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Write You - A Free Agent's Mentor-Mentee Relationship -- What Are the Rules and Where Can I Find One
Most business books and magazines sing the virtues of having or being a mentor. Even thoug
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
h we know how valuable a mentor can be to our success, we discover that finding the right fit is
; 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
not always easy. In this article, I discuss the ins and outs.
It is important that the mentor
It is important that the mentor
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
-mentee relationship is satisfying to both people involved.
- If you find someo
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ne you would like to have as a mentor, ask him or her if they are willing. If they back out g
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
racefully, or just say, "No," accept the answer graciously and without devastation.
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
>If you become a mentee, make sure that you know the ground rules - what you both expect from
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
the relationship. If your mentor suggests that you make certain changes to push yourself to a new
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
level, will you be willing to follow those suggestions?
Being a mentor can be satis
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
fying and exhilarating as long as you feel that your mentee is giving it his or her "all."
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
i>
If, however, you begin to feel drained and/or manipulated, it is time to bow out.
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
I recently became involved in a mentor-mentee situation where the young man I was meeting with o
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
n a regular basis gave me the impression that he was "using" my talents, abilities and knowledge
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
to advance his career rather than trying to develop his own talents, abilities and knowledge.
I feel strongly that as long as both of you feel that your relationship is beneficial,
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
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
b> keep it up; but once it isn't good for one and/or both of you, have the guts to move on.<
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
/ul>
So, ask yourself the following questions:
So, ask yourself the following questions:
- Who have been my best mento
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
rs over the years?
Is there someone I would like to have as a mentor now?
.
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
i>
Is there someone I would like to mentor now?
When and how will I st
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
art on my mentor quest?
The time is now! Try it -- you will be glad you did!
The time is now! Try it -- you will be glad you did!
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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