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Friday, March 13, 2009
Thursday, March 5, 2009
Drug Development Company Expands Storage Facility in the UK
According to this article in Clinical Trials Today, ALMAC Clinical Service has opened up additional storage facility in the UK due to the growing demand for cold-chain and controlled clinical supply storage.
Almac president Robert Dunlop mentions:
“The opening of the new storage warehouse is a testimony to our commitment to providing the highest quality of service and available capacity to our customers. As demand for both controlled drug and cold chain storage has grown steadily in recent times, we must provide our offerings in line with market demands.”
Will we be likely to see this same move for other drug development services companies?
Almac president Robert Dunlop mentions:
“The opening of the new storage warehouse is a testimony to our commitment to providing the highest quality of service and available capacity to our customers. As demand for both controlled drug and cold chain storage has grown steadily in recent times, we must provide our offerings in line with market demands.”
Will we be likely to see this same move for other drug development services companies?
Tuesday, February 24, 2009
Do clinical trials need to move back to the US?
In a recent post at the Wall Street Journal Health Blog, they take a look at how most late stage human clinical trials are done outside of the United States. One reason includes the ability to better monitor the ethical treatment of patients.
According to the article:
Currently, each site in the U.S. must separately approve a study, even if it’s part of a larger trial taking place with an identical protocol at other institutions across the country or world. The National Cancer Institute has started a review process for studies it funds in an attempt to minimize the time it takes for institutions to approve and start studies.
What do you see as driving clinical trials outside of the United States?
According to the article:
Currently, each site in the U.S. must separately approve a study, even if it’s part of a larger trial taking place with an identical protocol at other institutions across the country or world. The National Cancer Institute has started a review process for studies it funds in an attempt to minimize the time it takes for institutions to approve and start studies.
What do you see as driving clinical trials outside of the United States?
Friday, February 20, 2009
Research Analysts Reveal Trial Sites Want more EDC and Recruitment Investment
This article in outsourcing-pharma.com discusses according to a research report conducted by clinical research industry analysts at CenterWatch, study site operators want a greater use of EDC technologies and more pharma investment in order to improve patient recruitment and efficiency in clinical trials.
The growth of trials in developing countries and in Central Europe and Eastern Europe has increased the need for improvements in EDC. Have you seen a massive shift in the pharma industry using EDC technologies?
The growth of trials in developing countries and in Central Europe and Eastern Europe has increased the need for improvements in EDC. Have you seen a massive shift in the pharma industry using EDC technologies?
Thursday, February 19, 2009
Clinical Trials Congress 2009
Did you have a chance to make it to Philadelphia for the Clinical Trials Congress last week? If not, check out what ClinPage had to say about the event.
We get a large dose of such speakers every year at IIR’s annual Clinical Trials Congress. The 2009 event, in Philadelphia, had exactly what we had come to expect—high-level hand-wringing about the state of the industry, paired with ideas about what to do.
We get a large dose of such speakers every year at IIR’s annual Clinical Trials Congress. The 2009 event, in Philadelphia, had exactly what we had come to expect—high-level hand-wringing about the state of the industry, paired with ideas about what to do.
Tuesday, February 17, 2009
Cytel’s new software Increases Efficiency of AstraZeneca Clinical Trials
According to this article in outsourcing-pharma.com AstraZeneca has installed a custom version of Cytel’s East clinical trial design software in an effort to improve data handling and ensuring compliance with Clinical Data Interchange Standards Consortium (CDISC) guidelines.
These tools aid smaller clinical trials companies assess their trials at the halfway stage, potentially reducing the amount of money spent for the company. It will be interesting to see what other clinical trials companies will begin using Cytel’s new software.
These tools aid smaller clinical trials companies assess their trials at the halfway stage, potentially reducing the amount of money spent for the company. It will be interesting to see what other clinical trials companies will begin using Cytel’s new software.
Wednesday, February 11, 2009
Pfizer Discloses Payment Information for Clinical Trials
According to this article on outsourcing-pharma.com Pfizer will disclose payments made to principal investigators, major academic institutions and research sites involved in Phase I to IV trials that exceed $500 a year and non-monetary items such as meals that cost more than $25.
Pfizer is getting closer than any drug maker in terms of full disclosure, but if the Physician Payments Sunshine Act of 2009 is passed into law, it would require companies to disclose all payments exceeding $100 a year and would face a fine of up to $1 million if they do not comply.
Pfizer is getting closer than any drug maker in terms of full disclosure, but if the Physician Payments Sunshine Act of 2009 is passed into law, it would require companies to disclose all payments exceeding $100 a year and would face a fine of up to $1 million if they do not comply.
Friday, February 6, 2009
Phase Forward Reports Strong Earnings
We recently posted that Covance’s revenues for their fourth quarter was up, despite the downturn economy. Today I came across this article on ClinicalTrialsToday that discusses how another clinical trials company, Phase Forward, has also reported strong earnings this past quarter. Their revenues for the 4th quarter were $48.3 million compared to $37.8 in Q4 the previous year.
Will we continue to see this trend in clinical trials companies when they report their 4th quarter earnings?
Will we continue to see this trend in clinical trials companies when they report their 4th quarter earnings?
Wednesday, February 4, 2009
First Human Stem Cell Trials Begin
According to NewUniversity.org, UC Irvine researchers will be the first to test an embryonic stem cell treatment on humans in clinical trials. Although UCI researchers will be the first to treat humans using embryonic stem cells. This will not be the first time that humans have been treated in trials using stem cells. This is because previously neural stem cells derived from fetal brains have been used in USDA-approved trials. This is a step forward for stem cell research that had be halted by the Bush administration.
