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Main Subject - Dare to Be Unique
After an outstanding year working on the personal staff of a member of Congress, I was asked to lead a organiz
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
ation that did not previously exist. Everything pertaining to the organization was on paper and I found myself
; 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
in the middle of change management.
Many are called but few are chosen to lead. After returning to the Penta
Many are called but few are chosen to lead. After returning to the Penta
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
gon after a fellowship on Capitol Hill I was asked to head up a policy organization. For those of you who do n
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ot understand, policy is synonymous with organizational doctrine.
In other words, if the leader has to make a
In other words, if the leader has to make a
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
call on a important issue that impacts over half a million people, your policy office must lead the informati
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
on charge. They must provide concise regulations, review organizational policies, and have the ability to inte
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
rpret and unravel hot button legislative issues.
How did I respond to this important undertaking? The first t
How did I respond to this important undertaking? The first t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
hing I did was hire the best and brightest staff to surround myself. I need people who were not afraid to sear
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
ch for answers that would make the generals job easy.
I needed unique people, the kind that will not take no
I needed unique people, the kind that will not take no
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
or an answer. If you take no for an answer, likelihood is you will not be able to make the leaders job easier.
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
One could say I sought out problem solvers.
People that know how to solve problems understand what is at sta
People that know how to solve problems understand what is at sta
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
ke when it comes to making high level decisions. Let us take a look at my staff.
I hired a federal employee w
I hired a federal employee w
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
ho worked for the freedom of information act (FOIA), he was relentless in researching information that held li
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
ves in the balance. Then I hired a battle tested Sergeant who knew how to get to the ground level and work the
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
grapevine for better and better information.
Next I hired a young Captain to filter the data and coordinate
Next I hired a young Captain to filter the data and coordinate
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
high level signatures for our organizational doctrine. Last but not least, I hired a computer expert who knew
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
how to assemble all of the information to bring closure to our most important issues.
By the end of my tour,
By the end of my tour,
.
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
we made the most dramatic contributions of any organization. Fortunately I hired people who were leaders in th
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
eir own right. You will be able to do the same as long as you dare to hire people who just happen to be unique
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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