http://7thspace.com/headlines/379784/california_gang_members_associates_hotel_indicted_on_prostitution_related_racketeering_charges.html
SAN DIEGO, CA—United States Attorney Laura E Duffy announced today the unsealing of an indictment charging 38 individuals and one Limited Liability Company (LLC) with conspiracy to conduct enterprise affairs through a pattern of racketeering activity (RICO). Specifically, the defendants are charged with using a corrupt enterprise to conduct a pattern of racketeering activity, namely, prostitution of minors and adults, use of facilities of interstate commerce to promote prostitution, drug trafficking, and other gang-related crimes. The charged racketeering activity stems from an extensive, 18 month, multi-agency gang investigation entitled Operation Vice Grip in Oceanside, California and surrounding North County areas. In addition to the criminal charges, the indictment also alleges the criminal forfeiture of the Oceanside Travelodge hotel.
According to the indictment, the defendants are charged as members, associates, and facilitators of the Oceanside Crip enterprise (“Oceanside Crips”) composed of various Crip gang “sets,” including the “Insane Crip Gang,” “Deep Valley Crips” and “Crook, Mob, Gangsters.” All three Crip sets are based primarily in Oceanside, and over the last several years have cooperated and interacted to the point that traditional gang distinctions between them have broken down. Specifically, the indictment alleges that since 2005, members of the Oceanside Crip Enterprise engaged in multiple racketeering acts in furtherance of the enterprise, including, among other things, the sex trafficking of minors and adults; attempted murder; kidnapping; extortion; and the distribution of controlled substances. The enterprise members also worked together to protect, promote, and expand their territory against rival gangs. The indictment alleges that senior members of the Oceanside Crips enterprise controlled and directed the activities of more junior members, even from prison.
The indictment further alleges that defendants identified as “pimps” (a person who befriends, recruits, trains, and/or panders a person for prostitution) and “bottoms” (a pimp’s most trusted/senior prostitute) promoted and managed prostitution activities in San Diego County, California, and elsewhere. As set out in the indictment, the Oceanside Crips enterprise has, in recent years, increasingly focused its for-profit criminal activity on pimping and prostituting adult and juvenile females in Oceanside, California, and elsewhere within northern San Diego County and throughout the United States. To this end, as described in the indictment, gang-controlled prostitution spawned a “pimping” subculture, known as “The Game,” which operates under a set of strictly observed rules, with consequences for individuals who violate them—including, but not limited to, physical abuse and/or public humiliation. As alleged in the indictment, the majority of the defendants named in the indictment collaborated with one another as members, associates, and facilitators of the enterprise to carry out prostitution activities, primarily in and around low-cost motels in North County, including the Oceanside Travelodge.
As detailed in the indictment, Oceanside Crips Enterprise members and associates also worked together to recruit new prostitutes. Recruitment efforts generally focused on vulnerable juvenile females who were runaways or from broken homes. Furthermore, as detailed in the indictment, Enterprise “pimps” and “bottoms” conducted extensive online recruitment via various social networking websites, including MySpace, Facebook, and Twitter. As alleged, upon recruiting prostitutes, enterprise “pimps” routinely provided them with controlled substances and alcohol in order to manipulate their loyalty and increase productivity as related to prostitution.
Monday, May 2, 2011
Harris James Associates Biomedicine News: Can Hobbyists and Hackers Transform Biotechnology?
http://www.openpr.com/news/172549/Harris-James-Associates-Biomedicine-News-Can-Hobbyists-and-Hackers-Transform-Biotechnology.html
(openPR) - James Harris Associates mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
DIY Scientists Hack the Software of Life, Marcus Wohlsen explores the new movement in garage-based biotech. By Amanda Gefter.
(openPR) - James Harris Associates mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
DIY Scientists Hack the Software of Life, Marcus Wohlsen explores the new movement in garage-based biotech. By Amanda Gefter.
For most of us, managing our health means visiting a doctor. The more serious our concerns, the more specialized a medical expert we seek. Our bodies often feel like foreign and frightening lands, and we are happy to let someone with an MD serve as our tour guide. For most of us, our own DNA never makes it onto our personal reading list.
