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Showing posts with label clinical trials. Show all posts
Showing posts with label clinical trials. Show all posts
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?
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?
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.
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."
Friday, January 23, 2009
Project Management in the Life Sciences: Results from a 2008 Survey and Comparison with Previous Surveys over the Last Decade
If you didn't have a chance to catch the web seminar "Project Management in the Life Sciences: Results from a 2008 Survey and Comparison with Previous Surveys over the Last Decade" with Dr. Jann Neilson of Wyeth, please do! It was a very informative session.
Check it out here:
https://www1.gotomeeting.com/register/403770168
About the web seminar:
The Project Management Institute Pharmaceutical Specific Interest Group has sponsored 50-plus item surveys in 2001, 2002, 2005, and in the fourth quarter of 2008. There have been up to 711 respondents to each of the surveys. We have determined people’s profiles (e.g. what country they live in), the organization’s profile (e.g. large pharma, small pharma, biotech, CRO, consultant, etc.), and most of the questions were about project management in the person’s organization.
The seminar will describe the most interesting data from the 2008 survey and how it compares to previous surveys. For example, there will be a comparison of how project management occurs in large pharma, small pharma and biotech. Differences in how project management is performed in the US vs. EU vs. Canada will be shown. Comparisons between virtual and defined project management groups will be explored. Single vs. multiple function project management groups will be contrasted. These and other comparisons will be made in order to shown how project management in the life sciences is performed. As a bonus we will compare compensation and vacations in the US, EU and Canada.
Check it out here:
https://www1.gotomeeting.com/register/403770168
About the web seminar:
The Project Management Institute Pharmaceutical Specific Interest Group has sponsored 50-plus item surveys in 2001, 2002, 2005, and in the fourth quarter of 2008. There have been up to 711 respondents to each of the surveys. We have determined people’s profiles (e.g. what country they live in), the organization’s profile (e.g. large pharma, small pharma, biotech, CRO, consultant, etc.), and most of the questions were about project management in the person’s organization.
The seminar will describe the most interesting data from the 2008 survey and how it compares to previous surveys. For example, there will be a comparison of how project management occurs in large pharma, small pharma and biotech. Differences in how project management is performed in the US vs. EU vs. Canada will be shown. Comparisons between virtual and defined project management groups will be explored. Single vs. multiple function project management groups will be contrasted. These and other comparisons will be made in order to shown how project management in the life sciences is performed. As a bonus we will compare compensation and vacations in the US, EU and Canada.
Wednesday, January 21, 2009
Senator Criticizes Transparency Laws in Clinical Trials
According to this article on outsourcing-pharma.com, Senator Richard Moore has criticized laws in Massachusetts that enable pharma companies to hide payments made to physicians conducting clinical trials.
Moore believes that gifts and monetary compensation is public information and that it should not be hid from everyone. Moore later mentions:
“Patients and consumers generally have no idea what kind of relationships exist between their doctors and pharmaceutical companies or medical device manufacturers, relationships that result in billions of dollars per year in payments to health care practitioner.
Do you think that payments for physicians conducting clinical trials should be hid?
Moore believes that gifts and monetary compensation is public information and that it should not be hid from everyone. Moore later mentions:
“Patients and consumers generally have no idea what kind of relationships exist between their doctors and pharmaceutical companies or medical device manufacturers, relationships that result in billions of dollars per year in payments to health care practitioner.
Do you think that payments for physicians conducting clinical trials should be hid?
Tuesday, January 20, 2009
Clinical Investigators Financial Information
Released this month, The Food And Drug Administration’s Oversight Of Clinical Investigators’ Financial Information is now available. Read the document here.
Friday, January 16, 2009
Clinical Trials Thrive Through an Economic Downturn
Bob Coughlin, the president of the Massachusetts Biotechnology Council, believes that even though we are in the middle of an economic downturn, clinical trials are going through an economic boom according to this latest post on Applied Clinical Trials.
The rest of the post highlights their huge success in 2008, showing that their annual growth rate in employment has risen to 12% and that they have nearly 2,000 ongoing clinical trials in Massachusetts with major companies like Novartis, Genzyme, Bristol just to name a few. Is your company experiencing the same growth during this time of recession?
