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Answers - Adversity
In order for us to win in life, we must push through the adversity we face. Without facing it, we are poorly prepared for winning. The truth is most of us don’t welcome adversity like a long-lost friend. We don’t emb
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
race with passion the pain and setbacks that occur.
Alfred Russell Wallace was a famous botanist of the late 1800s. One day, Dr. Wallace was observing an Emperor butterfly struggling through the life and death adversi
Alfred Russell Wallace was a famous botanist of the late 1800s. One day, Dr. Wallace was observing an Emperor butterfly struggling through the life and death adversi
; 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
ty of escaping its cocoon. He wondered if he assisted the butterfly in its exit, what effect that would have on the butterfly. With a knife, Dr. Wallace made an incision the length of the cocoon that allowed the butte
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
fly to exit the cocoon with ease. The butterfly emerged from its cocoon, spread its wings, and died. The butterfly did not have to encounter adversity in struggling to exit the cocoon. Through the struggle, the butter
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
fly would have grown in strength. Since it failed to struggle and grow, it did not have the strength necessary to survive.
We often try to make incisions in our challenges and take the easy route. We take the quick e
We often try to make incisions in our challenges and take the easy route. We take the quick e
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
it as this butterfly did and fail to acquire the strength to compete. We often take the easy route to improve our skills. We never really work to achieve mastery in our career. When we really have to exit the cocoon
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
without the incision, we die in our cocoon. Pre-crafted tools can be very useful to our career, but they do not replace the skills we need to acquire to compete over the long term.
The skills of discipline, practice,
The skills of discipline, practice,
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
nd study, are only acquired through facing adversity by trial and error, success and failure. We must focus; learning to be the best in these skills will enable us to be masters of our careers. Going through the motio
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ns is not good enough. Michael Jordan, when asked about why he practiced so hard, said, “I’m not out there sweating for three hours every day just to find out what it feels like to sweat.” He was clearly there for a p
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
rpose…to prepare, so he could win. He was there to help his teammates prepare to win. George Allen, head coach for the Washington Redskins in the ‘70s, said, “Winning can be defined as the science of being totally pre
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
pared.” The skills you need in order to achieve mastery in sales take practice and preparation. The only way to win is to practice. Most people don’t win because of better equipment; they win by facing adversity to
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
gain strength and skill. They win through preparation. Does Tiger Woods win because of his golf clubs or golf ball? Tiger could probably play with a K-Mart special set of clubs and tear up the golf course. It’s the
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
kill that sets him apart. Strength comes from struggle, not from taking the path of least resistance. Adversity is not just a lesson for the next time in front of us. Adversity will be the greatest teacher we will ev
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
er have in life.
Take a quick look at your skills. Are you investing enough time in the improvement of those skills? Take a quick test. On a scale of 1 to 10, 1 being very poor and 10 being world-class, rate yourself
Take a quick look at your skills. Are you investing enough time in the improvement of those skills? Take a quick test. On a scale of 1 to 10, 1 being very poor and 10 being world-class, rate yourself
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
in the areas you have outlined.
How did you do? What area needs the most attention? Make the commitment to spend one hour a day to improve the biggest need areas now! Take out your day timer and write an hour in dai
How did you do? What area needs the most attention? Make the commitment to spend one hour a day to improve the biggest need areas now! Take out your day timer and write an hour in dai
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
ly to refine or practice or create what needs to be improved.
We all have areas where we fall short. We all fail at times. Abraham Lincoln said, “My great concern is not whether you have failed but whether you are c
We all have areas where we fall short. We all fail at times. Abraham Lincoln said, “My great concern is not whether you have failed but whether you are c
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
ntent with your failure.” It’s easy to ignore the failure of our skills and blame it on new technology, the market, other Agents, and our broker. We all have prepared and rehearsed reasons that don’t include us. Geor
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ge Bernard Shaw said, “People are always blaming their circumstances for what they are. I don’t believe in circumstances. The people who get on in this world are the people who get up and look for the circumstances th
.
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
y want, and if they can’t find them, make them.”
What circumstances or outcome do you want? What do you need to do to make them happen? They will not be achieved without working through adversity. You will have to s
What circumstances or outcome do you want? What do you need to do to make them happen? They will not be achieved without working through adversity. You will have to s
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
weat and struggle. It will be worth it in the end. The skill that you acquire will be permanent.
Ultimately, you will be able to say, “It’s not what happens to me that matters but what happens in me.” – Victor Frankl
Ultimately, you will be able to say, “It’s not what happens to me that matters but what happens in me.” – Victor Frankl
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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