Main Subject - Business

The reason most people never reach their goals is that they don't define them, or ever seriously consider them as believable or achievable. Winners can tell you where they are

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

going, what they plan to do along the way, and who will be sharing the adventure with them. - Denis Watley

Step Four to Achieving Career Joy - Commit to Action

What c

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

Examples of combination products may in

ame up for you when you were taking inventory? Were there any themes that kept emerging? How did it feel to wave your realistic magic wand and say what you want? For some people t

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

he answer is scary and by saying what they want, they suddenly feel a responsibility for achieving it and realize that if they don't, they only have themselves to blame.

I think

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

that is a pretty powerful concept actually because when we look at it from this perspective, we have 100% control over what we have and what we want. In fact, I would argue that w

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

Combination pro

have exactly what we want - or at least that which we are committed to getting. So, what do you want?

Look at the 8 areas of your life and then reflect on questions #4 and #6. W

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

e touched on the magic wand concept but what about the action plan? Do you have one? If you do, great. If not, it is time we get started.

Most people are good at setting goals. 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

hey can spend all day identifying something they want (set the goal) but the execution gets them every time. Why? Because setting them is one thing, working toward them tirelessly

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

every day no matter what is another. And that is what it takes. Daily commitment to achieving the goal is the only way it happens. Oil billionaire HL Hunt said success requires t

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

wo things: 1) you have to know exactly what you want and 2) you have to determine the price you will have to pay to achieve it and then get busy paying the price.

Achieving goals

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

takes time, energy, focus, commitment and the ability to overcome obstacles that are sure to get in your way.

Exercise:

1. Identify your top 3 goals in the area of your c

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

Following aspects would a

areer. (you can apply this process to all areas if you wish)

2. Identify a specific date by which you want to achieve your 3 goals.

3. Break each goal into 5 steps and identify

dd to the challenges in developing combination products:

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

5 things you must do or that must happen in order for you to reach this goal.

4. Create a time-line for each of the 5 steps for each goal. On this time-line include what you will

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

accomplish, by what specific date, how achieving it will move you closer to your ultimate goal, and how you will know you have accomplished it.

5. Make a commitment to view obst

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

acles as merely pebbles in the water and identify the support systems you have in place when you are faced with an obstacle.

6. If it feels right for you, share you goals with a

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

rusted friend.

7. Every night before you go to bed or first thing in the morning, spend 10 minutes focusing on your goal. Whether you choose to do a visualization where you see y

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

Professional from academic institutions, pharmaceutical industries, health care indust

ourself accomplishing your goals or you want to make a list of the things you will do today to bring you closer to your goal, it doesn't matter. What matters is that every day you

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

give your goals your attention. You will become what you think about most often. This daily practice will have a huge impact on whether or not you accomplish your goals. Keep you

.

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

r eyes forward but work in the present. And, when you are forced with choices each day, ask your self this question. Will this choice bring you closer to or further away from reac

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

Companies that provide selfless information through particip

hing your goal.

8. Think about how you will feel in 6 months or 3 years if you achieve your goals. Think about how you will feel if you don't.

Stay tuned next week for Step Five

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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