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Main Subject - Survival Without Computers
I was slowed down when my computer crashed and I had no data, no address book and not even my passwords to get back online. I didn’t think I was doing anyt
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
hing remarkable by bouncing back to productivity even with this handicap for a week. But from the feedback I’ve had from more than a few people, it seems p
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ralysis would have been the acceptable common option.
Yes, I got slowed down, but nothing critical was lost and no appointments missed. Why? Internal rese
Yes, I got slowed down, but nothing critical was lost and no appointments missed. Why? Internal rese
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ves, resources and drive. How do you survive in business today without your computer (or maybe it’s when your cell phone drops in the lake or your Ipod get
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
lost)?
There were three parts to my personal survival. They are:
A. Resourcefulness -- When things don’t go your way, you can have a pity party and choo
There were three parts to my personal survival. They are:
A. Resourcefulness -- When things don’t go your way, you can have a pity party and choo
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e to be paralyzed. Or you can decide to dig in to your reserves and available resources to propel you forward in spite of obstacles. I start with a simple
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
uestion: What’s the most important thing that needs to be done now and how do I do it (options)?
It’s a matter of choosing to get the work done and keepin
It’s a matter of choosing to get the work done and keepin
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
your priorities in order, or using this problem (any problem) as an excuse to procrastinate, or wallow in self-pity, or give up.
B. Intestinal Fortitude
B. Intestinal Fortitude
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
- This was my father’s term for the drive, determination, guts, stamina and the like to find a way or make a way when you hit a roadblock. Intestinal forti
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
ude keeps you going because the vision is clear, your passion is unquenchable and you are a winner – and winners never quit.
Of course when a glitch happe
Of course when a glitch happe
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
s, what matters is how you handle it, not deny it. Handling a problem head on, gives you an action plan. Action puts you in control. When you are in contro
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
l, the fear and panic can’t control you.
If a glitch with your computer is enough to put your whole business at risk, maybe you need a dose of intestinal
If a glitch with your computer is enough to put your whole business at risk, maybe you need a dose of intestinal
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ortitude to make some hard decisions to reduce that risk in the future, e.g. strategic investments in your infrastructure, etc. Look at the cost of the inv
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
stment compared to the direct cost or opportunity costs of a week offline (think salaries, sales, customer loyalty, customer satisfaction, product delays,
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
nd shipping delays).
C. Planning -- In this case, I was indeed lucky. The three days after the disk crash had already been blocked out to work on my three
C. Planning -- In this case, I was indeed lucky. The three days after the disk crash had already been blocked out to work on my three
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
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
year vision and budget to get there and the detailed plans for 2006. My schedule was already cleared of appointments, deadlines or correspondence.
As busi
As busi
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ess owners, we all need some reflection time to lift our sights and take a longer view of where we are going, otherwise, it's possible to short-change your
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
elf and the business.
The silver lining of my system crash was that without my own computer, I couldn’t be tempted to procrastinate or avoid the soul-sear
The silver lining of my system crash was that without my own computer, I couldn’t be tempted to procrastinate or avoid the soul-sear
.
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
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
hing and reflection this process requires. I was able to really concentrate on what I want to do professionally and personally for the next 12-36 months.
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
utting a timeline to the vision and goals accelerates the business momentum and recharges my batteries for the next 90 days to set it all in motion. Try it
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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