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E-Folder - Three Tips For Rebuilding Your Business After Tragedy Strikes
Okay, so your worst nightmare just came true. Your business was destroyed by forces beyond your control – by the forces of nature, a freak accident, a crime or maybe even a terrorist attack. Now what? Is your life over? Can you ever recover from this? Yes you can! There are three things you can do to determine the fina
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
l impact that this tragedy has on your life. No, you can’t make it go away, but you do have the power to make an internal choice of how it will affect you.
CHOOSE TO BELIEVE
It is essential that you stop and get your bearings. Assess where you are and what resources you have around you. Stop and assess the damage
CHOOSE TO BELIEVE
It is essential that you stop and get your bearings. Assess where you are and what resources you have around you. Stop and assess the damage
; 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
for what it is. Acknowledge it, but make a verbal declaration – out loud – that you will survive it. Yes, cancer and hurricanes are still terminal, but plenty of people survive them. Just a few days after Lance Armstrong was diagnosed with cancer, he held a press conference in which he boldly announced, “I want you all 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.
know that I intend to beat this disease, and further I intend to ride again as a professional cyclist.” That was back in 1996, when most people were predicting his early demise.
Was he a prophet? Did he receive a message in a dream? Did he know something that we didn’t know? No. None of the above. Lance Armstrong made
Was he a prophet? Did he receive a message in a dream? Did he know something that we didn’t know? No. None of the above. Lance Armstrong made
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
an internal decision to believe and to survive. Then he announced it publicly. This public verbalization of his belief seared it into his brain and his very soul. It came to pass because he really believed it and this undying belief helped him bring it to pass.
You can do the same thing. Acknowledge your opponent for w
You can do the same thing. Acknowledge your opponent for w
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
at it is and then calmly, but firmly announce to the world that you will beat this thing!
CHOOSE TO FOCUS ON INTANGIBLE VALUES
When everything is taken from us and we are left standing naked among the tattered ruins of our life, we suddenly realize what life is really all about. It’s not about how much money we hav
CHOOSE TO FOCUS ON INTANGIBLE VALUES
When everything is taken from us and we are left standing naked among the tattered ruins of our life, we suddenly realize what life is really all about. It’s not about how much money we hav
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, what kind of car we drive, or how big our house is. All that stuff can be wiped out in the blink of an eye.
It’s about something bigger than that. Something we can’t see and can’t measure. We can’t put our finger on it. We’re just glad to be alive. We’re just glad the sun came up this morning. Is that a bird we he
It’s about something bigger than that. Something we can’t see and can’t measure. We can’t put our finger on it. We’re just glad to be alive. We’re just glad the sun came up this morning. Is that a bird we he
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
ar singing? It suddenly sounds sweeter than we’ve ever heard it before. Is that a child we hear laughing? It somehow tickles us deep in our soul.
True survivors focus on intangible values above all else. It may sound trite and over-stated, but when you’re sitting among the ruins of your life, sit down and count what you
True survivors focus on intangible values above all else. It may sound trite and over-stated, but when you’re sitting among the ruins of your life, sit down and count what you
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
have left. It will refresh your soul and give you the energy you need to start over.
CHOOSE TO FOLLOW THE HEROE’S PATH
As shocking and incomprehensible as your tragedy may seem, remember there are many survivors and heroes who have gone before you who have survived worse. It is up to you to follow their path.
Soi
CHOOSE TO FOLLOW THE HEROE’S PATH
As shocking and incomprehensible as your tragedy may seem, remember there are many survivors and heroes who have gone before you who have survived worse. It is up to you to follow their path.
Soi
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
chiro Honda is a classic example of a true survivor who suffered repeated tragedies and kept coming back. In 1945, Soichiro was making piston rings at a small plant in Japan. But then something much worse than a hurricane destroyed the plant – it was a U.S. air raid. The bombs dropping from U.S. planes destroyed not onl
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
the plant, but most of the city. But Soichiro was a survivor. He chose where to put his focus. He collected the metal from left over military vehicles and airplanes and moved to a new city to open a small factory and continued production on a small scale. The end of the war brought an end to his piston ring produ
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
ction business. Even though he survived the war, he could not survive the end of the war.
At the end of World War II, Tokyo and most industrial cities had been destroyed. Gasoline was rationed and sometimes impossible to find, so he came up with an idea. In 1946, he took regular bicycles and installed small, mili
At the end of World War II, Tokyo and most industrial cities had been destroyed. Gasoline was rationed and sometimes impossible to find, so he came up with an idea. In 1946, he took regular bicycles and installed small, mili
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
tary surplus engines on them and started selling them. But he soon ran out of military surplus engines. It looked like another dead-end.
Did this stop Soichiro? No. He decided to start making his own small engines. However, there was one small problem - he had no money! So he wrote letters to bicycle shop owners throu
Did this stop Soichiro? No. He decided to start making his own small engines. However, there was one small problem - he had no money! So he wrote letters to bicycle shop owners throu
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
hout Japan, explaining his idea to make motorbikes and asking them to invest. With the money that a few of them invested, he started manufacturing his own engines and motorbikes. The first motorbikes he made were too big and bulky and very few Japanese bought them. Was this another dead end?
No. Soichiro listened to the
No. Soichiro listened to the
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
feedback and adjusted accordingly. Soichiro changed his approach. He stripped his motorbike down and made it much lighter. The new design won the Emperor’s Award. In time, this little motorbike captured 60% of the Japanese market and Soichiro began exporting them to Taiwan. In 1948, Soichiro established the Honda Motor
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
Company, which is one of the biggest manufacturers of cars and motorcycles in the world today.
What can you learn from Soichiro Honda? A total loss is an opportunity to start over with a clean slate. Have you ever wondered what you would do if you could start life over? Well, here’s your chance. Life has just handed you
What can you learn from Soichiro Honda? A total loss is an opportunity to start over with a clean slate. Have you ever wondered what you would do if you could start life over? Well, here’s your chance. Life has just handed you
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
a golden opportunity. Start with a fresh vision. Make a decision to start a new life.
What if you say, “But I’m not a very creative person. I’m out of ideas.” Take comfort - there is no reason to reinvent the wheel. Find people who are already succeeding at what you want to do and learn their secrets. Read books and
What if you say, “But I’m not a very creative person. I’m out of ideas.” Take comfort - there is no reason to reinvent the wheel. Find people who are already succeeding at what you want to do and learn their secrets. Read books and
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
articles about the legends in your industry. Get into the minds of these icons. There is no excuse for blindly stumbling in the dark to find your way. Find and follow the path of those who have gone before you. If there is a method or system to their success, then it is capable of being learned. If it is capable of bein
.
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
learned, then it is capable of being duplicated. Study it. Duplicate it. Then improve upon it.
Remember, you may have lost your house, your car, your health or maybe even your spouse. But no one can take away your determination to succeed, your inherent abilities, your intelligence or your creativity. These gifts, tal
Remember, you may have lost your house, your car, your health or maybe even your spouse. But no one can take away your determination to succeed, your inherent abilities, your intelligence or your creativity. These gifts, tal
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
ents and abilities haven’t gone anywhere. Wherever you go, they are still with you! These are your sails. Your belief in them is the wind that will blow you around the world.
Copyright 2005. All rights reserved. Daniel R. Castro, author of Critical Choices That Change Lives: How Heroes Turn Tragedy Into Triumph
Copyright 2005. All rights reserved. Daniel R. Castro, author of Critical Choices That Change Lives: How Heroes Turn Tragedy Into Triumph
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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