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E-Articles - Kissing Cyber-Frogs
People would have you believe there are only two kinds of Internet relationships: the kind where an innocent young girl gets sucked in to cyber-hell by a cunning psychopath....and the kind where magic steps in to connect two made-for-each-other lovers serendipity style, ending in a glorious wedding with horse-drawn carriages an
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
d flower petals. The former become frightening stories on news shows that parents watch with growing concern; the latter, Meg Ryan movies that interest lonely chatters praying for a similar fairy tale.
But I’m here to tell you about a third kind of Internet relationship. The kind where you get neither killed nor married at the
But I’m here to tell you about a third kind of Internet relationship. The kind where you get neither killed nor married at the
; 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
end, but emerge with lips that taste suspiciously like frog. I know because I’ve been there. I mean I’ve really been there.
I assure you that my definition of “been there” does not mean that I ventured shyly into the book lovers' chat room one day and exchanged flirtations with some Internet amphibian for a few hours.
I assure you that my definition of “been there” does not mean that I ventured shyly into the book lovers' chat room one day and exchanged flirtations with some Internet amphibian for a few hours.
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
My definition of “been there” involves hundreds of pages of e-mails (in hard copy, enabling endless late-night re-readings), enormous phone bills, a nifty language barrier, expensive plane tickets, friends and family diagnosing me as crazy, and hours upon hours upon still more hours of the dream-time existence that is Internet
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ove.
I was in my mid-twenties upon embarking on my "Internet Relationship Ride." At a favorite website I was reading bulletin board postings and thought, “hey - this guy’s from Germany...I’ll bet it would be interesting to have him as sort of an e-mail pal.” It was as innocent as that. So I wrote to him. And he wrote back in h
I was in my mid-twenties upon embarking on my "Internet Relationship Ride." At a favorite website I was reading bulletin board postings and thought, “hey - this guy’s from Germany...I’ll bet it would be interesting to have him as sort of an e-mail pal.” It was as innocent as that. So I wrote to him. And he wrote back in h
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
is Pidgin English. And before you could say “girl gone stupid,” I had fallen for this Deutschland Romeo.
You know how sometimes it’s easier to pour your heart out to strangers? That goes double for cyber-strangers. It’s so easy to tap-tap-tap at those keys and wait in hopeful anticipation for a response full of affirmation and
You know how sometimes it’s easier to pour your heart out to strangers? That goes double for cyber-strangers. It’s so easy to tap-tap-tap at those keys and wait in hopeful anticipation for a response full of affirmation and
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
validation.
Real-life friends were somehow flung aside as I raced home from work to check my e-mail or engage in hours-long instant chats, gobbling precious sleep time. The threshold I passed through was unmistakable. I entered a completely new existence - a world where love was blind, deaf, and dumb (in my case, exceptionall
Real-life friends were somehow flung aside as I raced home from work to check my e-mail or engage in hours-long instant chats, gobbling precious sleep time. The threshold I passed through was unmistakable. I entered a completely new existence - a world where love was blind, deaf, and dumb (in my case, exceptionall
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
y dumb.) What an addicting emotional rush! I couldn’t get enough.
In any Internet relationship, however, you are denied a certain instinct from which to draw conclusions. There is no body language, no vocal innuendo, no pheromones. There is so much missing. In the cyber-world, you fall in love with one piece of the person only
In any Internet relationship, however, you are denied a certain instinct from which to draw conclusions. There is no body language, no vocal innuendo, no pheromones. There is so much missing. In the cyber-world, you fall in love with one piece of the person only
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
no matter how complete that piece presents itself to be.
Here lay my biggest problem.
About a year into our relationship, my German flew to visit for 10 days. Much hoopla and anticipation centered around the very moment when we would meet one another’s eyes and seal our love forever in a magical whirlwind of emotional raptur
Here lay my biggest problem.
About a year into our relationship, my German flew to visit for 10 days. Much hoopla and anticipation centered around the very moment when we would meet one another’s eyes and seal our love forever in a magical whirlwind of emotional raptur
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
e. We spent weeks prior to his flight typing only of THE MOMENT. We built it up so much that I’m certain that any meeting, however celestial, could not have fulfilled our ridiculous expectations.