The rest of the post highlights their huge success in 2008, showing that their annual growth rate in employment has risen to 12% and that they have nearly 2,000 ongoing clinical trials in Massachusetts with major companies like Novartis, Genzyme, Bristol just to name a few. Is your company experiencing the same growth during this time of recession?
Tuesday, January 13, 2009
More Clinical Trials are Out of Compliance
Medical Product Outsourcing reports that the violation rate for clinical trial sponsors have gone up for the fiscal year of 2007, which has hit a 10 year high says the U.S. Food and Drug Administration.
Thirty three percent of the 40 clinical trial sponsors inspected by the center’s division of bioresearch monitoring were found to have some sort of regulatory violation, as opposed to 11 percent of 53 sponsors who were out of compliance the previous year. 2006 proved to be the best performance the industry had seen in 10 years. Can we expect 2008 numbers to produce similar results?
Thirty three percent of the 40 clinical trial sponsors inspected by the center’s division of bioresearch monitoring were found to have some sort of regulatory violation, as opposed to 11 percent of 53 sponsors who were out of compliance the previous year. 2006 proved to be the best performance the industry had seen in 10 years. Can we expect 2008 numbers to produce similar results?
Wednesday, January 7, 2009
Patient recruitment contributes to delays in biotechnology timelines
According to the Courier Mail in Australia, patient recruitment is one of the factors that causes biotechnology companies to run months, sometimes even years, behind on their time lines. The article suggests that a shortage of patients may be caused by the numerous competitive drugs in development.
Although running on time is a difficult thing to do, Graeme Wald, an analyst at Wilson HTM, said the smaller the trial, the lest likely there was to be a great time delay. Companies must follow ethics boards, work with doctors and find individuals that fit their target patient group.
Other things causing delays in the time lines of clinical trials: competitors' lawsuits, management changes, funding constraints or arguments with regulators.
Although running on time is a difficult thing to do, Graeme Wald, an analyst at Wilson HTM, said the smaller the trial, the lest likely there was to be a great time delay. Companies must follow ethics boards, work with doctors and find individuals that fit their target patient group.
Other things causing delays in the time lines of clinical trials: competitors' lawsuits, management changes, funding constraints or arguments with regulators.
Tuesday, January 6, 2009
Drug Money: Risky Economy Draws More Clinical Trial Participants
In Yesterday's show, WNYC's Brian Lehrer discussed the rise in Clinical Trials participants with the decline of the American economy.
Forbes/AP also covered this issue.
Do you think that its safe for the industry to see a rise in participants because of the slow economy? With fears that Clinical Trials and organizations could be seen as predators, what precautions should organizations take?
Forbes/AP also covered this issue.
Do you think that its safe for the industry to see a rise in participants because of the slow economy? With fears that Clinical Trials and organizations could be seen as predators, what precautions should organizations take?
Friday, January 2, 2009
Covance Names Three New Senior Executives
According to this article in Clinical Trials Today, Covance has added three new senior executive positions to its services team. Covance has appointed Glynis Neagle, M.D., vice president for medical affairs; Robert Bader, director for product safety services; and Thomas Noto, vice president for regulatory affairs.
All three have over 15 years of experience in the clinical trials industry. It will be exciting to see what changes that they will bring to the table.
Tuesday, December 23, 2008
Hard times leads to more patients for clinical trials
A recent news report from ABC 15 in Phoenix, Arizona reports that the current recession is leading more people to enroll as patients in clinical trials. Patients see this not only as a way to supplement their income, but also as a way to help perfect drugs that could be vital in future of their children.
Monday, December 22, 2008
CTC Best of 2008
As 2008 draws to a close, we'd like to share with you some of the most popular articles from the Clinical Trials Congress in 2008!
Web 2.0 ... Health 2.0 ... Research 2.0?
India Times: Recession not to hit clinical trials: CROs
Irish Medical Times: Cork University Hospital Opens Oncology Clinical Trials Unit
Zagats for Clinical Trial Sponsors and CROs
AHA Meeting 2008
Web 2.0 ... Health 2.0 ... Research 2.0?
India Times: Recession not to hit clinical trials: CROs
Irish Medical Times: Cork University Hospital Opens Oncology Clinical Trials Unit
Zagats for Clinical Trial Sponsors and CROs
AHA Meeting 2008
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