Main Subject - Business

Before we can begin setting goals, we first have to establish a couple of pretty important things. Goals are where we what to get to, aren’t they?

First, before we can figure out where we want to go, one of the t

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

hings we need to figure out is where we are now, plus why do we want to get to the goal?

Try this. Grab that trusty note pad and a pen or pencil. On the left side of the page make a list of all t

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

Examples of combination products may in

e things that you would like to see different in your life. Be as specific as you can. Now I have a word of caution here.

As you write the list, you might be tempted to focus on what you haven’t got in your life

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

et. This makes some people feel sad or even angry. So my suggestion is this. On the right hand side of the page, list all the things that you can think of that are working well and that you have achieved.

Take a

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

oment and be thankful for what you have already accomplished and what is working. It’s a universal truth that what you focus your attention on grows. Please don’t get caught up in the trap of thinking about what’s

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

Combination pro

wrong, be grateful for what’s working. What isn’t quite working yet for you isn’t right or wrong, it just isn’t working and soon it will change, won’t it?

Remember, you aren’t a finished product. You are a work i

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

progress. Take five minutes and get the lists started now. After you have completed this arcticle you can get back to your lists and build on them some more.

Secondly, let’s start another list. This is what I li

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

e to call the Core Values list. This list is essential to effective goal setting because it is what will help create the passion to propel you towards your goals. The core values list will clarify

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

who you are and why you want what you want in life.

Often, I find that people who bypass this step often end up setting goals that are chosen by someone else for them. That won’t work. Goals need to come from wit

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

in you. How do you determine your core values?

You need to look inward. You need to ask yourself what are the absolute most important things in your life. Then rank them in an order of personal importance.

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

That means, not what’s most important to your spouse or partner, your kids, your parents, your friends, your boss, your _________.

Make the list by ranking the items in importance to you.

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

Following aspects would a

Does this mean that I’m suggesting you be totally selfish and self centered while ignoring the wishes of everyone else? Heck no. In fact, one would hope that your priorities are basically in alignment with those o

dd to the challenges in developing combination products:

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

at least your spouse or partner, your kids, your parents and your boss. If they are not there might be other issues in play.

Those people will generally, but not always, be supportive of you. Friends may be anot

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

er issue. Have you ever heard the expression, “birds of a feather flock together”? Generally, that’s why people are friends, isn’t it?

As you begin to achieve more successes in your life, both financially and per

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

onally, because of your choices that work for you, be aware that others may not be comfortable with your achievements. This will be especially true if they don’t have the drive and passion that you will develop.

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

ome actually may try to discourage you. Just be aware. Let’s take stock of some things that might be considered core values that may help move you towards certain goals.

The love of family

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

Professional from academic institutions, pharmaceutical industries, health care indust

The desire to help people

The need to be recognized

The desire to display strong ethics

A strong spiritual life

The need for adventure

The need for security

The de

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

ire for a lavish lifestyle

The need to feel fulfilled

The need to feel happy

The need to feel good

These are examples of some core values. I don’t say one is better than another i

.

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

your life because it is your life and you get to choose. You must build your personal list because it’s these core values that will provide the answer as to why you want to pursue a particular goal. Without under

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

Companies that provide selfless information through particip

tanding why you want to achieve a goal your ship will be rudderless. Goal setting really does work if you do it well. Those who don’t have clearly established goals, seldom achieve at the highest levels of success

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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As business owners and professionals, we made the decision to open our business for many reasons. The first one is (or should have been) because we have a love of what we do. We want a worklife focused on what we love doing and what we're most skilled at doing. The second reason is often that we want control over our lives: We don't want someone telling us what we’re worth.We want to control our schedule. We want to control our life.

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