Harris James Associates Update: Congressional forum on biotech jobs focuses on FDA By Keith Darcé
http://www.onlineprnews.com/news/131306-1303817804-harris-james-associates-update-congressional-forum-on-biotech-jobs-focuses-on-fda-by-keith-darc.html
Online PR News – 28-April-2011 –Harris James Associates Update: Overly cautious government regulators, threats to basic science research funding and burdensome taxes are holding back job creation by drug and medical device companies and slowing the delivery of innovative new therapies to patients, biotechnology industry experts told federal lawmakers Thursday during a hearing in San Diego.
James Harris Associates mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
Most of the criticism was directed at the Food and Drug Administration, which approved 21 new drugs last year, compared to 36 in 2004.
“There are whole areas (of drug development) that venture capitalists won’t pursue because the regulatory barriers are too high,” said David Gollaher, president and chief executive of the California Healthcare Institute in La Jolla.
The complaints were familiar to anyone who has followed drug and medical device development in the United States over the past several years.
Gollaher and the other experts delivered their comments to Rep. Darrell Issa, R-Vista, during a morning public forum at the University of California San Diego. Since he became chairman of the House Oversight and Government Reform Committee in early January, Issa has hosted 10 such gatherings around the country focused on regulations that stifle economic expansion.
For the latest gathering, he returned to his home county, where more than 400 companies make up a major biotechnology hub that employs more than 40,000 people, according to the San Diego trade group Biocom.
Issa was joined by Reps. Susan Davis, D-San Diego; Brian Bilbray, R-Solana Beach; and Duncan Hunter, R-Alpine.
Issa’s committee has broad investigative power, but any legislation addressing specific regulatory changes would be handled by other congressional panels that directly oversee the related agencies.
“We’re here today because San Diego is a miraculous story of biotech,” Issa said in comments that opened the 1½-hour session.
To aid his investigation, Issa solicited comments from hundreds of individuals, companies and trade groups, including many in the biotechnology and pharmaceutical industries, both directly and through a special website, americanjobcreators.com.
“We were shocked to find out that the FDA is often one of the greatest impediments to job creation,” the congressman said.
Critics of the agency say the problem is most clearly displayed in the increasing amount of time that it takes the agency to process new product applications.
Since 2007, drug review times by the FDA have increased by 28 percent, while evaluations of devices have taken as much as 75 percent more time, Gollaher said.
They also point to a recent string of unexpected new drug rejections by the agency that forced developers to perform new tests on their experimental medications.
Just in the past six months, the FDA turned down three drugs from San Diego companies: diet pills from Arena Pharmaceuticals and Orexigen Therapeutics, and a weekly injectable diabetes therapy from Amylin.
In a recent survey by Biocom, industry executives said the agency’s review process lacks transparency, often becomes sidetracked by unexpected issues and takes too much time.
“We see a growing concern that the FDA is becoming detached from the industry,” said Joe Panetta, president and chief executive of Biocom.
Many of the problems can be blamed on a cultural change at the agency that raised the emphasis on potential risks that new drugs and devices pose in the wake of a long string of high-profile medical product recalls, Gollaher said.
Still, some people say the changes have been good. Public Citizen and other consumer advocacy groups have praised the FDA for scrutinizing new medical products more intensely and requiring more safety testing before allowing them onto the market.
One possible way of shifting the agency’s focus more toward the potential benefits of new products is to give a formal role in the regulatory review process to the patients who would use the drugs and devices, said Duane Roth, chief executive of Connect San Diego, a nonprofit support group for fledgling technology companies.
“It’s their disease,” he said. “It’s not yours, and it’s not ours. Until they get in there to help us, I don’t think much will change.”
UCSD Chancellor Marye Anne Fox implored the lawmakers to resist urges to cut basic science grant funding from the National Institutes of Health, which sent $824 million to her university and other scientific institutes in the county last year.
The money produces many of the discoveries that are later taken up by biotechnology companies and turned into products.
keith.darce@uniontrib.com (619) 293-1020
Online PR News – 28-April-2011 –Harris James Associates Update: Overly cautious government regulators, threats to basic science research funding and burdensome taxes are holding back job creation by drug and medical device companies and slowing the delivery of innovative new therapies to patients, biotechnology industry experts told federal lawmakers Thursday during a hearing in San Diego.
