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Digg It - But It Will Take Too Long
Sitting in a waiting area above the tradeshow floor, I watched the forklift drivers deliver crates and boxes to small groups who were waiting to transform their rented cement flo
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
ors into inviting marketing endeavors for the next day's expo opening, hosting seven thousand conference attendees.
A microcosm of differing work styles, I found it fascinating
A microcosm of differing work styles, I found it fascinating
; 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
to watch. In one area, a half-dozen people were standing around, leaning against the crates and talking, as one young woman went about unpacking the boxes and organizing the mate
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
rials. Ah yes, I recognized those don't-exert-too-much-effort-until-the-boss-arrives people.
In another space, I noticed some just-enough-to-get-by folks, more focused on gettin
In another space, I noticed some just-enough-to-get-by folks, more focused on gettin
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
g their booth done, than getting it done right. Their work contrasted sharply with two individuals, methodically unpacking and constructing their tiny allocated space, carefully
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
transforming it into a beautifully orchestrated welcome for their potential customers.
As I watched the tradeshow floor emerge, it struck me that people handle their careers in
As I watched the tradeshow floor emerge, it struck me that people handle their careers in
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
much the same manner. Some wait to demonstrate their initiative and ability until someone with authority is watching, believing someone else is responsible for their success. Oth
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
ers approach work as a paycheck rather than an opportunity, limiting both in the process. Still others align their efforts with the why behind the what, owning their results and
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
learning and growing in the process.
This latter group involves people who are winning at working. They're offering the best of who they are, with or without the watchful eyes o
This latter group involves people who are winning at working. They're offering the best of who they are, with or without the watchful eyes o
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
f influential decision makers or bosses. Their work is a reflection of who they are and they feel accountable for each task they're responsible to do. They're not waiting for the
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ir career to happen when someone discovers them, anoints them, or promotes them. They're creating their successful future by every day quality performance, ongoing learning, init
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
iative, and disciplined actions.
People who are winning at working operate with the wisdom found in the African proverb, "If you wait for tomorrow, tomorrow comes. If you don't
People who are winning at working operate with the wisdom found in the African proverb, "If you wait for tomorrow, tomorrow comes. If you don't
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
wait for tomorrow, tomorrow comes." They understand the tomorrow they want is housed in their todays.
In one year, or three or five, they'll have mastered the new skill, written
In one year, or three or five, they'll have mastered the new skill, written
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
the novel, finished the degree, or taken on the next challenge. They'll be the ones with bigger paychecks, larger responsibilities, and pursued life dreams. They'll be the ones
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
running the tradeshow if that's their desire, not setting it up.
You see, people who are winning don't think "it will take too long" to do the job right, tackle the difficult pr
You see, people who are winning don't think "it will take too long" to do the job right, tackle the difficult pr
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
oject, or accomplish a goal. They don't think it will take too long to get additional education, develop a needed skill, or make a life dream happen. To them, it's not about the
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
time it takes to accomplish what they desire; it's about taking the first step, then the next and the next. It's about the continuous process of creating the work, and the life,
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
they desire. People who are winning at working see the not starting, the not working towards big goals, the not achieving their life's potential as the time that's wasted.
Five
Five
.
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
years from now, these winning at working people will be five years ahead in knowledge, skills, goals, and accomplishments. Each year they're leveraging the future they want, one
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
step at a time. What about you? In five years, it's going to be five years from now. What will you have leveraged for your future?
(c) 2007 Nan S. Russell. All rights reserved.
(c) 2007 Nan S. Russell. All rights reserved.
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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