Needless to say, it did not.
It is awkward, to say the least, to be abruptly presented with someone whom you have never seen in per
Needless to say, it did not.
It is awkward, to say the least, to be abruptly presented with someone whom you have never seen in per
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
son and yet are supposedly in love with. He disembarked the plane. We recognized one another (we had of course exchanged many pictures by this time). We moved aside to embrace and - gulp - kiss.
There was no magic whatsoever. No bells of heaven pealing in joyful acknowledgement of our union. No cherubs flitting around us. Noth
There was no magic whatsoever. No bells of heaven pealing in joyful acknowledgement of our union. No cherubs flitting around us. Noth
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
ing, really, except two intensely nervous individuals regarding one another with something significantly less than adoration while valiantly attempting to convey the fairy-tale script and stage direction we had written.
Suffice it to say that the entire visit remained awkward. In real-life, this man was still sweet. But also,
Suffice it to say that the entire visit remained awkward. In real-life, this man was still sweet. But also,
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
mazingly, QUIET! Of course it never occurred to me that we’d have anything but rich conversations that lasted till giddy dawns. For obvious reasons, you can’t be a quiet person on the Internet. All you have are words. And as an extrovert, I could neither fathom nor interpret this shy, silent German man.
I wish I could tell you
I wish I could tell you
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
that the visit ended and, with maturity and grace, we went our separate ways. But I found myself unable and unwilling to walk away. I had worked too hard, believed too completely. I began to deny my inner voice...you know, the one everyone is always telling you to listen to. It’s the language barrier, I told myself. It’s the s
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
trangeness of a new country. It’s anything we can get past, work through.
During his visit, I actually found myself longing for him to leave so that we could settle back into our comfortable cyber-love. And that’s exactly what happened. I took a German class and managed a 200-or-so-word vocabulary. Ich bin ein Americanerin. Vo
During his visit, I actually found myself longing for him to leave so that we could settle back into our comfortable cyber-love. And that’s exactly what happened. I took a German class and managed a 200-or-so-word vocabulary. Ich bin ein Americanerin. Vo
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
ist die toilette? That kind of thing. We chatted on the phone more so I could practice. We wrote long, exhausting e-mails about his shy behavior and how we could become closer in spite of it.
For another full year I attempted to jam this square peg into a round hole. Finally I flew to his country, alone, determined that it wo
For another full year I attempted to jam this square peg into a round hole. Finally I flew to his country, alone, determined that it wo
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
ld be different this time. Oh, it was different all right. Different in a complete disaster kind of way. This time I was unable to deny my instinct. It’s hard to keep the blinders on when every cell in your body is crying “get me the hell out of here!” Culture shock provided a grueling backdrop for my epiphany.
I needed to end
I needed to end
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
it. End it all. I simply was not suited for anything even close to expatriotism. I didn’t enjoy my German class, I didn’t enjoy my make-believe life, and I just didn’t have the energy to pretend my way through one more day of this sham. I used this somber realization as a springboard for a conversation with my German, during w
.
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
hich I finally ended our ridiculous relationship.
I still think about the German from time to time. I’m sure that he’ll make someone a very nice (albeit very quiet) husband. And I don’t regret my Internet relationship, any more than I’ve regretted any mistake in life from which I’ve learned something...even if I had to learn i
I still think about the German from time to time. I’m sure that he’ll make someone a very nice (albeit very quiet) husband. And I don’t regret my Internet relationship, any more than I’ve regretted any mistake in life from which I’ve learned something...even if I had to learn i
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
t by behaving like an idiot.
So if you’re thinking about having an Internet fling, I wish you a safe adventure and much love and luck...but mostly, I wish you the sense to always trust your instincts. A frog is a frog, no matter how princely he seems online. And the taste of a frog’s kiss does not wash easily off a fool’s lips
So if you’re thinking about having an Internet fling, I wish you a safe adventure and much love and luck...but mostly, I wish you the sense to always trust your instincts. A frog is a frog, no matter how princely he seems online. And the taste of a frog’s kiss does not wash easily off a fool’s lips
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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