James Harris Associates mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
Most of the criticism was directed at the Food and Drug Administration, which approved 21 new drugs last year, compared to 36 in 2004.
“There are whole areas (of drug development) that venture capitalists won’t pursue because the regulatory barriers are too high,” said David Gollaher, president and chief executive of the California Healthcare Institute in La Jolla.
The complaints were familiar to anyone who has followed drug and medical device development in the United States over the past several years.
Gollaher and the other experts delivered their comments to Rep. Darrell Issa, R-Vista, during a morning public forum at the University of California San Diego. Since he became chairman of the House Oversight and Government Reform Committee in early January, Issa has hosted 10 such gatherings around the country focused on regulations that stifle economic expansion.
For the latest gathering, he returned to his home county, where more than 400 companies make up a major biotechnology hub that employs more than 40,000 people, according to the San Diego trade group Biocom.
Issa was joined by Reps. Susan Davis, D-San Diego; Brian Bilbray, R-Solana Beach; and Duncan Hunter, R-Alpine.
Issa’s committee has broad investigative power, but any legislation addressing specific regulatory changes would be handled by other congressional panels that directly oversee the related agencies.
“We’re here today because San Diego is a miraculous story of biotech,” Issa said in comments that opened the 1½-hour session.
To aid his investigation, Issa solicited comments from hundreds of individuals, companies and trade groups, including many in the biotechnology and pharmaceutical industries, both directly and through a special website, americanjobcreators.com.
“We were shocked to find out that the FDA is often one of the greatest impediments to job creation,” the congressman said.
Critics of the agency say the problem is most clearly displayed in the increasing amount of time that it takes the agency to process new product applications.
Since 2007, drug review times by the FDA have increased by 28 percent, while evaluations of devices have taken as much as 75 percent more time, Gollaher said.
They also point to a recent string of unexpected new drug rejections by the agency that forced developers to perform new tests on their experimental medications.
Just in the past six months, the FDA turned down three drugs from San Diego companies: diet pills from Arena Pharmaceuticals and Orexigen Therapeutics, and a weekly injectable diabetes therapy from Amylin.
In a recent survey by Biocom, industry executives said the agency’s review process lacks transparency, often becomes sidetracked by unexpected issues and takes too much time.
“We see a growing concern that the FDA is becoming detached from the industry,” said Joe Panetta, president and chief executive of Biocom.
Many of the problems can be blamed on a cultural change at the agency that raised the emphasis on potential risks that new drugs and devices pose in the wake of a long string of high-profile medical product recalls, Gollaher said.
Still, some people say the changes have been good. Public Citizen and other consumer advocacy groups have praised the FDA for scrutinizing new medical products more intensely and requiring more safety testing before allowing them onto the market.
One possible way of shifting the agency’s focus more toward the potential benefits of new products is to give a formal role in the regulatory review process to the patients who would use the drugs and devices, said Duane Roth, chief executive of Connect San Diego, a nonprofit support group for fledgling technology companies.
“It’s their disease,” he said. “It’s not yours, and it’s not ours. Until they get in there to help us, I don’t think much will change.”
UCSD Chancellor Marye Anne Fox implored the lawmakers to resist urges to cut basic science grant funding from the National Institutes of Health, which sent $824 million to her university and other scientific institutes in the county last year.
The money produces many of the discoveries that are later taken up by biotechnology companies and turned into products.
keith.darce@uniontrib.com (619) 293-1020
Harris James Associates News: Nautic Partners buys Omnicare Clinical Research
http://www.onlineprnews.com/news/133166-1304057284-harris-james-associates-news-nautic-partners-buys-omnicare-clinical-research.html
Online PR News – 30-April-2011 –By PBN Staff, PROVIDENCE – Private equity firm Nautic Partners acquired Omnicare Clinical Research on Thursday.
Harris James Associates News Compilation - JHA mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
Omnicare CR, headquartered in King of Prussia, Pa., conducts early phase, phase II, III and late phase clinical trials for pharmaceutical, biotechnology and medical device industries. It also provides technical services supporting clinical trials, with a focus on data management and biostatistics services.
