Do you believe in coincidences? Well, as I was writing this article, I got an email from past colleague.
The last time we "talked" was by email 2 ye
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
ars ago. And yet, when I got her email today, I was delighted to hear from her (even though she was writing to ask me for something).
We lose touch
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
with people all the time -- in our professional lives and personal lives -- for various reasons.
For example, this year, with the birth of our secon
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
d baby, followed by our relocation across the country, along with my involvement in completing my book I haven't been able to stay in touch with many
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
people. After all, there's only so much time in the day!
Then, when it comes time to reconnect, many people feel awkward about it. And many people d
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
on't reconnect just because of that sense of awkwardness.
However, reconnecting can be delightful -- just like I was delighted to hear from my colle
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
ague earlier today.
And just like my past contacts are happy to hear from me, as I reach out to reconnect with them, now that things are beginning t
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
o get back to "normal".
So what allows people to reconnect with each other comfortably, even after long periods of silence?
- First,
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
>keeping in touch is a two-way street. If I've lost touch with someone, it means that *neither* of us have initiated contact with the other.
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
In other words, it's not just *one* person's responsibility to keep in touch. So chances are, when I do initiate contact, the other person will be h
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
appy to hear from me -- especially, if we had a good relationship in the past.
Of course, if we didn't have a relationship in the past, it's a diffe
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
rent story -- and a topic for a future article.
- Second, whenever an opportunity arises, use it to reconnect. For instance,
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
I'll use occasions like someone's birthday, or some event in my life (e.g. my farewell party) to reconnect. And when I do get in touch, I'll usually
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
bring the person up to date with what's been going on with me (if they don't know already), so they have a sense of why I haven't kept in touch.
Sin
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ce most people are busy themselves, they usually understand and forgive the lapse.
Again, the important thing to notice is that these are people wit
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
h whom I had already built a relationship in the past. So I know their birthdays, and have an interest in their lives, as they do in mine.
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
So reconnecting with someone after a long time, even if you're doing so because you want something from the other person, can be completel
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
y free of any awkwardness, if
- You have already invested the time earlier to build a relationship that can survive periods of little or no
.
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
contact.
-
Both people in the relationship get something from keeping it alive, and therefore both people take responsibility to do so.
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
>
Check it out -- I think you'll find examples of these kinds of relationships in your own life.
Business relationships aren't any different
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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