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Advice Pool - The Pigeon Dance
When I was in my twenties, I flew from New York to Germany to light a fire under my disappointing Internet relationship with a guy named Karl. He was a kind fellow, this German, and had thoughtfully arranged a bus trip for us to Paris for a weekend during my stay. I looked forward to this diversion from our awkward visit. Heck, who doesn’t
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
want to see Paris?
I especially welcomed the idea of Karl’s friend Helga and her British boyfriend, Henry, coming along with us. I’d never met them before and I didn’t speak more than a hundred words of German. Since everyone spoke English, though, I wasn’t too worried about communication.
My mistake!
When Karl first introduced me to Hen
I especially welcomed the idea of Karl’s friend Helga and her British boyfriend, Henry, coming along with us. I’d never met them before and I didn’t speak more than a hundred words of German. Since everyone spoke English, though, I wasn’t too worried about communication.
My mistake!
When Karl first introduced me to Hen
; 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
y and Helga, they offered mushy handshakes and smirky smiles. I gave them my best “happy to meet you” in German, which I’d practiced carefully for just such an occasion. They nodded impatiently – yes, whatever - and turned as one away from me to speak in German to Karl.
When we boarded the bus, Karl and I found seats and Henry and Helga sa
When we boarded the bus, Karl and I found seats and Henry and Helga sa
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
t directly across the aisle. The tour bus operator explained Einstein’s theory of relativity, I think, or perhaps told the location of the exits. I’m not sure, because he was (surprise, surprise) speaking German. To say that this bus trip was excruciatingly long would be an injustice to time’s inexhaustible ability to drag its feet when it
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
o pleases. In real time we’re talking six or seven hours. In my mind, though, I had entered a vacuum where time stood excruciatingly still.
It’s not that I expected the tour operator and bus passengers to speak English for my benefit. I did hope, though, that Karl, Henry and Helga might utter an English phrase or two now and again - just f
It’s not that I expected the tour operator and bus passengers to speak English for my benefit. I did hope, though, that Karl, Henry and Helga might utter an English phrase or two now and again - just f
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
r fun. Helga was especially reluctant to do so. Karl did talk to me a bit – as official boyfriend he was obligated, I suppose.
After a while, Henry and Helga retreated into a private couple-world of kiss, whisper and giggle. Karl and I had no such inclination and yet were forced by proximity to witness theirs. Awkwardly we shared a small s
After a while, Henry and Helga retreated into a private couple-world of kiss, whisper and giggle. Karl and I had no such inclination and yet were forced by proximity to witness theirs. Awkwardly we shared a small s
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
pace on the stuffy bus seat, sitting stiff and silent as they smooched away. I stared out the window at the endless Belgian fields, and Karl stared at me, apparently not knowing what to say or how to say it.
When we finally arrived in Paris, I realized that Helga had it out for me. She shot me several nasty looks while we were waiting to c
When we finally arrived in Paris, I realized that Helga had it out for me. She shot me several nasty looks while we were waiting to c
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
tch the Metro to our hotel. Boarding the subway train, she deliberately stepped on the heel of my shoe, scraping the back of my ankle hard. On the train she ignored me, speaking brashly to the others and bursting out in sharp laughter at intervals just long enough to make me cringe with paranoia. Neither Karl nor Henry seemed to notice or c
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
are.
Then the situation worsened. Left alone for a moment while the boys used the bathroom, Helga and I stood in silent face-off. I smiled my most disarming smile and tried to say “I like your outfit” in German, figuring flattery might break her down. No luck. She sighed derisively, shook her head, and turned away from me.
I surrendered q
Then the situation worsened. Left alone for a moment while the boys used the bathroom, Helga and I stood in silent face-off. I smiled my most disarming smile and tried to say “I like your outfit” in German, figuring flattery might break her down. No luck. She sighed derisively, shook her head, and turned away from me.
I surrendered q
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
ickly, remaining as pleasant as possible to everyone yet feeling miserable inside. It’s always bothered me when someone inexplicably doesn’t like me, and this was no exception. To make matters worse, I now had culture shock on top of culture shock, for I was in yet another new country – this one notorious for its indigenous xenophobes.
Ver
Ver
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ally armed with nothing more than sil vous plait, I spoke to Parisian waitress and shopkeeper alike in the English-with-a-French-accent people use when they can't speak French at all. To my surprise, I was well received by the locals. Perhaps their behavior seemed akin to warmth only because I’d grown used to chilly Helga, but either way, I
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
wasn’t complaining.