As part of the deal, its parent company, Ominicare Inc., has provided Omnicare CR with access to its proprietary database of de-identified information exclusive to the field of clinical research and lasting for five years.
“Omnicare has carved out an attractive niche in the [clinical research organization] industry as a global, full-service provider serving the mid-sized pharmaceutical market, the medical device market and the biotechnology market,” said Chris Crosby, managing director of Nautic. The firm did not disclose the financial details of the acquisition.
It is the 10th investment by Nautic Partners’ most recent fund, Nautic Partners VI, and its third health care investment.
James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries. Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.
Online PR News – 30-April-2011 –By PBN Staff, PROVIDENCE – Private equity firm Nautic Partners acquired Omnicare Clinical Research on Thursday.
Harris James Associates News Compilation - JHA mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
Omnicare CR, headquartered in King of Prussia, Pa., conducts early phase, phase II, III and late phase clinical trials for pharmaceutical, biotechnology and medical device industries. It also provides technical services supporting clinical trials, with a focus on data management and biostatistics services.
As part of the deal, its parent company, Ominicare Inc., has provided Omnicare CR with access to its proprietary database of de-identified information exclusive to the field of clinical research and lasting for five years.
“Omnicare has carved out an attractive niche in the [clinical research organization] industry as a global, full-service provider serving the mid-sized pharmaceutical market, the medical device market and the biotechnology market,” said Chris Crosby, managing director of Nautic. The firm did not disclose the financial details of the acquisition.
It is the 10th investment by Nautic Partners’ most recent fund, Nautic Partners VI, and its third health care investment.
James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries. Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.
Harris James Associates News: Nautic Partners buys Omnicare Clinical Research
http://www.pressbox.co.uk/detailed/Business/Harris_James_Associates_Our_Strategy_656036.html
By PBN Staff, PROVIDENCE – Private equity firm Nautic Partners acquired Omnicare Clinical Research on Thursday.
Harris James Associates News Compilation - JHA mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
Omnicare CR, headquartered in King of Prussia, Pa., conducts early phase, phase II, III and late phase clinical trials for pharmaceutical, biotechnology and medical device industries. It also provides technical services supporting clinical trials, with a focus on data management and biostatistics services.
As part of the deal, its parent company, Ominicare Inc., has provided Omnicare CR with access to its proprietary database of de-identified information exclusive to the field of clinical research and lasting for five years.
“Omnicare has carved out an attractive niche in the [clinical research organization] industry as a global, full-service provider serving the mid-sized pharmaceutical market, the medical device market and the biotechnology market,” said Chris Crosby, managing director of Nautic. The firm did not disclose the financial details of the acquisition.
It is the 10th investment by Nautic Partners’ most recent fund, Nautic Partners VI, and its third health care investment.
James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries. Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.
By PBN Staff, PROVIDENCE – Private equity firm Nautic Partners acquired Omnicare Clinical Research on Thursday.
Harris James Associates News Compilation - JHA mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
Omnicare CR, headquartered in King of Prussia, Pa., conducts early phase, phase II, III and late phase clinical trials for pharmaceutical, biotechnology and medical device industries. It also provides technical services supporting clinical trials, with a focus on data management and biostatistics services.
As part of the deal, its parent company, Ominicare Inc., has provided Omnicare CR with access to its proprietary database of de-identified information exclusive to the field of clinical research and lasting for five years.
“Omnicare has carved out an attractive niche in the [clinical research organization] industry as a global, full-service provider serving the mid-sized pharmaceutical market, the medical device market and the biotechnology market,” said Chris Crosby, managing director of Nautic. The firm did not disclose the financial details of the acquisition.
It is the 10th investment by Nautic Partners’ most recent fund, Nautic Partners VI, and its third health care investment.
James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries. Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.
