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.
Five tips for life science execs
Making the Most: -
Ronald Rosenberg
05/10/06
While there is no magic formula that leads to a higher salary (except being CEO; see It's Good to Be CEO ), experts agree that there are things to keep in mind when negotiating compensation for a new job. For starters: it's all a negotiation.
1. Negotiation starts at the first phone call
A typical initial telephone screening will include 'How much money are you looking to earn?' "The money question is both real and psychological, so if you say, 'Money is not that important, but getting the job done is,' it may sound nice but that's simply naäve or worse," cautions William Morin, chief operating officer of WJM Associates, a New York-based executive coaching and advisory firm. Experts advise having a number in your head and calling that a low range, or answering that overall compensation is important and turning the question back to the interviewer. Either way, be ready for the question and answer with authority.
2. Choose salary over bonus (when you can)
The tradeoffs between salary and bonus are key negotiating points, especially when the company won't budge on the salary, notes Barbara Preston, senior executive recruiter at Pharmascouts.com, based in La Jolla, Calif. She recalls how a medicinal chemist was getting a top scientific management position at a West Coast startup biotech company and was offered a $10,000 bonus. Instead, he asked and received an additional $5,000 in salary and $2,000 for the sign-on bonus. His reasoning: a one-time bonus is taxed at 50%. Plus, adding the $5,000 to base pay helps later when yearly raises and promotions are based on annual salary.
3. Use vacations as currency
Negotiate vacation time aggressively, as companies may be more willing to extend vacation than boost salary. Try to put into an agreement that any vacation time not taken is paid in dollars equivalent to daily salary. "Vacations are not deal breakers in small biotech companies," says Preston. "I recently had one senior scientist who was getting his first executive position at about $110,000 for an 80-person biotech company and was about to negotiate for a third week. The company gave him what he wanted with no salary change, in part, because these executives are so busy, they often don't take all their vacation time. However, they want to make sure the time is available so they often ask and get it." Still, many companies take a "use it or lose it" attitude toward vacations for midlevel executives such as directors and managers. If they don't use the paid time off, it's gone, and very few companies let them carry it over to the next year. However, for senior executives, vacation policies are more flexible.
4. Talk up multiple offers
When dealing with two competing offers, there is a division of opinion over how much candor should be expressed. "Just say 'I have a couple of opportunities and here are the things about your job that are important for me in this offer,' and leave it at that," says Rossella Derickson, a principal at Corporate-Wisdom.com, an executive development and management training firm in Saratoga, Calif. Preston says that candidates can be straightforward and tactful (without divulging every detail) in acknowledging the dual proposals and in asking one company if it can match the other's offer. "Candidates' biggest mistake is that they often sit back and wait to see which offer comes through rather than being proactive," says Preston.
5. Spell out unplanned endings
Executive employment agreements need to spell out terms in the case of being fired or if the company is acquired and management changes hands. This will offer not only some cash when looking for a new job but also help protect against a loss of vested equity. "In the life sciences industry most companies don't have formalized severance programs," notes Deb Bilak, a principal at Buck Consultants, a New York-based human resources consulting and management firm. "That's not unusual given that there are many small companies." With small companies be creative. A six-month severance package is optimal, but if one is not offered, seek a higher signing bonus, suggests Linda Whitney, president of the Sonder Group, a biotechnology search and placement services firm in Sudbury, Mass.
Ronald Rosenberg
05/10/06
While there is no magic formula that leads to a higher salary (except being CEO; see It's Good to Be CEO ), experts agree that there are things to keep in mind when negotiating compensation for a new job. For starters: it's all a negotiation.
1. Negotiation starts at the first phone call
A typical initial telephone screening will include 'How much money are you looking to earn?' "The money question is both real and psychological, so if you say, 'Money is not that important, but getting the job done is,' it may sound nice but that's simply naäve or worse," cautions William Morin, chief operating officer of WJM Associates, a New York-based executive coaching and advisory firm. Experts advise having a number in your head and calling that a low range, or answering that overall compensation is important and turning the question back to the interviewer. Either way, be ready for the question and answer with authority.
2. Choose salary over bonus (when you can)
The tradeoffs between salary and bonus are key negotiating points, especially when the company won't budge on the salary, notes Barbara Preston, senior executive recruiter at Pharmascouts.com, based in La Jolla, Calif. She recalls how a medicinal chemist was getting a top scientific management position at a West Coast startup biotech company and was offered a $10,000 bonus. Instead, he asked and received an additional $5,000 in salary and $2,000 for the sign-on bonus. His reasoning: a one-time bonus is taxed at 50%. Plus, adding the $5,000 to base pay helps later when yearly raises and promotions are based on annual salary.
