Main Subject - Business

Well, you’ve read keys to leadership before, probably enough to fill a sizeable key ring! But let’s face it, leadership is about people – who else would you lead? So if it is

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

about people, there ought to be a way to systematically become more effective. And I’m not just talking about folks at work, but also about leadership with your spouse and chil

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

Examples of combination products may in

ren.

So what’s the scoop?

The key, as in almost any worthwhile endeavor, has to do with having a plan. In this case the plan involves defining three important “people area qu

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

estions”: “What are my roles?” “What are my key relationships within each of those roles?” And “What are the responsibilities that go along with each of those relationships?”

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

First off, What are my roles? Each of us has roles in life, some more than others. You might have a role as a boss, or as an employee. You might even have both! You might h

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

Combination pro

ve a role as a wife or a husband, or as a father or mother. My own key roles are as a boss, as a husband, and as a father. Whatever your key roles are, write them down on 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

left side of a piece of paper, and leave room between them.

Study those roles for a minute or two. Each role will have key relationships within it. For instance, if you are a

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

employee, you have a manager, supervisor, or an executive you report to. That’s a key relationship. You may also have a few people who work with you on a company team, and ag

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

ain, those are key relationships. Don’t put everyone in the company down, but capture the key few. List the key relationships to the right of each role you have on your paper.

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

Leave space to the right of each relationship, because you’ve still got more to do!

As an example, I have a role as a father, and the key relationships for me in that role inc

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

ude my three sons. I would list their three names to the right of my role as “father”. Now that wasn’t so hard, was it?

The third area to consider to make this leadership exe

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

Following aspects would a

rcise work is the responsibilities that go along with each of the relationships. Take some time to think about these. What do each of these people need from you in order be mo

dd to the challenges in developing combination products:

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

e effective themselves? If you’re a boss and the key relationship you are considering is that of an employee who reports to you, it might be communication. It might also be en

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

couragement, or a regular time each week to give you feedback. In the role of a father, you have to consider the age of the child you’re dealing with: a 12 year old needs a lot

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

more time than an 18 year old; and the activities you do with him or her will be considerably different. Whatever those key responsibilities, as you think of them list them to

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

he right of each relationship.

Now you’ve got a full sheet, I’ll bet! The final step is to start taking those responsibilities and making time for them. And this is important

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

Professional from academic institutions, pharmaceutical industries, health care indust

: if you’ve identified your key roles, and your key relationships within each role, and your key responsibilities for each relationship, you have a list of some of the most imp

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

rtant activities you can take time for in your life. Putting aside time here will make those who are important to you more effective. But it will do a lot more than that. Tim

.

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

e spent here will heal hurt feelings, it will smooth out misunderstandings, it will energize interactions. You will find that you get along better with these people, and that c

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

Companies that provide selfless information through particip

ises will begin to disappear in those relationships.

And isn’t that what true leadership is about…making others more effective? Try this out, I think you’ll find that it works

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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