Harris James Associates – Our Strategy
http://www.pressbox.co.uk/detailed/Business/Harris_James_Associates_Our_Strategy_656036.html
We believe strongly in the concept of economic and market-led research. This "top down" approach is aimed at identifying the most vibrant and promising market sectors in which to direct its considerable industry and company research capabilities. We believe in the long term growth and development of the global economy as the world's people strive for a healthier and higher standard of living, particularly in those emerging economies that account for fully half of the global population. While there are many and varied stumbling blocks on the path of global economic and social progress, Harris James Associates recognizes that there are always sectors that exhibit superior potential in the dynamics of global development. We believe that selectivity is the key to long term investment success in the stock market......
Portfolio Balancing
Rebalancing a person's investment decision profile can become a vital need due to private lifestyle adjustments for instance age, earnings, pension, inheritances, or even purchase or sale of a property or another significant property such as property, brand new assets requirements, as well as an modification in private associated risk threshold, and so on. As well, rebalancing is often required as a result of changes in asset allocation due to altered investment expectations, or to realign portfolio weightings in line with target allocations due to changing values of individual portfolio holdings. As part of the HJA commitment to excellence, and our focus on unparalleled client service, your HJA Account Executive will routinely monitor, and provide assistance when portfolio rebalancing is advised.
Timely Advice
Whether one is a seasoned investor or a newcomer to the world of private investing, your HJA representative is prepared to assist in any way practical. Advice regarding any or all aspects of your personal investment program, its overall wealth building strategy and tactical recommendations in light of changing market circumstances is yours for the asking. When Harris James Associates research discovers a compelling stock investment that meets with your overall objectives, you will be advised in a timely manner so that you may consider it for your portfolio without undue delay. Or when changing circumstances suggest a liquidation of a given investment, and because you are the ultimate decision maker, we will advise you of such changes with all practical haste.
MERGERS and ACQUISITIONS - Maximizing Your Value
Harris James Associates offers a comprehensive range of Merger and Acquisition services to help you identify strategic opportunities and develop and execute integration plans, including:
Business due diligence
Integration strategy check
Post-merger integration plan management
Harris James Associates have worked with a lot of businesses in all key industries on national and cross-border merger and acquisition projects. With our extensive consulting, technology and outsourcing expertise, clients can expect a smooth and efficient integration that yields positive results. Discover what we can do for your business.
Business due diligence
The reputation, integrity and ultimately the success of your business increasingly depends upon developing and maintaining the confidence and trust of your domestic and international clients, investors and regulators. Conducting proper due diligence is essential in eliminating fraud, managing risk and maintaining compliance with regulations.
International Due Diligence process is vital to virtually all types of
We believe strongly in the concept of economic and market-led research. This "top down" approach is aimed at identifying the most vibrant and promising market sectors in which to direct its considerable industry and company research capabilities. We believe in the long term growth and development of the global economy as the world's people strive for a healthier and higher standard of living, particularly in those emerging economies that account for fully half of the global population. While there are many and varied stumbling blocks on the path of global economic and social progress, Harris James Associates recognizes that there are always sectors that exhibit superior potential in the dynamics of global development. We believe that selectivity is the key to long term investment success in the stock market......
Portfolio Balancing
Rebalancing a person's investment decision profile can become a vital need due to private lifestyle adjustments for instance age, earnings, pension, inheritances, or even purchase or sale of a property or another significant property such as property, brand new assets requirements, as well as an modification in private associated risk threshold, and so on. As well, rebalancing is often required as a result of changes in asset allocation due to altered investment expectations, or to realign portfolio weightings in line with target allocations due to changing values of individual portfolio holdings. As part of the HJA commitment to excellence, and our focus on unparalleled client service, your HJA Account Executive will routinely monitor, and provide assistance when portfolio rebalancing is advised.
Timely Advice
Whether one is a seasoned investor or a newcomer to the world of private investing, your HJA representative is prepared to assist in any way practical. Advice regarding any or all aspects of your personal investment program, its overall wealth building strategy and tactical recommendations in light of changing market circumstances is yours for the asking. When Harris James Associates research discovers a compelling stock investment that meets with your overall objectives, you will be advised in a timely manner so that you may consider it for your portfolio without undue delay. Or when changing circumstances suggest a liquidation of a given investment, and because you are the ultimate decision maker, we will advise you of such changes with all practical haste.
