Advice You - Business

Each of us as we travel through life into our very personal future follows our own unique path. As we day by day, travel into the future, we make a variety of choic

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

es, decisions as well as take any number of actions – some positive, some negative, some better some worse than others. But, in the end; the end of the day or the

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

Examples of combination products may in

nd of a life we have all created the tapestry of our lives one day and one choice at a time.

It is unfortunate that many people do not have a clue as to where they

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

ant to end up, what they want to see or the roads they want to take. Oh, many of these people may say they are “on the right path,” but that is often their ego’s ne

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

d to protect itself from the criticism or judgements of others. In reality they don’t have a clue where they are going or why so they just trudge forward another day

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

Combination pro

until they come to that time or place that speaks to them so loudly they can no longer ignore or avoid it’s counsel: YOU ARE TRAVELLING ALONG THE WRONG PATH. YOU AR

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

GOING IN THE WRONG DIRECTION. YOU ARE RUNNIING OUT OF TIME. THE TIIME TO CHANGE COURSE IS NOW BEFORE IT IS TOO LATE.

As a fellow traveler for many years I have 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

o found myself lost, going in the wrong direction or been insecure I my position along the way and was easily persuaded to follow someone else’s idea of what they th

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

ught my path should be. Sound familiar? I have known hundreds of people, no maybe thousands who are not happy with where they are on the path and won’t be able to

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

e happy until they change direction or even get on another path. One of the interesting discoveries I have made in life of late is, that wherever I go, there I am.

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

I can change the path or the direction on the path but the traveler will still be me: with all of my opinions, prejudices, issues, judgements, dreams, hopes, frustra

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

Following aspects would a

ions etc. If the journey is to either be more fun, more rewarding or more satisfying in the end I must also be willing to look at the traveler and not just the path

dd to the challenges in developing combination products:

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

he/she is on.

What can we do to ensure we are on the right path, we stay true to it regardless of the pressures form others or our environment and find satisfaction

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

in the journey along the way?

1. Spend adequate quiet time alone reflecting on your life. Where you are. Where you want to be in the future. What needs to chan

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

e in order to reach that outcome, etc.
2. Refuse to be manipulated, coerced, pressured or lulled off the path that feels right for you. Be true to your own

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

inner guidance system.
3. Be patient as you travel into your future. Everything takes time, nurturing, faith and persistence. The outcomes of your short-te

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

Professional from academic institutions, pharmaceutical industries, health care indust

m actions are not always immediate or apparent.
4. Do something every day that moves you further along your path.
5. If or when you discover you are trav

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

lling the wrong path or in the wrong direction. Correct it, but first ensure that you ask yourself enough of the right questions before you abandon your current

.

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

direction. Nothing to be gained by jumping from one boat heading in the wrong direction to another one heading in the wrong direction.
6. Keep asking yours

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

Companies that provide selfless information through particip

lf – why am I on this path? As long as you can answer that question with a satisfactory answer for yourself – keep at it, no matter how long or hard the journey

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.adviceyou.org.ua/article/36621/adviceyou-Are-You-On-The-Right-Path-Into-Your-Future.html">Are You On The Right Path Into Your Future?</a>

BB link (for phorums):
[url=http://www.adviceyou.org.ua/article/36621/adviceyou-Are-You-On-The-Right-Path-Into-Your-Future.html]Are You On The Right Path Into Your Future?[/url]

Maid in the Shade considers branding a key element in building their business. This is a brief case study of how they have developed their brand over the years.

Do you have customers that you are currently working with who are NOT your Dream Customers? Do they demand extra time? Are they unprofitable? These customers are holes in your Business Bucket. They drain your time and your energy. It's time to implement a No-Leak Marketing Strategy. Author Wendy Maynard gives you the tips you need to plug your marketing holes.

Tailoring your resume and cover letter for each specific job listing can be the difference between getting an interview or getting filed away.

Tags

Links

Advice You - Are You On The Right Path Into Your Future?

Related Articles: