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Advice Pool - Whiners Need Not Apply
Sometime last summer I decided to host a pity party and invite all my friends. Well, not all my friends, exactly. Only those whose livelihoods might have, like mine, been suffering from the downward slide of the economy. To make the guest list, invitees w
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
ould have to possess the ability to grumble, gripe, groan, fuss, snarl, scream, fret, rant and complain -- preferably all at the same time. I wanted world-class whiners at my party. Optimists need not apply.
The idea for the party came about following se
The idea for the party came about following se
; 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
veral back-to-back conversations with different editors, all of whom relayed to me different versions of the same scenario: advertising sales are down, there are fewer magazines pages to fill, so we don't have as many assignments for contract writers like
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
you. Almost overnight, or so it seemed, the regular work I'd come to count on disappeared. "Sorry," my editors said. "But do keep in touch."
But I didn’t. And instead of bucking up and marketing myself to new clients, instead of choosing to view this "ch
But I didn’t. And instead of bucking up and marketing myself to new clients, instead of choosing to view this "ch
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
allenge" as an "opportunity" like I'd been taught in so many motivational seminars, I chose to complain. Loudly. With great chest-heaving drama. Picture Joan Crawford, wrist to forehead, lying in a bed strewn with movie magazines and you have some idea of
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
my approach. Why tire myself getting new business, I argued, when sympathy was so much easier to elicit?
The beauty of my pity party was that it was not time- or location-dependent. Instead it was an ad hoc celebration that occurred on the phone and ove
The beauty of my pity party was that it was not time- or location-dependent. Instead it was an ad hoc celebration that occurred on the phone and ove
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
dinner, and lasted from mid-summer until well into October. The lengthy guest list included such luminaries as other freelance "worst-market-in-15 years" writers; graphic "clients-just-aren't-spending-money" designers; and software "we're-wondering-how-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-make-it-through-December" executives. These people made the cut because I knew they'd confirm my belief that the economy was in the toilet and there was no work to be found. Anyone whose work might be humming along as usual or, worse yet, improving -- t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
his includes criminal lawyers and unemployment counselors -- were conveniently left off the invitation list.
Whenever I met a fellow partygoer I'd ask, perhaps a bit too eagerly: "So how bad is it? Any bill collectors yet? Tell me again about losing that
Whenever I met a fellow partygoer I'd ask, perhaps a bit too eagerly: "So how bad is it? Any bill collectors yet? Tell me again about losing that
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
contract and this time don't leave anything out."
It was such a bad case of selective perception that I interpreted everything around me as proof that work was not available. I'd spot smiling families playing in the park and assume the parents must've lo
It was such a bad case of selective perception that I interpreted everything around me as proof that work was not available. I'd spot smiling families playing in the park and assume the parents must've lo
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
st their jobs. I'd see people laughing at restaurants and assume they were drunk, probably as a way of masking their deep internal misery.
I was so convinced I'd never be hired for another writing assignment that I stopped even trying to find work. I did
I was so convinced I'd never be hired for another writing assignment that I stopped even trying to find work. I did
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
n't call any of my corporate clients. I didn't pitch new story ideas to editors. Instead, I stayed home, played computer solitaire and wished I'd saved more money.
Then, I met with my personal coach, a wise and wonderful woman whom I pay to keep me on tr
Then, I met with my personal coach, a wise and wonderful woman whom I pay to keep me on tr
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
ck in life.
"Shari," she said gently. "All of us create our own realities. Your situation seems hopeless because that's how you've decided it should be. How would you act if you knew the economy was good and work was available?"
"Ummm," I said. "I guess
"Shari," she said gently. "All of us create our own realities. Your situation seems hopeless because that's how you've decided it should be. How would you act if you knew the economy was good and work was available?"
"Ummm," I said. "I guess
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
I'd line up some story ideas?" I answered her tentatively, as if asking a question.
"Good," she said. "Then what would you do?"
"Ummm, I guess I'd call some editors?"
Then, doing her best not to sound like my mother, she asked me: "Have you called any
"Good," she said. "Then what would you do?"
"Ummm, I guess I'd call some editors?"
Then, doing her best not to sound like my mother, she asked me: "Have you called any
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
editors lately?"
I got the picture.
I spent the following Sunday researching potential story ideas and preparing letters for my magazine clients. I sent the letters out via e-mail and within 24 jaw-dropping hours I had three new assignments. A week lat
I got the picture.
I spent the following Sunday researching potential story ideas and preparing letters for my magazine clients. I sent the letters out via e-mail and within 24 jaw-dropping hours I had three new assignments. A week lat
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
r, a fourth came in, and two weeks after that, an associate of mine called about some international speaking opportunities.
When I first started in business for myself, an experienced entrepreneur told me that even during down times I should always proje
When I first started in business for myself, an experienced entrepreneur told me that even during down times I should always proje
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
ct a positive, successful image. So what if clients hadn't paid me in months or that I hadn't changed out of my terrycloth robe in days? Every inquiry about my business should be met with the same response: "It's terrific! Never been better!"
I subscribe
I subscribe
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
d to this fake-it-till-you-make-it philosophy for a long time and you know what? It works. But apparently, last summer, after years of round-the-clock, worry-free assignments, I had forgotten that success, confidence and happiness are often a matter of wh
.
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
re you place your attention. When I finally got out of bed, picked up the movie magazines and began to act like a successful professional, the work appeared with stunning rapidity.
My pity party is now over, thankfully, and friends who grew tired of my b
My pity party is now over, thankfully, and friends who grew tired of my b
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
leak line of questioning are no longer darting down the baby aisle in supermarkets in order to avoid me. My professional confidence index is up and I'm now looking for optimists to celebrate with me. Whiners need not apply.
Copyright, 2005, Shari Caudron
Copyright, 2005, Shari Caudron
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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