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Recently I decided to stretch my athletic abilities and add a running program to my regular exercise routine. Although I had tried to run in the past, my level of success was pretty pathetic. This time, however, I decided to follow my own advice and find some expert runners

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

who could teach me how to run. And that is exactly what I did.

Our local roadrunner’s organization was about to begin a running clinic for inexperienced runners. I immediately signed up for the program. During the second class, we were asked to run one mile at our top sp

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

Examples of combination products may in

ed. What I lack in skill and endurance, I make up for in competitiveness, so I clocked in a mile at 9:28 (9 minutes and 28 seconds). While this may seem paltry for an experienced runner, I can assure you that it was a major accomplishment for me. During this speed test, I

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

began to see outstanding leadership qualities of one of my coaches emerge. Vera, one of the trainers, was absolutely thrilled with my time. She told me what a wonderful time it was for someone so new to running. I started to think that maybe I could finally learn to run af

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 all.

Almost two weeks later, I had a major lapse in judgment and signed up for a 5K (3.1 mile race). Now remember, I had just started running 3 1/2 weeks before and here I was ready to compete with 1,100 runners, some of whom could run a 5K in between commercials (not qu

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

Combination pro

ite, but they were very fast).

When I arrived at the race, I saw Vera at the registration desk and went over to her. “Vera,” I said, “I don’t know how to run a race. What do I do?” She looked up at me with a big smile and said, “You ran a 9:28 as your fast mile. Just aim

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

for a 10 minute pace for the first mile and you’ll be fine.” I walked away thinking that she had totally lost her mind. I couldn’t possibly sustain a 10-minute per mile pace for 3 miles. The best I had been able to do was just over 11 minutes per mile.

I ran the race, run

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

ning part of the way, walking part of the way, huffing and puffing most of the way, and wondering what I was doing there when I could be home sitting on the couch watching TV. A short while after the race ended, I discovered my time. I had run at a pace of 9:55 (9 minutes a

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

d 55 seconds) per mile. I couldn’t wait to share my success with Vera.

At the next class, I told Vera my time and she was delighted. “That’s wonderful,” she said, again with a huge smile and total conviction. “You’ll definitely be able to get down to an 8 minute mile.” A

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 8-minute mile? At this point, I can’t even imagine running 5 miles without having to walk. However, Vera is an expert and if she thinks I can, maybe I can.

Vera believed in me. While I didn’t believe that I could live up to Vera’s expectation of an 8 minute mile, I was

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

illing to borrow her belief in me and continue to try to get my endurance up and my time down. As I struggled to run and breathe at the same time, wanting to quit more than once, I repeated to myself, “Vera says I can do an 8 minute mile.” This kept my motivation in gear an

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

Following aspects would a

my feet in motion, even when I wanted to chuck the whole idea of becoming a runner.

You can use Vera’s leadership strategy to get your team and other people in your life to strive for better performance.

SET A HIGHER GOAL

Look at where your team member is currently perfor

dd to the challenges in developing combination products:

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

ming and set a higher goal. Make sure the goal is realistic for that individual. It must be something that you believe he or she can achieve. If, after I ran a 9:28 mile, Vera told me that I could run a 5-minute mile, I never would have believed her. She gave me a goal th

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

t she believed was possible for me, and since it was not that far away from what I had already done, it seemed that if I put forth the effort then I could achieve it.

COMMUNICATE YOUR EXPECTATION

Let the person know what your expectation is of him or her. Too often, people

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

underestimate their own abilities. However, there is a part of them that would like to believe they could do better. People usually meet the expectations that others have of them. Let your team members borrow your faith in them, while they might not yet have enough faith

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

n their own abilities.

BE A CHEERLEADER

Things don’t always go smoothly when people try to achieve something and there is a strong tendency to get discouraged and give up. That’s when you must encourage your team to keep on trying. Again, communicate your faith in their a

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

Professional from academic institutions, pharmaceutical industries, health care indust

bility to succeed. When I complained to Vera that I was still having a hard time breathing during my runs, she told me not to worry, that I would get there if I kept up with my workouts. Your consistent positive attitude is a critical to your team’s success.

CARE ABOUT YOU

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

TEAM

The bottom line that makes this entire strategy work is that you must genuinely care about your team members. Make them feel special. When Vera told me the exact time of my fast run, I was shocked that she remembered it without looking at her notes. This made me fee

.

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

l that she really cared about me and I began to trust her more. If your team doesn’t trust you, they will perceive everything that you say and do as manipulation. When they know that you value them, they will gladly let you lead them to greater accomplishments.

Follow this

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

Companies that provide selfless information through particip

strategy with your team and watch their performance soar. As for me, I still don’t know if I’ll ever be able to run an 8-minute mile. Vera thinks I can, so I’ll continue to practice even when I feel like quitting, and hopefully, one day I’ll live up to her expectation of me

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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In business, the entrepreneur’s aim is usually to generate a huge profit. Not just any profit, wealth. Wealth is usually the ending outcome of what drives a business long term. In taking a deeper look at wealth in business, wealth comes when you not only have passive income, but also when you have assets to back it up.

They say that image is everything and some of us have seen it all. Have you ever went into a store and just could not believe what you were seeing behind the counter? Is that a real human? Without trying to make the world into a civilization like the “Borg” there are a few things you need to think about in your small business.

Too many meetings, too little time. When the true cost of holding just one meeting is accurately calculated, it should provide sufficient motivation for us to want to ensure that all of our meetings are meaningful, necessary and can be justified.

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