MERGERS and ACQUISITIONS - Maximizing Your Value
Harris James Associates offers a comprehensive range of Merger and Acquisition services to help you identify strategic opportunities and develop and execute integration plans, including:
Business due diligence
Integration strategy check
Post-merger integration plan management
Harris James Associates have worked with a lot of businesses in all key industries on national and cross-border merger and acquisition projects. With our extensive consulting, technology and outsourcing expertise, clients can expect a smooth and efficient integration that yields positive results. Discover what we can do for your business.
Business due diligence
The reputation, integrity and ultimately the success of your business increasingly depends upon developing and maintaining the confidence and trust of your domestic and international clients, investors and regulators. Conducting proper due diligence is essential in eliminating fraud, managing risk and maintaining compliance with regulations.
International Due Diligence process is vital to virtually all types of
Harris James Associates Update: Congressional forum on biotech jobs focuses on FDA By Keith Darcé
http://www.release-news.com/index.php/finance/95748-harris-james-associates-update-congressional-forum-on-biotech-jobs-focuses-on-fda-by-keith-darce.html
Harris James Associates Update: Overly cautious government regulators, threats to basic science research funding and burdensome taxes are holding back job creation by drug and medical device companies and slowing the delivery of innovative new therapies to patients, biotechnology industry experts told federal lawmakers Thursday during a hearing in San Diego. James Harris Associates mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful. Most of the criticism was directed at the Food and Drug Administration, which approved 21 new drugs last year, compared to 36 in 2004.
"There are whole areas (of drug development) that venture capitalists won't pursue because the regulatory barriers are too high," said David Gollaher, president and chief executive of the California Healthcare Institute in La Jolla. The complaints were familiar to anyone who has followed drug and medical device development in the United States over the past several years. Gollaher and the other experts delivered their comments to Rep. Darrell Issa, R-Vista, during a morning public forum at the University of California San Diego. Since he became chairman of the House Oversight and Government Reform Committee in early January, Issa has hosted 10 such gatherings around the country focused on regulations that stifle economic expansion. For the latest gathering, he returned to his home county, where more than 400 companies make up a major biotechnology hub that employs more than 40,000 people, according to the San Diego trade group Biocom. Issa was joined by Reps.
Susan Davis, D-San Diego; Brian Bilbray, R-Solana Beach; and Duncan Hunter, R-Alpine. Issa's committee has broad investigative power, but any legislation addressing specific regulatory changes would be handled by other congressional panels that directly oversee the related agencies. "We're here today because San Diego is a miraculous story of biotech," Issa said in comments that opened the 1½-hour session. To aid his investigation, Issa solicited comments from hundreds of individuals, companies and trade groups, including many in the biotechnology and pharmaceutical industries, both directly and through a special website, americanjobcreators.com. "We were shocked to find out that the FDA is often one of the greatest impediments to job creation," the congressman said.
Critics of the agency say the problem is most clearly displayed in the increasing amount of time that it takes the agency to process new product applications. Since 2007, drug review times by the FDA have increased by 28 percent, while evaluations of devices have taken as much as 75 percent more time, Gollaher said. They also point to a recent string of unexpected new drug rejections by the agency that forced developers to perform new tests on their experimental medications. Just in the past six months, the FDA turned down three drugs from San Diego companies: diet pills from Arena Pharmaceuticals and Orexigen Therapeutics, and a weekly injectable diabetes therapy from Amylin. In a recent survey by Biocom, industry executives said the agency's review process lacks transparency, often becomes sidetracked by unexpected issues and takes too much time.
"We see a growing concern that the FDA is becoming detached from the industry," said Joe Panetta, president and chief executive of Biocom. Many of the problems can be blamed on a cultural change at the agency that raised the emphasis on potential risks that new drugs and devices pose in the wake of a long string of high-profile medical product recalls, Gollaher said. Still, some people say the changes have been good. Public Citizen and other consumer advocacy groups have praised the FDA for scrutinizing new medical products more intensely and requiring more safety testing before allowing them onto the market. One possible way of shifting the agency's focus more toward the potential benefits of new products is to give a formal role in the regulatory review process to the patients who would use the drugs and devices, said Duane Roth, chief executive of Connect San Diego, a nonprofit support group for fledgling technology companies. "It's their disease," he said.
