With $10 billion worth of branded biologics set to go off patent in 2006, many generics manufacturers are gearing up to produce generic biologicals. And looking at the broader pharmaceutical market, 42 blockbuster drugs will loose their patent in 2007, accounting for an astonishing $82 billion in sales. However, debate rages as to whether true equivalents of biological drugs can be produced. The situation is mainly two-sided – generics manufacturers versus drug originators – with the exception of Biogen, one of biotech’s leaders, which refutes the argument that different cell lines cannot produce equivalent drugs. This is because Biogen’s drug, Avonex®, was approved by FDA despite the fact that clinical trials were conducted with product produced from a different cell line than the one used to produce the current marketed product.
In the biotech camp, industry representatives agree that protein analysis techniques are not advanced enough yet to allow for a safe generic biological. Their argument is that manufacturing methods vary. Proteins may be produced by mammalian cells, yeast, E. coli, or even genetically-engineered plants. All of these organisms have a unique biological signature in the form of post-translational modifications. In particular, regulators are concerned that changes in surface carbohydrates could impact efficacy or cause immunogenicity. At the same time, there is no clear regulatory pathway for the approval of generic biologicals at this time.
On the other side of the fence, generics manufacturers use Biogen as an example to demonstrate that bioequivalence can be achieved using different cell lines to produce the same drug. Generics manufacturers also argue that if a change occurs in a protein, there is no reason why they couldn’t go back and find out why.
The truth probably lies somewhere in between these two schools of thought. Analytical techniques need to advance, but the right expertise and process can go a long way toward mitigating the risks of generic biologicals.
It is also important to consider that costs to produce generic biologicals will probably not be too much different than the original therapeutic, especially since generics manufacturers will likely have to conduct some clinical trials.
Copyright © 1996-2007, VertMarkets, Inc
Sunday, July 15, 2007
India Takes on New Roles in Drug Development & Production
The confluence of several circumstances has elevated India’s stature within the pharmaceutical industry. Initially recognized as a cost-effective outlet for drug manufacturing, especially generics, India’s role has grown to encompass higher level contract research and clinical trials. Thanks to the amendment of India’s patent act in March 2005, which introduced product patents, an increasing number of multinational pharmaceutical companies are bringing their R&D operations to India.
The fact that India has the largest number of FDA–approved drug manufacturing facilities outside the U.S. makes India even more attractive to large pharmaceutical companies. The country also has an educated and English-speaking workforce with vast expertise in the areas of basic science, biotechnology, computational science, statistics and engineering. The combination of India’s proven expertise in other industries, such as IT, its safety in terms of regulations and patent protections, and its competitiveness from a skill and cost standpoint, are among the reasons that the Indian biotech sector is expected to achieve $5 billion in revenues by 2010, as estimated by the Department of Biotechnology (DBT), Government of India.
Copyright © 1996-2007, VertMarkets, Inc
The fact that India has the largest number of FDA–approved drug manufacturing facilities outside the U.S. makes India even more attractive to large pharmaceutical companies. The country also has an educated and English-speaking workforce with vast expertise in the areas of basic science, biotechnology, computational science, statistics and engineering. The combination of India’s proven expertise in other industries, such as IT, its safety in terms of regulations and patent protections, and its competitiveness from a skill and cost standpoint, are among the reasons that the Indian biotech sector is expected to achieve $5 billion in revenues by 2010, as estimated by the Department of Biotechnology (DBT), Government of India.
Copyright © 1996-2007, VertMarkets, Inc
Clinical research shows that Women become sexually aroused as quickly as men
· NewScientist.com news service
· Roxanne Khamsi
Women may have a reputation for demanding lengthy foreplay, but they become sexually aroused as quickly as men, according to a new study that used thermal imaging to measure increased blood flow to genital regions.
While watching pornography, both sexes reach peak arousal within 10 minutes, on average, researchers report.
Earlier attempts to record sexual arousal have involved invasive probes and electrodes, according to Tuuli Kukkonen, who helped conduct the study led by Irv Binik at McGill University Health Centre in Montreal, Canada.
For women participating in previous studies, this sometimes meant the use of an uncomfortable probe similar to a tampon, inserted into the vagina.
Such invasive methods “made studying sexual arousal very difficult” and comparing sexual response between men and women even more challenging, says Kukkonen, as the measurement techniques differed between the sexes.
For this reason, Kukkonen and her colleagues used thermal imaging to record raised temperatures in subjects’ genital areas. The thermal imaging camera can measure temperature changes from a distance and relay the information to a computer for analysis.
Tell-tale signs
More heat indicates greater blood flow to the genital area, a tell-tale sign of sexual arousal. Kukkonen says that modern thermal imaging technology is much more sophisticated than earlier versions, and can now accurately measure temperature changes of 0.001°C within a few square millimetres.
In the new study, 28 men and 30 women first watched a video of the Canadian countryside in a room on their own, so that researchers could establish each individual’s baseline temperatures.
Subjects were naked from the waist down and positioned themselves such that their genital area was exposed and readable by the thermal imaging device. The participants next watched another video with the same subject matter, or one featuring pornography, horror or comedic clips from the Best Bits of Mr Bean.
Maximum arousal
The computer only registered a spike in genital temperatures while subjects watched pornography, and not the other films. In those viewing porn, these temperatures increased by about 2°C, on average.
