Your Space - Self Improvement

Sometimes when I refer to the Authentic Self, I receive confused looks. Can you imagine? Authentic is a word which is commonly used to describe an article or concept as genuine. When I talk about the Authentic Self, h

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

owever, I am referring to who we really are at our core, a unique blend of four equal components: values; passions; talents; skills.

So, this summer plan a road trip. Gas prices don’t matter; you don’t even need a car.

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

Examples of combination products may in

But an exploratory attitude is necessary. You’ll be taking a voyage toward this new self, to a state called Authentic. It’s a place where you may not immediately recognize the people and it will take some work to get

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

there. But when you arrive, decisions are easier, success is genuine and your life feels complete.

Let’s begin this journey by looking at a compass designed for our Authentic Self. For easy recall, we’ll still use the

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

standard points: N, S, E, W. This compass serves as a manual for our expedition to Authentic.

N=Notice the Should’s. Should’s and their evil twin, Must, maneuver you away from your Authentic Self. They are danger word

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

Combination pro

. Avoid them at all costs! If you find yourself using should or must in your life, you will be perpetually disappointed in your life. Because by speaking in should and must you measure your life against someone else’

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

s standard. This is a recipe for failure and frustration. Our Authentic Self is measured by our own internal standards.

S=Start with honesty. Do you speak truthfully and behave in a way which illustrates your persona

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

integrity? Are you aware of how your mind speaks to you? When we begin all acts with our honest self facing forward we know that our subsequent thoughts and actions are worth following. Honesty honors your Authentic

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

Self and others, anything else simply does not.

E=Envision your desires and wishes as essential. Think of them as powerful conductors. Desires and wishes are like leafy greens and healthful blueberries to our Authenti

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

Self, essential foods for strong growth. When we accept our desires and wishes as crucial and do some dreaming about what it takes to bring them to fruition, we start the process of their actualization. This actualiza

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

ion is one of the ways that we nourish our Authentic Self.

W=Wander with your values in mind. Ramble along this journey with your 4-6 unique values in the forefront of your mind. They are essential to living your Auth

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

Following aspects would a

entic Self. Values are the reference points that you hold ‘most personally meaningful in your life’. You use them to make decisions, act with confident trust and remind you of your Authentic Self. If you haven’t atten

dd to the challenges in developing combination products:

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

ed Awaken Your Passion and unearthed your 4-6 values, email me for an activity that can get you jumpstarted on figuring out one of them.

With this compass in mind, you are ready to start your journey toward Authentic.

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

Here’s what you do next:

Plan at least one day (24 consecutive hours-travel not included) where you will be away from your home & office. Make this escape alone. Borrow a friend’s beach house or her apartment while sh

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

is away at her beach house. Book yourself into a room at a hotel or retreat center. Many retreat centers are centered around individual time alone. Wherever you go, do not bring anyone with you. Do not spend time

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 food preparation. Elect to order room service or bring in take-out. If you are a foodie like me, pack some delicacies that you especially love.

Once you have made a date with yourself, plan your time away. Gas up t

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

Professional from academic institutions, pharmaceutical industries, health care indust

he car in advance. Leave your cell phone in the car. Your family can manage for 24 hours without speaking to you. Keep your laptop at home. Turn off the phones in your new space. If you like colored pens or sharp pe

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

cils, bring those. Consider candles, bottles of cream soda, flowers or whatever else you would like to make this new space completely yours. Bring a blank notebook and something to write with. Make this time all about

.

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

you. The important thing is to schedule this time and plan for your journey. Next time, we will discuss what we’ll do on our Authentic retreat. Happy trails!

Bonus Challenge:If you are going to try this experiment

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

Companies that provide selfless information through particip

let me know I’ll give you a little extra coaching before your retreat and after. And, I’ll also send you a coupon for $50 off Personal Revolution!-A self-esteem retreat for women. Just for being a daring experimenter

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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