Think Different Do Different DO IT
Por quem foi que me trocaram
Quando estava a olhar pra ti?
Pousa a tua mão na minha
E, sem me olhares, sorri.
Sorri do teu pensamento
Porque eu só quero pensar
Que é de mim que ele está feito
É que tens para mo dar.
Depois aperta-me a mão
E vira os olhos a mim...
Por quem foi que me trocaram
Quando estás a olhar-me assim?
When I am dead, my dearest,
Sing no sad songs for me;
Plant thou no roses at my head,
Nor shady cypress tree:
Be the green grass above me
With showers and dewdrops wet;
And if thou wilt, remember,
And if thou wilt, forget.
I shall not see the shadows,
I shall not feel the rain;
I shall not hear the nightingale
Sing on, as if in pain:
And dreaming through the twilight
That doth not rise nor set,
Haply I may remember,
And haply may forget.
Christina Rossetti
When I am dead, my dearest,
Sing no sad songs for me;
Plant thou no roses at my head,
Nor shady cypress tree:
Be the green grass above me
With showers and dewdrops wet;
And if thou wilt, remember,
And if thou wilt, forget.
I shall not see the shadows,
I shall not feel the rain;
I shall not hear the nightingale
Sing on, as if in pain:
And dreaming through the twilight
That doth not rise nor set,
Haply I may remember,
And haply may forget.
(Cecília Meireles)
Mudaram as estações
Nada mudou
Mas eu sei que alguma coisa aconteceu
Tá tudo assim tão diferente
Se lembra quando a gente chegou a um dia acreditar
Que tudo era pra sempre, sem saber
Que o pra sempre, sempre acaba
Mas nada vai conseguir mudar o que ficou
Quando penso eu alguém, só penso em você
E ai então, estamos bem
Mesmo com tantos motivos
Pra deixar tudo como está
Nem desistir, nem tentar agora
Tanto faz
Estamos indo de volta pra casa
Con un clavel granate temblando en la boca
Con una varita de mimbre en la mano
Por una verea que llega hasta el rio
Iba Antonio Vargas Heredia el Gitano.
In my case it would not be to have
20/20 hindsight,
it would have to be 20/20 aptitude
I would have been an opera singer 
I studied, fought for it. But there was one thing missing "IT 
You are either born with it or not, like a Callas. 
I was born with many good gifts, but not that one.”
I chose to be happy
and never again give anybody the power to hurt me. That doesn’t mean I built a barrier around; quite the contrary
But it is a fact – nobody, no matter what kind of abusing words chose to greet me with, has the power to hurt. I don’t hate anybody and I do not seek revenge. I call it FREEDOM
– it is in our brain it is a choice. Afterwards I decided to try to find the reason why people are so unkind to each other. And I realized that this works like a chain – nobody teaches you, because few people understand what is going on. A has just been told something unpleasant by someone “higher” than him He needs to get rid of that negative feeling.
So, A goes to B and says something nasty. (B is “lower” than A). B needs to take this weight off his shoulders; therefore he goes to C and says something rude. Chain of events: someone was unkind to A and it propagates endlessly.
The meaning for” Higher and Lower” is that either the person his above the other on a professional base or has some power over the other, even just emotional power.
People have always had the tendency to make confidences to me; probably they understand that I never talk about other people’s lives.
After releasing the burden they think “Oh, what have I done?” And the next thing you know they are saying something unkind and untruth about me. Do I care? NO. I couldn’t are less, it doesn’t hurt it doesn’t change my life or my smile
We are born into this culture, our parents are not aware so can’t teach us. There are very few people that mange to get rid of this.
But let me say it too, you pay a price for this freedom; society will not accept independent minds.”
No that does not exist, there is no machine translation that can come even closer to a normal translation, let alone a technical translation, I think that is what you are doing.
The structure of the Dutch language and English are completely different and you rely on machine translation?
When I do that, just for fun, anything in English is translated into Brazilian which makes me laugh to tears and the order of verbs and other sentence elements is upside down, you have “things” doing tasks for persons and persons look like things.
