things wrong with statements addressing criteria than there are things right.

If you have ever went jobhunting, which of course most of us have, chances are your search began on the World Wide Web. Unless of course you predate the Internet. Truth be told, there are scores of career websites filled with hundreds of thousands of jobs. There are absolutely tons of jobs available in every industry imaginable. You just need to know where to look, and what to look for.

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