Clinical Trials Congress

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noreply@blogger.com (Unknown) — Fri, 13 Mar 2009 14:49:00 +0000

We would like to thank you for your continued readership! We’ve officially moved over to http://Futurebiopharma.blogspot.com where we will cover a broad variety of topics across the pharma industry like clinical trials, outsourcing, vaccine development, and project management. Make sure to subscribe to our new feed!

Drug Development Company Expands Storage Facility in the UK

noreply@blogger.com (Unknown) — Thu, 05 Mar 2009 19:24:00 +0000

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?

Do clinical trials need to move back to the US?

noreply@blogger.com (Anonymous) — Tue, 24 Feb 2009 15:48:00 +0000

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?

Research Analysts Reveal Trial Sites Want more EDC and Recruitment Investment

noreply@blogger.com (Unknown) — Fri, 20 Feb 2009 20:38:00 +0000

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?

Clinical Trials Congress 2009

noreply@blogger.com (Anonymous) — Thu, 19 Feb 2009 16:34:00 +0000

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.

Cytel’s new software Increases Efficiency of AstraZeneca Clinical Trials

noreply@blogger.com (Unknown) — Tue, 17 Feb 2009 19:44:00 +0000

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.

Pfizer Discloses Payment Information for Clinical Trials

noreply@blogger.com (Unknown) — Wed, 11 Feb 2009 16:58:00 +0000

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.

Phase Forward Reports Strong Earnings

noreply@blogger.com (Unknown) — Fri, 06 Feb 2009 19:42:00 +0000

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?

First Human Stem Cell Trials Begin

noreply@blogger.com (Unknown) — Wed, 04 Feb 2009 15:24:00 +0000

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.

Covance Revenues are up despite the Downturn Economy

noreply@blogger.com (Unknown) — Tue, 03 Feb 2009 18:14:00 +0000

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.

Oracle's Clinical database

noreply@blogger.com (Anonymous) — Mon, 02 Feb 2009 16:02:00 +0000

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.

Medical Research Is About to Slam Into a Wall

noreply@blogger.com (The PharmaSherpa) — Sat, 31 Jan 2009 17:32:00 +0000

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

Study Refutes Claims on AIDS Drug Trials

noreply@blogger.com (Unknown) — Fri, 30 Jan 2009 16:00:00 +0000

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

Stem Cell Based Clinical Trials Get the Green Light

noreply@blogger.com (Unknown) — Thu, 29 Jan 2009 20:27:00 +0000

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?

Clinical trials sharing information electronically

noreply@blogger.com (Anonymous) — Wed, 28 Jan 2009 15:26:00 +0000

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."

Acurian is Increasing Clinical Trial Information Virally

noreply@blogger.com (Unknown) — Tue, 27 Jan 2009 14:40:00 +0000

Allison Proffit at Bio-IT World discusses the new social media method that Acurian is using to increase awareness about clinical trials. The application, Click It Forward, runs on Facebook and MySpace was started by Acurian, it allows Facebook and MySpace members sign up, and then share the info with their friends. As a user’s friends sign up for Click it Forward, Acurian will donate money to one of 20 medical causes chosen by the user.

What do you think of Clinical Trials organizations looking to social media to increase awareness? We'd like to hear your thoughts.

GAO Criticizes the FDA’s ability to Oversee Clinical Trials

noreply@blogger.com (Unknown) — Mon, 26 Jan 2009 14:48:00 +0000

According to this post on outsourcing-pharma.com, the US Department of Health and Human Services has identified that the FDA has failed to provide sufficient oversight to ensure the protection of patients participating in clinical trials. This has in turn caused the GAO to conduct its own investigation of the FDA’s ability to oversee clinical trials, which started in 2007. The GAO is highly concerned that the FDA is not analyzing the impact age has on the safety and efficacy of the drug when the drug generally treats conditions for the more elderly.

Project Management in the Life Sciences: Results from a 2008 Survey and Comparison with Previous Surveys over the Last Decade

noreply@blogger.com (Anonymous) — Fri, 23 Jan 2009 16:07:00 +0000

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.

Updated Calendar of FDA Decisions and Clinical Trials

noreply@blogger.com (Unknown) — Thu, 22 Jan 2009 18:42:00 +0000

If you're in the world of Clinical Trials, you know how frustrating it can be to wait on the FDA approval or rejection of the pharmaceuticals you've worked on. Check out this post at Seeking Alpha that shows a handy way to see what decisions are slated to be made on certain drugs and clinical trials. What big decisions are you waiting on? We'd like to hear your thoughts.

Senator Criticizes Transparency Laws in Clinical Trials

noreply@blogger.com (Unknown) — Wed, 21 Jan 2009 19:52:00 +0000

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?

Clinical Investigators Financial Information

noreply@blogger.com (Anonymous) — Tue, 20 Jan 2009 14:57:00 +0000

Released this month, The Food And Drug Administration’s Oversight Of Clinical Investigators’ Financial Information is now available. Read the document here.

Acurian raises clinical trials awareness with new social networking app

noreply@blogger.com (Anonymous) — Mon, 19 Jan 2009 19:56:00 +0000

Acurian, a company who focuses on patient recruitment and retention software, has introduced a new social networking app. Click It Forward is a clinical trials and awareness tool that allows users of MySpace and Facebook. It will allow a broader audience to know more about recruitment for clinical trials.

The application works like this:
People register and install the free Click it Forward application on their Facebook or MySpace page, and then spread the application exponentially by inviting their online friends to install it. In doing so, they gain points based on how many friends subsequently install Click it Forward. The more points gained, the more money that Acurian donates to a selection of preferred medical causes selected by the user upon registration. The application also integrates Google™ Earth so that users can see a dynamic, visual map of their own Click it Forward network.

Source:
Earth Times

Clinical Trials Thrive Through an Economic Downturn

noreply@blogger.com (Unknown) — Fri, 16 Jan 2009 19:32:00 +0000

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?

New clinical trial at Johns Hopkins

noreply@blogger.com (Anonymous) — Thu, 15 Jan 2009 16:03:00 +0000

MEMOTEXT will be tested for its effects on people with glaucoma. There will be 500 people recruited using telephone calls and text messages.

Amos Adler, president of MEMOTEXT, finds it to be an honor to collaborate on this special grant and believes this new interface will significantly improve medication adherence in patients with glaucoma. The company is confident this trial will demonstrate that their technology-driven adherence solutions help patients managing various conditions.

For more information on the trial, click here.

FDA Limits Interest in Clinical Trials

noreply@blogger.com (Unknown) — Wed, 14 Jan 2009 15:49:00 +0000

According to an editorial in yesterday's New York Times, the F.D.A has a seemingly limited interest in clinical trials--and this may be to the detriment of quality food and drugs that are created through these trials. For instance, its a federal requirement that the makers of drugs or medical devices receive financial information from the scientists conducting clinical trials before the trials start and to inform the F.D.A of any conflicts, yet fewer than 1% of of makers report any discrepancies. Someone is lining their pockets and the F.D.A is turning their heads.

From The New York Times:
The agency’s lax performance underscores the need for Congress to pass legislation requiring all drug and device makers to report their financial arrangements with doctors in a public databank. That would make it harder for clinical investigators or sponsoring companies to hide potential conflicts, including those that might bias clinical trials for the F.D.A. Do you agree with this editorial? What legislation should occur?