Tuesday, February 3, 2009
Covance Revenues are up despite the Downturn Economy
ClinicalTrialsToday.com reports that Covance, biopharmaceutical drug development services company, has released very strong 4th quarter earnings in early and late-stage development segments.
Total revenue and net revenue are up from the same period last year, even though the state of our economy has faltered in the last couple of months. Joe Herring, Covance chairman and CEO, recently mentioned in a company release that:
"reduced demand in our Early Development segment from a combination of a lower level of new project initiations and increased project delays in our toxicology and clinical pharmacology services led to a sequential decline in segment revenue and operating income."
It will be interesting to see 4th quarter earnings of other clinical trials companies and see if they had comparable results.
Total revenue and net revenue are up from the same period last year, even though the state of our economy has faltered in the last couple of months. Joe Herring, Covance chairman and CEO, recently mentioned in a company release that:
"reduced demand in our Early Development segment from a combination of a lower level of new project initiations and increased project delays in our toxicology and clinical pharmacology services led to a sequential decline in segment revenue and operating income."
It will be interesting to see 4th quarter earnings of other clinical trials companies and see if they had comparable results.
Monday, February 2, 2009
Oracle's Clinical database
ClinPage takes a look at what Oracle is doing to to stay prevalent in the clinical trial management software space. Patti Devereux Gaves, the senior director of product strategy at Oracle, recently stated that they're working on new endeveors to stay on the top in the field. For the whole story, read here.
Saturday, January 31, 2009
Medical Research Is About to Slam Into a Wall
Medical Research is at risk of slamming into a wall if smart people outside of drug development do not get engaged. This is the conclusion reached by Katie Hood, CEO of the Michael J Fox Foundation for Parkinson's Research, in a posting this week at the Huffington Post.
Hood does a great job of breaking down the impact of a faltering economy upon an already strained system. Pharma is axing researchers. Biotechs are at great risk for bankruptcy. Venture capitalists are retreating. Government is not prepared to pick up the slack. Private foundations lack the capital or scope.
Is a new role for the public sector needed to ensure that the current 10-15 years to develop a new therapy does not get longer instead of shorter?
Co-posted from www.pharmasherpa.com
Hood does a great job of breaking down the impact of a faltering economy upon an already strained system. Pharma is axing researchers. Biotechs are at great risk for bankruptcy. Venture capitalists are retreating. Government is not prepared to pick up the slack. Private foundations lack the capital or scope.
Is a new role for the public sector needed to ensure that the current 10-15 years to develop a new therapy does not get longer instead of shorter?
Co-posted from www.pharmasherpa.com
Friday, January 30, 2009
Study Refutes Claims on AIDS Drug Trials
Many were concerned that between the years 1985 and 1996, foster children in the NYC area were unwillingly subjected to clinical trials for H.I.V.
An investigation into the participation of New York City foster children in clinical drug trials for H.I.V. and AIDS over a nearly 20-year period has found no evidence that any children died as a result of the trials or that the foster children were selected because of their race.
Further coverage for this can be found:
Study Refutes Claims on AIDS Drug Trials New York Times
No Foster Children Died From Participation in New York HIV Drug ... Kaiser network.org
Study: NY Foster Kids Not Exploited for AIDS Research EDGE Boston
An investigation into the participation of New York City foster children in clinical drug trials for H.I.V. and AIDS over a nearly 20-year period has found no evidence that any children died as a result of the trials or that the foster children were selected because of their race.
Further coverage for this can be found:
Study Refutes Claims on AIDS Drug Trials New York Times
No Foster Children Died From Participation in New York HIV Drug ... Kaiser network.org
Study: NY Foster Kids Not Exploited for AIDS Research EDGE Boston
Thursday, January 29, 2009
Stem Cell Based Clinical Trials Get the Green Light
According to this article on outsourcing-pharma.com the FDA has given the green light to first clinical trials of a stem cell based therapy. The clinical trials of the treatment GRNOPC1 uses stem cells to regrow damaged spinal cord cells in patients with acute spinal cord injury. The approval of this treatment comes at a time when George Bush is no longer the president. Now that Obama is in office, will we see more clinical trials approved by the FDA?
Wednesday, January 28, 2009
Clinical trials sharing information electronically
A new study by IntraLinks Poll shares that 50% of clinical trials professionals share critical information via email, 15% via fax and 14% via overnight courier.
Those considering using electronic means to share data were concerned about: security (40 percent), ease and flexibility of use (23 percent), speed of information sharing (17 percent), standardization across the enterprise (7 percent) and shipping/travel cost savings (7 percent).
Alison Shurell, the vice president of life sciences product marketing at IntraLinks had this to say about the new research:
"Executives may not realize that study start-up communication and management can be made simpler, faster and more secure by employing online solutions. Using an online workspace enables sponsors, CROs, sites, IRBs and others in a clinical trial to exchange information instantaneously in the most secure environment available. Our life sciences clients who have shifted the clinical trial process to an online solution have reported tremendous improvements in overall productivity and efficiency."
Those considering using electronic means to share data were concerned about: security (40 percent), ease and flexibility of use (23 percent), speed of information sharing (17 percent), standardization across the enterprise (7 percent) and shipping/travel cost savings (7 percent).
Alison Shurell, the vice president of life sciences product marketing at IntraLinks had this to say about the new research:
"Executives may not realize that study start-up communication and management can be made simpler, faster and more secure by employing online solutions. Using an online workspace enables sponsors, CROs, sites, IRBs and others in a clinical trial to exchange information instantaneously in the most secure environment available. Our life sciences clients who have shifted the clinical trial process to an online solution have reported tremendous improvements in overall productivity and efficiency."
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