"It's not yours, and it's not ours. Until they get in there to help us, I don't think much will change." UCSD Chancellor Marye Anne Fox implored the lawmakers to resist urges to cut basic science grant funding from the National Institutes of Health, which sent $824 million to her university and other scientific institutes in the county last year. The money produces many of the discoveries that are later taken up by biotechnology companies and turned into products. keith.darce@uniontrib.com (619) 293-1020 James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries. Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.
Harris James Associates Update: Overly cautious government regulators, threats to basic science research funding and burdensome taxes are holding back job creation by drug and medical device companies and slowing the delivery of innovative new therapies to patients, biotechnology industry experts told federal lawmakers Thursday during a hearing in San Diego. James Harris Associates mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful. Most of the criticism was directed at the Food and Drug Administration, which approved 21 new drugs last year, compared to 36 in 2004.
"There are whole areas (of drug development) that venture capitalists won't pursue because the regulatory barriers are too high," said David Gollaher, president and chief executive of the California Healthcare Institute in La Jolla. The complaints were familiar to anyone who has followed drug and medical device development in the United States over the past several years. Gollaher and the other experts delivered their comments to Rep. Darrell Issa, R-Vista, during a morning public forum at the University of California San Diego. Since he became chairman of the House Oversight and Government Reform Committee in early January, Issa has hosted 10 such gatherings around the country focused on regulations that stifle economic expansion. For the latest gathering, he returned to his home county, where more than 400 companies make up a major biotechnology hub that employs more than 40,000 people, according to the San Diego trade group Biocom. Issa was joined by Reps.
Susan Davis, D-San Diego; Brian Bilbray, R-Solana Beach; and Duncan Hunter, R-Alpine. Issa's committee has broad investigative power, but any legislation addressing specific regulatory changes would be handled by other congressional panels that directly oversee the related agencies. "We're here today because San Diego is a miraculous story of biotech," Issa said in comments that opened the 1½-hour session. To aid his investigation, Issa solicited comments from hundreds of individuals, companies and trade groups, including many in the biotechnology and pharmaceutical industries, both directly and through a special website, americanjobcreators.com. "We were shocked to find out that the FDA is often one of the greatest impediments to job creation," the congressman said.
Critics of the agency say the problem is most clearly displayed in the increasing amount of time that it takes the agency to process new product applications. Since 2007, drug review times by the FDA have increased by 28 percent, while evaluations of devices have taken as much as 75 percent more time, Gollaher said. They also point to a recent string of unexpected new drug rejections by the agency that forced developers to perform new tests on their experimental medications. Just in the past six months, the FDA turned down three drugs from San Diego companies: diet pills from Arena Pharmaceuticals and Orexigen Therapeutics, and a weekly injectable diabetes therapy from Amylin. In a recent survey by Biocom, industry executives said the agency's review process lacks transparency, often becomes sidetracked by unexpected issues and takes too much time.
"We see a growing concern that the FDA is becoming detached from the industry," said Joe Panetta, president and chief executive of Biocom. Many of the problems can be blamed on a cultural change at the agency that raised the emphasis on potential risks that new drugs and devices pose in the wake of a long string of high-profile medical product recalls, Gollaher said. Still, some people say the changes have been good. Public Citizen and other consumer advocacy groups have praised the FDA for scrutinizing new medical products more intensely and requiring more safety testing before allowing them onto the market. One possible way of shifting the agency's focus more toward the potential benefits of new products is to give a formal role in the regulatory review process to the patients who would use the drugs and devices, said Duane Roth, chief executive of Connect San Diego, a nonprofit support group for fledgling technology companies. "It's their disease," he said.
"It's not yours, and it's not ours. Until they get in there to help us, I don't think much will change." UCSD Chancellor Marye Anne Fox implored the lawmakers to resist urges to cut basic science grant funding from the National Institutes of Health, which sent $824 million to her university and other scientific institutes in the county last year. The money produces many of the discoveries that are later taken up by biotechnology companies and turned into products. keith.darce@uniontrib.com (619) 293-1020 James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries. Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.
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