I am sorry to disagree with the Proofreading theory to cut costs~
Proofreading is not about revising a translation and correct it, in fact, re-translate, Proof reading is just to see if the dots, commas, and such minor things are in place. Translation agencies try to cut costs that way,
but you will not get a good technical translator to accept it, I can tell you that from my own experience as a technical translator.
I work with sick/ill people, I volunteer since I was very young. The first time I went international I was 17th.I thought I owned the problems of life.
I remember I was looking around, a bit surprised and then a young man turned in his wheel chair and smiled at me.
I never forgot that moment and I think about it whenever I need perspective and I always say, when things get bad, “I still have my two legs”.
I am just watching how a big fat horrible fly got trapped in a tiny spiders web, what efforts she does to get free and how useless they are, it is fascinating, one is thrice the size of the other! Just like this video!
Marketing exclusivity in EU and U.S.A provided a monopolistic market without “me-too”/generics competitors, to pharma companies. The “blueprint “of strategies making hay while the sun shines of legal loopholes and incentives, made the call for searching the pot of gold, in the orphan drug market, worth the while for Big Pharma. “To give the devil his due,” orphan drug laws and the pharma industry made great contributions towards the cure of millions of people suffering from uncommon and frequently life-threatening diseases. However, he who pays the piper calls the tune, and it is necessary to strike a new balance between innovation support and industry profit and pricing, between incentives and competition.
Rare Diseases, Paradox of Rarity Orphan Drugs, Current Legislation, the Caveat, Searching For That Pot of Gold, “All Good Things Must Come To an End”
There is no single, widely accepted definition for rare diseases:
§ EU - "life-threatening or chronically debilitating disease” affecting than10.patientsconcomitantly with absence of existing treatmentcovers some tropical diseases
Paradox of Rarity
Even though the “diseases are rare, rare diseases patients are many”.
Rare Diseases have low prevalence/heterogeneity, patients are a minority, and the market is too small for pharma investment in orphan drugs R&D; the relentless work of patient advocates and parent’s organizations, urged governments to enact legislation with incentives to encourage the pharmaceutical industry to search for treatments for orphan diseases.
Ultra Orphan Diseases are extremely rare chronically debilitating or life threatening conditions; neglected diseases are common and transmissible primarily affecting patients in developing countries- their market is unprofitable – they are not rare diseases, but are orphan diseases because pharmaceutical companies neglect them.
Orphan diseases have a wide range of disorders and symptoms, varying between and within each condition, 80% have genetic origins, and collectively, affect 350 million people worldwide.
Current Legislation:
US – The Orphan Drug Act (ODA) 1983
Incentives:
§ Waived PDUFA fee (more than $1 million/application)
§ Accelerated Approval (for serious and life-threatening illnesses (using surrogate endpoints – open trials) –of an NDA- (the company cansell drugs to patients that are not part of clinical trials, while the testing is still going on)
The Rare Disease Act (2002) - disorders affecting fewer than 200.000 people or about 1 in 1.500 people
The Creating Hope Act of 2011 (U.S. Senator Bob Casey (D-PA)), not yet passed
EU - Regulation (EC) No 141/2000; Commission Regulation (EC) No 847/2000
Incentives
§ Acess To The Centralized Authorization Procedure
FDA & EMEA agreed to utilize a common application process in 2007
The caveat here is monopolistic advantages raise questions over touting health benefits in absence of good proof. The assertion that orphan drugs target few patients does not apply to all cases, and distorts the purpose of orphan drug laws. Strategies that paid off huge profits:
Facts:
§ A drug for a common disease may develop an indication for a rare disease (e.g. “Viagra/Revatio”, Pfizer)
Searching For That Pot of Gold
“Piecemeal Strategy”
“Orphan Blockbusters”
Market exclusivity-monopoly and orphan drugs intended for the 200.000 people limit:
Sponsors not only reaped considerable benefits as recovered all development costs two years after access to the market:
§ Drugs for chronic diseases (administered to patients during a prolonged time)as Genzyme’s “Ceredase” for “Glaucher´s” disease
Provisions of “The Patient Protection and Affordable Care Act” (PPAC Act) Of 2010
§ These Provisions Do Not Apply To Orphan Drugs
FDA & EMEA agreed to utilize a common application process in 2007
The caveat here is monopolistic advantages raise questions over touting health benefits in absence of good proof. The assertion that orphan drugs target few patients does not apply to all cases, and distorts the purpose of orphan drug laws. Strategies that paid off huge profits
Facts:
§ A drug for a common disease may develop an indication for a rare disease (e.g. “Viagra/Revatio”, Pfizer)
Searching For That Pot of Gold
“Piecemeal Strategy”
“Orphan Blockbusters”
Market exclusivity-monopoly and orphan drugs intended for the 200.000 people limit:
Sponsors not only reaped considerable benefits as recovered all development costs two years after access to the market:
§ Drugs for chronic diseases (administered to patients during a prolonged time)as Genzyme’s “Ceredase” for “Glaucher´s” disease
Provisions of “The Patient Protection and Affordable Care Act” (PPAC Act) Of 2010
§ These Provisions Do Not Apply To Orphan Drugs
However, “All Good Things Must come to an end"
§ The Treasury Department is now considering whether to limit the exclusions for orphan drugs (1)
§ The Office of Pharmacy Affairs of the U.S. Health Resources Services Administration (HRSA) is currently addressing the drug discounting
component, and the corresponding orphan drug exclusion of the PPAC Act (1)
Sometimes, a Song Says it Better: “I Want It All” (2) (1) http://www.lexisnexis.com/community/taxlaw/blogs/lexistaxstaffanalyses/archiv... (2) “I want It All” (Queen) * “Orphans of God” (Avalon’s Lyrics)
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Marketing exclusivity in EU and U.S.A provided a monopolistic market for orphan drugs without “me-too”/generics competitors, to pharma companies.
Orphan drug laws and the pharma industry made great contributions towards the cure of millions of people offering from uncommon and frequently life-threatening diseases. However, it is necessary to strike a new balance between incentives and competition.There is no single, widely accepted definition for rare diseases:Paradox of Rarity
Even though the “diseases are rare, rare diseases patients are many”.
Rare Diseases have low prevalence/heterogeneity, patients are a minority,and the market is too small for pharma investment in orphan drugs R&D; the relentless work of patient advocates and parent’s organizations, urged governments to enact legislation with incentives to encourage the pharmaceutical industry to search for treatments for orphan diseases.
Ultra Orphan Diseases are extremely rare chronically debilitating or life threatening conditions; neglected diseases are common and transmissible primarily affecting patients in developing countries- their market is unprofitable – they are not rare diseases, but are orphan diseases because pharmaceutical companies neglect them.
Orphan diseases have a wide range of disorders and symptoms, varying between and within each condition, 80% have genetic origins, and collectively, affect 350 million people worldwide.Current Legislation:
US – The Orphan Drug Act (ODA) 1983
Incentives:
The Rare Disease Act (2002)- disorders affecting fewer than 200.000 people or about 1 in 1.500 people
The Creating Hope Act of 2011(U.S. Senator Bob Casey (D-PA)), not yet passed
EU - Regulation (EC) No 141/2000; Commission Regulation (EC) No 847/2000
Incentives
FDA & EMEA agreed to utilize a common application process in 2007
The caveat here is monopolistic advantages raise questions over touting health benefits in absence of good proof. The assertion that orphan drugs target few patients does not apply to all cases, and distorts the purpose of orphan drug laws. Strategies that paid off huge profits:
Facts:
Searching For That Pot of Gold
“Piecemeal Strategy”
“Orphan Blockbusters”
Market exclusivity-monopoly and orphan drugs intended for the 200.000 people limit:
Sponsors not only reaped considerable benefits as recovered all development costs two years after access to the market:
Provisions of “The Patient Protection and Affordable Care Act” (PPAC Act) Of 2010
However, “All Good Things Must Come To an End”
Sometimes, a Song Says it Better: “I Want It All” (2)