Moreover, men reached peak sexual arousal in 665 seconds – about 10 minutes – while women arrived at maximal arousal in 743 seconds. The difference between the times was not statistically significant, the researchers point out.
The findings, which were presented on 30 September at the Canadian Sex Research Forum conference in Ottawa, go against the common assumption that women take longer to become aroused, says Kukkonen.
She adds that the more accurate thermal imaging technology now available may hold promise as a diagnostic tool for sexual dysfunction in both sexes
· Roxanne Khamsi
Women may have a reputation for demanding lengthy foreplay, but they become sexually aroused as quickly as men, according to a new study that used thermal imaging to measure increased blood flow to genital regions.
While watching pornography, both sexes reach peak arousal within 10 minutes, on average, researchers report.
Earlier attempts to record sexual arousal have involved invasive probes and electrodes, according to Tuuli Kukkonen, who helped conduct the study led by Irv Binik at McGill University Health Centre in Montreal, Canada.
For women participating in previous studies, this sometimes meant the use of an uncomfortable probe similar to a tampon, inserted into the vagina.
Such invasive methods “made studying sexual arousal very difficult” and comparing sexual response between men and women even more challenging, says Kukkonen, as the measurement techniques differed between the sexes.
For this reason, Kukkonen and her colleagues used thermal imaging to record raised temperatures in subjects’ genital areas. The thermal imaging camera can measure temperature changes from a distance and relay the information to a computer for analysis.
Tell-tale signs
More heat indicates greater blood flow to the genital area, a tell-tale sign of sexual arousal. Kukkonen says that modern thermal imaging technology is much more sophisticated than earlier versions, and can now accurately measure temperature changes of 0.001°C within a few square millimetres.
In the new study, 28 men and 30 women first watched a video of the Canadian countryside in a room on their own, so that researchers could establish each individual’s baseline temperatures.
Subjects were naked from the waist down and positioned themselves such that their genital area was exposed and readable by the thermal imaging device. The participants next watched another video with the same subject matter, or one featuring pornography, horror or comedic clips from the Best Bits of Mr Bean.
Maximum arousal
The computer only registered a spike in genital temperatures while subjects watched pornography, and not the other films. In those viewing porn, these temperatures increased by about 2°C, on average.
Moreover, men reached peak sexual arousal in 665 seconds – about 10 minutes – while women arrived at maximal arousal in 743 seconds. The difference between the times was not statistically significant, the researchers point out.
The findings, which were presented on 30 September at the Canadian Sex Research Forum conference in Ottawa, go against the common assumption that women take longer to become aroused, says Kukkonen.
She adds that the more accurate thermal imaging technology now available may hold promise as a diagnostic tool for sexual dysfunction in both sexes
Sunday, July 8, 2007
Top 10 Biotech companies in the world
1 Amgen
2 Genentech
3 Serono
4 Biogen Idec
5 Gilead Sciences
6 Genzyme Corp.
7 MedImmune
8 Chiron Corp.
9 Millennium Pharmaceuticals
10 ImClone
2 Genentech
3 Serono
4 Biogen Idec
5 Gilead Sciences
6 Genzyme Corp.
7 MedImmune
8 Chiron Corp.
9 Millennium Pharmaceuticals
10 ImClone
Top 20 Pharma companies in the world
1 Pfizer
2 Sanofi-Aventis
3 GlaxoSmithKline
4 AstraZeneca
5 Johnson & Johnson
6 Merck & Co.
7 Novartis
8 Roche
9 Bristol-Myers Squibb
10 Wyeth
11 Eli Lilly & Co.
12 Abbott Laboratories
13 Boehringer-Ingelheim
14 Takeda Pharmaceutical
15 Schering-Plough
16 Astellas Pharma
17 Daiichi-Sankyo
18 Novo Nordisk
19 Eisai
20 Bayer AG
2 Sanofi-Aventis
3 GlaxoSmithKline
4 AstraZeneca
5 Johnson & Johnson
6 Merck & Co.
7 Novartis
8 Roche
9 Bristol-Myers Squibb
10 Wyeth
11 Eli Lilly & Co.
12 Abbott Laboratories
13 Boehringer-Ingelheim
14 Takeda Pharmaceutical
15 Schering-Plough
16 Astellas Pharma
17 Daiichi-Sankyo
18 Novo Nordisk
19 Eisai
20 Bayer AG
Friday, July 6, 2007
Comments about clinical research jobs and salaries
Just wanted to add a general comment about the Pay scale chart of salary ranges for clinical research professionals.
Generally a clinical research associate with around 2-3 years of field monitoring experience can hope to make anywhere between 65k-85k per year in the pharma and biotech industry.
I know Contract research monitors who are making around 150-160 k annually!!!!
A project manager would be making around 100 k with the same duration of project management experience.
Generally academic settings pay less when compared to the industry.
The most important career advancement tool is hands on experience,experience and of course more experience.
Having a Masters,ACRP,DIA or SOCRA certification might help in certain situations also.
Generally a clinical research associate with around 2-3 years of field monitoring experience can hope to make anywhere between 65k-85k per year in the pharma and biotech industry.
I know Contract research monitors who are making around 150-160 k annually!!!!
A project manager would be making around 100 k with the same duration of project management experience.
Generally academic settings pay less when compared to the industry.
The most important career advancement tool is hands on experience,experience and of course more experience.
Having a Masters,ACRP,DIA or SOCRA certification might help in certain situations also.
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