3. Use vacations as currency
Negotiate vacation time aggressively, as companies may be more willing to extend vacation than boost salary. Try to put into an agreement that any vacation time not taken is paid in dollars equivalent to daily salary. "Vacations are not deal breakers in small biotech companies," says Preston. "I recently had one senior scientist who was getting his first executive position at about $110,000 for an 80-person biotech company and was about to negotiate for a third week. The company gave him what he wanted with no salary change, in part, because these executives are so busy, they often don't take all their vacation time. However, they want to make sure the time is available so they often ask and get it." Still, many companies take a "use it or lose it" attitude toward vacations for midlevel executives such as directors and managers. If they don't use the paid time off, it's gone, and very few companies let them carry it over to the next year. However, for senior executives, vacation policies are more flexible.
4. Talk up multiple offers
When dealing with two competing offers, there is a division of opinion over how much candor should be expressed. "Just say 'I have a couple of opportunities and here are the things about your job that are important for me in this offer,' and leave it at that," says Rossella Derickson, a principal at Corporate-Wisdom.com, an executive development and management training firm in Saratoga, Calif. Preston says that candidates can be straightforward and tactful (without divulging every detail) in acknowledging the dual proposals and in asking one company if it can match the other's offer. "Candidates' biggest mistake is that they often sit back and wait to see which offer comes through rather than being proactive," says Preston.
5. Spell out unplanned endings
Executive employment agreements need to spell out terms in the case of being fired or if the company is acquired and management changes hands. This will offer not only some cash when looking for a new job but also help protect against a loss of vested equity. "In the life sciences industry most companies don't have formalized severance programs," notes Deb Bilak, a principal at Buck Consultants, a New York-based human resources consulting and management firm. "That's not unusual given that there are many small companies." With small companies be creative. A six-month severance package is optimal, but if one is not offered, seek a higher signing bonus, suggests Linda Whitney, president of the Sonder Group, a biotechnology search and placement services firm in Sudbury, Mass.
Clinical research careers
The time is ripeWith pharmaceutical companies outsourcing drug testing, jobs in clinical research are growing fast.
Mike Mortimer
If you are considering a career in clinical research, your timing could not be better. Pharmaceutical companies are increasingly opting to outsource clinical testing of potential new drugs. This shift is fuelling massive growth among the contract research organizations (CROs) engaged in doing the work — a trend that seems likely to continue for some time.Pharmaceutical companies are under increasing pressure to develop blockbuster drugs quickly and at the lowest possible cost, while fending off challenges from manufacturers producing generic versions of drugs that have come off patent.
Clinical studies typically account for nearly half of the billion-dollar cost of developing a drug, so companies are now tending to engage CROs to run the trials in order to maximize investment by reducing the time required to develop and bring a new drug to market.
If you are considering a career in clinical research, your timing could not be better.
A 2006 Goldman Sachs report concluded that the CRO industry is expected to grow at an annual rate of 13% through to 2010, while biotech and pharma spending on drug development is expected to grow at an annual rate of only 11.1% for the same period — suggesting that the role of CROs is expanding in size and importance.This is leading to a growing backlog of trials among some CROs, which translates into a need for more staff.
The CRO industry is clearly growing, as are the associated careers opportunities. For those with the right educational background, and a willingness to take on cutting-edge clinical science and to learn managerial skills, an engaging and stimulating career awaits.
For those with the right educational background, and a willingness to take on cutting-edge clinical science and to learn managerial skills, an engaging and stimulating career awaits.
Mike Mortimer is executive vice-president of global human resources at Quintiles Transnational in Durham, North Carolina.
Article brought to you by: Nature Jobs
Mike Mortimer
If you are considering a career in clinical research, your timing could not be better. Pharmaceutical companies are increasingly opting to outsource clinical testing of potential new drugs. This shift is fuelling massive growth among the contract research organizations (CROs) engaged in doing the work — a trend that seems likely to continue for some time.Pharmaceutical companies are under increasing pressure to develop blockbuster drugs quickly and at the lowest possible cost, while fending off challenges from manufacturers producing generic versions of drugs that have come off patent.
Clinical studies typically account for nearly half of the billion-dollar cost of developing a drug, so companies are now tending to engage CROs to run the trials in order to maximize investment by reducing the time required to develop and bring a new drug to market.
If you are considering a career in clinical research, your timing could not be better.
A 2006 Goldman Sachs report concluded that the CRO industry is expected to grow at an annual rate of 13% through to 2010, while biotech and pharma spending on drug development is expected to grow at an annual rate of only 11.1% for the same period — suggesting that the role of CROs is expanding in size and importance.This is leading to a growing backlog of trials among some CROs, which translates into a need for more staff.
The CRO industry is clearly growing, as are the associated careers opportunities. For those with the right educational background, and a willingness to take on cutting-edge clinical science and to learn managerial skills, an engaging and stimulating career awaits.
For those with the right educational background, and a willingness to take on cutting-edge clinical science and to learn managerial skills, an engaging and stimulating career awaits.
Mike Mortimer is executive vice-president of global human resources at Quintiles Transnational in Durham, North Carolina.
Article brought to you by: Nature Jobs
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