For the rest of the day and into that evening, Helga raged on. She used every opportunity to subtly snub, snicker, and sigh in my general direction. She laughed when I ordered food. She smiled when I stumbled. She rolled her eyes and walked three steps ahead; she single-handedly directed both our city tour and conversa
For the rest of the day and into that evening, Helga raged on. She used every opportunity to subtly snub, snicker, and sigh in my general direction. She laughed when I ordered food. She smiled when I stumbled. She rolled her eyes and walked three steps ahead; she single-handedly directed both our city tour and conversa
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
ional tone. Henry seemed too love-struck to care, and Karl was wimpy - helpless as a rag and just as mute.
By the morning of day two I was beginning to visibly wither from mental strain. When Karl suggested we all buy baguettes and sit by the Seine River, I numbly agreed; this seemed at least a peaceful activity, and I was getting hungry.
By the morning of day two I was beginning to visibly wither from mental strain. When Karl suggested we all buy baguettes and sit by the Seine River, I numbly agreed; this seemed at least a peaceful activity, and I was getting hungry.
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
So, laden with the muddy coffee and steaming bread Parisians enjoy, we arranged ourselves along the grassy bank - Helga rudely sitting almost square in front of me.
To this day I remember clearly how I lifted my anguished gaze from Helga’s back to the mocking clouds of France, and breathed a silent prayer:
God, please, please just let me
To this day I remember clearly how I lifted my anguished gaze from Helga’s back to the mocking clouds of France, and breathed a silent prayer:
God, please, please just let me
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
eep it together until I get back to my own country and I swear I’ll never, ever chat on the Internet again to anyone, at any time, for even the most important reason. Amen.
A moment later I was hit on the nose with a tiny dot of white goo, which turned out to be spatter from a large puddle of white goo, deposited unceremoniously onto Helga
A moment later I was hit on the nose with a tiny dot of white goo, which turned out to be spatter from a large puddle of white goo, deposited unceremoniously onto Helga
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
s honey-colored hair by a passing pigeon.
I instantly envisioned Bert from Sesame Street doing his famous pigeon dance. Perhaps he had dispatched this pooping pigeon all the way from America on my behalf!
It was all I could do not to laugh out loud.
“Back home, that’s considered good luck,” I instead piped up, forcing a solemn face.
Hel
I instantly envisioned Bert from Sesame Street doing his famous pigeon dance. Perhaps he had dispatched this pooping pigeon all the way from America on my behalf!
It was all I could do not to laugh out loud.
“Back home, that’s considered good luck,” I instead piped up, forcing a solemn face.
Hel
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
ga shrieked in disgust, threw her bird poop baguette to the ground, and wiped a hand in the goopy wreck of her hair. As fate would have it, none of us had procured napkins with our snacks, so Henry started rooting around for a hanky. Empty handed, he turned to me and begged a cloth.
Spitefully, I thought to myself, I hope I don’t have anyt
Spitefully, I thought to myself, I hope I don’t have anyt
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ing --but I reached in my pocket anyway, and guess what? I did have something: a snotty, old, and very used tissue.
I held it up as if in explanation; my inner dialogue taking on a British accent: Certainly we can’t use this nasty thing to clean her hair.
Henry paused for just a moment. We had walked quite a distance from anyone who could
I held it up as if in explanation; my inner dialogue taking on a British accent: Certainly we can’t use this nasty thing to clean her hair.
Henry paused for just a moment. We had walked quite a distance from anyone who could
.
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
provide us with towel or tissue, so this dirty snot-rag would have to suffice. Wisely saying nothing to Helga, Henry reached tentatively for the tissue, dropped it onto Helga’s sloppy hair, and mopped rather ineffectively at the whole mess.
Riveted, I looked on in awed and joyful disbelief.
Helga had to walk quite a distance that day, sp
Riveted, I looked on in awed and joyful disbelief.
Helga had to walk quite a distance that day, sp
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
rting both bird poop and American snot in her hair. I would be lying if I said I didn’t relish every last second of that walk.
After all, it’s not every day that Bert and Instant Karma get together to do the famous pigeon dance. I thoroughly enjoyed my front-row seat for their fine and just performance.
* Names changed to protect privacy
After all, it’s not every day that Bert and Instant Karma get together to do the famous pigeon dance. I thoroughly enjoyed my front-row seat for their fine and just performance.
* Names changed to protect privacy
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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