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Leadership is the lost art of mobilizing people to get results. At no time is that more important than during times of change. As a change leader

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

turn around and see if anyone is following you. The first principle of leadership is that you have followers. Is there anyone there behind you …

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

Examples of combination products may in

I mean really there?

If you’re the new VP of Miracle One change project you’d better be sure you have followers and not just followers, but peop

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

le who follow because they want to go where you’re going. Take a look below and see what I mean. We’ll start with the question of why someone wou

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

d follow you in the first place. It’s for one of the reasons outlined below.

1. Position: This is pretty simple, you hold a position and there i

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

Combination pro

s respect and culture that says people who work for that ‘position’ will follow you because they have to. An example would be the military or the

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

police. There is clear rank and whether you truly are a leader or not, people must follow your lead. This category is the norm in most organizati

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

ons.

2. Desire: When someone follows you out of desire they want something you can give them. It could be more money, promotion, position or any

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

number of other things. This is pretty simple and is found anywhere leadership positions are found and it is probably one of the more common reas

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

ons people follow you.

3. Demand: Here you’ll find people who are perhaps long term employees and they work in the department or company you now

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

head and they simply must go along with you and your direction or lack thereof. They are found in every organization.

4. Leadership: This is wha

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

Following aspects would a

t you want for the majority of the people in your organization. They follow your lead and direction because of who you are and where you’re going

dd to the challenges in developing combination products:

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

You have a vision and an ability to communicate. People feel inspired and want to go with you. True leaders have followers in this category.

As

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

a leader, especially a change leader, you want to make sure you understand your followers and why they are standing behind you. You will never g

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

t one-hundred percent of your followers in category four of true leadership but you should be honing your skills as a leader to get there, at lea

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

st eighty-percent of your followers anyway. Yet most leaders don’t even know or care about why someone follows them. You need to be different if

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

Professional from academic institutions, pharmaceutical industries, health care indust

ou want to succeed at the business of change.

Leaders have followers because of who they are and where they’re going. In corporate America today

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

most so called leaders fall into category one or two and are happy to be there because they don’t know the difference. You’ll always have ten pe

.

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

cent in category three and each person has a mix of followers for sure, but true leaders are going somewhere that others genuinely want to go. Yo

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

Companies that provide selfless information through particip

u have to develop that kind of leadership and the ability to communicate during times of change if you want to be a real change leader.

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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